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The largest U.S. physician organization on Tuesday took a step to prepare for future payments for administration of two leading COVID-19 vaccine candidates, publishing new billing codes tailored to track each use of these medications.

The American Medical Association updated its CPT code set to reflect the expected future availability of COVID-19 vaccines. The new codes apply to the experimental vaccine being developed by Pfizer, in collaboration with a smaller German firm BioNTech, and to the similar product expected from Moderna, according to an AMA press release.

Positive news has emerged this week about both of these vaccines, which were developed using a newer – and as yet unproven – approach. They seek to use messenger RNA to instruct cells to produce a target protein for SARS-CoV-2.

New York–based Pfizer on Monday announced interim phase 3 data that was widely viewed as promising. Pfizer said the vaccine appeared to be 90% effective in preventing COVID-19 in trial volunteers who were without evidence of prior infection of the virus.

In a press release, Pfizer said it plans to ask the Food and Drug Administration to consider a special clearance, known as an emergency-use authorization, “soon after” a safety milestone is achieved in its vaccine trial. That milestone could be reached this month.

Moderna said it was on track to report early data from a late-stage trial of its experimental coronavirus vaccine later this month, and could file with the FDA for an emergency-use authorization in early December, according to a Reuters report.

The severity of the global pandemic has put the FDA under pressure to move quickly on approval of COVID-19 vaccines, based on limited data, while also working to make sure these products are safe. The creation of CPT codes for each of two coronavirus vaccines, as well as accompanying administration codes, will set up a way to keep tabs on each dose of each of these shots, the AMA said.

American Medical Association

“Correlating each coronavirus vaccine with its own unique CPT code provides analytical advantages to help track, allocate and optimize resources as an immunization program ramps up in the United States,” AMA President Susan R. Bailey, MD, said in the release.

AMA plans to introduce more vaccine-specific CPT codes as more vaccine candidates approach FDA review. These vaccine-specific CPT codes can go into effect only after the FDA grants a clearance.

The newly created Category I CPT codes and long descriptors for the vaccine products are:
 

• 91300; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3mL dosage, diluent reconstituted, for intramuscular use (Pfizer/BioNTech)
• 91301; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 100 mcg/0.5mL dosage, for intramuscular use (Moderna)

These two administrative codes would apply to the Pfizer-BioNTech shot:

• 0001A; Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3 mL dosage, diluent reconstituted; first dose.
• 0002A; Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3 mL dosage, diluent reconstituted; second dose.

And these two administrative codes would apply to the Moderna shot:

• 0011A; Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 100 mcg/0.5 mL dosage; first dose.
• 0012A; Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 100 mcg/0.5 mL dosage; second dose.

A version of this article originally appeared on Medscape.com.

The largest U.S. physician organization on Tuesday took a step to prepare for future payments for administration of two leading COVID-19 vaccine candidates, publishing new billing codes tailored to track each use of these medications.

The American Medical Association updated its CPT code set to reflect the expected future availability of COVID-19 vaccines. The new codes apply to the experimental vaccine being developed by Pfizer, in collaboration with a smaller German firm BioNTech, and to the similar product expected from Moderna, according to an AMA press release.

Positive news has emerged this week about both of these vaccines, which were developed using a newer – and as yet unproven – approach. They seek to use messenger RNA to instruct cells to produce a target protein for SARS-CoV-2.

New York–based Pfizer on Monday announced interim phase 3 data that was widely viewed as promising. Pfizer said the vaccine appeared to be 90% effective in preventing COVID-19 in trial volunteers who were without evidence of prior infection of the virus.

In a press release, Pfizer said it plans to ask the Food and Drug Administration to consider a special clearance, known as an emergency-use authorization, “soon after” a safety milestone is achieved in its vaccine trial. That milestone could be reached this month.

Moderna said it was on track to report early data from a late-stage trial of its experimental coronavirus vaccine later this month, and could file with the FDA for an emergency-use authorization in early December, according to a Reuters report.

The severity of the global pandemic has put the FDA under pressure to move quickly on approval of COVID-19 vaccines, based on limited data, while also working to make sure these products are safe. The creation of CPT codes for each of two coronavirus vaccines, as well as accompanying administration codes, will set up a way to keep tabs on each dose of each of these shots, the AMA said.

American Medical Association

“Correlating each coronavirus vaccine with its own unique CPT code provides analytical advantages to help track, allocate and optimize resources as an immunization program ramps up in the United States,” AMA President Susan R. Bailey, MD, said in the release.

AMA plans to introduce more vaccine-specific CPT codes as more vaccine candidates approach FDA review. These vaccine-specific CPT codes can go into effect only after the FDA grants a clearance.

The newly created Category I CPT codes and long descriptors for the vaccine products are:
 

• 91300; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3mL dosage, diluent reconstituted, for intramuscular use (Pfizer/BioNTech)
• 91301; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 100 mcg/0.5mL dosage, for intramuscular use (Moderna)

These two administrative codes would apply to the Pfizer-BioNTech shot:

• 0001A; Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3 mL dosage, diluent reconstituted; first dose.
• 0002A; Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3 mL dosage, diluent reconstituted; second dose.

And these two administrative codes would apply to the Moderna shot:

• 0011A; Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 100 mcg/0.5 mL dosage; first dose.
• 0012A; Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 100 mcg/0.5 mL dosage; second dose.

A version of this article originally appeared on Medscape.com.

The largest U.S. physician organization on Tuesday took a step to prepare for future payments for administration of two leading COVID-19 vaccine candidates, publishing new billing codes tailored to track each use of these medications.

The American Medical Association updated its CPT code set to reflect the expected future availability of COVID-19 vaccines. The new codes apply to the experimental vaccine being developed by Pfizer, in collaboration with a smaller German firm BioNTech, and to the similar product expected from Moderna, according to an AMA press release.

Positive news has emerged this week about both of these vaccines, which were developed using a newer – and as yet unproven – approach. They seek to use messenger RNA to instruct cells to produce a target protein for SARS-CoV-2.

New York–based Pfizer on Monday announced interim phase 3 data that was widely viewed as promising. Pfizer said the vaccine appeared to be 90% effective in preventing COVID-19 in trial volunteers who were without evidence of prior infection of the virus.

In a press release, Pfizer said it plans to ask the Food and Drug Administration to consider a special clearance, known as an emergency-use authorization, “soon after” a safety milestone is achieved in its vaccine trial. That milestone could be reached this month.

Moderna said it was on track to report early data from a late-stage trial of its experimental coronavirus vaccine later this month, and could file with the FDA for an emergency-use authorization in early December, according to a Reuters report.

The severity of the global pandemic has put the FDA under pressure to move quickly on approval of COVID-19 vaccines, based on limited data, while also working to make sure these products are safe. The creation of CPT codes for each of two coronavirus vaccines, as well as accompanying administration codes, will set up a way to keep tabs on each dose of each of these shots, the AMA said.

American Medical Association

“Correlating each coronavirus vaccine with its own unique CPT code provides analytical advantages to help track, allocate and optimize resources as an immunization program ramps up in the United States,” AMA President Susan R. Bailey, MD, said in the release.

AMA plans to introduce more vaccine-specific CPT codes as more vaccine candidates approach FDA review. These vaccine-specific CPT codes can go into effect only after the FDA grants a clearance.

The newly created Category I CPT codes and long descriptors for the vaccine products are:
 

• 91300; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3mL dosage, diluent reconstituted, for intramuscular use (Pfizer/BioNTech)
• 91301; severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 100 mcg/0.5mL dosage, for intramuscular use (Moderna)

These two administrative codes would apply to the Pfizer-BioNTech shot:

• 0001A; Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3 mL dosage, diluent reconstituted; first dose.
• 0002A; Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 30 mcg/0.3 mL dosage, diluent reconstituted; second dose.

And these two administrative codes would apply to the Moderna shot:

• 0011A; Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 100 mcg/0.5 mL dosage; first dose.
• 0012A; Immunization administration by intramuscular injection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19]) vaccine, mRNA-LNP, spike protein, preservative free, 100 mcg/0.5 mL dosage; second dose.

A version of this article originally appeared on Medscape.com.

For patients suspected of having a large-vessel occlusion stroke, direct transfer to a comprehensive stroke center capable of endovascular therapy that is farther away than a local primary stroke center does not necessarily produce better functional stroke outcomes, a new study has shown.

In the RACECAT trial, functional outcomes were similar for patients suspected of having a large-vessel occlusion stroke who were located in areas not currently served by a comprehensive stroke center, whether they were first taken to a local primary stroke center or whether they were transported over a longer distance to a comprehensive center.

“Under the particular conditions in our study where we had a very well-organized system, a ‘mothership’ transfer protocol for patients with suspected large-vessel occlusion has not proven superior over the ‘drip-and-ship’ protocol, but the opposite is also true,” lead investigator Marc Ribo, MD, concluded.

Dr. Ribo, assistant professor of neurology at Hospital Vall d’Hebron, Barcelona, presented the RACECAT results at the European Stroke Organisation–World Stroke Organisation (ESO-WSO) Conference 2020.

Dr. Ribo said in an interview that there is a feeling among the stroke community that patients with a suspected large-vessel occlusion should be transferred directly to a comprehensive stroke center capable of performing endovascular thrombectomy, even if there is a nearer, smaller primary stroke center where patients are usually taken first for thrombolysis.

“Many stroke neurologists believe we are losing time by sending patients with severe stroke to a local hospital and that we should skip this step, but this is controversial area,” he commented. “Our findings suggest that we should not automatically bypass local stroke centers.”

Dr. Ribo pointed out that the local centers performed very well in the study, with very fast “in/out” times for patients who were subsequently transferred for thrombectomy.

“On the basis of our results, we recommend that if a local stroke center can perform well like ours did – if they are within the time indicators for treating and transferring patients – then they should keep receiving these patients. But if they are not performing well in this regard, then they should probably be bypassed,” he commented.

The RACECAT trial was well received by stroke experts at an ESO-WSO 2020 press conference at which it was discussed.

Stefan Kiechl, MD, Medical University Innsbruck (Austria), described the trial as “outstanding,” adding: “It has addressed a very important question. It is a big achievement in stroke medicine.”

Patrik Michel, MD, Lausanne (Switzerland) University Hospital, said that “this is a very important and highly sophisticated trial in terms of design and execution. The message is that it doesn’t matter which pathway is used, but it is important to have a well-organized network with highly trained paramedics.”
 

RACECAT

The RACECAT trial was conducted in the Catalonia region of Spain. Twenty-seven hospitals participated, including 7 comprehensive stroke centers and 20 local stroke centers.

The trial included stroke patients with suspected large-vessel occlusion stroke, as determined on the basis of evaluation by paramedics using the criteria of a Rapid Arterial Occlusion Evaluation (RACE) scale score above 4 and on the basis of a call to a vascular neurologist. For inclusion in the study, patients had to be in a geographical area not served by a comprehensive stroke center and to have an estimated arrival time to a comprehensive center of less than 7 hours from symptom onset in order that thrombectomy would be possible.

Of 7,475 stroke code patients evaluated, 1,401 met the inclusion criteria and were randomly assigned to be transferred to a local hospital or to a comprehensive stroke center farther away.

Baseline characteristics were similar between the two groups. The patients had severe strokes with an average National Institutes of Health Stroke Scale score of 17. It was later confirmed that 46% of the patients enrolled in the study had a large-vessel occlusion stroke.

Results showed that time from symptom onset to hospital arrival was 142 minutes for those taken to a local center and 216 minutes for those taken to a comprehensive stroke center. Of those taken to a local hospital, 86% arrived within 4 hours of symptom onset and so were potential candidates for thrombolysis, compared with 76% of those taken to a comprehensive center.

Of the patients taken to a local hospital, 60% were given thrombolysis versus 43% of those taken immediately to a comprehensive center. On the other hand, 50% of patients who were taken directly to a comprehensive center underwent thrombectomy, compared with 40% who were first taken to a local center.

For patients who received thrombolysis, time to tissue plasminogen activator administration was 120 minutes for those treated at a local hospital versus 155 minutes for those taken directly to a comprehensive center.

For patients who received thrombectomy, time from symptom onset to groin puncture was 270 minutes if they were first taken to a local hospital and were then transferred, versus 214 minutes for those taken directly to the comprehensive center.

The primary efficacy endpoint was functional outcome using Modified Rankin Scale (mRS) shift analysis at 90 days for ischemic stroke patients. This showed a “completely flat” result, Dr. Ribo reported, with an adjusted hazard ratio of 1.029 for patients taken to a comprehensive center in comparison with those taken to a local center.

“There was absolutely no trend towards benefit in one group over the other,” he said.
 

What about hemorrhagic stroke?

The study also evaluated functional outcomes for the whole population enrolled. “If we make the decision just based on thrombectomy-eligible patients, we may harm the rest of the patients, so we did this study to look at the whole population of severe stroke patients,” Dr. Ribo said.

Of the study population, 25% of patients were found to have had a hemorrhagic stroke.

“The problem is, at the prehospital level, it is impossible to know if a patient is having a large-vessel occlusion ischemic stroke or a hemorrhagic stroke,” Dr. Ribo explained. “We have to make a decision for the whole population, and while a longer transport time to get to a comprehensive stroke center might help a patient with a large-vessel occlusion ischemic stroke, it might not be so appropriate for patients with a hemorrhagic stroke who need to have their blood pressure stabilized as soon as possible.”

For the whole population, the mRS shift analysis at 90 days was also neutral, with an aHR of 0.965.

When considering only patients with hemorrhagic stroke, the adjusted hazard ratio for the mRS shift analysis at 90 days was 1.216, which was still nonsignificant (95% confidence interval, 0.864-1.709). This included a nonsignificant increase in mortality among those taken directly to a comprehensive center.

“If we had better tools for a certain diagnosis in the field, then we could consider taking large-vessel occlusion ischemic stroke patients to a comprehensive center and hemorrhagic stroke patients to the local stroke center, but so far, we don’t have this option apart from a few places using mobile stroke units with CT scanners,” Dr. Ribo noted.

Transfer times to comprehensive centers in the study ranged from 30 minutes to 2.5 hours. “There might well be a difference in outcomes for short and long transfers, and we may be able to offer different transfer protocols in these different situations, and we are looking at that, but the study was only stopped in June, and we haven’t had a chance to analyze those results yet,” Dr. Ribo added.

Complications during transport occurred in 0.5% of those taken to a local hospital and in 1% of those taken directly to a comprehensive center. “We were concerned about complications with longer transfers, but these numbers are quite low. Intubations were very low – just one patient taken to a local center, versus three or four in the longer transfer group,” he added.

For both local and comprehensive centers, treatment times were impressive in the study. For local hospitals, the average in/out time was just 60 minutes for patients who went to a comprehensive center; for patients receiving thrombolysis, the average door to needle time was around 30 minutes.

Time to thrombectomy in the comprehensive center for patients transferred from a local hospital was also very fast, with an average door to groin puncture time of less than 40 minutes. “This shows we have a very well-oiled system,” Dr. Ribo said.

“There is always going to be a balance between a quicker time to thrombolysis by taking a patient to the closest hospital but a quicker time to thrombectomy if patients are taken straight to the comprehensive center,” he concluded. “But in our system, where we are achieving fast treatment and transfer times, our results show that patients had timely access to reperfusion therapies regardless of transfer protocol, and under these circumstances, it is fine for the emergency services to take stroke patients to the closest stroke center.”
 

Results applicable elsewhere?

During the discussion at an ESO-WSO 2020 press conference, other experts pointed out that the Catalonia group is a leader in this field, being the pioneers of the RACE score used in this study for paramedics to identify suspected large-vessel occlusions. This led to questions about the applicability of the results.

“The performance by paramedics was very good using the RACE scale, and the performance times were very impressive. Are these results applicable elsewhere?” Dr. Kiechl asked.

Dr. Ribo said the combination of the RACE score and a call with a vascular neurologist was of “great value” in identifying appropriate patients. Half of the patients selected in this way for the trial were confirmed to have a large-vessel occlusion. “That is a good result,” he added.

He noted that the performance of the local hospitals improved dramatically during the study. “They had an incentive to work on their times. They could have lost most of their stroke patients if their results came out worse. We told them they had an opportunity to show that they have a role in treating these patients, and they took that opportunity.”

Dr. Ribo said there were lessons here for those involved in acute stroke care. “When creating stroke transfer policies in local networks, the performances of individual centers need to be taken into account. If primary stroke centers are motivated and can work in a well-coordinated way and perform to within the recommended times, then they can keep receiving stroke code patients. This should be possible in most developed countries.”

Noting that the in/out time of 60 minutes at local hospitals was “very impressive,” Dr. Kiechl asked how such fast times were achieved.

Dr. Ribo responded that, to a great extent, this was because of ambulance staff. “We have trained the paramedics to anticipate a second transfer after delivering the patient to the local hospital so they can prepare for this rather than waiting for a second call.”

Dr. Ribo pointed out that there were other advantages in taking patients to local centers first. “For those that do not need to be transferred on, they will be closer to relatives. It is very difficult for the family if the patient is hundreds of miles away. And there may be a cost advantage. We did look at costs, but haven’t got that data yet.”

He said: “If local stroke centers do not treat so many stroke code patients, they will lose their expertise, and that will be detrimental to the remaining patients who are taken there. We want to try to maintain a good standard of stroke care across a decent spread of hospitals—not just a couple of major comprehensive centers,” he added.

Commenting on the study, Jesse Dawson, MD, University of Glasgow, who was chair of the plenary session at which the study was presented, said: “RACECAT is very interesting but needs a lot of thought to dissect. My takeaway is that we know that time to reperfusion is key, and we need to get these times as low as possible, but we don’t need to chase a particular care pathway. Thus, if your country/geography suits ‘drip and ship’ better, this is acceptable. If direct to endovascular is possible or you are close to such a center, then this is ideal. But within those paradigms, be as fast as possible.”

He added that results of the subgroups with regard to transfer time will be helpful.

The RACECAT study was funded by Fundacio Ictus Malaltia Vascular.

A version of this article originally appeared on Medscape.com.

For patients suspected of having a large-vessel occlusion stroke, direct transfer to a comprehensive stroke center capable of endovascular therapy that is farther away than a local primary stroke center does not necessarily produce better functional stroke outcomes, a new study has shown.

In the RACECAT trial, functional outcomes were similar for patients suspected of having a large-vessel occlusion stroke who were located in areas not currently served by a comprehensive stroke center, whether they were first taken to a local primary stroke center or whether they were transported over a longer distance to a comprehensive center.

“Under the particular conditions in our study where we had a very well-organized system, a ‘mothership’ transfer protocol for patients with suspected large-vessel occlusion has not proven superior over the ‘drip-and-ship’ protocol, but the opposite is also true,” lead investigator Marc Ribo, MD, concluded.

Dr. Ribo, assistant professor of neurology at Hospital Vall d’Hebron, Barcelona, presented the RACECAT results at the European Stroke Organisation–World Stroke Organisation (ESO-WSO) Conference 2020.

Dr. Ribo said in an interview that there is a feeling among the stroke community that patients with a suspected large-vessel occlusion should be transferred directly to a comprehensive stroke center capable of performing endovascular thrombectomy, even if there is a nearer, smaller primary stroke center where patients are usually taken first for thrombolysis.

“Many stroke neurologists believe we are losing time by sending patients with severe stroke to a local hospital and that we should skip this step, but this is controversial area,” he commented. “Our findings suggest that we should not automatically bypass local stroke centers.”

Dr. Ribo pointed out that the local centers performed very well in the study, with very fast “in/out” times for patients who were subsequently transferred for thrombectomy.

“On the basis of our results, we recommend that if a local stroke center can perform well like ours did – if they are within the time indicators for treating and transferring patients – then they should keep receiving these patients. But if they are not performing well in this regard, then they should probably be bypassed,” he commented.

The RACECAT trial was well received by stroke experts at an ESO-WSO 2020 press conference at which it was discussed.

Stefan Kiechl, MD, Medical University Innsbruck (Austria), described the trial as “outstanding,” adding: “It has addressed a very important question. It is a big achievement in stroke medicine.”

Patrik Michel, MD, Lausanne (Switzerland) University Hospital, said that “this is a very important and highly sophisticated trial in terms of design and execution. The message is that it doesn’t matter which pathway is used, but it is important to have a well-organized network with highly trained paramedics.”
 

RACECAT

The RACECAT trial was conducted in the Catalonia region of Spain. Twenty-seven hospitals participated, including 7 comprehensive stroke centers and 20 local stroke centers.

The trial included stroke patients with suspected large-vessel occlusion stroke, as determined on the basis of evaluation by paramedics using the criteria of a Rapid Arterial Occlusion Evaluation (RACE) scale score above 4 and on the basis of a call to a vascular neurologist. For inclusion in the study, patients had to be in a geographical area not served by a comprehensive stroke center and to have an estimated arrival time to a comprehensive center of less than 7 hours from symptom onset in order that thrombectomy would be possible.

Of 7,475 stroke code patients evaluated, 1,401 met the inclusion criteria and were randomly assigned to be transferred to a local hospital or to a comprehensive stroke center farther away.

Baseline characteristics were similar between the two groups. The patients had severe strokes with an average National Institutes of Health Stroke Scale score of 17. It was later confirmed that 46% of the patients enrolled in the study had a large-vessel occlusion stroke.

Results showed that time from symptom onset to hospital arrival was 142 minutes for those taken to a local center and 216 minutes for those taken to a comprehensive stroke center. Of those taken to a local hospital, 86% arrived within 4 hours of symptom onset and so were potential candidates for thrombolysis, compared with 76% of those taken to a comprehensive center.

Of the patients taken to a local hospital, 60% were given thrombolysis versus 43% of those taken immediately to a comprehensive center. On the other hand, 50% of patients who were taken directly to a comprehensive center underwent thrombectomy, compared with 40% who were first taken to a local center.

For patients who received thrombolysis, time to tissue plasminogen activator administration was 120 minutes for those treated at a local hospital versus 155 minutes for those taken directly to a comprehensive center.

For patients who received thrombectomy, time from symptom onset to groin puncture was 270 minutes if they were first taken to a local hospital and were then transferred, versus 214 minutes for those taken directly to the comprehensive center.

The primary efficacy endpoint was functional outcome using Modified Rankin Scale (mRS) shift analysis at 90 days for ischemic stroke patients. This showed a “completely flat” result, Dr. Ribo reported, with an adjusted hazard ratio of 1.029 for patients taken to a comprehensive center in comparison with those taken to a local center.

“There was absolutely no trend towards benefit in one group over the other,” he said.
 

What about hemorrhagic stroke?

The study also evaluated functional outcomes for the whole population enrolled. “If we make the decision just based on thrombectomy-eligible patients, we may harm the rest of the patients, so we did this study to look at the whole population of severe stroke patients,” Dr. Ribo said.

Of the study population, 25% of patients were found to have had a hemorrhagic stroke.

“The problem is, at the prehospital level, it is impossible to know if a patient is having a large-vessel occlusion ischemic stroke or a hemorrhagic stroke,” Dr. Ribo explained. “We have to make a decision for the whole population, and while a longer transport time to get to a comprehensive stroke center might help a patient with a large-vessel occlusion ischemic stroke, it might not be so appropriate for patients with a hemorrhagic stroke who need to have their blood pressure stabilized as soon as possible.”

For the whole population, the mRS shift analysis at 90 days was also neutral, with an aHR of 0.965.

When considering only patients with hemorrhagic stroke, the adjusted hazard ratio for the mRS shift analysis at 90 days was 1.216, which was still nonsignificant (95% confidence interval, 0.864-1.709). This included a nonsignificant increase in mortality among those taken directly to a comprehensive center.

“If we had better tools for a certain diagnosis in the field, then we could consider taking large-vessel occlusion ischemic stroke patients to a comprehensive center and hemorrhagic stroke patients to the local stroke center, but so far, we don’t have this option apart from a few places using mobile stroke units with CT scanners,” Dr. Ribo noted.

Transfer times to comprehensive centers in the study ranged from 30 minutes to 2.5 hours. “There might well be a difference in outcomes for short and long transfers, and we may be able to offer different transfer protocols in these different situations, and we are looking at that, but the study was only stopped in June, and we haven’t had a chance to analyze those results yet,” Dr. Ribo added.

Complications during transport occurred in 0.5% of those taken to a local hospital and in 1% of those taken directly to a comprehensive center. “We were concerned about complications with longer transfers, but these numbers are quite low. Intubations were very low – just one patient taken to a local center, versus three or four in the longer transfer group,” he added.

For both local and comprehensive centers, treatment times were impressive in the study. For local hospitals, the average in/out time was just 60 minutes for patients who went to a comprehensive center; for patients receiving thrombolysis, the average door to needle time was around 30 minutes.

Time to thrombectomy in the comprehensive center for patients transferred from a local hospital was also very fast, with an average door to groin puncture time of less than 40 minutes. “This shows we have a very well-oiled system,” Dr. Ribo said.

“There is always going to be a balance between a quicker time to thrombolysis by taking a patient to the closest hospital but a quicker time to thrombectomy if patients are taken straight to the comprehensive center,” he concluded. “But in our system, where we are achieving fast treatment and transfer times, our results show that patients had timely access to reperfusion therapies regardless of transfer protocol, and under these circumstances, it is fine for the emergency services to take stroke patients to the closest stroke center.”
 

Results applicable elsewhere?

During the discussion at an ESO-WSO 2020 press conference, other experts pointed out that the Catalonia group is a leader in this field, being the pioneers of the RACE score used in this study for paramedics to identify suspected large-vessel occlusions. This led to questions about the applicability of the results.

“The performance by paramedics was very good using the RACE scale, and the performance times were very impressive. Are these results applicable elsewhere?” Dr. Kiechl asked.

Dr. Ribo said the combination of the RACE score and a call with a vascular neurologist was of “great value” in identifying appropriate patients. Half of the patients selected in this way for the trial were confirmed to have a large-vessel occlusion. “That is a good result,” he added.

He noted that the performance of the local hospitals improved dramatically during the study. “They had an incentive to work on their times. They could have lost most of their stroke patients if their results came out worse. We told them they had an opportunity to show that they have a role in treating these patients, and they took that opportunity.”

Dr. Ribo said there were lessons here for those involved in acute stroke care. “When creating stroke transfer policies in local networks, the performances of individual centers need to be taken into account. If primary stroke centers are motivated and can work in a well-coordinated way and perform to within the recommended times, then they can keep receiving stroke code patients. This should be possible in most developed countries.”

Noting that the in/out time of 60 minutes at local hospitals was “very impressive,” Dr. Kiechl asked how such fast times were achieved.

Dr. Ribo responded that, to a great extent, this was because of ambulance staff. “We have trained the paramedics to anticipate a second transfer after delivering the patient to the local hospital so they can prepare for this rather than waiting for a second call.”

Dr. Ribo pointed out that there were other advantages in taking patients to local centers first. “For those that do not need to be transferred on, they will be closer to relatives. It is very difficult for the family if the patient is hundreds of miles away. And there may be a cost advantage. We did look at costs, but haven’t got that data yet.”

He said: “If local stroke centers do not treat so many stroke code patients, they will lose their expertise, and that will be detrimental to the remaining patients who are taken there. We want to try to maintain a good standard of stroke care across a decent spread of hospitals—not just a couple of major comprehensive centers,” he added.

Commenting on the study, Jesse Dawson, MD, University of Glasgow, who was chair of the plenary session at which the study was presented, said: “RACECAT is very interesting but needs a lot of thought to dissect. My takeaway is that we know that time to reperfusion is key, and we need to get these times as low as possible, but we don’t need to chase a particular care pathway. Thus, if your country/geography suits ‘drip and ship’ better, this is acceptable. If direct to endovascular is possible or you are close to such a center, then this is ideal. But within those paradigms, be as fast as possible.”

He added that results of the subgroups with regard to transfer time will be helpful.

The RACECAT study was funded by Fundacio Ictus Malaltia Vascular.

A version of this article originally appeared on Medscape.com.

For patients suspected of having a large-vessel occlusion stroke, direct transfer to a comprehensive stroke center capable of endovascular therapy that is farther away than a local primary stroke center does not necessarily produce better functional stroke outcomes, a new study has shown.

In the RACECAT trial, functional outcomes were similar for patients suspected of having a large-vessel occlusion stroke who were located in areas not currently served by a comprehensive stroke center, whether they were first taken to a local primary stroke center or whether they were transported over a longer distance to a comprehensive center.

“Under the particular conditions in our study where we had a very well-organized system, a ‘mothership’ transfer protocol for patients with suspected large-vessel occlusion has not proven superior over the ‘drip-and-ship’ protocol, but the opposite is also true,” lead investigator Marc Ribo, MD, concluded.

Dr. Ribo, assistant professor of neurology at Hospital Vall d’Hebron, Barcelona, presented the RACECAT results at the European Stroke Organisation–World Stroke Organisation (ESO-WSO) Conference 2020.

Dr. Ribo said in an interview that there is a feeling among the stroke community that patients with a suspected large-vessel occlusion should be transferred directly to a comprehensive stroke center capable of performing endovascular thrombectomy, even if there is a nearer, smaller primary stroke center where patients are usually taken first for thrombolysis.

“Many stroke neurologists believe we are losing time by sending patients with severe stroke to a local hospital and that we should skip this step, but this is controversial area,” he commented. “Our findings suggest that we should not automatically bypass local stroke centers.”

Dr. Ribo pointed out that the local centers performed very well in the study, with very fast “in/out” times for patients who were subsequently transferred for thrombectomy.

“On the basis of our results, we recommend that if a local stroke center can perform well like ours did – if they are within the time indicators for treating and transferring patients – then they should keep receiving these patients. But if they are not performing well in this regard, then they should probably be bypassed,” he commented.

The RACECAT trial was well received by stroke experts at an ESO-WSO 2020 press conference at which it was discussed.

Stefan Kiechl, MD, Medical University Innsbruck (Austria), described the trial as “outstanding,” adding: “It has addressed a very important question. It is a big achievement in stroke medicine.”

Patrik Michel, MD, Lausanne (Switzerland) University Hospital, said that “this is a very important and highly sophisticated trial in terms of design and execution. The message is that it doesn’t matter which pathway is used, but it is important to have a well-organized network with highly trained paramedics.”
 

RACECAT

The RACECAT trial was conducted in the Catalonia region of Spain. Twenty-seven hospitals participated, including 7 comprehensive stroke centers and 20 local stroke centers.

The trial included stroke patients with suspected large-vessel occlusion stroke, as determined on the basis of evaluation by paramedics using the criteria of a Rapid Arterial Occlusion Evaluation (RACE) scale score above 4 and on the basis of a call to a vascular neurologist. For inclusion in the study, patients had to be in a geographical area not served by a comprehensive stroke center and to have an estimated arrival time to a comprehensive center of less than 7 hours from symptom onset in order that thrombectomy would be possible.

Of 7,475 stroke code patients evaluated, 1,401 met the inclusion criteria and were randomly assigned to be transferred to a local hospital or to a comprehensive stroke center farther away.

Baseline characteristics were similar between the two groups. The patients had severe strokes with an average National Institutes of Health Stroke Scale score of 17. It was later confirmed that 46% of the patients enrolled in the study had a large-vessel occlusion stroke.

Results showed that time from symptom onset to hospital arrival was 142 minutes for those taken to a local center and 216 minutes for those taken to a comprehensive stroke center. Of those taken to a local hospital, 86% arrived within 4 hours of symptom onset and so were potential candidates for thrombolysis, compared with 76% of those taken to a comprehensive center.

Of the patients taken to a local hospital, 60% were given thrombolysis versus 43% of those taken immediately to a comprehensive center. On the other hand, 50% of patients who were taken directly to a comprehensive center underwent thrombectomy, compared with 40% who were first taken to a local center.

For patients who received thrombolysis, time to tissue plasminogen activator administration was 120 minutes for those treated at a local hospital versus 155 minutes for those taken directly to a comprehensive center.

For patients who received thrombectomy, time from symptom onset to groin puncture was 270 minutes if they were first taken to a local hospital and were then transferred, versus 214 minutes for those taken directly to the comprehensive center.

The primary efficacy endpoint was functional outcome using Modified Rankin Scale (mRS) shift analysis at 90 days for ischemic stroke patients. This showed a “completely flat” result, Dr. Ribo reported, with an adjusted hazard ratio of 1.029 for patients taken to a comprehensive center in comparison with those taken to a local center.

“There was absolutely no trend towards benefit in one group over the other,” he said.
 

What about hemorrhagic stroke?

The study also evaluated functional outcomes for the whole population enrolled. “If we make the decision just based on thrombectomy-eligible patients, we may harm the rest of the patients, so we did this study to look at the whole population of severe stroke patients,” Dr. Ribo said.

Of the study population, 25% of patients were found to have had a hemorrhagic stroke.

“The problem is, at the prehospital level, it is impossible to know if a patient is having a large-vessel occlusion ischemic stroke or a hemorrhagic stroke,” Dr. Ribo explained. “We have to make a decision for the whole population, and while a longer transport time to get to a comprehensive stroke center might help a patient with a large-vessel occlusion ischemic stroke, it might not be so appropriate for patients with a hemorrhagic stroke who need to have their blood pressure stabilized as soon as possible.”

For the whole population, the mRS shift analysis at 90 days was also neutral, with an aHR of 0.965.

When considering only patients with hemorrhagic stroke, the adjusted hazard ratio for the mRS shift analysis at 90 days was 1.216, which was still nonsignificant (95% confidence interval, 0.864-1.709). This included a nonsignificant increase in mortality among those taken directly to a comprehensive center.

“If we had better tools for a certain diagnosis in the field, then we could consider taking large-vessel occlusion ischemic stroke patients to a comprehensive center and hemorrhagic stroke patients to the local stroke center, but so far, we don’t have this option apart from a few places using mobile stroke units with CT scanners,” Dr. Ribo noted.

Transfer times to comprehensive centers in the study ranged from 30 minutes to 2.5 hours. “There might well be a difference in outcomes for short and long transfers, and we may be able to offer different transfer protocols in these different situations, and we are looking at that, but the study was only stopped in June, and we haven’t had a chance to analyze those results yet,” Dr. Ribo added.

Complications during transport occurred in 0.5% of those taken to a local hospital and in 1% of those taken directly to a comprehensive center. “We were concerned about complications with longer transfers, but these numbers are quite low. Intubations were very low – just one patient taken to a local center, versus three or four in the longer transfer group,” he added.

For both local and comprehensive centers, treatment times were impressive in the study. For local hospitals, the average in/out time was just 60 minutes for patients who went to a comprehensive center; for patients receiving thrombolysis, the average door to needle time was around 30 minutes.

Time to thrombectomy in the comprehensive center for patients transferred from a local hospital was also very fast, with an average door to groin puncture time of less than 40 minutes. “This shows we have a very well-oiled system,” Dr. Ribo said.

“There is always going to be a balance between a quicker time to thrombolysis by taking a patient to the closest hospital but a quicker time to thrombectomy if patients are taken straight to the comprehensive center,” he concluded. “But in our system, where we are achieving fast treatment and transfer times, our results show that patients had timely access to reperfusion therapies regardless of transfer protocol, and under these circumstances, it is fine for the emergency services to take stroke patients to the closest stroke center.”
 

Results applicable elsewhere?

During the discussion at an ESO-WSO 2020 press conference, other experts pointed out that the Catalonia group is a leader in this field, being the pioneers of the RACE score used in this study for paramedics to identify suspected large-vessel occlusions. This led to questions about the applicability of the results.

“The performance by paramedics was very good using the RACE scale, and the performance times were very impressive. Are these results applicable elsewhere?” Dr. Kiechl asked.

Dr. Ribo said the combination of the RACE score and a call with a vascular neurologist was of “great value” in identifying appropriate patients. Half of the patients selected in this way for the trial were confirmed to have a large-vessel occlusion. “That is a good result,” he added.

He noted that the performance of the local hospitals improved dramatically during the study. “They had an incentive to work on their times. They could have lost most of their stroke patients if their results came out worse. We told them they had an opportunity to show that they have a role in treating these patients, and they took that opportunity.”

Dr. Ribo said there were lessons here for those involved in acute stroke care. “When creating stroke transfer policies in local networks, the performances of individual centers need to be taken into account. If primary stroke centers are motivated and can work in a well-coordinated way and perform to within the recommended times, then they can keep receiving stroke code patients. This should be possible in most developed countries.”

Noting that the in/out time of 60 minutes at local hospitals was “very impressive,” Dr. Kiechl asked how such fast times were achieved.

Dr. Ribo responded that, to a great extent, this was because of ambulance staff. “We have trained the paramedics to anticipate a second transfer after delivering the patient to the local hospital so they can prepare for this rather than waiting for a second call.”

Dr. Ribo pointed out that there were other advantages in taking patients to local centers first. “For those that do not need to be transferred on, they will be closer to relatives. It is very difficult for the family if the patient is hundreds of miles away. And there may be a cost advantage. We did look at costs, but haven’t got that data yet.”

He said: “If local stroke centers do not treat so many stroke code patients, they will lose their expertise, and that will be detrimental to the remaining patients who are taken there. We want to try to maintain a good standard of stroke care across a decent spread of hospitals—not just a couple of major comprehensive centers,” he added.

Commenting on the study, Jesse Dawson, MD, University of Glasgow, who was chair of the plenary session at which the study was presented, said: “RACECAT is very interesting but needs a lot of thought to dissect. My takeaway is that we know that time to reperfusion is key, and we need to get these times as low as possible, but we don’t need to chase a particular care pathway. Thus, if your country/geography suits ‘drip and ship’ better, this is acceptable. If direct to endovascular is possible or you are close to such a center, then this is ideal. But within those paradigms, be as fast as possible.”

He added that results of the subgroups with regard to transfer time will be helpful.

The RACECAT study was funded by Fundacio Ictus Malaltia Vascular.

A version of this article originally appeared on Medscape.com.

No significant differences in major adverse cardiovascular events (MACE) emerged between methotrexate and hydroxychloroquine (HCQ) treatment in a comparison of adults 65 years or older with rheumatoid arthritis. However, researchers reported some elevation in risk for stroke in the methotrexate group and for myocardial infarction and heart failure in the HCQ group.

The primary outcome, a composite of MI, stroke, or cardiovascular death, had an incidence of 23.39 per 1,000 person-years in the methotrexate group versus 24.33 in the HCQ group in this observational study of nearly 60,000 people.

“These results suggest an importance of looking at different individual events of cardiovascular disease rather than the whole ‘CV’ disease only,” Seoyoung Kim, MD, said in an interview. “The other important thing is that the mortality was not significantly different between the two groups.”

For example, the researchers reported 256 cardiovascular-related deaths in the methotrexate group and 263 such deaths in the HCQ cohort.
 

Addressing a recognized risk

“It is well known that patients with rheumatoid arthritis have excessive morbidity and mortality,” Dr. Kim, of the division of rheumatology at Brigham and Women’s Hospital and associate professor of medicine at Harvard Medical School in Boston, said at the virtual annual meeting of the American College of Rheumatology.

Among prior studies in this area, the Cardiovascular Inflammation Reduction Trial (CIRT) found no significant reduction in cardiovascular events among people taking methotrexate versus placebo. However, the study of 4,786 people was not specific to RA, Dr. Kim said. The lack of efficacy on this endpoint prompted researchers to stop CIRT early.

“So what does the conclusion of the CIRT trial mean for rheumatoid arthritis patients?” Dr. Kim asked.

To find out, she and colleagues compared risk of MACE among participants newly starting either methotrexate or HCQ. The study included 59,329 people aged 65 and older who were identified through Medicare claims data from 2008 to 2016. Mean age was 74 years, and 80% were women.

The investigators used propensity score matching to control for multiple covariates for demographics, other medications, and comorbidities. Use of other medications was similar between groups, including glucocorticoids, NSAIDs, and statins. Baseline cardiovascular morbidities likewise were well balanced, Dr. Kim said.

The hazard ratio for the primary MACE outcome was 0.96 (95% confidence interval, 0.86-1.08).

Secondary outcomes

MI was less common in the methotrexate group, for example, with an incidence of 8.49 per 1,000 person-years versus 10.68 per 1,000 person-years in the HCQ cohort. This finding was statically significant, Dr. Kim said, with a hazard ratio of 0.80 favoring methotrexate.

Heart failure also occurred less often in the methotrexate cohort, with an incidence rate of 8.57 per 1,000 person-years versus a rate of 14.24 in the HCQ group. The hazard ratio again favored methotrexate at 0.60.

In contrast, strokes were more common with methotrexate than with (incidence of 7.94 vs. 6.01 per 1,000 person-years).

Another secondary outcome, all-cause mortality, was not significantly different between groups. There were 821 deaths in the methotrexate group (28.65 per 1,000 person-years) and 796 deaths in the HCQ group (31.33 per 1,000 person-years).
 

Studying causality next?

Session moderator Maya Buch, MD, PhD, professor of rheumatology at the University of Manchester (England), asked Dr. Kim why she found significant differences in some secondary outcomes but not the primary composite endpoint.

“When we think of cardiovascular diseases, we tend to think of them all developing through the same mechanism. But perhaps the exact mechanism might not be identical,” Dr. Kim replied. The findings do not suggest causality because the study was observational, she added, “but maybe this will lead to a randomized, controlled trial.”

When asked for comment, Dr. Buch said that the study was “interesting” and “suggestive of differences in type of MACE between the two drugs evaluated,” but that there should be caution in interpreting the findings because of the lack of detailed information on RA disease and activity in claims databases, in addition to other factors, even though the investigators made adjustments for known differences through propensity score matching.

The division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital supported the study. Dr. Kim has received support for Brigham and Women’s Hospital for unrelated research from Pfizer, AbbVie, Roche, and Bristol-Myers Squibb. Several other coauthors reported having financial relationships with pharmaceutical companies that make drugs for RA. Dr. Buch had no relevant disclosures.

SOURCE: He M et al. Arthritis Rheumatol. 2020;72(suppl 10): Abstract 1993.

No significant differences in major adverse cardiovascular events (MACE) emerged between methotrexate and hydroxychloroquine (HCQ) treatment in a comparison of adults 65 years or older with rheumatoid arthritis. However, researchers reported some elevation in risk for stroke in the methotrexate group and for myocardial infarction and heart failure in the HCQ group.

The primary outcome, a composite of MI, stroke, or cardiovascular death, had an incidence of 23.39 per 1,000 person-years in the methotrexate group versus 24.33 in the HCQ group in this observational study of nearly 60,000 people.

“These results suggest an importance of looking at different individual events of cardiovascular disease rather than the whole ‘CV’ disease only,” Seoyoung Kim, MD, said in an interview. “The other important thing is that the mortality was not significantly different between the two groups.”

For example, the researchers reported 256 cardiovascular-related deaths in the methotrexate group and 263 such deaths in the HCQ cohort.
 

Addressing a recognized risk

“It is well known that patients with rheumatoid arthritis have excessive morbidity and mortality,” Dr. Kim, of the division of rheumatology at Brigham and Women’s Hospital and associate professor of medicine at Harvard Medical School in Boston, said at the virtual annual meeting of the American College of Rheumatology.

Among prior studies in this area, the Cardiovascular Inflammation Reduction Trial (CIRT) found no significant reduction in cardiovascular events among people taking methotrexate versus placebo. However, the study of 4,786 people was not specific to RA, Dr. Kim said. The lack of efficacy on this endpoint prompted researchers to stop CIRT early.

“So what does the conclusion of the CIRT trial mean for rheumatoid arthritis patients?” Dr. Kim asked.

To find out, she and colleagues compared risk of MACE among participants newly starting either methotrexate or HCQ. The study included 59,329 people aged 65 and older who were identified through Medicare claims data from 2008 to 2016. Mean age was 74 years, and 80% were women.

The investigators used propensity score matching to control for multiple covariates for demographics, other medications, and comorbidities. Use of other medications was similar between groups, including glucocorticoids, NSAIDs, and statins. Baseline cardiovascular morbidities likewise were well balanced, Dr. Kim said.

The hazard ratio for the primary MACE outcome was 0.96 (95% confidence interval, 0.86-1.08).

Secondary outcomes

MI was less common in the methotrexate group, for example, with an incidence of 8.49 per 1,000 person-years versus 10.68 per 1,000 person-years in the HCQ cohort. This finding was statically significant, Dr. Kim said, with a hazard ratio of 0.80 favoring methotrexate.

Heart failure also occurred less often in the methotrexate cohort, with an incidence rate of 8.57 per 1,000 person-years versus a rate of 14.24 in the HCQ group. The hazard ratio again favored methotrexate at 0.60.

In contrast, strokes were more common with methotrexate than with (incidence of 7.94 vs. 6.01 per 1,000 person-years).

Another secondary outcome, all-cause mortality, was not significantly different between groups. There were 821 deaths in the methotrexate group (28.65 per 1,000 person-years) and 796 deaths in the HCQ group (31.33 per 1,000 person-years).
 

Studying causality next?

Session moderator Maya Buch, MD, PhD, professor of rheumatology at the University of Manchester (England), asked Dr. Kim why she found significant differences in some secondary outcomes but not the primary composite endpoint.

“When we think of cardiovascular diseases, we tend to think of them all developing through the same mechanism. But perhaps the exact mechanism might not be identical,” Dr. Kim replied. The findings do not suggest causality because the study was observational, she added, “but maybe this will lead to a randomized, controlled trial.”

When asked for comment, Dr. Buch said that the study was “interesting” and “suggestive of differences in type of MACE between the two drugs evaluated,” but that there should be caution in interpreting the findings because of the lack of detailed information on RA disease and activity in claims databases, in addition to other factors, even though the investigators made adjustments for known differences through propensity score matching.

The division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital supported the study. Dr. Kim has received support for Brigham and Women’s Hospital for unrelated research from Pfizer, AbbVie, Roche, and Bristol-Myers Squibb. Several other coauthors reported having financial relationships with pharmaceutical companies that make drugs for RA. Dr. Buch had no relevant disclosures.

SOURCE: He M et al. Arthritis Rheumatol. 2020;72(suppl 10): Abstract 1993.

No significant differences in major adverse cardiovascular events (MACE) emerged between methotrexate and hydroxychloroquine (HCQ) treatment in a comparison of adults 65 years or older with rheumatoid arthritis. However, researchers reported some elevation in risk for stroke in the methotrexate group and for myocardial infarction and heart failure in the HCQ group.

The primary outcome, a composite of MI, stroke, or cardiovascular death, had an incidence of 23.39 per 1,000 person-years in the methotrexate group versus 24.33 in the HCQ group in this observational study of nearly 60,000 people.

“These results suggest an importance of looking at different individual events of cardiovascular disease rather than the whole ‘CV’ disease only,” Seoyoung Kim, MD, said in an interview. “The other important thing is that the mortality was not significantly different between the two groups.”

For example, the researchers reported 256 cardiovascular-related deaths in the methotrexate group and 263 such deaths in the HCQ cohort.
 

Addressing a recognized risk

“It is well known that patients with rheumatoid arthritis have excessive morbidity and mortality,” Dr. Kim, of the division of rheumatology at Brigham and Women’s Hospital and associate professor of medicine at Harvard Medical School in Boston, said at the virtual annual meeting of the American College of Rheumatology.

Among prior studies in this area, the Cardiovascular Inflammation Reduction Trial (CIRT) found no significant reduction in cardiovascular events among people taking methotrexate versus placebo. However, the study of 4,786 people was not specific to RA, Dr. Kim said. The lack of efficacy on this endpoint prompted researchers to stop CIRT early.

“So what does the conclusion of the CIRT trial mean for rheumatoid arthritis patients?” Dr. Kim asked.

To find out, she and colleagues compared risk of MACE among participants newly starting either methotrexate or HCQ. The study included 59,329 people aged 65 and older who were identified through Medicare claims data from 2008 to 2016. Mean age was 74 years, and 80% were women.

The investigators used propensity score matching to control for multiple covariates for demographics, other medications, and comorbidities. Use of other medications was similar between groups, including glucocorticoids, NSAIDs, and statins. Baseline cardiovascular morbidities likewise were well balanced, Dr. Kim said.

The hazard ratio for the primary MACE outcome was 0.96 (95% confidence interval, 0.86-1.08).

Secondary outcomes

MI was less common in the methotrexate group, for example, with an incidence of 8.49 per 1,000 person-years versus 10.68 per 1,000 person-years in the HCQ cohort. This finding was statically significant, Dr. Kim said, with a hazard ratio of 0.80 favoring methotrexate.

Heart failure also occurred less often in the methotrexate cohort, with an incidence rate of 8.57 per 1,000 person-years versus a rate of 14.24 in the HCQ group. The hazard ratio again favored methotrexate at 0.60.

In contrast, strokes were more common with methotrexate than with (incidence of 7.94 vs. 6.01 per 1,000 person-years).

Another secondary outcome, all-cause mortality, was not significantly different between groups. There were 821 deaths in the methotrexate group (28.65 per 1,000 person-years) and 796 deaths in the HCQ group (31.33 per 1,000 person-years).
 

Studying causality next?

Session moderator Maya Buch, MD, PhD, professor of rheumatology at the University of Manchester (England), asked Dr. Kim why she found significant differences in some secondary outcomes but not the primary composite endpoint.

“When we think of cardiovascular diseases, we tend to think of them all developing through the same mechanism. But perhaps the exact mechanism might not be identical,” Dr. Kim replied. The findings do not suggest causality because the study was observational, she added, “but maybe this will lead to a randomized, controlled trial.”

When asked for comment, Dr. Buch said that the study was “interesting” and “suggestive of differences in type of MACE between the two drugs evaluated,” but that there should be caution in interpreting the findings because of the lack of detailed information on RA disease and activity in claims databases, in addition to other factors, even though the investigators made adjustments for known differences through propensity score matching.

The division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital supported the study. Dr. Kim has received support for Brigham and Women’s Hospital for unrelated research from Pfizer, AbbVie, Roche, and Bristol-Myers Squibb. Several other coauthors reported having financial relationships with pharmaceutical companies that make drugs for RA. Dr. Buch had no relevant disclosures.

SOURCE: He M et al. Arthritis Rheumatol. 2020;72(suppl 10): Abstract 1993.

About 1 in 11 patients discharged after COVID-19 treatment is readmitted to the same hospital, according to researchers from the Centers for Disease Control and Prevention (CDC).

Older age and chronic diseases are associated with increased risk, said senior author Adi V. Gundlapalli, MD, PhD, chief public health informatics officer of the CDC’s Center for Surveillance, Epidemiology, and Laboratory Services.

Gundlapalli and colleagues published the finding November 9 in Morbidity and Mortality Weekly Report.

To get a picture of readmission after COVID-19 hospitalization, the researchers analyzed records of 126,137 patients hospitalized with COVID-19 between March and July and included in the Premier Healthcare Database, which covers discharge records from 865 nongovernmental, community, and teaching hospitals.

Overall, 15% of the patients died during hospitalization. Of those who survived to discharge, 9% were readmitted to the same hospital within 2 months of discharge; 1.6% of patients were readmitted more than once. The median interval from discharge to first readmission was 8 days (interquartile range, 3-20 days). This short interval suggests that patients are probably not suffering a relapse, Gundlapalli said in an interview. More likely they experienced some adverse event, such as difficulty breathing, that led their caretakers to send them back to the hospital.

Forty-five percent of the primary discharge diagnoses after readmission were infectious and parasitic diseases, primarily COVID-19. The next most common were circulatory system symptoms (11%) and digestive symptoms (7%).

After controlling for covariates, the researchers found that patients were more likely to be readmitted if they had chronic obstructive pulmonary disease (odds ratio [OR], 1.4), heart failure (OR, 1.6), diabetes (OR, 1.2), or chronic kidney disease (OR, 1.6).

They also found increased odds among patients discharged from the index hospitalization to a skilled nursing facility (OR, 1.4) or with home health organization support (OR, 1.3), compared with being discharged to home or self-care. Looked at another way, the rate of readmission was 15% among those discharged to a skilled nursing facility, 12% among those needing home health care and 7% of those discharged to home or self-care.

The researchers also found that people who had been hospitalized within 3 months prior to the index hospitalization were 2.6 times more likely to be readmitted than were those without prior inpatient care.

Further, the odds of readmission increased significantly among people over 65 years of age, compared with people aged 18 to 39 years.

“The results are not surprising,” Gundlapalli said. “We have known from before that elderly patients, especially with chronic conditions, certain clinical conditions, and those who have been hospitalized before, are at risk for readmission.”

But admitting COVID-19 patients requires special planning because they must be isolated and because more personal protective equipment (PPE) is required, he pointed out.

One unexpected finding from the report is that non-Hispanic White people were more likely to be readmitted than were people of other racial or ethnic groups. This contrasts with other research showing Hispanic and Black individuals are more severely affected by COVID-19 than White people. More research is needed to explain this result, Gundlapalli said.

The authors have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

About 1 in 11 patients discharged after COVID-19 treatment is readmitted to the same hospital, according to researchers from the Centers for Disease Control and Prevention (CDC).

Older age and chronic diseases are associated with increased risk, said senior author Adi V. Gundlapalli, MD, PhD, chief public health informatics officer of the CDC’s Center for Surveillance, Epidemiology, and Laboratory Services.

Gundlapalli and colleagues published the finding November 9 in Morbidity and Mortality Weekly Report.

To get a picture of readmission after COVID-19 hospitalization, the researchers analyzed records of 126,137 patients hospitalized with COVID-19 between March and July and included in the Premier Healthcare Database, which covers discharge records from 865 nongovernmental, community, and teaching hospitals.

Overall, 15% of the patients died during hospitalization. Of those who survived to discharge, 9% were readmitted to the same hospital within 2 months of discharge; 1.6% of patients were readmitted more than once. The median interval from discharge to first readmission was 8 days (interquartile range, 3-20 days). This short interval suggests that patients are probably not suffering a relapse, Gundlapalli said in an interview. More likely they experienced some adverse event, such as difficulty breathing, that led their caretakers to send them back to the hospital.

Forty-five percent of the primary discharge diagnoses after readmission were infectious and parasitic diseases, primarily COVID-19. The next most common were circulatory system symptoms (11%) and digestive symptoms (7%).

After controlling for covariates, the researchers found that patients were more likely to be readmitted if they had chronic obstructive pulmonary disease (odds ratio [OR], 1.4), heart failure (OR, 1.6), diabetes (OR, 1.2), or chronic kidney disease (OR, 1.6).

They also found increased odds among patients discharged from the index hospitalization to a skilled nursing facility (OR, 1.4) or with home health organization support (OR, 1.3), compared with being discharged to home or self-care. Looked at another way, the rate of readmission was 15% among those discharged to a skilled nursing facility, 12% among those needing home health care and 7% of those discharged to home or self-care.

The researchers also found that people who had been hospitalized within 3 months prior to the index hospitalization were 2.6 times more likely to be readmitted than were those without prior inpatient care.

Further, the odds of readmission increased significantly among people over 65 years of age, compared with people aged 18 to 39 years.

“The results are not surprising,” Gundlapalli said. “We have known from before that elderly patients, especially with chronic conditions, certain clinical conditions, and those who have been hospitalized before, are at risk for readmission.”

But admitting COVID-19 patients requires special planning because they must be isolated and because more personal protective equipment (PPE) is required, he pointed out.

One unexpected finding from the report is that non-Hispanic White people were more likely to be readmitted than were people of other racial or ethnic groups. This contrasts with other research showing Hispanic and Black individuals are more severely affected by COVID-19 than White people. More research is needed to explain this result, Gundlapalli said.

The authors have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

About 1 in 11 patients discharged after COVID-19 treatment is readmitted to the same hospital, according to researchers from the Centers for Disease Control and Prevention (CDC).

Older age and chronic diseases are associated with increased risk, said senior author Adi V. Gundlapalli, MD, PhD, chief public health informatics officer of the CDC’s Center for Surveillance, Epidemiology, and Laboratory Services.

Gundlapalli and colleagues published the finding November 9 in Morbidity and Mortality Weekly Report.

To get a picture of readmission after COVID-19 hospitalization, the researchers analyzed records of 126,137 patients hospitalized with COVID-19 between March and July and included in the Premier Healthcare Database, which covers discharge records from 865 nongovernmental, community, and teaching hospitals.

Overall, 15% of the patients died during hospitalization. Of those who survived to discharge, 9% were readmitted to the same hospital within 2 months of discharge; 1.6% of patients were readmitted more than once. The median interval from discharge to first readmission was 8 days (interquartile range, 3-20 days). This short interval suggests that patients are probably not suffering a relapse, Gundlapalli said in an interview. More likely they experienced some adverse event, such as difficulty breathing, that led their caretakers to send them back to the hospital.

Forty-five percent of the primary discharge diagnoses after readmission were infectious and parasitic diseases, primarily COVID-19. The next most common were circulatory system symptoms (11%) and digestive symptoms (7%).

After controlling for covariates, the researchers found that patients were more likely to be readmitted if they had chronic obstructive pulmonary disease (odds ratio [OR], 1.4), heart failure (OR, 1.6), diabetes (OR, 1.2), or chronic kidney disease (OR, 1.6).

They also found increased odds among patients discharged from the index hospitalization to a skilled nursing facility (OR, 1.4) or with home health organization support (OR, 1.3), compared with being discharged to home or self-care. Looked at another way, the rate of readmission was 15% among those discharged to a skilled nursing facility, 12% among those needing home health care and 7% of those discharged to home or self-care.

The researchers also found that people who had been hospitalized within 3 months prior to the index hospitalization were 2.6 times more likely to be readmitted than were those without prior inpatient care.

Further, the odds of readmission increased significantly among people over 65 years of age, compared with people aged 18 to 39 years.

“The results are not surprising,” Gundlapalli said. “We have known from before that elderly patients, especially with chronic conditions, certain clinical conditions, and those who have been hospitalized before, are at risk for readmission.”

But admitting COVID-19 patients requires special planning because they must be isolated and because more personal protective equipment (PPE) is required, he pointed out.

One unexpected finding from the report is that non-Hispanic White people were more likely to be readmitted than were people of other racial or ethnic groups. This contrasts with other research showing Hispanic and Black individuals are more severely affected by COVID-19 than White people. More research is needed to explain this result, Gundlapalli said.

The authors have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

As an East Coast transplant residing in Texas, I look forward to the annual sojourn home to celebrate the holidays with family and friends – as do many of our patients and their families. But this is 2020. SARS-CoV-2, the causative agent of COVID-19, is still circulating. To make matters worse, cases are rising in 45 states and internationally. The day of this writing 102,831 new cases were reported in the United States. As we prepare for the holidays, it is time to rethink how safe it is to travel and/or gather with people who do not live in our household.

Social distancing, wearing masks, and hand washing have been strategies recommended to help mitigate the spread of the virus. We know adherence is not always 100%. The reality is that several families will consider traveling and gathering with others over the holidays. Their actions may lead to increased infections, hospitalizations, and even deaths. It behooves us to at least remind them of the potential consequences of the activity, and if travel and/or holiday gatherings are inevitable, to provide some guidance to help them look at both the risks and benefits and offer strategies to minimize infection and spread.
 

What should be considered prior to travel?

Here is a list of points to ponder:

• Is your patient is in a high-risk group for developing severe disease or visiting someone who is in a high-risk group?
• What is their mode of transportation?
• What is their destination?
• How prevalent is the disease at their destination, compared with their community?
• What will be their accommodations?
• How will attendees prepare for the gathering, if at all?
• Will multiple families congregate after quarantining for 2 weeks or simply arrive?
• At the destination, will people wear masks and socially distance?
• Is an outdoor venue an option?

All of these questions should be considered by patients.
 

Review high-risk groups

In terms of high-risk groups, we usually focus on underlying medical conditions or extremes of age, but Black and LatinX children and their families have been diagnosed with COVID-19 and hospitalized more frequently than other racial/ ethnic groups in the United States. Of 277,285 school-aged children infected between March 1 and Sept. 19, 2020, 42% were LatinX, 32% White, and 17% Black, yet they comprise 18%, 60%, and 11% of the U.S. population, respectively. Of those hospitalized, 45% were LatinX, 22% White, and 24% Black. LatinX and Black children also have disproportionately higher mortality rates.

Think about transmission and how to mitigate it

Many patients erroneously think combining multiple households for small group gatherings is inconsequential. These types of gatherings serve as a continued source of SARS-CoV-2 spread. For example, a person in Illinois with mild upper respiratory infection symptoms attended a funeral; he reported embracing the family members after the funeral. He dined with two people the evening prior to the funeral, sharing the meal using common serving dishes. Four days later, he attended a birthday party with nine family members. Some of the family members with symptoms subsequently attended church, infecting another church attendee. A cluster of 16 cases of COVID-19 was subsequently identified, including three deaths likely resulting from this one introduction of COVID-19 at these two family gatherings.

In Tennessee and Wisconsin, household transmission of SARS-CoV-2 was studied prospectively. A total of 101 index cases and 191 asymptomatic household contacts were enrolled between April and Sept. 2020; 102 of 191 (53%) had SARS-CoV-2 detected during the 14-day follow-up. Most infections (75%) were identified within 5 days and occurred whether the index case was an adult or child.

Lastly, one adolescent was identified as the source for an outbreak at a family gathering where 15 persons from five households and four states shared a house between 8 and 25 days in July 2020. Six additional members visited the house. The index case had an exposure to COVID-19 and had a negative antigen test 4 days after exposure. She was asymptomatic when tested. She developed nasal congestion 2 days later, the same day she and her family departed for the gathering. A total of 11 household contacts developed confirmed, suspected, or probable COVID-19, and the teen developed symptoms. This report illustrates how easily SARS-CoV-2 is transmitted, and how when implemented, mitigation strategies work because none of the six who only visited the house was infected. It also serves as a reminder that antigen testing is indicated only for use within the first 5-12 days of onset of symptoms. In this case, the adolescent was asymptomatic when tested and had a false-negative test result.
 

Ponder modes of transportation

How will your patient arrive to their holiday destination? Nonstop travel by car with household members is probably the safest way. However, for many families, buses and trains are the only options, and social distancing may be challenging. Air travel is a must for others. Acquisition of COVID-19 during air travel appears to be low, but not absent based on how air enters and leaves the cabin. The challenge is socially distancing throughout the check in and boarding processes, as well as minimizing contact with common surfaces. There also is loss of social distancing once on board. Ideally, masks should be worn during the flight. Additionally, for those with international destinations, most countries now require a negative polymerase chain reaction COVID-19 test within a specified time frame for entry.

Essentially the safest place for your patients during the holidays is celebrating at home with their household contacts. The risk for disease acquisition increases with travel. You will not have the opportunity to discuss holiday plans with most parents. However, you can encourage them to consider the pros and cons of travel with reminders via telephone, e-mail, and /or social messaging directly from your practices similar to those sent for other medically necessary interventions. As for me, I will be celebrating virtually this year. There is a first time for everything.

For additional information that also is patient friendly, the Centers for Disease Control and Prevention offers information about travel within the United States and international travel.
 

Dr. Word is a pediatric infectious disease specialist and director of the Houston Travel Medicine Clinic. She said she had no relevant financial disclosures. Email her at [email protected].

As an East Coast transplant residing in Texas, I look forward to the annual sojourn home to celebrate the holidays with family and friends – as do many of our patients and their families. But this is 2020. SARS-CoV-2, the causative agent of COVID-19, is still circulating. To make matters worse, cases are rising in 45 states and internationally. The day of this writing 102,831 new cases were reported in the United States. As we prepare for the holidays, it is time to rethink how safe it is to travel and/or gather with people who do not live in our household.

Social distancing, wearing masks, and hand washing have been strategies recommended to help mitigate the spread of the virus. We know adherence is not always 100%. The reality is that several families will consider traveling and gathering with others over the holidays. Their actions may lead to increased infections, hospitalizations, and even deaths. It behooves us to at least remind them of the potential consequences of the activity, and if travel and/or holiday gatherings are inevitable, to provide some guidance to help them look at both the risks and benefits and offer strategies to minimize infection and spread.
 

What should be considered prior to travel?

Here is a list of points to ponder:

• Is your patient is in a high-risk group for developing severe disease or visiting someone who is in a high-risk group?
• What is their mode of transportation?
• What is their destination?
• How prevalent is the disease at their destination, compared with their community?
• What will be their accommodations?
• How will attendees prepare for the gathering, if at all?
• Will multiple families congregate after quarantining for 2 weeks or simply arrive?
• At the destination, will people wear masks and socially distance?
• Is an outdoor venue an option?

All of these questions should be considered by patients.
 

Review high-risk groups

In terms of high-risk groups, we usually focus on underlying medical conditions or extremes of age, but Black and LatinX children and their families have been diagnosed with COVID-19 and hospitalized more frequently than other racial/ ethnic groups in the United States. Of 277,285 school-aged children infected between March 1 and Sept. 19, 2020, 42% were LatinX, 32% White, and 17% Black, yet they comprise 18%, 60%, and 11% of the U.S. population, respectively. Of those hospitalized, 45% were LatinX, 22% White, and 24% Black. LatinX and Black children also have disproportionately higher mortality rates.

Think about transmission and how to mitigate it

Many patients erroneously think combining multiple households for small group gatherings is inconsequential. These types of gatherings serve as a continued source of SARS-CoV-2 spread. For example, a person in Illinois with mild upper respiratory infection symptoms attended a funeral; he reported embracing the family members after the funeral. He dined with two people the evening prior to the funeral, sharing the meal using common serving dishes. Four days later, he attended a birthday party with nine family members. Some of the family members with symptoms subsequently attended church, infecting another church attendee. A cluster of 16 cases of COVID-19 was subsequently identified, including three deaths likely resulting from this one introduction of COVID-19 at these two family gatherings.

In Tennessee and Wisconsin, household transmission of SARS-CoV-2 was studied prospectively. A total of 101 index cases and 191 asymptomatic household contacts were enrolled between April and Sept. 2020; 102 of 191 (53%) had SARS-CoV-2 detected during the 14-day follow-up. Most infections (75%) were identified within 5 days and occurred whether the index case was an adult or child.

Lastly, one adolescent was identified as the source for an outbreak at a family gathering where 15 persons from five households and four states shared a house between 8 and 25 days in July 2020. Six additional members visited the house. The index case had an exposure to COVID-19 and had a negative antigen test 4 days after exposure. She was asymptomatic when tested. She developed nasal congestion 2 days later, the same day she and her family departed for the gathering. A total of 11 household contacts developed confirmed, suspected, or probable COVID-19, and the teen developed symptoms. This report illustrates how easily SARS-CoV-2 is transmitted, and how when implemented, mitigation strategies work because none of the six who only visited the house was infected. It also serves as a reminder that antigen testing is indicated only for use within the first 5-12 days of onset of symptoms. In this case, the adolescent was asymptomatic when tested and had a false-negative test result.
 

Ponder modes of transportation

How will your patient arrive to their holiday destination? Nonstop travel by car with household members is probably the safest way. However, for many families, buses and trains are the only options, and social distancing may be challenging. Air travel is a must for others. Acquisition of COVID-19 during air travel appears to be low, but not absent based on how air enters and leaves the cabin. The challenge is socially distancing throughout the check in and boarding processes, as well as minimizing contact with common surfaces. There also is loss of social distancing once on board. Ideally, masks should be worn during the flight. Additionally, for those with international destinations, most countries now require a negative polymerase chain reaction COVID-19 test within a specified time frame for entry.

Essentially the safest place for your patients during the holidays is celebrating at home with their household contacts. The risk for disease acquisition increases with travel. You will not have the opportunity to discuss holiday plans with most parents. However, you can encourage them to consider the pros and cons of travel with reminders via telephone, e-mail, and /or social messaging directly from your practices similar to those sent for other medically necessary interventions. As for me, I will be celebrating virtually this year. There is a first time for everything.

For additional information that also is patient friendly, the Centers for Disease Control and Prevention offers information about travel within the United States and international travel.
 

Dr. Word is a pediatric infectious disease specialist and director of the Houston Travel Medicine Clinic. She said she had no relevant financial disclosures. Email her at [email protected].

As an East Coast transplant residing in Texas, I look forward to the annual sojourn home to celebrate the holidays with family and friends – as do many of our patients and their families. But this is 2020. SARS-CoV-2, the causative agent of COVID-19, is still circulating. To make matters worse, cases are rising in 45 states and internationally. The day of this writing 102,831 new cases were reported in the United States. As we prepare for the holidays, it is time to rethink how safe it is to travel and/or gather with people who do not live in our household.

Social distancing, wearing masks, and hand washing have been strategies recommended to help mitigate the spread of the virus. We know adherence is not always 100%. The reality is that several families will consider traveling and gathering with others over the holidays. Their actions may lead to increased infections, hospitalizations, and even deaths. It behooves us to at least remind them of the potential consequences of the activity, and if travel and/or holiday gatherings are inevitable, to provide some guidance to help them look at both the risks and benefits and offer strategies to minimize infection and spread.
 

What should be considered prior to travel?

Here is a list of points to ponder:

• Is your patient is in a high-risk group for developing severe disease or visiting someone who is in a high-risk group?
• What is their mode of transportation?
• What is their destination?
• How prevalent is the disease at their destination, compared with their community?
• What will be their accommodations?
• How will attendees prepare for the gathering, if at all?
• Will multiple families congregate after quarantining for 2 weeks or simply arrive?
• At the destination, will people wear masks and socially distance?
• Is an outdoor venue an option?

All of these questions should be considered by patients.
 

Review high-risk groups

In terms of high-risk groups, we usually focus on underlying medical conditions or extremes of age, but Black and LatinX children and their families have been diagnosed with COVID-19 and hospitalized more frequently than other racial/ ethnic groups in the United States. Of 277,285 school-aged children infected between March 1 and Sept. 19, 2020, 42% were LatinX, 32% White, and 17% Black, yet they comprise 18%, 60%, and 11% of the U.S. population, respectively. Of those hospitalized, 45% were LatinX, 22% White, and 24% Black. LatinX and Black children also have disproportionately higher mortality rates.

Think about transmission and how to mitigate it

Many patients erroneously think combining multiple households for small group gatherings is inconsequential. These types of gatherings serve as a continued source of SARS-CoV-2 spread. For example, a person in Illinois with mild upper respiratory infection symptoms attended a funeral; he reported embracing the family members after the funeral. He dined with two people the evening prior to the funeral, sharing the meal using common serving dishes. Four days later, he attended a birthday party with nine family members. Some of the family members with symptoms subsequently attended church, infecting another church attendee. A cluster of 16 cases of COVID-19 was subsequently identified, including three deaths likely resulting from this one introduction of COVID-19 at these two family gatherings.

In Tennessee and Wisconsin, household transmission of SARS-CoV-2 was studied prospectively. A total of 101 index cases and 191 asymptomatic household contacts were enrolled between April and Sept. 2020; 102 of 191 (53%) had SARS-CoV-2 detected during the 14-day follow-up. Most infections (75%) were identified within 5 days and occurred whether the index case was an adult or child.

Lastly, one adolescent was identified as the source for an outbreak at a family gathering where 15 persons from five households and four states shared a house between 8 and 25 days in July 2020. Six additional members visited the house. The index case had an exposure to COVID-19 and had a negative antigen test 4 days after exposure. She was asymptomatic when tested. She developed nasal congestion 2 days later, the same day she and her family departed for the gathering. A total of 11 household contacts developed confirmed, suspected, or probable COVID-19, and the teen developed symptoms. This report illustrates how easily SARS-CoV-2 is transmitted, and how when implemented, mitigation strategies work because none of the six who only visited the house was infected. It also serves as a reminder that antigen testing is indicated only for use within the first 5-12 days of onset of symptoms. In this case, the adolescent was asymptomatic when tested and had a false-negative test result.
 

Ponder modes of transportation

How will your patient arrive to their holiday destination? Nonstop travel by car with household members is probably the safest way. However, for many families, buses and trains are the only options, and social distancing may be challenging. Air travel is a must for others. Acquisition of COVID-19 during air travel appears to be low, but not absent based on how air enters and leaves the cabin. The challenge is socially distancing throughout the check in and boarding processes, as well as minimizing contact with common surfaces. There also is loss of social distancing once on board. Ideally, masks should be worn during the flight. Additionally, for those with international destinations, most countries now require a negative polymerase chain reaction COVID-19 test within a specified time frame for entry.

Essentially the safest place for your patients during the holidays is celebrating at home with their household contacts. The risk for disease acquisition increases with travel. You will not have the opportunity to discuss holiday plans with most parents. However, you can encourage them to consider the pros and cons of travel with reminders via telephone, e-mail, and /or social messaging directly from your practices similar to those sent for other medically necessary interventions. As for me, I will be celebrating virtually this year. There is a first time for everything.

For additional information that also is patient friendly, the Centers for Disease Control and Prevention offers information about travel within the United States and international travel.
 

Dr. Word is a pediatric infectious disease specialist and director of the Houston Travel Medicine Clinic. She said she had no relevant financial disclosures. Email her at [email protected].

With this week’s announcement that Pfizer’s vaccine candidate against SARS-CoV-2 was 90% effective in preventing COVID-19, the world is one step closer to an effective vaccine.

Nevertheless, with a limited supply of initial doses, the question becomes, who should get it first? Individuals with severe mental illness should be a priority group to receive a COVID-19 vaccine, assert the authors of a perspective article published Nov. 1 in World Psychiatry.

Patients with underlying physical conditions, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes, chronic kidney disease, obesity, immunodeficiency, and cancer, are particularly vulnerable to developing more severe illness and dying from COVID-19.

In these populations, the risk of a more severe course of infection or early death is significant enough for the U.S. National Academies of Sciences, Engineering, and Medicine to make these patients priority recipients of a vaccine against COVID-19.

Marc De Hert, MD, PhD, professor of psychiatry at KU Leuven (Belgium), and coauthors argued that those with severe mental illness also fit into this group.

Even without factoring COVID-19 into the calculation, those with severe mental illness have a two- to threefold higher mortality rate than the general population, resulting in reduction in life expectancy of 10-20 years, they noted. This is largely because of physical diseases including cardiovascular disease, type 2 diabetes, and respiratory ailments.

Individuals with severe mental illness also have higher rates of obesity than the general population and obesity is a risk factor for dying from COVID-19.
 

High-risk population

Like their peers with physical illnesses, recent studies suggest that those with severe mental illness are also at increased risk of morbidity and mortality from COVID-19.

For example, a recent U.S. case-control study with over 61 million adults showed that those recently diagnosed with a mental health disorder had a significantly increased risk for COVID-19 infection, an effect strongest for depression and schizophrenia.

Other recent studies have confirmed these data, including one linking a psychiatric diagnosis in patients hospitalized with COVID-19 to a significantly increased risk for death, as reported by Medscape Medical News.

Dr. De Hert and colleagues put these findings into perspective with this example: In 2017, there were an estimated 11.2 million adults in the United States with severe mental illness. Taking into account the 8.5% death rate in COVID-19 patients recently diagnosed with a severe mental illness, this means that about 1 million patients with severe mental illness in the United States would die if all were infected with the virus.

In light of this knowledge, and taking into account published ethical principles that should guide vaccine allocation, Dr. De Hert and colleagues said it is “paramount” that persons with severe mental illness be prioritized to guarantee that they receive a COVID-19 vaccine during the first phase of its distribution.

“It is our responsibility as psychiatrists in this global health crisis to advocate for the needs of our patients with governments and public health policy bodies,” they wrote.

The authors also encourage public health agencies to develop and implement targeted programs to ensure that patients with severe mental illness and their health care providers “are made aware of these increased risks as well as the benefits of vaccination.”
 

An argument for fairness

Paul S. Appelbaum, MD, professor of psychiatry, medicine, and law at Columbia University, New York, also believes those with severe mental illness should be a priority group for a COVID vaccine.

“When we’re prioritizing groups for a COVID-19 vaccine, let’s not forget that people with serious mental illness have much lower life expectancies, more obesity, and more undiagnosed chronic conditions. They should be a priority group,” Dr. Appelbaum said in an interview.

“The argument for including people with severe mental illnesses among the vulnerable populations who should be prioritized for receipt of a COVID-19 vaccine is an argument for fairness in constructing that group,” he added.

“Like people with other chronic conditions associated with poor outcomes after SARS-CoV-2 infection, people with severe mental illnesses are more likely to be hospitalized and more likely to die. Although they are often systematically ignored when decisions are made about allocation of resources, there is some hope that, with enough public attention to this issue, they can be included this time,” Dr. Appelbaum said.

Dr. De Hert and Dr. Applebaum disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

With this week’s announcement that Pfizer’s vaccine candidate against SARS-CoV-2 was 90% effective in preventing COVID-19, the world is one step closer to an effective vaccine.

Nevertheless, with a limited supply of initial doses, the question becomes, who should get it first? Individuals with severe mental illness should be a priority group to receive a COVID-19 vaccine, assert the authors of a perspective article published Nov. 1 in World Psychiatry.

Patients with underlying physical conditions, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes, chronic kidney disease, obesity, immunodeficiency, and cancer, are particularly vulnerable to developing more severe illness and dying from COVID-19.

In these populations, the risk of a more severe course of infection or early death is significant enough for the U.S. National Academies of Sciences, Engineering, and Medicine to make these patients priority recipients of a vaccine against COVID-19.

Marc De Hert, MD, PhD, professor of psychiatry at KU Leuven (Belgium), and coauthors argued that those with severe mental illness also fit into this group.

Even without factoring COVID-19 into the calculation, those with severe mental illness have a two- to threefold higher mortality rate than the general population, resulting in reduction in life expectancy of 10-20 years, they noted. This is largely because of physical diseases including cardiovascular disease, type 2 diabetes, and respiratory ailments.

Individuals with severe mental illness also have higher rates of obesity than the general population and obesity is a risk factor for dying from COVID-19.
 

High-risk population

Like their peers with physical illnesses, recent studies suggest that those with severe mental illness are also at increased risk of morbidity and mortality from COVID-19.

For example, a recent U.S. case-control study with over 61 million adults showed that those recently diagnosed with a mental health disorder had a significantly increased risk for COVID-19 infection, an effect strongest for depression and schizophrenia.

Other recent studies have confirmed these data, including one linking a psychiatric diagnosis in patients hospitalized with COVID-19 to a significantly increased risk for death, as reported by Medscape Medical News.

Dr. De Hert and colleagues put these findings into perspective with this example: In 2017, there were an estimated 11.2 million adults in the United States with severe mental illness. Taking into account the 8.5% death rate in COVID-19 patients recently diagnosed with a severe mental illness, this means that about 1 million patients with severe mental illness in the United States would die if all were infected with the virus.

In light of this knowledge, and taking into account published ethical principles that should guide vaccine allocation, Dr. De Hert and colleagues said it is “paramount” that persons with severe mental illness be prioritized to guarantee that they receive a COVID-19 vaccine during the first phase of its distribution.

“It is our responsibility as psychiatrists in this global health crisis to advocate for the needs of our patients with governments and public health policy bodies,” they wrote.

The authors also encourage public health agencies to develop and implement targeted programs to ensure that patients with severe mental illness and their health care providers “are made aware of these increased risks as well as the benefits of vaccination.”
 

An argument for fairness

Paul S. Appelbaum, MD, professor of psychiatry, medicine, and law at Columbia University, New York, also believes those with severe mental illness should be a priority group for a COVID vaccine.

“When we’re prioritizing groups for a COVID-19 vaccine, let’s not forget that people with serious mental illness have much lower life expectancies, more obesity, and more undiagnosed chronic conditions. They should be a priority group,” Dr. Appelbaum said in an interview.

“The argument for including people with severe mental illnesses among the vulnerable populations who should be prioritized for receipt of a COVID-19 vaccine is an argument for fairness in constructing that group,” he added.

“Like people with other chronic conditions associated with poor outcomes after SARS-CoV-2 infection, people with severe mental illnesses are more likely to be hospitalized and more likely to die. Although they are often systematically ignored when decisions are made about allocation of resources, there is some hope that, with enough public attention to this issue, they can be included this time,” Dr. Appelbaum said.

Dr. De Hert and Dr. Applebaum disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

With this week’s announcement that Pfizer’s vaccine candidate against SARS-CoV-2 was 90% effective in preventing COVID-19, the world is one step closer to an effective vaccine.

Nevertheless, with a limited supply of initial doses, the question becomes, who should get it first? Individuals with severe mental illness should be a priority group to receive a COVID-19 vaccine, assert the authors of a perspective article published Nov. 1 in World Psychiatry.

Patients with underlying physical conditions, such as cardiovascular disease, chronic obstructive pulmonary disease, diabetes, chronic kidney disease, obesity, immunodeficiency, and cancer, are particularly vulnerable to developing more severe illness and dying from COVID-19.

In these populations, the risk of a more severe course of infection or early death is significant enough for the U.S. National Academies of Sciences, Engineering, and Medicine to make these patients priority recipients of a vaccine against COVID-19.

Marc De Hert, MD, PhD, professor of psychiatry at KU Leuven (Belgium), and coauthors argued that those with severe mental illness also fit into this group.

Even without factoring COVID-19 into the calculation, those with severe mental illness have a two- to threefold higher mortality rate than the general population, resulting in reduction in life expectancy of 10-20 years, they noted. This is largely because of physical diseases including cardiovascular disease, type 2 diabetes, and respiratory ailments.

Individuals with severe mental illness also have higher rates of obesity than the general population and obesity is a risk factor for dying from COVID-19.
 

High-risk population

Like their peers with physical illnesses, recent studies suggest that those with severe mental illness are also at increased risk of morbidity and mortality from COVID-19.

For example, a recent U.S. case-control study with over 61 million adults showed that those recently diagnosed with a mental health disorder had a significantly increased risk for COVID-19 infection, an effect strongest for depression and schizophrenia.

Other recent studies have confirmed these data, including one linking a psychiatric diagnosis in patients hospitalized with COVID-19 to a significantly increased risk for death, as reported by Medscape Medical News.

Dr. De Hert and colleagues put these findings into perspective with this example: In 2017, there were an estimated 11.2 million adults in the United States with severe mental illness. Taking into account the 8.5% death rate in COVID-19 patients recently diagnosed with a severe mental illness, this means that about 1 million patients with severe mental illness in the United States would die if all were infected with the virus.

In light of this knowledge, and taking into account published ethical principles that should guide vaccine allocation, Dr. De Hert and colleagues said it is “paramount” that persons with severe mental illness be prioritized to guarantee that they receive a COVID-19 vaccine during the first phase of its distribution.

“It is our responsibility as psychiatrists in this global health crisis to advocate for the needs of our patients with governments and public health policy bodies,” they wrote.

The authors also encourage public health agencies to develop and implement targeted programs to ensure that patients with severe mental illness and their health care providers “are made aware of these increased risks as well as the benefits of vaccination.”
 

An argument for fairness

Paul S. Appelbaum, MD, professor of psychiatry, medicine, and law at Columbia University, New York, also believes those with severe mental illness should be a priority group for a COVID vaccine.

“When we’re prioritizing groups for a COVID-19 vaccine, let’s not forget that people with serious mental illness have much lower life expectancies, more obesity, and more undiagnosed chronic conditions. They should be a priority group,” Dr. Appelbaum said in an interview.

“The argument for including people with severe mental illnesses among the vulnerable populations who should be prioritized for receipt of a COVID-19 vaccine is an argument for fairness in constructing that group,” he added.

“Like people with other chronic conditions associated with poor outcomes after SARS-CoV-2 infection, people with severe mental illnesses are more likely to be hospitalized and more likely to die. Although they are often systematically ignored when decisions are made about allocation of resources, there is some hope that, with enough public attention to this issue, they can be included this time,” Dr. Appelbaum said.

Dr. De Hert and Dr. Applebaum disclosed no relevant financial relationships.

This article first appeared on Medscape.com.

Cardiologists are already old hands at virtual meetings this year and are fast becoming experts on Zoom and other teleconferencing platforms, if not on how to unmute their microphones.

With expectations perhaps elevated and the new communications genre’s novelty on the wane, the American Heart Association (AHA) Scientific Sessions 2020 has a chance to both innovate with familiar formats and captivate with the field’s latest research findings.

Although the virtual AHA 2020 might not satisfy longings for face-to-face networking, shop talk, or kidding around over coffee, it will feature many traditional elements of the live conferences adapted for ear buds and small screens. They include late-breaking science (LBS) presentations and panel discussions, poster and live oral abstract presentations, meet-the-trialist talks, fireside-chat discussion forums, early career events, and satellite symposia.

The event may well hold lessons for future iterations of AHA Scientific Sessions in the postpandemic world, which some foresee as, potentially, an amalgam of the time-honored live format and a robust, complementary online presence.

Late-Breaking Science 1. Friday, November 13, 10:30 AM - 11:30 AM CST

The LBS sessions launch with the GALACTIC-HF trial, which — the world recently learned — may expand the burgeoning list of meds shown to improve clinical outcomes in chronic heart failure (HF) with reduced ejection fraction (HFrEF).

In cursory top-line results announced last month, those in the trial of more than 8000 patients who were randomly assigned to receive omecamtiv mecarbil (Amgen/Cytokinetics/Servier) showed a slight but significant benefit for the primary end point of cardiovascular (CV) death or HF events. The hazard ratio (HR), compared with standard care, was 0.92 (95% CI, 0.86 - 0.99; P = .025), noted a press release from Amgen.

Among the announcement’s few other details was a short take on safety outcomes: no difference in risk for “adverse events, including major ischemic cardiac events,” between the active and control groups. The presentation is sure to provide further insights and caveats, if any, along with other information crucial to the study’s interpretation.

Next on the schedule is the closely watched AFFIRM-AHF, billed as the first major outcomes trial of iron administration to iron-deficient patients with acute HF. It randomly assigned more than 1000 such patients to receive IV ferric carboxymaltose or a placebo. The first dose was given in-hospital and subsequent doses at home for 24 weeks or until patients were no longer iron deficient. They were followed to 1 year for the primary end point of recurrent HF hospitalizations or CV death.

The session wraps with the VITAL Rhythm trial, a substudy of the doubly randomized VITAL trial that explored the effects of vitamin D and omega-3 fatty acid supplementation on CV and cancer risk in more than 25,000 patients in the community. The substudy explored the effects of two active therapies, a preparation of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) (Omacor, Reliant Pharmaceuticals) or vitamin D3 supplements, on new-onset atrial fibrillation (AF) as the primary end point; it also looked at risk for sudden death.
 

Late-Breaking Science 2. Friday, November 13, 12:00 PM - 1:00 PM CST

Dominating the session in two presentations, the (TIPS)-3 trial explored a polypill primary-prevention strategy and daily aspirin with vitamin D supplementation in three separate placebo-controlled comparisons in more than 5700 “intermediate risk” participants 55 years and older, mostly in developing countries.

The daily polypill in this trial is a combination of hydrochlorothiazide 25 mg, atenolol 100 mg, ramipril 10 mg, and simvastatin 40 mg; aspirin was given at 75 mg daily and vitamin D at 60,000 IU monthly.

The participants are followed for a primary end point composed of major CV disease, HF, resuscitated cardiac arrest, or ischemia-driven revascularization for the polypill comparison; CV events or cancer for the aspirin comparison; and fracture risk for the vitamin D component of the trial.

In the Swedish Cardiopulmonary Bioimage Study (SCAPIS), presented third in the session, a random sample of adults from throughout Sweden, projected at about 30,000, underwent a 2-day evaluation for metabolic risk factors plus ultrasound and coronary and lung CT scans. The group has been followed for risks for myocardial infarction (MI), sudden death, and other cardiac diseases; and chronic obstructive pulmonary disease (COPD) and other lung disorders.
 

Late-Breaking Science 3. Saturday, November 14, 12:00 PM - 1:00 PM CST

The field may learn more mechanistically about MI associated with nonobstructed coronary arteries (MINOCA) than ever before from the Heart Attack Research Program-Imaging Study (HARP). The observational study is enrolling a projected 450 patients with suspected MI and ischemic symptoms who were referred for cardiac catheterization.

Their evaluation includes coronary optical coherence tomographic (OCT) scanning and cardiac magnetic resonance (CMR) imaging for evidence of coronary plaque disruption as the primary end point. The patients are to be followed for 10 years for a composite of death, unstable angina, stroke, recurrent MI, diagnostic or interventional catheterization, and cardiac hospitalization.

The major direct oral anticoagulant (DOAC) comparisons with warfarin in atrial fibrillation (AF) didn’t include many patients with prosthetic valve implants. In contrast, the RIVER trial enrolled 1005 adults with either persistent or paroxysmal AF and bioprosthetic mitral valves and assigned them to rivaroxaban 20 mg or the vitamin K antagonist.

The presentation will include the noninferiority primary outcome of major clinical events, which is stroke, transient ischemic attack (TIA), major bleeding, death from any cause, valve thrombosis, other systemic embolism, or HF hospitalization over 12 months.

This session also includes ALPHEUS, a trial pitting ticagrelor (Brilinta/Brilique, AstraZeneca) against mainstay clopidogrel in a setting that is mostly uncharted for such comparisons, elective percutaneous coronary intervention (PCI).

About 1900 patients with stable coronary disease were randomly assigned to a month of treatment with either agent on top of continuous aspirin. The primary end point is PCI-related MI or myocardial injury within 48 hours of the procedure.
 

Late-Breaking Science 4. Sunday, November 15, 9:00 AM - 10:00 AM CST

The Self-Assessment Method for Statin Side-effects Or Nocebo (SAMSON) trial may be one of the AHA 2020 frontrunners for early buzz and anticipation. So it’s with some irony that it’s also among the smallest of the LBS studies, at 60 patients, which was nonetheless considered sufficient due to its unusual design.

SAMSON is the latest and perhaps most rigorous attempt to clarify whether symptoms, especially muscle pain or discomfort, attributed to statins by many patients are pharmacologic in origin or, rather, a nocebo effect from negative expectations about statin side effects.

The study patients, all of whom had previously halted statins because of side effects, were assigned to follow three separate regimens, each for month, in a randomized order; they did that four times, for a total of 12 months. The regimens consisted of atorvastatin 20 mg daily, a placebo, or neither.

Patients kept daily logs of any perceived side effects. Parity between side effects experienced on the statin and the placebo would point to a nocebo effect, whereas a significant excess on atorvastatin would suggest they are direct drug effects.

The session also features two randomized trials each on a unique omega-3 fatty acid preparation for either secondary prevention or high-risk primary prevention, in both cases compared with a corn-oil placebo.

The Omega-3 Fatty Acids in Elderly Patients with Myocardial Infarction (OMEMI) trial randomly assigned more than 1000 elderly post-MI patients to take Pikasol (Orkla Care) at 1.8 g EPA and DHA per day or the placebo. It looked for all-cause mortality, nonfatal MI, stroke, revascularization, or hospitalization for new or worsened HF over 24 months.

The STRENGTH trial, with a planned enrollment of about 13,000 high-vascular-risk patients, looked primarily at the effect of daily treatment with Epanova (AstraZeneca), which also contains DHA and EPA, on the composite of CV death, nonfatal MI or stroke, coronary revascularization, and hospitalization for unstable angina. The trial was halted early for low likelihood of benefit, AstraZeneca announced in January of this year.
 

Late-Breaking Science 5. Sunday, November 15, 7:15 PM - 8:30 PM CST

Slated for the session is the primary analysis of the PIONEER 3 trial, conducted in the United States, Europe, and Japan. It compared the BuMA Supreme biodegradable drug-coated stent (SinoMed) with the durable Xience (Abbott Vascular) and Promus (Boston Scientific) drug-eluting stents. The trial followed more than 1600 patients treated for chronic stable angina or acute coronary syndrome (ACS) for the 1-year composite of cardiac death, target-vessel-related MI, and clinically driven target-lesion revascularization.
 

Late-Breaking Science 6. Monday, November 16, 9:00 AM - 10:00 AM CST

The EARLY-AF trial enrolled 303 patients with symptomatic paroxysmal or persistent AF suitable for catheter ablation, assigning them to pulmonary vein isolation (PVI) by cryoablation using the Arctic Front (Medtronic) system or antiarrhythmic drug therapy for rhythm control. The primary end point is time to recurrence of AF, atrial flutter, or atrial tachycardia, whether symptomatic or asymptomatic, as determined by implantable loop recorder. Patients will also be followed for symptoms and arrhythmia burden.

Also in the session, the SEARCH-AF study randomized almost 400 patients undergoing cardiac surgery who were engaged subacutely with one of two commercial portable cardiac rhythm monitoring devices (CardioSTAT, Icentia; or SEEQ, Medtronic) or, alternatively, to receive usual postoperative care

The patients, considered to be at high risk for stroke with no history of AF, were followed for the primary end point of cumulative burden of AF or atrial flutter exceeding 6 minutes or documentation of either arrhythmia by 12-lead ECG within 30 days.

Two other studies in the session look at different approaches to AF screening, one using a handheld ECG monitor in the primary care setting and the other wearable monitors in the form of a patch or wristband. The VITAL-AF presentation is titled “Screening for Atrial Fibrillation in Older Adults at Primary Care Visits Using Single Lead Electrocardiograms.” The other presentation, on the study mSToPS, is called “Three-Year Clinical Outcomes in a Nationwide, Randomized, Pragmatic Clinical Trial of Atrial Fibrillation Screening — Mhealth Screening to Prevent Strokes.”
 

Late-Breaking Science 7. Monday, November 16, 7:00 PM - 8:30 PM CST

In the randomized FIDELIO-DKD trial with more than 5700 patients with type 2 diabetes and associated kidney disease, those assigned to the novel mineralocorticoid receptor antagonist (MRA) finerenone (Bayer) showed an 18% drop in risk for adverse renal events, including death from renal causes (P = .001), over a median of 2.6 years. That primary outcome was previously presented in detail at a nephrology meeting and published in the New England Journal of Medicine in October.

Patients on the MRA showed a similar reduction in a composite CV-event end point, it was also reported at that time. A follow-up presentation at the AHA sessions promises to dive deeper into the trial’s CV outcomes.

In the RAPID-CTCA study, slated next for the session, 1749 patients with suspected or confirmed intermediate-risk ACS were randomly assigned to undergo computed tomographic coronary angiography (CTCA) for guiding treatment decisions or a standard-of-care strategy. It followed patients for the primary end point of death or nonfatal MI over 1 year.

Rilonacept (Arcalyst, Kiniksa/Regeneron) is an interleukin-1α and -1β inhibitor used in several autoinflammatory diseases that went unsuccessfully before regulators for the treatment of gout. The RHAPSODY trial has now explored its use against recurrent pericarditis in a randomized trial that entered 86 patients 12 years and older who had previously experienced at least three episodes.

In top-line results reported to investors in June, patients assigned to receive the drug instead of placebo in weekly injections showed a 96% drop in risk for pericarditis recurrence and “no or minimal pain” on more than 90% of days in the trial. A full presentation is expected during this LBS session.

Also on the schedule is the THALES study, which led the US Food and Drug Administration (FDA) to expand indications for ticagrelor to include stroke prevention in patients with a history of acute ischemic stroke or high-risk TIA based on the trial’s primary results published in July.

In THALES, more than 11,000 patients with mild to moderate acute noncardiogenic ischemic stroke or TIA were randomly assigned within 24 hours to start on daily aspirin with or without ticagrelor given as a 180 mg loading dose followed by 90 mg twice daily for 30 days.

At the end of a month, it was reported, those on dual antiplatelet therapy showed a 17% risk reduction (P = .02) for the primary end point of stroke or death, at the cost of a slight but significant increase in “severe” bleeding (0.5% vs 0.1%; P = .001).

The session is to conclude with two related studies that fell victim in part to the COVID-19 pandemic, both of which explored sotagliflozin (Zynquista, Sanofi/Lexicon), an inhibitor of both sodium-glucose cotransporters 1 and 2 (SGLT1 and SGLT2, respectively) in patients with type 2 diabetes.

SOLOIST-WHF had entered 1222 such patients hospitalized with urgent or worsening HF at 466 centers and randomly assigned them to receive sotagliflozin or placebo; they were followed for the composite of CV death or HF events. SCORED reached an enrollment of 10,584 patients with diabetes and chronic kidney disease at 754 hospitals, following them for the same primary end point.

Lexicon announced in March that the trials would be “closed out early” because of the unavailability of funding “together with uncertainties relating to the COVID-19 pandemic on the trials.” The LBS presentation is expected to include analyses of available data; SOLOIST-WHF launched in summer 2018 and SCORED began in November 2017.
 

Late-Breaking Science 8. Tuesday, November 17, 9:00 AM - 10:00 AM CST

Most of this LBS session is devoted to the AHA COVID-19 Cardiovascular Disease registry, which is looking at the hospital journey, clinical course, and outcomes of patients hospitalized with SARS-CoV-2 infections at centers participating in the organization’s Get With The Guidelines (GWTG) quality-improvement program. As of September, the registry included data from more than 15,000 patients.

Scheduled presentations include a summary of the registry’s design and initial results; an analysis of racial and ethnic variation in therapy and clinical outcomes; an exploration of how body mass index influenced outcomes, including death, use of mechanical ventilation, and cardiovascular end points, in patients with COVID-19; and a deep dive into the relation between CV disease and clinical outcomes in the cohort.

The last of this LBS block’s five talks will cover the randomized Influenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated Heart Failure (INVESTED) trial, which compared vaccination with high-dose trivalent influenza vaccine or a standard-dose quadrivalent vaccine in 5388 adults with a history of hospitalization for either MI or HF. Patients were required to have at least one other CV risk factor, such as older age, reduced left ventricular ejection fraction, or diabetes.

INVESTED tracked the patients at 190 centers across an initial pilot flu season and three subsequent flu seasons for the primary end point of death from any cause or cardiopulmonary hospitalization.

The trial is one of at least three that have been looking at the effect of flu vaccination on cardiovascular outcomes; results from the other two — IAMI, with more than 2500 participants, and RCT-IVVE, with an enrollment of 4871 — are planned for presentation in 2021, theheart.org | Medscape Cardiology recently reported.
 

Late-Breaking Science 9. Tuesday, November 17, 12:00 PM - 1:00 PM CST

The conference’s concluding LBS session features three studies that relied on technologic strategies for modifying patient compliance and other care behaviors and one that used human-centered design principles to develop a group-care model aimed improving the management of diabetes, hypertension, and other noncommunicable diseases in economically disadvantaged regions of Kenya.

The EPIC-HF trial tested a strategy for improving HFrEF medication-plan engagement by use of a video and documents delivered to patients several times by email or text prior to their follow-up clinic appointments. The strategy was compared with usual care for its effect on HF-medication optimization over 1 month and 1 year in a total of 306 patients.

Following EPIC-HF on the schedule is the MYROAD trial, looking at the efficacy of discharge instructions provided to patients with acute HF as an audio recording that they and their physicians could replay on demand, the idea being to increase adherence to the instructions. The trial’s 1073 patients were assigned to the novel strategy or usual care and followed for HF rehospitalization within 30 days.

MYROAD is to be followed by a presentation entitled “Digital Care Transformation: One-Year Report of >5,000 Patients Enrolled in a Remote Algorithm-Based CV Risk Management Program to Achieve Optimal Lipid and Hypertension Control.”

Rounding out the LBS session: the Bridging Income Generation With Group Integrated Care (BIGPIC) program, a pilot study that developed and executed “a healthcare delivery model targeting health behaviors, medication adherence, and financial barriers to accessing healthcare” in four rural counties in Kenya.

The model features locally developed plans, tailored for regional needs, that are said to “combine the benefits of microfinance with the peer support available through group medical care to enhance management of hypertension and diabetes.” The microfinance component is aimed at improving household economies to alleviate the financial burden of care and clinic attendance, and for the health effects of improved quality of life.

The study randomized 2890 adults with diabetes or prediabetes to one of four groups: usual care plus microfinance group support, group medical visits only or combined with microfinance group support, or usual care only. They were followed for changes in systolic blood pressure and CV-risk score over 12 months.

Lloyd-Jones and Fauci declared no conflicts.

This article first appeared on Medscape.com.

Cardiologists are already old hands at virtual meetings this year and are fast becoming experts on Zoom and other teleconferencing platforms, if not on how to unmute their microphones.

With expectations perhaps elevated and the new communications genre’s novelty on the wane, the American Heart Association (AHA) Scientific Sessions 2020 has a chance to both innovate with familiar formats and captivate with the field’s latest research findings.

Although the virtual AHA 2020 might not satisfy longings for face-to-face networking, shop talk, or kidding around over coffee, it will feature many traditional elements of the live conferences adapted for ear buds and small screens. They include late-breaking science (LBS) presentations and panel discussions, poster and live oral abstract presentations, meet-the-trialist talks, fireside-chat discussion forums, early career events, and satellite symposia.

The event may well hold lessons for future iterations of AHA Scientific Sessions in the postpandemic world, which some foresee as, potentially, an amalgam of the time-honored live format and a robust, complementary online presence.

Late-Breaking Science 1. Friday, November 13, 10:30 AM - 11:30 AM CST

The LBS sessions launch with the GALACTIC-HF trial, which — the world recently learned — may expand the burgeoning list of meds shown to improve clinical outcomes in chronic heart failure (HF) with reduced ejection fraction (HFrEF).

In cursory top-line results announced last month, those in the trial of more than 8000 patients who were randomly assigned to receive omecamtiv mecarbil (Amgen/Cytokinetics/Servier) showed a slight but significant benefit for the primary end point of cardiovascular (CV) death or HF events. The hazard ratio (HR), compared with standard care, was 0.92 (95% CI, 0.86 - 0.99; P = .025), noted a press release from Amgen.

Among the announcement’s few other details was a short take on safety outcomes: no difference in risk for “adverse events, including major ischemic cardiac events,” between the active and control groups. The presentation is sure to provide further insights and caveats, if any, along with other information crucial to the study’s interpretation.

Next on the schedule is the closely watched AFFIRM-AHF, billed as the first major outcomes trial of iron administration to iron-deficient patients with acute HF. It randomly assigned more than 1000 such patients to receive IV ferric carboxymaltose or a placebo. The first dose was given in-hospital and subsequent doses at home for 24 weeks or until patients were no longer iron deficient. They were followed to 1 year for the primary end point of recurrent HF hospitalizations or CV death.

The session wraps with the VITAL Rhythm trial, a substudy of the doubly randomized VITAL trial that explored the effects of vitamin D and omega-3 fatty acid supplementation on CV and cancer risk in more than 25,000 patients in the community. The substudy explored the effects of two active therapies, a preparation of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) (Omacor, Reliant Pharmaceuticals) or vitamin D3 supplements, on new-onset atrial fibrillation (AF) as the primary end point; it also looked at risk for sudden death.
 

Late-Breaking Science 2. Friday, November 13, 12:00 PM - 1:00 PM CST

Dominating the session in two presentations, the (TIPS)-3 trial explored a polypill primary-prevention strategy and daily aspirin with vitamin D supplementation in three separate placebo-controlled comparisons in more than 5700 “intermediate risk” participants 55 years and older, mostly in developing countries.

The daily polypill in this trial is a combination of hydrochlorothiazide 25 mg, atenolol 100 mg, ramipril 10 mg, and simvastatin 40 mg; aspirin was given at 75 mg daily and vitamin D at 60,000 IU monthly.

The participants are followed for a primary end point composed of major CV disease, HF, resuscitated cardiac arrest, or ischemia-driven revascularization for the polypill comparison; CV events or cancer for the aspirin comparison; and fracture risk for the vitamin D component of the trial.

In the Swedish Cardiopulmonary Bioimage Study (SCAPIS), presented third in the session, a random sample of adults from throughout Sweden, projected at about 30,000, underwent a 2-day evaluation for metabolic risk factors plus ultrasound and coronary and lung CT scans. The group has been followed for risks for myocardial infarction (MI), sudden death, and other cardiac diseases; and chronic obstructive pulmonary disease (COPD) and other lung disorders.
 

Late-Breaking Science 3. Saturday, November 14, 12:00 PM - 1:00 PM CST

The field may learn more mechanistically about MI associated with nonobstructed coronary arteries (MINOCA) than ever before from the Heart Attack Research Program-Imaging Study (HARP). The observational study is enrolling a projected 450 patients with suspected MI and ischemic symptoms who were referred for cardiac catheterization.

Their evaluation includes coronary optical coherence tomographic (OCT) scanning and cardiac magnetic resonance (CMR) imaging for evidence of coronary plaque disruption as the primary end point. The patients are to be followed for 10 years for a composite of death, unstable angina, stroke, recurrent MI, diagnostic or interventional catheterization, and cardiac hospitalization.

The major direct oral anticoagulant (DOAC) comparisons with warfarin in atrial fibrillation (AF) didn’t include many patients with prosthetic valve implants. In contrast, the RIVER trial enrolled 1005 adults with either persistent or paroxysmal AF and bioprosthetic mitral valves and assigned them to rivaroxaban 20 mg or the vitamin K antagonist.

The presentation will include the noninferiority primary outcome of major clinical events, which is stroke, transient ischemic attack (TIA), major bleeding, death from any cause, valve thrombosis, other systemic embolism, or HF hospitalization over 12 months.

This session also includes ALPHEUS, a trial pitting ticagrelor (Brilinta/Brilique, AstraZeneca) against mainstay clopidogrel in a setting that is mostly uncharted for such comparisons, elective percutaneous coronary intervention (PCI).

About 1900 patients with stable coronary disease were randomly assigned to a month of treatment with either agent on top of continuous aspirin. The primary end point is PCI-related MI or myocardial injury within 48 hours of the procedure.
 

Late-Breaking Science 4. Sunday, November 15, 9:00 AM - 10:00 AM CST

The Self-Assessment Method for Statin Side-effects Or Nocebo (SAMSON) trial may be one of the AHA 2020 frontrunners for early buzz and anticipation. So it’s with some irony that it’s also among the smallest of the LBS studies, at 60 patients, which was nonetheless considered sufficient due to its unusual design.

SAMSON is the latest and perhaps most rigorous attempt to clarify whether symptoms, especially muscle pain or discomfort, attributed to statins by many patients are pharmacologic in origin or, rather, a nocebo effect from negative expectations about statin side effects.

The study patients, all of whom had previously halted statins because of side effects, were assigned to follow three separate regimens, each for month, in a randomized order; they did that four times, for a total of 12 months. The regimens consisted of atorvastatin 20 mg daily, a placebo, or neither.

Patients kept daily logs of any perceived side effects. Parity between side effects experienced on the statin and the placebo would point to a nocebo effect, whereas a significant excess on atorvastatin would suggest they are direct drug effects.

The session also features two randomized trials each on a unique omega-3 fatty acid preparation for either secondary prevention or high-risk primary prevention, in both cases compared with a corn-oil placebo.

The Omega-3 Fatty Acids in Elderly Patients with Myocardial Infarction (OMEMI) trial randomly assigned more than 1000 elderly post-MI patients to take Pikasol (Orkla Care) at 1.8 g EPA and DHA per day or the placebo. It looked for all-cause mortality, nonfatal MI, stroke, revascularization, or hospitalization for new or worsened HF over 24 months.

The STRENGTH trial, with a planned enrollment of about 13,000 high-vascular-risk patients, looked primarily at the effect of daily treatment with Epanova (AstraZeneca), which also contains DHA and EPA, on the composite of CV death, nonfatal MI or stroke, coronary revascularization, and hospitalization for unstable angina. The trial was halted early for low likelihood of benefit, AstraZeneca announced in January of this year.
 

Late-Breaking Science 5. Sunday, November 15, 7:15 PM - 8:30 PM CST

Slated for the session is the primary analysis of the PIONEER 3 trial, conducted in the United States, Europe, and Japan. It compared the BuMA Supreme biodegradable drug-coated stent (SinoMed) with the durable Xience (Abbott Vascular) and Promus (Boston Scientific) drug-eluting stents. The trial followed more than 1600 patients treated for chronic stable angina or acute coronary syndrome (ACS) for the 1-year composite of cardiac death, target-vessel-related MI, and clinically driven target-lesion revascularization.
 

Late-Breaking Science 6. Monday, November 16, 9:00 AM - 10:00 AM CST

The EARLY-AF trial enrolled 303 patients with symptomatic paroxysmal or persistent AF suitable for catheter ablation, assigning them to pulmonary vein isolation (PVI) by cryoablation using the Arctic Front (Medtronic) system or antiarrhythmic drug therapy for rhythm control. The primary end point is time to recurrence of AF, atrial flutter, or atrial tachycardia, whether symptomatic or asymptomatic, as determined by implantable loop recorder. Patients will also be followed for symptoms and arrhythmia burden.

Also in the session, the SEARCH-AF study randomized almost 400 patients undergoing cardiac surgery who were engaged subacutely with one of two commercial portable cardiac rhythm monitoring devices (CardioSTAT, Icentia; or SEEQ, Medtronic) or, alternatively, to receive usual postoperative care

The patients, considered to be at high risk for stroke with no history of AF, were followed for the primary end point of cumulative burden of AF or atrial flutter exceeding 6 minutes or documentation of either arrhythmia by 12-lead ECG within 30 days.

Two other studies in the session look at different approaches to AF screening, one using a handheld ECG monitor in the primary care setting and the other wearable monitors in the form of a patch or wristband. The VITAL-AF presentation is titled “Screening for Atrial Fibrillation in Older Adults at Primary Care Visits Using Single Lead Electrocardiograms.” The other presentation, on the study mSToPS, is called “Three-Year Clinical Outcomes in a Nationwide, Randomized, Pragmatic Clinical Trial of Atrial Fibrillation Screening — Mhealth Screening to Prevent Strokes.”
 

Late-Breaking Science 7. Monday, November 16, 7:00 PM - 8:30 PM CST

In the randomized FIDELIO-DKD trial with more than 5700 patients with type 2 diabetes and associated kidney disease, those assigned to the novel mineralocorticoid receptor antagonist (MRA) finerenone (Bayer) showed an 18% drop in risk for adverse renal events, including death from renal causes (P = .001), over a median of 2.6 years. That primary outcome was previously presented in detail at a nephrology meeting and published in the New England Journal of Medicine in October.

Patients on the MRA showed a similar reduction in a composite CV-event end point, it was also reported at that time. A follow-up presentation at the AHA sessions promises to dive deeper into the trial’s CV outcomes.

In the RAPID-CTCA study, slated next for the session, 1749 patients with suspected or confirmed intermediate-risk ACS were randomly assigned to undergo computed tomographic coronary angiography (CTCA) for guiding treatment decisions or a standard-of-care strategy. It followed patients for the primary end point of death or nonfatal MI over 1 year.

Rilonacept (Arcalyst, Kiniksa/Regeneron) is an interleukin-1α and -1β inhibitor used in several autoinflammatory diseases that went unsuccessfully before regulators for the treatment of gout. The RHAPSODY trial has now explored its use against recurrent pericarditis in a randomized trial that entered 86 patients 12 years and older who had previously experienced at least three episodes.

In top-line results reported to investors in June, patients assigned to receive the drug instead of placebo in weekly injections showed a 96% drop in risk for pericarditis recurrence and “no or minimal pain” on more than 90% of days in the trial. A full presentation is expected during this LBS session.

Also on the schedule is the THALES study, which led the US Food and Drug Administration (FDA) to expand indications for ticagrelor to include stroke prevention in patients with a history of acute ischemic stroke or high-risk TIA based on the trial’s primary results published in July.

In THALES, more than 11,000 patients with mild to moderate acute noncardiogenic ischemic stroke or TIA were randomly assigned within 24 hours to start on daily aspirin with or without ticagrelor given as a 180 mg loading dose followed by 90 mg twice daily for 30 days.

At the end of a month, it was reported, those on dual antiplatelet therapy showed a 17% risk reduction (P = .02) for the primary end point of stroke or death, at the cost of a slight but significant increase in “severe” bleeding (0.5% vs 0.1%; P = .001).

The session is to conclude with two related studies that fell victim in part to the COVID-19 pandemic, both of which explored sotagliflozin (Zynquista, Sanofi/Lexicon), an inhibitor of both sodium-glucose cotransporters 1 and 2 (SGLT1 and SGLT2, respectively) in patients with type 2 diabetes.

SOLOIST-WHF had entered 1222 such patients hospitalized with urgent or worsening HF at 466 centers and randomly assigned them to receive sotagliflozin or placebo; they were followed for the composite of CV death or HF events. SCORED reached an enrollment of 10,584 patients with diabetes and chronic kidney disease at 754 hospitals, following them for the same primary end point.

Lexicon announced in March that the trials would be “closed out early” because of the unavailability of funding “together with uncertainties relating to the COVID-19 pandemic on the trials.” The LBS presentation is expected to include analyses of available data; SOLOIST-WHF launched in summer 2018 and SCORED began in November 2017.
 

Late-Breaking Science 8. Tuesday, November 17, 9:00 AM - 10:00 AM CST

Most of this LBS session is devoted to the AHA COVID-19 Cardiovascular Disease registry, which is looking at the hospital journey, clinical course, and outcomes of patients hospitalized with SARS-CoV-2 infections at centers participating in the organization’s Get With The Guidelines (GWTG) quality-improvement program. As of September, the registry included data from more than 15,000 patients.

Scheduled presentations include a summary of the registry’s design and initial results; an analysis of racial and ethnic variation in therapy and clinical outcomes; an exploration of how body mass index influenced outcomes, including death, use of mechanical ventilation, and cardiovascular end points, in patients with COVID-19; and a deep dive into the relation between CV disease and clinical outcomes in the cohort.

The last of this LBS block’s five talks will cover the randomized Influenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated Heart Failure (INVESTED) trial, which compared vaccination with high-dose trivalent influenza vaccine or a standard-dose quadrivalent vaccine in 5388 adults with a history of hospitalization for either MI or HF. Patients were required to have at least one other CV risk factor, such as older age, reduced left ventricular ejection fraction, or diabetes.

INVESTED tracked the patients at 190 centers across an initial pilot flu season and three subsequent flu seasons for the primary end point of death from any cause or cardiopulmonary hospitalization.

The trial is one of at least three that have been looking at the effect of flu vaccination on cardiovascular outcomes; results from the other two — IAMI, with more than 2500 participants, and RCT-IVVE, with an enrollment of 4871 — are planned for presentation in 2021, theheart.org | Medscape Cardiology recently reported.
 

Late-Breaking Science 9. Tuesday, November 17, 12:00 PM - 1:00 PM CST

The conference’s concluding LBS session features three studies that relied on technologic strategies for modifying patient compliance and other care behaviors and one that used human-centered design principles to develop a group-care model aimed improving the management of diabetes, hypertension, and other noncommunicable diseases in economically disadvantaged regions of Kenya.

The EPIC-HF trial tested a strategy for improving HFrEF medication-plan engagement by use of a video and documents delivered to patients several times by email or text prior to their follow-up clinic appointments. The strategy was compared with usual care for its effect on HF-medication optimization over 1 month and 1 year in a total of 306 patients.

Following EPIC-HF on the schedule is the MYROAD trial, looking at the efficacy of discharge instructions provided to patients with acute HF as an audio recording that they and their physicians could replay on demand, the idea being to increase adherence to the instructions. The trial’s 1073 patients were assigned to the novel strategy or usual care and followed for HF rehospitalization within 30 days.

MYROAD is to be followed by a presentation entitled “Digital Care Transformation: One-Year Report of >5,000 Patients Enrolled in a Remote Algorithm-Based CV Risk Management Program to Achieve Optimal Lipid and Hypertension Control.”

Rounding out the LBS session: the Bridging Income Generation With Group Integrated Care (BIGPIC) program, a pilot study that developed and executed “a healthcare delivery model targeting health behaviors, medication adherence, and financial barriers to accessing healthcare” in four rural counties in Kenya.

The model features locally developed plans, tailored for regional needs, that are said to “combine the benefits of microfinance with the peer support available through group medical care to enhance management of hypertension and diabetes.” The microfinance component is aimed at improving household economies to alleviate the financial burden of care and clinic attendance, and for the health effects of improved quality of life.

The study randomized 2890 adults with diabetes or prediabetes to one of four groups: usual care plus microfinance group support, group medical visits only or combined with microfinance group support, or usual care only. They were followed for changes in systolic blood pressure and CV-risk score over 12 months.

Lloyd-Jones and Fauci declared no conflicts.

This article first appeared on Medscape.com.

Cardiologists are already old hands at virtual meetings this year and are fast becoming experts on Zoom and other teleconferencing platforms, if not on how to unmute their microphones.

With expectations perhaps elevated and the new communications genre’s novelty on the wane, the American Heart Association (AHA) Scientific Sessions 2020 has a chance to both innovate with familiar formats and captivate with the field’s latest research findings.

Although the virtual AHA 2020 might not satisfy longings for face-to-face networking, shop talk, or kidding around over coffee, it will feature many traditional elements of the live conferences adapted for ear buds and small screens. They include late-breaking science (LBS) presentations and panel discussions, poster and live oral abstract presentations, meet-the-trialist talks, fireside-chat discussion forums, early career events, and satellite symposia.

The event may well hold lessons for future iterations of AHA Scientific Sessions in the postpandemic world, which some foresee as, potentially, an amalgam of the time-honored live format and a robust, complementary online presence.

Late-Breaking Science 1. Friday, November 13, 10:30 AM - 11:30 AM CST

The LBS sessions launch with the GALACTIC-HF trial, which — the world recently learned — may expand the burgeoning list of meds shown to improve clinical outcomes in chronic heart failure (HF) with reduced ejection fraction (HFrEF).

In cursory top-line results announced last month, those in the trial of more than 8000 patients who were randomly assigned to receive omecamtiv mecarbil (Amgen/Cytokinetics/Servier) showed a slight but significant benefit for the primary end point of cardiovascular (CV) death or HF events. The hazard ratio (HR), compared with standard care, was 0.92 (95% CI, 0.86 - 0.99; P = .025), noted a press release from Amgen.

Among the announcement’s few other details was a short take on safety outcomes: no difference in risk for “adverse events, including major ischemic cardiac events,” between the active and control groups. The presentation is sure to provide further insights and caveats, if any, along with other information crucial to the study’s interpretation.

Next on the schedule is the closely watched AFFIRM-AHF, billed as the first major outcomes trial of iron administration to iron-deficient patients with acute HF. It randomly assigned more than 1000 such patients to receive IV ferric carboxymaltose or a placebo. The first dose was given in-hospital and subsequent doses at home for 24 weeks or until patients were no longer iron deficient. They were followed to 1 year for the primary end point of recurrent HF hospitalizations or CV death.

The session wraps with the VITAL Rhythm trial, a substudy of the doubly randomized VITAL trial that explored the effects of vitamin D and omega-3 fatty acid supplementation on CV and cancer risk in more than 25,000 patients in the community. The substudy explored the effects of two active therapies, a preparation of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) (Omacor, Reliant Pharmaceuticals) or vitamin D3 supplements, on new-onset atrial fibrillation (AF) as the primary end point; it also looked at risk for sudden death.
 

Late-Breaking Science 2. Friday, November 13, 12:00 PM - 1:00 PM CST

Dominating the session in two presentations, the (TIPS)-3 trial explored a polypill primary-prevention strategy and daily aspirin with vitamin D supplementation in three separate placebo-controlled comparisons in more than 5700 “intermediate risk” participants 55 years and older, mostly in developing countries.

The daily polypill in this trial is a combination of hydrochlorothiazide 25 mg, atenolol 100 mg, ramipril 10 mg, and simvastatin 40 mg; aspirin was given at 75 mg daily and vitamin D at 60,000 IU monthly.

The participants are followed for a primary end point composed of major CV disease, HF, resuscitated cardiac arrest, or ischemia-driven revascularization for the polypill comparison; CV events or cancer for the aspirin comparison; and fracture risk for the vitamin D component of the trial.

In the Swedish Cardiopulmonary Bioimage Study (SCAPIS), presented third in the session, a random sample of adults from throughout Sweden, projected at about 30,000, underwent a 2-day evaluation for metabolic risk factors plus ultrasound and coronary and lung CT scans. The group has been followed for risks for myocardial infarction (MI), sudden death, and other cardiac diseases; and chronic obstructive pulmonary disease (COPD) and other lung disorders.
 

Late-Breaking Science 3. Saturday, November 14, 12:00 PM - 1:00 PM CST

The field may learn more mechanistically about MI associated with nonobstructed coronary arteries (MINOCA) than ever before from the Heart Attack Research Program-Imaging Study (HARP). The observational study is enrolling a projected 450 patients with suspected MI and ischemic symptoms who were referred for cardiac catheterization.

Their evaluation includes coronary optical coherence tomographic (OCT) scanning and cardiac magnetic resonance (CMR) imaging for evidence of coronary plaque disruption as the primary end point. The patients are to be followed for 10 years for a composite of death, unstable angina, stroke, recurrent MI, diagnostic or interventional catheterization, and cardiac hospitalization.

The major direct oral anticoagulant (DOAC) comparisons with warfarin in atrial fibrillation (AF) didn’t include many patients with prosthetic valve implants. In contrast, the RIVER trial enrolled 1005 adults with either persistent or paroxysmal AF and bioprosthetic mitral valves and assigned them to rivaroxaban 20 mg or the vitamin K antagonist.

The presentation will include the noninferiority primary outcome of major clinical events, which is stroke, transient ischemic attack (TIA), major bleeding, death from any cause, valve thrombosis, other systemic embolism, or HF hospitalization over 12 months.

This session also includes ALPHEUS, a trial pitting ticagrelor (Brilinta/Brilique, AstraZeneca) against mainstay clopidogrel in a setting that is mostly uncharted for such comparisons, elective percutaneous coronary intervention (PCI).

About 1900 patients with stable coronary disease were randomly assigned to a month of treatment with either agent on top of continuous aspirin. The primary end point is PCI-related MI or myocardial injury within 48 hours of the procedure.
 

Late-Breaking Science 4. Sunday, November 15, 9:00 AM - 10:00 AM CST

The Self-Assessment Method for Statin Side-effects Or Nocebo (SAMSON) trial may be one of the AHA 2020 frontrunners for early buzz and anticipation. So it’s with some irony that it’s also among the smallest of the LBS studies, at 60 patients, which was nonetheless considered sufficient due to its unusual design.

SAMSON is the latest and perhaps most rigorous attempt to clarify whether symptoms, especially muscle pain or discomfort, attributed to statins by many patients are pharmacologic in origin or, rather, a nocebo effect from negative expectations about statin side effects.

The study patients, all of whom had previously halted statins because of side effects, were assigned to follow three separate regimens, each for month, in a randomized order; they did that four times, for a total of 12 months. The regimens consisted of atorvastatin 20 mg daily, a placebo, or neither.

Patients kept daily logs of any perceived side effects. Parity between side effects experienced on the statin and the placebo would point to a nocebo effect, whereas a significant excess on atorvastatin would suggest they are direct drug effects.

The session also features two randomized trials each on a unique omega-3 fatty acid preparation for either secondary prevention or high-risk primary prevention, in both cases compared with a corn-oil placebo.

The Omega-3 Fatty Acids in Elderly Patients with Myocardial Infarction (OMEMI) trial randomly assigned more than 1000 elderly post-MI patients to take Pikasol (Orkla Care) at 1.8 g EPA and DHA per day or the placebo. It looked for all-cause mortality, nonfatal MI, stroke, revascularization, or hospitalization for new or worsened HF over 24 months.

The STRENGTH trial, with a planned enrollment of about 13,000 high-vascular-risk patients, looked primarily at the effect of daily treatment with Epanova (AstraZeneca), which also contains DHA and EPA, on the composite of CV death, nonfatal MI or stroke, coronary revascularization, and hospitalization for unstable angina. The trial was halted early for low likelihood of benefit, AstraZeneca announced in January of this year.
 

Late-Breaking Science 5. Sunday, November 15, 7:15 PM - 8:30 PM CST

Slated for the session is the primary analysis of the PIONEER 3 trial, conducted in the United States, Europe, and Japan. It compared the BuMA Supreme biodegradable drug-coated stent (SinoMed) with the durable Xience (Abbott Vascular) and Promus (Boston Scientific) drug-eluting stents. The trial followed more than 1600 patients treated for chronic stable angina or acute coronary syndrome (ACS) for the 1-year composite of cardiac death, target-vessel-related MI, and clinically driven target-lesion revascularization.
 

Late-Breaking Science 6. Monday, November 16, 9:00 AM - 10:00 AM CST

The EARLY-AF trial enrolled 303 patients with symptomatic paroxysmal or persistent AF suitable for catheter ablation, assigning them to pulmonary vein isolation (PVI) by cryoablation using the Arctic Front (Medtronic) system or antiarrhythmic drug therapy for rhythm control. The primary end point is time to recurrence of AF, atrial flutter, or atrial tachycardia, whether symptomatic or asymptomatic, as determined by implantable loop recorder. Patients will also be followed for symptoms and arrhythmia burden.

Also in the session, the SEARCH-AF study randomized almost 400 patients undergoing cardiac surgery who were engaged subacutely with one of two commercial portable cardiac rhythm monitoring devices (CardioSTAT, Icentia; or SEEQ, Medtronic) or, alternatively, to receive usual postoperative care

The patients, considered to be at high risk for stroke with no history of AF, were followed for the primary end point of cumulative burden of AF or atrial flutter exceeding 6 minutes or documentation of either arrhythmia by 12-lead ECG within 30 days.

Two other studies in the session look at different approaches to AF screening, one using a handheld ECG monitor in the primary care setting and the other wearable monitors in the form of a patch or wristband. The VITAL-AF presentation is titled “Screening for Atrial Fibrillation in Older Adults at Primary Care Visits Using Single Lead Electrocardiograms.” The other presentation, on the study mSToPS, is called “Three-Year Clinical Outcomes in a Nationwide, Randomized, Pragmatic Clinical Trial of Atrial Fibrillation Screening — Mhealth Screening to Prevent Strokes.”
 

Late-Breaking Science 7. Monday, November 16, 7:00 PM - 8:30 PM CST

In the randomized FIDELIO-DKD trial with more than 5700 patients with type 2 diabetes and associated kidney disease, those assigned to the novel mineralocorticoid receptor antagonist (MRA) finerenone (Bayer) showed an 18% drop in risk for adverse renal events, including death from renal causes (P = .001), over a median of 2.6 years. That primary outcome was previously presented in detail at a nephrology meeting and published in the New England Journal of Medicine in October.

Patients on the MRA showed a similar reduction in a composite CV-event end point, it was also reported at that time. A follow-up presentation at the AHA sessions promises to dive deeper into the trial’s CV outcomes.

In the RAPID-CTCA study, slated next for the session, 1749 patients with suspected or confirmed intermediate-risk ACS were randomly assigned to undergo computed tomographic coronary angiography (CTCA) for guiding treatment decisions or a standard-of-care strategy. It followed patients for the primary end point of death or nonfatal MI over 1 year.

Rilonacept (Arcalyst, Kiniksa/Regeneron) is an interleukin-1α and -1β inhibitor used in several autoinflammatory diseases that went unsuccessfully before regulators for the treatment of gout. The RHAPSODY trial has now explored its use against recurrent pericarditis in a randomized trial that entered 86 patients 12 years and older who had previously experienced at least three episodes.

In top-line results reported to investors in June, patients assigned to receive the drug instead of placebo in weekly injections showed a 96% drop in risk for pericarditis recurrence and “no or minimal pain” on more than 90% of days in the trial. A full presentation is expected during this LBS session.

Also on the schedule is the THALES study, which led the US Food and Drug Administration (FDA) to expand indications for ticagrelor to include stroke prevention in patients with a history of acute ischemic stroke or high-risk TIA based on the trial’s primary results published in July.

In THALES, more than 11,000 patients with mild to moderate acute noncardiogenic ischemic stroke or TIA were randomly assigned within 24 hours to start on daily aspirin with or without ticagrelor given as a 180 mg loading dose followed by 90 mg twice daily for 30 days.

At the end of a month, it was reported, those on dual antiplatelet therapy showed a 17% risk reduction (P = .02) for the primary end point of stroke or death, at the cost of a slight but significant increase in “severe” bleeding (0.5% vs 0.1%; P = .001).

The session is to conclude with two related studies that fell victim in part to the COVID-19 pandemic, both of which explored sotagliflozin (Zynquista, Sanofi/Lexicon), an inhibitor of both sodium-glucose cotransporters 1 and 2 (SGLT1 and SGLT2, respectively) in patients with type 2 diabetes.

SOLOIST-WHF had entered 1222 such patients hospitalized with urgent or worsening HF at 466 centers and randomly assigned them to receive sotagliflozin or placebo; they were followed for the composite of CV death or HF events. SCORED reached an enrollment of 10,584 patients with diabetes and chronic kidney disease at 754 hospitals, following them for the same primary end point.

Lexicon announced in March that the trials would be “closed out early” because of the unavailability of funding “together with uncertainties relating to the COVID-19 pandemic on the trials.” The LBS presentation is expected to include analyses of available data; SOLOIST-WHF launched in summer 2018 and SCORED began in November 2017.
 

Late-Breaking Science 8. Tuesday, November 17, 9:00 AM - 10:00 AM CST

Most of this LBS session is devoted to the AHA COVID-19 Cardiovascular Disease registry, which is looking at the hospital journey, clinical course, and outcomes of patients hospitalized with SARS-CoV-2 infections at centers participating in the organization’s Get With The Guidelines (GWTG) quality-improvement program. As of September, the registry included data from more than 15,000 patients.

Scheduled presentations include a summary of the registry’s design and initial results; an analysis of racial and ethnic variation in therapy and clinical outcomes; an exploration of how body mass index influenced outcomes, including death, use of mechanical ventilation, and cardiovascular end points, in patients with COVID-19; and a deep dive into the relation between CV disease and clinical outcomes in the cohort.

The last of this LBS block’s five talks will cover the randomized Influenza Vaccine to Effectively Stop Cardio Thoracic Events and Decompensated Heart Failure (INVESTED) trial, which compared vaccination with high-dose trivalent influenza vaccine or a standard-dose quadrivalent vaccine in 5388 adults with a history of hospitalization for either MI or HF. Patients were required to have at least one other CV risk factor, such as older age, reduced left ventricular ejection fraction, or diabetes.

INVESTED tracked the patients at 190 centers across an initial pilot flu season and three subsequent flu seasons for the primary end point of death from any cause or cardiopulmonary hospitalization.

The trial is one of at least three that have been looking at the effect of flu vaccination on cardiovascular outcomes; results from the other two — IAMI, with more than 2500 participants, and RCT-IVVE, with an enrollment of 4871 — are planned for presentation in 2021, theheart.org | Medscape Cardiology recently reported.
 

Late-Breaking Science 9. Tuesday, November 17, 12:00 PM - 1:00 PM CST

The conference’s concluding LBS session features three studies that relied on technologic strategies for modifying patient compliance and other care behaviors and one that used human-centered design principles to develop a group-care model aimed improving the management of diabetes, hypertension, and other noncommunicable diseases in economically disadvantaged regions of Kenya.

The EPIC-HF trial tested a strategy for improving HFrEF medication-plan engagement by use of a video and documents delivered to patients several times by email or text prior to their follow-up clinic appointments. The strategy was compared with usual care for its effect on HF-medication optimization over 1 month and 1 year in a total of 306 patients.

Following EPIC-HF on the schedule is the MYROAD trial, looking at the efficacy of discharge instructions provided to patients with acute HF as an audio recording that they and their physicians could replay on demand, the idea being to increase adherence to the instructions. The trial’s 1073 patients were assigned to the novel strategy or usual care and followed for HF rehospitalization within 30 days.

MYROAD is to be followed by a presentation entitled “Digital Care Transformation: One-Year Report of >5,000 Patients Enrolled in a Remote Algorithm-Based CV Risk Management Program to Achieve Optimal Lipid and Hypertension Control.”

Rounding out the LBS session: the Bridging Income Generation With Group Integrated Care (BIGPIC) program, a pilot study that developed and executed “a healthcare delivery model targeting health behaviors, medication adherence, and financial barriers to accessing healthcare” in four rural counties in Kenya.

The model features locally developed plans, tailored for regional needs, that are said to “combine the benefits of microfinance with the peer support available through group medical care to enhance management of hypertension and diabetes.” The microfinance component is aimed at improving household economies to alleviate the financial burden of care and clinic attendance, and for the health effects of improved quality of life.

The study randomized 2890 adults with diabetes or prediabetes to one of four groups: usual care plus microfinance group support, group medical visits only or combined with microfinance group support, or usual care only. They were followed for changes in systolic blood pressure and CV-risk score over 12 months.

Lloyd-Jones and Fauci declared no conflicts.

This article first appeared on Medscape.com.

Of his many plans to expand insurance coverage, President-elect Joe Biden’s simplest strategy is lowering the eligibility age for Medicare from 65 to 60.

But the plan is sure to face long odds, even if the Democrats can snag control of the Senate in January by winning two runoff elections in Georgia.

roobcio/Thinkstock

Republicans, who fought the creation of Medicare in the 1960s and typically oppose expanding government entitlement programs, are not the biggest obstacle. Instead, the nation’s hospitals, a powerful political force, are poised to derail any effort. Hospitals fear adding millions of people to Medicare will cost them billions of dollars in revenue.

“Hospitals certainly are not going to be happy with it,” said Jonathan Oberlander, professor of health policy and management at the University of North Carolina at Chapel Hill.

Medicare reimbursement rates for patients admitted to hospitals average half what commercial or employer-sponsored insurance plans pay.

“It will be a huge lift [in Congress] as the realities of lower Medicare reimbursement rates will activate some powerful interests against this,” said Josh Archambault, a senior fellow with the conservative Foundation for Government Accountability.

Biden, who turns 78 this month, said his plan will help Americans who retire early and those who are unemployed or can’t find jobs with health benefits.

“It reflects the reality that, even after the current crisis ends, older Americans are likely to find it difficult to secure jobs,” Biden wrote in April.

Lowering the Medicare eligibility age is popular. About 85% of Democrats and 69% of Republicans favor allowing those as young as 50 to buy into Medicare, according to a KFF tracking poll from January 2019. (KHN is an editorially independent program of KFF.)

Although opposition from the hospital industry is expected to be fierce, that is not the only obstacle to Biden’s plan.

Critics, especially Republicans on Capitol Hill, will point to the nation’s $3 trillion budget deficit as well as the dim outlook for the Medicare Hospital Insurance Trust Fund. That fund is on track to reach insolvency in 2024. That means there won’t be enough money to fully pay hospitals and nursing homes for inpatient care for Medicare beneficiaries.

Moreover, it’s unclear whether expanding Medicare will fit on the Democrats’ crowded health agenda, which also includes dealing with the COVID-19 pandemic, possibly rescuing the Affordable Care Act if the Supreme Court strikes down part or all of the law in a current case, expanding Obamacare subsidies and lowering drug costs.

Biden’s proposal is a nod to the liberal wing of the Democratic Party, which has advocated for Sen. Bernie Sanders’ (I-Vt.) government-run “Medicare for All” health system that would provide universal coverage. Biden opposed that effort, saying the nation could not afford it. He wanted to retain the private health insurance system, which covers 180 million people.

To expand coverage, Biden has proposed two major initiatives. In addition to the Medicare eligibility change, he wants Congress to approve a government-run health plan that people could buy into instead of purchasing coverage from insurance companies on their own or through the Obamacare marketplaces. Insurers helped beat back this “public option” initiative in 2009 during the congressional debate over the ACA.

The appeal of lowering Medicare eligibility to help those without insurance lies with leveraging a popular government program that has low administrative costs.

“It is hard to find a reform idea that is more popular than opening up Medicare” to people as young as 60, Oberlander said. He said early retirees would like the concept, as would employers, who could save on their health costs as workers gravitate to Medicare.

The eligibility age has been set at 65 since Medicare was created in 1965 as part of President Lyndon Johnson’s Great Society reform package. It was designed to coincide with the age when people at that time qualified for Social Security. Today, people generally qualify for early, reduced Social Security benefits at age 62, though they have to wait until age 66 for full benefits.

While people can qualify on the basis of other criteria, such as having a disability or end-stage renal disease, 85% of the 57 million Medicare enrollees are in the program simply because they’re old enough.

Lowering the age to 60 could add as many as 23 million people to Medicare, according to an analysis by the consulting firm Avalere Health. It’s unclear, however, if everyone who would be eligible would sign up or if Biden would limit the expansion to the 1.7 million people in that age range who are uninsured and the 3.2 million who buy coverage on their own.

Avalere says 3.2 million people in that age group buy coverage on the individual market.

While the 60-to-65 group has the lowest uninsured rate (8%) among adults, it has the highest health costs and pays the highest rates for individual coverage, said Cristina Boccuti, director of health policy at West Health, a nonpartisan research group.

About 13 million of those between 60 and 65 have coverage through their employer, according to Avalere. While they would not have to drop coverage to join Medicare, they could possibly opt to also pay to join the federal program and use it as a wraparound for their existing coverage. Medicare might then pick up costs for some services that the consumers would have to shoulder out-of-pocket.

Some 4 million people between 60 and 65 are enrolled in Medicaid, the state-federal health insurance program for low-income people. Shifting them to Medicare would make that their primary health insurer, a move that would save states money since they split Medicaid costs with the federal government.

Chris Pope, a senior fellow with the conservative Manhattan Institute, said getting health industry support, particularly from hospitals, will be vital for any health coverage expansion. “Hospitals are very aware about generous commercial rates being replaced by lower Medicare rates,” he said.

“Members of Congress, a lot of them are close to their hospitals and do not want to see them with a revenue hole,” he said.

President Barack Obama made a deal with the industry on the way to passing the ACA. In exchange for gaining millions of paying customers and lowering their uncompensated care by billions of dollars, the hospital industry agreed to give up future Medicare funds designed to help them cope with the uninsured. Showing the industry’s prowess on Capitol Hill, Congress has delayed those funding cuts for more than six years.

Jacob Hacker, a Yale University political scientist, noted that expanding Medicare would reduce the number of Americans who rely on employer-sponsored coverage. The pitfalls of the employer system were highlighted in 2020 as millions lost their jobs and workplace health coverage.

Even if they can win the two Georgia seats and take control of the Senate with the vice president breaking any ties, Democrats would be unlikely to pass major legislation without GOP support — unless they are willing to jettison the long-standing filibuster rule so they can pass most legislation with a simple 51-vote majority instead of 60 votes.

Hacker said that slim margin would make it difficult for Democrats to deal with many health issues all at once.

“Congress is not good at parallel processing,” Hacker said, referring to handling multiple priorities at the same time. “And the window is relatively short.”

KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

Of his many plans to expand insurance coverage, President-elect Joe Biden’s simplest strategy is lowering the eligibility age for Medicare from 65 to 60.

But the plan is sure to face long odds, even if the Democrats can snag control of the Senate in January by winning two runoff elections in Georgia.

roobcio/Thinkstock

Republicans, who fought the creation of Medicare in the 1960s and typically oppose expanding government entitlement programs, are not the biggest obstacle. Instead, the nation’s hospitals, a powerful political force, are poised to derail any effort. Hospitals fear adding millions of people to Medicare will cost them billions of dollars in revenue.

“Hospitals certainly are not going to be happy with it,” said Jonathan Oberlander, professor of health policy and management at the University of North Carolina at Chapel Hill.

Medicare reimbursement rates for patients admitted to hospitals average half what commercial or employer-sponsored insurance plans pay.

“It will be a huge lift [in Congress] as the realities of lower Medicare reimbursement rates will activate some powerful interests against this,” said Josh Archambault, a senior fellow with the conservative Foundation for Government Accountability.

Biden, who turns 78 this month, said his plan will help Americans who retire early and those who are unemployed or can’t find jobs with health benefits.

“It reflects the reality that, even after the current crisis ends, older Americans are likely to find it difficult to secure jobs,” Biden wrote in April.

Lowering the Medicare eligibility age is popular. About 85% of Democrats and 69% of Republicans favor allowing those as young as 50 to buy into Medicare, according to a KFF tracking poll from January 2019. (KHN is an editorially independent program of KFF.)

Although opposition from the hospital industry is expected to be fierce, that is not the only obstacle to Biden’s plan.

Critics, especially Republicans on Capitol Hill, will point to the nation’s $3 trillion budget deficit as well as the dim outlook for the Medicare Hospital Insurance Trust Fund. That fund is on track to reach insolvency in 2024. That means there won’t be enough money to fully pay hospitals and nursing homes for inpatient care for Medicare beneficiaries.

Moreover, it’s unclear whether expanding Medicare will fit on the Democrats’ crowded health agenda, which also includes dealing with the COVID-19 pandemic, possibly rescuing the Affordable Care Act if the Supreme Court strikes down part or all of the law in a current case, expanding Obamacare subsidies and lowering drug costs.

Biden’s proposal is a nod to the liberal wing of the Democratic Party, which has advocated for Sen. Bernie Sanders’ (I-Vt.) government-run “Medicare for All” health system that would provide universal coverage. Biden opposed that effort, saying the nation could not afford it. He wanted to retain the private health insurance system, which covers 180 million people.

To expand coverage, Biden has proposed two major initiatives. In addition to the Medicare eligibility change, he wants Congress to approve a government-run health plan that people could buy into instead of purchasing coverage from insurance companies on their own or through the Obamacare marketplaces. Insurers helped beat back this “public option” initiative in 2009 during the congressional debate over the ACA.

The appeal of lowering Medicare eligibility to help those without insurance lies with leveraging a popular government program that has low administrative costs.

“It is hard to find a reform idea that is more popular than opening up Medicare” to people as young as 60, Oberlander said. He said early retirees would like the concept, as would employers, who could save on their health costs as workers gravitate to Medicare.

The eligibility age has been set at 65 since Medicare was created in 1965 as part of President Lyndon Johnson’s Great Society reform package. It was designed to coincide with the age when people at that time qualified for Social Security. Today, people generally qualify for early, reduced Social Security benefits at age 62, though they have to wait until age 66 for full benefits.

While people can qualify on the basis of other criteria, such as having a disability or end-stage renal disease, 85% of the 57 million Medicare enrollees are in the program simply because they’re old enough.

Lowering the age to 60 could add as many as 23 million people to Medicare, according to an analysis by the consulting firm Avalere Health. It’s unclear, however, if everyone who would be eligible would sign up or if Biden would limit the expansion to the 1.7 million people in that age range who are uninsured and the 3.2 million who buy coverage on their own.

Avalere says 3.2 million people in that age group buy coverage on the individual market.

While the 60-to-65 group has the lowest uninsured rate (8%) among adults, it has the highest health costs and pays the highest rates for individual coverage, said Cristina Boccuti, director of health policy at West Health, a nonpartisan research group.

About 13 million of those between 60 and 65 have coverage through their employer, according to Avalere. While they would not have to drop coverage to join Medicare, they could possibly opt to also pay to join the federal program and use it as a wraparound for their existing coverage. Medicare might then pick up costs for some services that the consumers would have to shoulder out-of-pocket.

Some 4 million people between 60 and 65 are enrolled in Medicaid, the state-federal health insurance program for low-income people. Shifting them to Medicare would make that their primary health insurer, a move that would save states money since they split Medicaid costs with the federal government.

Chris Pope, a senior fellow with the conservative Manhattan Institute, said getting health industry support, particularly from hospitals, will be vital for any health coverage expansion. “Hospitals are very aware about generous commercial rates being replaced by lower Medicare rates,” he said.

“Members of Congress, a lot of them are close to their hospitals and do not want to see them with a revenue hole,” he said.

President Barack Obama made a deal with the industry on the way to passing the ACA. In exchange for gaining millions of paying customers and lowering their uncompensated care by billions of dollars, the hospital industry agreed to give up future Medicare funds designed to help them cope with the uninsured. Showing the industry’s prowess on Capitol Hill, Congress has delayed those funding cuts for more than six years.

Jacob Hacker, a Yale University political scientist, noted that expanding Medicare would reduce the number of Americans who rely on employer-sponsored coverage. The pitfalls of the employer system were highlighted in 2020 as millions lost their jobs and workplace health coverage.

Even if they can win the two Georgia seats and take control of the Senate with the vice president breaking any ties, Democrats would be unlikely to pass major legislation without GOP support — unless they are willing to jettison the long-standing filibuster rule so they can pass most legislation with a simple 51-vote majority instead of 60 votes.

Hacker said that slim margin would make it difficult for Democrats to deal with many health issues all at once.

“Congress is not good at parallel processing,” Hacker said, referring to handling multiple priorities at the same time. “And the window is relatively short.”

KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

Of his many plans to expand insurance coverage, President-elect Joe Biden’s simplest strategy is lowering the eligibility age for Medicare from 65 to 60.

But the plan is sure to face long odds, even if the Democrats can snag control of the Senate in January by winning two runoff elections in Georgia.

roobcio/Thinkstock

Republicans, who fought the creation of Medicare in the 1960s and typically oppose expanding government entitlement programs, are not the biggest obstacle. Instead, the nation’s hospitals, a powerful political force, are poised to derail any effort. Hospitals fear adding millions of people to Medicare will cost them billions of dollars in revenue.

“Hospitals certainly are not going to be happy with it,” said Jonathan Oberlander, professor of health policy and management at the University of North Carolina at Chapel Hill.

Medicare reimbursement rates for patients admitted to hospitals average half what commercial or employer-sponsored insurance plans pay.

“It will be a huge lift [in Congress] as the realities of lower Medicare reimbursement rates will activate some powerful interests against this,” said Josh Archambault, a senior fellow with the conservative Foundation for Government Accountability.

Biden, who turns 78 this month, said his plan will help Americans who retire early and those who are unemployed or can’t find jobs with health benefits.

“It reflects the reality that, even after the current crisis ends, older Americans are likely to find it difficult to secure jobs,” Biden wrote in April.

Lowering the Medicare eligibility age is popular. About 85% of Democrats and 69% of Republicans favor allowing those as young as 50 to buy into Medicare, according to a KFF tracking poll from January 2019. (KHN is an editorially independent program of KFF.)

Although opposition from the hospital industry is expected to be fierce, that is not the only obstacle to Biden’s plan.

Critics, especially Republicans on Capitol Hill, will point to the nation’s $3 trillion budget deficit as well as the dim outlook for the Medicare Hospital Insurance Trust Fund. That fund is on track to reach insolvency in 2024. That means there won’t be enough money to fully pay hospitals and nursing homes for inpatient care for Medicare beneficiaries.

Moreover, it’s unclear whether expanding Medicare will fit on the Democrats’ crowded health agenda, which also includes dealing with the COVID-19 pandemic, possibly rescuing the Affordable Care Act if the Supreme Court strikes down part or all of the law in a current case, expanding Obamacare subsidies and lowering drug costs.

Biden’s proposal is a nod to the liberal wing of the Democratic Party, which has advocated for Sen. Bernie Sanders’ (I-Vt.) government-run “Medicare for All” health system that would provide universal coverage. Biden opposed that effort, saying the nation could not afford it. He wanted to retain the private health insurance system, which covers 180 million people.

To expand coverage, Biden has proposed two major initiatives. In addition to the Medicare eligibility change, he wants Congress to approve a government-run health plan that people could buy into instead of purchasing coverage from insurance companies on their own or through the Obamacare marketplaces. Insurers helped beat back this “public option” initiative in 2009 during the congressional debate over the ACA.

The appeal of lowering Medicare eligibility to help those without insurance lies with leveraging a popular government program that has low administrative costs.

“It is hard to find a reform idea that is more popular than opening up Medicare” to people as young as 60, Oberlander said. He said early retirees would like the concept, as would employers, who could save on their health costs as workers gravitate to Medicare.

The eligibility age has been set at 65 since Medicare was created in 1965 as part of President Lyndon Johnson’s Great Society reform package. It was designed to coincide with the age when people at that time qualified for Social Security. Today, people generally qualify for early, reduced Social Security benefits at age 62, though they have to wait until age 66 for full benefits.

While people can qualify on the basis of other criteria, such as having a disability or end-stage renal disease, 85% of the 57 million Medicare enrollees are in the program simply because they’re old enough.

Lowering the age to 60 could add as many as 23 million people to Medicare, according to an analysis by the consulting firm Avalere Health. It’s unclear, however, if everyone who would be eligible would sign up or if Biden would limit the expansion to the 1.7 million people in that age range who are uninsured and the 3.2 million who buy coverage on their own.

Avalere says 3.2 million people in that age group buy coverage on the individual market.

While the 60-to-65 group has the lowest uninsured rate (8%) among adults, it has the highest health costs and pays the highest rates for individual coverage, said Cristina Boccuti, director of health policy at West Health, a nonpartisan research group.

About 13 million of those between 60 and 65 have coverage through their employer, according to Avalere. While they would not have to drop coverage to join Medicare, they could possibly opt to also pay to join the federal program and use it as a wraparound for their existing coverage. Medicare might then pick up costs for some services that the consumers would have to shoulder out-of-pocket.

Some 4 million people between 60 and 65 are enrolled in Medicaid, the state-federal health insurance program for low-income people. Shifting them to Medicare would make that their primary health insurer, a move that would save states money since they split Medicaid costs with the federal government.

Chris Pope, a senior fellow with the conservative Manhattan Institute, said getting health industry support, particularly from hospitals, will be vital for any health coverage expansion. “Hospitals are very aware about generous commercial rates being replaced by lower Medicare rates,” he said.

“Members of Congress, a lot of them are close to their hospitals and do not want to see them with a revenue hole,” he said.

President Barack Obama made a deal with the industry on the way to passing the ACA. In exchange for gaining millions of paying customers and lowering their uncompensated care by billions of dollars, the hospital industry agreed to give up future Medicare funds designed to help them cope with the uninsured. Showing the industry’s prowess on Capitol Hill, Congress has delayed those funding cuts for more than six years.

Jacob Hacker, a Yale University political scientist, noted that expanding Medicare would reduce the number of Americans who rely on employer-sponsored coverage. The pitfalls of the employer system were highlighted in 2020 as millions lost their jobs and workplace health coverage.

Even if they can win the two Georgia seats and take control of the Senate with the vice president breaking any ties, Democrats would be unlikely to pass major legislation without GOP support — unless they are willing to jettison the long-standing filibuster rule so they can pass most legislation with a simple 51-vote majority instead of 60 votes.

Hacker said that slim margin would make it difficult for Democrats to deal with many health issues all at once.

“Congress is not good at parallel processing,” Hacker said, referring to handling multiple priorities at the same time. “And the window is relatively short.”

KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

Matthew Lewin, MD, PhD, founder of the Center for Exploration and Travel Health at the California Academy of Sciences, was researching snakebite treatments in rural locations in preparation for an expedition to the Philippines in 2011.

The story of a renowned herpetologist from the academy, Joseph Slowinski, who was bitten by a highly venomous krait in Myanmar and couldn’t get to a hospital in time to save his life a decade earlier, weighed on the emergency room doctor.

“I concluded that I needed something small and compact and that doesn’t care what kind of snake,” Dr. Lewin said.

It didn’t exist. That set Dr. Lewin in pursuit of a modern snakebite drug, a journey that finds his Corte Madera, Calif., company, Ophirex, nearing a promising oral treatment that fits in a pocket; is stable, easy to use, and affordable; and treats the venom from many species. “That’s the holy grail of snakebite treatment,” he said.

His work has gotten a boost with multimillion-dollar grants from a British charity and the U.S. Army. If it works – and it has been shown to work extremely well in mice and pigs – it could save tens of thousands of lives a year.

Dr. Lewin and Ophirex are not alone in their quest. Snakebites kill nearly 140,000 people a year, overwhelmingly in impoverished rural areas of Asia and Africa without adequate medical infrastructure and knowledge to administer antivenom. Though just a few people die each year in the United States from snakebites, the problem has risen to the top of the list of global health concerns in recent years. Funding has soared, and other research groups have also done promising work on new treatments. Herpetologists say deforestation and climate change are increasing human-snake encounters by forcing snakes to move to new habitats.

Dr. Lewin’s research is centered on a drug called varespladib. The enzyme inhibitor has proven itself in in-vitro lab studies and has effectively saved mice and pigs dosed with venom.

Along the way, Dr. Lewin and his team have come across another potential use for the drug. Varespladib has a positive effect on acute respiratory distress syndrome, associated with COVID-19. Next year, Ophirex will conduct human trials for the possible treatment of the condition funded with $9.9 million from the Army.

The link to a snakebite? The inflammation of the lungs caused by the coronavirus produces the sPLA2 enzyme. A more deadly version of the same enzyme is produced by snake venom.

The other companies that have come up with promising approaches to snakebite aren’t as far along as Ophirex. At the University of California-Irvine, chemist Ken Shea and his team created a nanogel – a kind of polymer used in medical applications – that blocks key proteins in the venom that cause cell destruction. At the Technical University of Denmark, Copenhagen, Andreas Laustsen is looking at engineering bacteria to manufacture anti-venom in fermentation tanks.

The days of incising a snakebite and sucking out the poison are long over, but the current treatment for venomous snakebites remains archaic.

Since the early 1900s, antivenom has been made by injecting horses or other animals with venom milked from snakes and diluted. The animals’ immune systems generate antibodies over several months, and blood plasma is taken from the animals and antibodies extracted from it.

It’s extremely expensive. Hospitals in the United States can charge as much as $15,000 a vial – and a single snakebite might require anywhere from 4 to 50 vials. Moreover, antivenom exists for little more than half the world’s species of venomous snakes.

A major problem is the roughly 2 hours it takes on average for a snakebite victim to reach a hospital and begin treatment. The chemical weapon that is venom starts immediately to destroy cells as it digests its next meal, making fast treatment essential to saving lives and preventing tissue loss.

“The two-hour window between fang and needle is where the most damage occurs,” said Leslie Boyer, director of the University of Arizona’s Venom Immunochemistry, Pharmacology and Emergency Response (VIPER) Institute. “We have a saying, ‘Time is tissue.’ ”

That’s why the search for a new snakebite drug has focused on an inexpensive treatment that can be taken into the field. Dr. Lewin’s drug wouldn’t replace antivenom. Instead, he thinks of it as the first line of defense until the victim can reach a hospital for antivenom treatment.

Dr. Lewin said he expects the drug to be inexpensive, so people in regions where snakebites are common can afford it.

Venom is extremely complicated chemically, and Dr. Lewin began his search by sussing out which of its myriad components to block. He zeroed in on the sPLA2 enzyme.

Surveying the literature about drugs that had been clinically tested for other conditions, he came across varespladib. It had been developed jointly by Eli Lilly and Shionogi, a Japanese pharmaceutical company, as a possible treatment for sepsis. They had never taken it to market.

If it worked, Dr. Lewin could license the right to produce the drug, which had already been thoroughly studied and was shown to be safe.

He placed venom in an array of test tubes. Varespladib and other drugs were added to the venom. He then added a reagent. If the venom was still active, the solution would turn yellow; if it was neutralized, it would remain clear.

The vials with varespladib “came up completely blank,” he said. “It was so stunning I said, ‘I must have made a mistake.’ ”

With a small grant, he sent the drug to the Yale Center for Molecular Discovery and found that varespladib effectively neutralized the venom of snakes found on six continents. The results were published in the journal Toxins and sent ripples through the small community of snakebite researchers.

Dr. Lewin then conducted tests on mice and pigs. Both were successful.

Human clinical trials are next, but they have been delayed by the pandemic. They are scheduled to get underway next spring.

Along the way, Dr. Lewin was fortunate enough to make some good connections that led to funding. In 2012, he attended a party at the Mill Valley, Calif., home of Jerry Harrison, the former guitarist and keyboardist for Talking Heads. Mr. Harrison had long been interested in business and start-ups – he said he was the most careful reader of the ’80s band’s contracts – and at the party he asked “if anyone had any ideas lying fallow,” Mr. Harrison said.

“And Matt pipes up and says, ‘I have this idea how to prevent people from dying from snakebites,’ ” Mr. Harrison said.

The musician said he was a bit taken aback by such an unusual and dire problem, but “I thought if it can save lives we have to do it,” he said. He became an investor and cofounder of Ophirex with Dr. Lewin.

Dr. Lewin met Lt. Col. Rebecca Carter, a biochemist who was assigned to lead the Medical Modernization Division of Air Force Special Operations Command, in 2016 when she attended a Venom Week conference in Greenville, N.C. He was presenting the results of his mouse studies. She told him about her first mission: to find a universal antivenom for medics on special operations teams in Africa. She persuaded the Special Operations Command Biomedical Research Advisory Group, which specializes in getting critical projects to production, to grant Ophirex $148,000 in 2017. She later retired from the Air Force and now works for Ophirex as vice president.

More multimillion-dollar grants followed, including the Army’s COVID grant. Clinical trials are scheduled to begin this winter.

Despite the progress and the sudden cash flow, Dr. Lewin tamps down talk of a universal snakebite cure. “There’s enough evidence to say the drug deserves to have its day in clinical trials,” he said.

KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

Matthew Lewin, MD, PhD, founder of the Center for Exploration and Travel Health at the California Academy of Sciences, was researching snakebite treatments in rural locations in preparation for an expedition to the Philippines in 2011.

The story of a renowned herpetologist from the academy, Joseph Slowinski, who was bitten by a highly venomous krait in Myanmar and couldn’t get to a hospital in time to save his life a decade earlier, weighed on the emergency room doctor.

“I concluded that I needed something small and compact and that doesn’t care what kind of snake,” Dr. Lewin said.

It didn’t exist. That set Dr. Lewin in pursuit of a modern snakebite drug, a journey that finds his Corte Madera, Calif., company, Ophirex, nearing a promising oral treatment that fits in a pocket; is stable, easy to use, and affordable; and treats the venom from many species. “That’s the holy grail of snakebite treatment,” he said.

His work has gotten a boost with multimillion-dollar grants from a British charity and the U.S. Army. If it works – and it has been shown to work extremely well in mice and pigs – it could save tens of thousands of lives a year.

Dr. Lewin and Ophirex are not alone in their quest. Snakebites kill nearly 140,000 people a year, overwhelmingly in impoverished rural areas of Asia and Africa without adequate medical infrastructure and knowledge to administer antivenom. Though just a few people die each year in the United States from snakebites, the problem has risen to the top of the list of global health concerns in recent years. Funding has soared, and other research groups have also done promising work on new treatments. Herpetologists say deforestation and climate change are increasing human-snake encounters by forcing snakes to move to new habitats.

Dr. Lewin’s research is centered on a drug called varespladib. The enzyme inhibitor has proven itself in in-vitro lab studies and has effectively saved mice and pigs dosed with venom.

Along the way, Dr. Lewin and his team have come across another potential use for the drug. Varespladib has a positive effect on acute respiratory distress syndrome, associated with COVID-19. Next year, Ophirex will conduct human trials for the possible treatment of the condition funded with $9.9 million from the Army.

The link to a snakebite? The inflammation of the lungs caused by the coronavirus produces the sPLA2 enzyme. A more deadly version of the same enzyme is produced by snake venom.

The other companies that have come up with promising approaches to snakebite aren’t as far along as Ophirex. At the University of California-Irvine, chemist Ken Shea and his team created a nanogel – a kind of polymer used in medical applications – that blocks key proteins in the venom that cause cell destruction. At the Technical University of Denmark, Copenhagen, Andreas Laustsen is looking at engineering bacteria to manufacture anti-venom in fermentation tanks.

The days of incising a snakebite and sucking out the poison are long over, but the current treatment for venomous snakebites remains archaic.

Since the early 1900s, antivenom has been made by injecting horses or other animals with venom milked from snakes and diluted. The animals’ immune systems generate antibodies over several months, and blood plasma is taken from the animals and antibodies extracted from it.

It’s extremely expensive. Hospitals in the United States can charge as much as $15,000 a vial – and a single snakebite might require anywhere from 4 to 50 vials. Moreover, antivenom exists for little more than half the world’s species of venomous snakes.

A major problem is the roughly 2 hours it takes on average for a snakebite victim to reach a hospital and begin treatment. The chemical weapon that is venom starts immediately to destroy cells as it digests its next meal, making fast treatment essential to saving lives and preventing tissue loss.

“The two-hour window between fang and needle is where the most damage occurs,” said Leslie Boyer, director of the University of Arizona’s Venom Immunochemistry, Pharmacology and Emergency Response (VIPER) Institute. “We have a saying, ‘Time is tissue.’ ”

That’s why the search for a new snakebite drug has focused on an inexpensive treatment that can be taken into the field. Dr. Lewin’s drug wouldn’t replace antivenom. Instead, he thinks of it as the first line of defense until the victim can reach a hospital for antivenom treatment.

Dr. Lewin said he expects the drug to be inexpensive, so people in regions where snakebites are common can afford it.

Venom is extremely complicated chemically, and Dr. Lewin began his search by sussing out which of its myriad components to block. He zeroed in on the sPLA2 enzyme.

Surveying the literature about drugs that had been clinically tested for other conditions, he came across varespladib. It had been developed jointly by Eli Lilly and Shionogi, a Japanese pharmaceutical company, as a possible treatment for sepsis. They had never taken it to market.

If it worked, Dr. Lewin could license the right to produce the drug, which had already been thoroughly studied and was shown to be safe.

He placed venom in an array of test tubes. Varespladib and other drugs were added to the venom. He then added a reagent. If the venom was still active, the solution would turn yellow; if it was neutralized, it would remain clear.

The vials with varespladib “came up completely blank,” he said. “It was so stunning I said, ‘I must have made a mistake.’ ”

With a small grant, he sent the drug to the Yale Center for Molecular Discovery and found that varespladib effectively neutralized the venom of snakes found on six continents. The results were published in the journal Toxins and sent ripples through the small community of snakebite researchers.

Dr. Lewin then conducted tests on mice and pigs. Both were successful.

Human clinical trials are next, but they have been delayed by the pandemic. They are scheduled to get underway next spring.

Along the way, Dr. Lewin was fortunate enough to make some good connections that led to funding. In 2012, he attended a party at the Mill Valley, Calif., home of Jerry Harrison, the former guitarist and keyboardist for Talking Heads. Mr. Harrison had long been interested in business and start-ups – he said he was the most careful reader of the ’80s band’s contracts – and at the party he asked “if anyone had any ideas lying fallow,” Mr. Harrison said.

“And Matt pipes up and says, ‘I have this idea how to prevent people from dying from snakebites,’ ” Mr. Harrison said.

The musician said he was a bit taken aback by such an unusual and dire problem, but “I thought if it can save lives we have to do it,” he said. He became an investor and cofounder of Ophirex with Dr. Lewin.

Dr. Lewin met Lt. Col. Rebecca Carter, a biochemist who was assigned to lead the Medical Modernization Division of Air Force Special Operations Command, in 2016 when she attended a Venom Week conference in Greenville, N.C. He was presenting the results of his mouse studies. She told him about her first mission: to find a universal antivenom for medics on special operations teams in Africa. She persuaded the Special Operations Command Biomedical Research Advisory Group, which specializes in getting critical projects to production, to grant Ophirex $148,000 in 2017. She later retired from the Air Force and now works for Ophirex as vice president.

More multimillion-dollar grants followed, including the Army’s COVID grant. Clinical trials are scheduled to begin this winter.

Despite the progress and the sudden cash flow, Dr. Lewin tamps down talk of a universal snakebite cure. “There’s enough evidence to say the drug deserves to have its day in clinical trials,” he said.

KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

Matthew Lewin, MD, PhD, founder of the Center for Exploration and Travel Health at the California Academy of Sciences, was researching snakebite treatments in rural locations in preparation for an expedition to the Philippines in 2011.

The story of a renowned herpetologist from the academy, Joseph Slowinski, who was bitten by a highly venomous krait in Myanmar and couldn’t get to a hospital in time to save his life a decade earlier, weighed on the emergency room doctor.

“I concluded that I needed something small and compact and that doesn’t care what kind of snake,” Dr. Lewin said.

It didn’t exist. That set Dr. Lewin in pursuit of a modern snakebite drug, a journey that finds his Corte Madera, Calif., company, Ophirex, nearing a promising oral treatment that fits in a pocket; is stable, easy to use, and affordable; and treats the venom from many species. “That’s the holy grail of snakebite treatment,” he said.

His work has gotten a boost with multimillion-dollar grants from a British charity and the U.S. Army. If it works – and it has been shown to work extremely well in mice and pigs – it could save tens of thousands of lives a year.

Dr. Lewin and Ophirex are not alone in their quest. Snakebites kill nearly 140,000 people a year, overwhelmingly in impoverished rural areas of Asia and Africa without adequate medical infrastructure and knowledge to administer antivenom. Though just a few people die each year in the United States from snakebites, the problem has risen to the top of the list of global health concerns in recent years. Funding has soared, and other research groups have also done promising work on new treatments. Herpetologists say deforestation and climate change are increasing human-snake encounters by forcing snakes to move to new habitats.

Dr. Lewin’s research is centered on a drug called varespladib. The enzyme inhibitor has proven itself in in-vitro lab studies and has effectively saved mice and pigs dosed with venom.

Along the way, Dr. Lewin and his team have come across another potential use for the drug. Varespladib has a positive effect on acute respiratory distress syndrome, associated with COVID-19. Next year, Ophirex will conduct human trials for the possible treatment of the condition funded with $9.9 million from the Army.

The link to a snakebite? The inflammation of the lungs caused by the coronavirus produces the sPLA2 enzyme. A more deadly version of the same enzyme is produced by snake venom.

The other companies that have come up with promising approaches to snakebite aren’t as far along as Ophirex. At the University of California-Irvine, chemist Ken Shea and his team created a nanogel – a kind of polymer used in medical applications – that blocks key proteins in the venom that cause cell destruction. At the Technical University of Denmark, Copenhagen, Andreas Laustsen is looking at engineering bacteria to manufacture anti-venom in fermentation tanks.

The days of incising a snakebite and sucking out the poison are long over, but the current treatment for venomous snakebites remains archaic.

Since the early 1900s, antivenom has been made by injecting horses or other animals with venom milked from snakes and diluted. The animals’ immune systems generate antibodies over several months, and blood plasma is taken from the animals and antibodies extracted from it.

It’s extremely expensive. Hospitals in the United States can charge as much as $15,000 a vial – and a single snakebite might require anywhere from 4 to 50 vials. Moreover, antivenom exists for little more than half the world’s species of venomous snakes.

A major problem is the roughly 2 hours it takes on average for a snakebite victim to reach a hospital and begin treatment. The chemical weapon that is venom starts immediately to destroy cells as it digests its next meal, making fast treatment essential to saving lives and preventing tissue loss.

“The two-hour window between fang and needle is where the most damage occurs,” said Leslie Boyer, director of the University of Arizona’s Venom Immunochemistry, Pharmacology and Emergency Response (VIPER) Institute. “We have a saying, ‘Time is tissue.’ ”

That’s why the search for a new snakebite drug has focused on an inexpensive treatment that can be taken into the field. Dr. Lewin’s drug wouldn’t replace antivenom. Instead, he thinks of it as the first line of defense until the victim can reach a hospital for antivenom treatment.

Dr. Lewin said he expects the drug to be inexpensive, so people in regions where snakebites are common can afford it.

Venom is extremely complicated chemically, and Dr. Lewin began his search by sussing out which of its myriad components to block. He zeroed in on the sPLA2 enzyme.

Surveying the literature about drugs that had been clinically tested for other conditions, he came across varespladib. It had been developed jointly by Eli Lilly and Shionogi, a Japanese pharmaceutical company, as a possible treatment for sepsis. They had never taken it to market.

If it worked, Dr. Lewin could license the right to produce the drug, which had already been thoroughly studied and was shown to be safe.

He placed venom in an array of test tubes. Varespladib and other drugs were added to the venom. He then added a reagent. If the venom was still active, the solution would turn yellow; if it was neutralized, it would remain clear.

The vials with varespladib “came up completely blank,” he said. “It was so stunning I said, ‘I must have made a mistake.’ ”

With a small grant, he sent the drug to the Yale Center for Molecular Discovery and found that varespladib effectively neutralized the venom of snakes found on six continents. The results were published in the journal Toxins and sent ripples through the small community of snakebite researchers.

Dr. Lewin then conducted tests on mice and pigs. Both were successful.

Human clinical trials are next, but they have been delayed by the pandemic. They are scheduled to get underway next spring.

Along the way, Dr. Lewin was fortunate enough to make some good connections that led to funding. In 2012, he attended a party at the Mill Valley, Calif., home of Jerry Harrison, the former guitarist and keyboardist for Talking Heads. Mr. Harrison had long been interested in business and start-ups – he said he was the most careful reader of the ’80s band’s contracts – and at the party he asked “if anyone had any ideas lying fallow,” Mr. Harrison said.

“And Matt pipes up and says, ‘I have this idea how to prevent people from dying from snakebites,’ ” Mr. Harrison said.

The musician said he was a bit taken aback by such an unusual and dire problem, but “I thought if it can save lives we have to do it,” he said. He became an investor and cofounder of Ophirex with Dr. Lewin.

Dr. Lewin met Lt. Col. Rebecca Carter, a biochemist who was assigned to lead the Medical Modernization Division of Air Force Special Operations Command, in 2016 when she attended a Venom Week conference in Greenville, N.C. He was presenting the results of his mouse studies. She told him about her first mission: to find a universal antivenom for medics on special operations teams in Africa. She persuaded the Special Operations Command Biomedical Research Advisory Group, which specializes in getting critical projects to production, to grant Ophirex $148,000 in 2017. She later retired from the Air Force and now works for Ophirex as vice president.

More multimillion-dollar grants followed, including the Army’s COVID grant. Clinical trials are scheduled to begin this winter.

Despite the progress and the sudden cash flow, Dr. Lewin tamps down talk of a universal snakebite cure. “There’s enough evidence to say the drug deserves to have its day in clinical trials,” he said.

KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

Choosing which hospitalized COVID-19 patients receive potentially lifesaving care, making urgent calls for ventilators and other equipment, and triaging care based on patient age and comorbidities were among the challenges revealed in new feedback from health care leaders and frontline workers.

Even though many hospitals have contingency plans for how to allocate resources and triage patient care during crisis capacity, for many providers during the real-world COVID-19 trial of these protocols, they fell short.

Many hospital crisis capacity plans, for example, were too general to address all the specific challenges arising during the pandemic, investigators report in a study published online Nov. 6 in JAMA Network Open.

“Our research shows that the types of challenges and approach to resource limitation in real-world clinical settings during the pandemic differed in practice from how we had prepared in theory,” lead author Catherine Butler, MD, told Medscape Medical News. Insufficient dialysis treatment time, staff shortages, and routine supply scarcity are examples “for which there was not an established plan or approach for appropriate allocation.”

“This left frontline clinicians to determine what constituted an acceptable standard of care and to make difficult allocation decisions at the bedside,” added Butler, acting instructor in the Division of Nephrology at the University of Washington in Seattle and a research fellow at the VA Health Services Research and Development Seattle-Denver Center of Innovation.

The investigators conducted semistructured interviews in April and May with 61 clinicians and health leaders. Mean age was 46 years, 63% were women, and participants practiced in 15 states. Most participants hailed from locations hard-hit by the pandemic at the time, including Seattle, New York City, and New Orleans.
 

Triage tribulations

The qualitative study included comments from respondents on three major themes that emerged: planning for crisis capacity, adapting to resource limitation, and the multiple unprecedented barriers to care delivery.

Overall, planning and support from institutional leaders varied. One provider said, “Talking to administration, and they just seemed really disengaged with the problem. We asked multiple times if there was a triage command center or a plan for what would occur if we got to the point where we had to triage resources. They said there was, but they wouldn’t provide it to us.”

Another had a more positive experience. “The biggest deal in the ethics world in the last 2 months has been preparing in case we need to triage. So, we have a very detailed, elaborate, well thought-out triage policy … that was done at the highest levels of the system.”

Clinicians said they participate on triage teams – despite the moral weight and likely emotional burden – out of a sense of duty.

Interestingly, some providers on these teams also reported a reluctance to reveal their participation to colleagues. “I didn’t feel like I should tell anybody … even some of my close friends who are physicians and nurses here … that I’ve been asked to be on this [triage team],” one respondent said. “I didn’t feel like I should make it known.”
 

Adapting to scarce resources

Multiple providers said they faced difficult care decisions because of limited dialysis or supply shortages. “They felt that this patient had the greatest likelihood of benefiting from most aggressive therapy. … I think there was probably like 5 or 6 patients in the ICU … and then you had this 35-year-old with no comorbidities,” one respondent said. “That’s who the ICU dialyzed, and I couldn’t really disagree.”

“I emailed all of [my colleagues], and I said ‘Help! We need X, we need CRRT [continuous renal replacement therapy] machines, we need dialysates,’ “ another responded.

“One of the attendings had a tweet when we were running out of CRRT. He had a tweet about, ‘Can anybody give us supplies for CRRT?’ So, it got to that. You do anything. You get really desperate,” the clinician said.

Other providers reported getting innovative under the circumstances. “My partner’s son, he actually borrowed a couple of 3D printers. He printed some of these face shields, and then they got the formula, or the specifics as to how to make this particular connection to connect to a dialysis machine to generate dialysate. So, he also printed some of those from the 3D printer.”
 

Dire situations with dialysis

Another respondent understood the focus on ventilators and ICU beds throughout the crisis, but said “no one has acknowledged that dialysis has been one of the most, if not the most, limited resources.”

Another clinician expressed surprise at a decision made in the face of limited availability of traditional dialysis. “A month ago, people said we were going to do acute peritoneal dialysis [PD]. And I said, ‘No, we’re not going to do acute PD. PD, it’s not that great for acute patients, sick people in the ICUs. I don’t think we’re going to do PD.’

“Three days later we were doing acute PD. I mean, that was unbelievable!”

Some institutions rationed dialysis therapy. “We went through the entire list at the beginning of the week and [said], this person has to dialyze these days, this person would probably benefit from a dialysis session, a third group person we could probably just string along and medically manage if we needed to,” one provider said.

Another respondent reported a different strategy. “No one was not getting dialysis, but there were a lot of people getting minimal dialysis. Even though people were getting treated, resources were very stretched.”
 

Changing family dynamics

COVID-19 has naturally changed how clinicians speak with families. One respondent recalled looking at the ICU physician and being like, ‘Have you talked to the son this week?’ And she’s like, ‘Oh my God, no. … Did you talk to the son?’ I’m like, ‘Oh my God, no.’ “

They realized, the respondent added, “that none of us had called the family because it’s just not in your workflow. You’re so used to the family being there.”

Multiple providers also feared a conversation with family regarding necessary changes to care given the limitation of resources during the pandemic.

“Most families have been actually very understanding. This is a crisis, and we’re in a pandemic, and we’re all doing things we wouldn’t normally do.”

Another respondent said, “We were pretty honest about how resources were limited and how we were doing with this COVID-19 surge. And I think we talked about how the usual ability to provide aggressive dialysis was not the case with COVID-19. There was a lot of understanding, sometimes to my surprise. I would think people would be more upset when hearing something like that.”

Many clinicians facing these challenges experience moral distress, the researchers noted.

“Early in the pandemic, it became quickly apparent that possible resource limitation, such as scarce ventilators, was a major ethical concern. There was robust debate and discussion published in medical journals and the popular press about how to appropriately allocate health care resources,” the University of Washington’s Butler said.

“Transparency, accountability, and standardized processes for rationing these resources in ‘crisis capacity’ settings were seen as key to avoiding the impact of implicit bias and moral distress for clinicians,” she added.
 

Lessons learned

In terms of potential solutions that could mitigate these challenges in the future, health care leaders “could develop standardized protocols or guidelines for allocating a broader range of potentially scarce health care resources even before ‘crisis capacity’ is declared,” Butler said.

Furthermore, no frontline worker should have to go it alone. “Medical ethicists and/or other clinicians familiar with ethical considerations in settings of scarce health care resources might provide bedside consultation and collaborate with frontline providers who must grapple with the impact of more subtle forms of resource limitation on clinical decision-making.”

The study was partially funded by grants from the National Institute of Diabetes and Digestive and Kidney Diseases and a COVID-19 Research Award from the University of Washington Institute of Translational Health Sciences given to Butler.
 

This article first appeared on Medscape.com.

Choosing which hospitalized COVID-19 patients receive potentially lifesaving care, making urgent calls for ventilators and other equipment, and triaging care based on patient age and comorbidities were among the challenges revealed in new feedback from health care leaders and frontline workers.

Even though many hospitals have contingency plans for how to allocate resources and triage patient care during crisis capacity, for many providers during the real-world COVID-19 trial of these protocols, they fell short.

Many hospital crisis capacity plans, for example, were too general to address all the specific challenges arising during the pandemic, investigators report in a study published online Nov. 6 in JAMA Network Open.

“Our research shows that the types of challenges and approach to resource limitation in real-world clinical settings during the pandemic differed in practice from how we had prepared in theory,” lead author Catherine Butler, MD, told Medscape Medical News. Insufficient dialysis treatment time, staff shortages, and routine supply scarcity are examples “for which there was not an established plan or approach for appropriate allocation.”

“This left frontline clinicians to determine what constituted an acceptable standard of care and to make difficult allocation decisions at the bedside,” added Butler, acting instructor in the Division of Nephrology at the University of Washington in Seattle and a research fellow at the VA Health Services Research and Development Seattle-Denver Center of Innovation.

The investigators conducted semistructured interviews in April and May with 61 clinicians and health leaders. Mean age was 46 years, 63% were women, and participants practiced in 15 states. Most participants hailed from locations hard-hit by the pandemic at the time, including Seattle, New York City, and New Orleans.
 

Triage tribulations

The qualitative study included comments from respondents on three major themes that emerged: planning for crisis capacity, adapting to resource limitation, and the multiple unprecedented barriers to care delivery.

Overall, planning and support from institutional leaders varied. One provider said, “Talking to administration, and they just seemed really disengaged with the problem. We asked multiple times if there was a triage command center or a plan for what would occur if we got to the point where we had to triage resources. They said there was, but they wouldn’t provide it to us.”

Another had a more positive experience. “The biggest deal in the ethics world in the last 2 months has been preparing in case we need to triage. So, we have a very detailed, elaborate, well thought-out triage policy … that was done at the highest levels of the system.”

Clinicians said they participate on triage teams – despite the moral weight and likely emotional burden – out of a sense of duty.

Interestingly, some providers on these teams also reported a reluctance to reveal their participation to colleagues. “I didn’t feel like I should tell anybody … even some of my close friends who are physicians and nurses here … that I’ve been asked to be on this [triage team],” one respondent said. “I didn’t feel like I should make it known.”
 

Adapting to scarce resources

Multiple providers said they faced difficult care decisions because of limited dialysis or supply shortages. “They felt that this patient had the greatest likelihood of benefiting from most aggressive therapy. … I think there was probably like 5 or 6 patients in the ICU … and then you had this 35-year-old with no comorbidities,” one respondent said. “That’s who the ICU dialyzed, and I couldn’t really disagree.”

“I emailed all of [my colleagues], and I said ‘Help! We need X, we need CRRT [continuous renal replacement therapy] machines, we need dialysates,’ “ another responded.

“One of the attendings had a tweet when we were running out of CRRT. He had a tweet about, ‘Can anybody give us supplies for CRRT?’ So, it got to that. You do anything. You get really desperate,” the clinician said.

Other providers reported getting innovative under the circumstances. “My partner’s son, he actually borrowed a couple of 3D printers. He printed some of these face shields, and then they got the formula, or the specifics as to how to make this particular connection to connect to a dialysis machine to generate dialysate. So, he also printed some of those from the 3D printer.”
 

Dire situations with dialysis

Another respondent understood the focus on ventilators and ICU beds throughout the crisis, but said “no one has acknowledged that dialysis has been one of the most, if not the most, limited resources.”

Another clinician expressed surprise at a decision made in the face of limited availability of traditional dialysis. “A month ago, people said we were going to do acute peritoneal dialysis [PD]. And I said, ‘No, we’re not going to do acute PD. PD, it’s not that great for acute patients, sick people in the ICUs. I don’t think we’re going to do PD.’

“Three days later we were doing acute PD. I mean, that was unbelievable!”

Some institutions rationed dialysis therapy. “We went through the entire list at the beginning of the week and [said], this person has to dialyze these days, this person would probably benefit from a dialysis session, a third group person we could probably just string along and medically manage if we needed to,” one provider said.

Another respondent reported a different strategy. “No one was not getting dialysis, but there were a lot of people getting minimal dialysis. Even though people were getting treated, resources were very stretched.”
 

Changing family dynamics

COVID-19 has naturally changed how clinicians speak with families. One respondent recalled looking at the ICU physician and being like, ‘Have you talked to the son this week?’ And she’s like, ‘Oh my God, no. … Did you talk to the son?’ I’m like, ‘Oh my God, no.’ “

They realized, the respondent added, “that none of us had called the family because it’s just not in your workflow. You’re so used to the family being there.”

Multiple providers also feared a conversation with family regarding necessary changes to care given the limitation of resources during the pandemic.

“Most families have been actually very understanding. This is a crisis, and we’re in a pandemic, and we’re all doing things we wouldn’t normally do.”

Another respondent said, “We were pretty honest about how resources were limited and how we were doing with this COVID-19 surge. And I think we talked about how the usual ability to provide aggressive dialysis was not the case with COVID-19. There was a lot of understanding, sometimes to my surprise. I would think people would be more upset when hearing something like that.”

Many clinicians facing these challenges experience moral distress, the researchers noted.

“Early in the pandemic, it became quickly apparent that possible resource limitation, such as scarce ventilators, was a major ethical concern. There was robust debate and discussion published in medical journals and the popular press about how to appropriately allocate health care resources,” the University of Washington’s Butler said.

“Transparency, accountability, and standardized processes for rationing these resources in ‘crisis capacity’ settings were seen as key to avoiding the impact of implicit bias and moral distress for clinicians,” she added.
 

Lessons learned

In terms of potential solutions that could mitigate these challenges in the future, health care leaders “could develop standardized protocols or guidelines for allocating a broader range of potentially scarce health care resources even before ‘crisis capacity’ is declared,” Butler said.

Furthermore, no frontline worker should have to go it alone. “Medical ethicists and/or other clinicians familiar with ethical considerations in settings of scarce health care resources might provide bedside consultation and collaborate with frontline providers who must grapple with the impact of more subtle forms of resource limitation on clinical decision-making.”

The study was partially funded by grants from the National Institute of Diabetes and Digestive and Kidney Diseases and a COVID-19 Research Award from the University of Washington Institute of Translational Health Sciences given to Butler.
 

This article first appeared on Medscape.com.

Choosing which hospitalized COVID-19 patients receive potentially lifesaving care, making urgent calls for ventilators and other equipment, and triaging care based on patient age and comorbidities were among the challenges revealed in new feedback from health care leaders and frontline workers.

Even though many hospitals have contingency plans for how to allocate resources and triage patient care during crisis capacity, for many providers during the real-world COVID-19 trial of these protocols, they fell short.

Many hospital crisis capacity plans, for example, were too general to address all the specific challenges arising during the pandemic, investigators report in a study published online Nov. 6 in JAMA Network Open.

“Our research shows that the types of challenges and approach to resource limitation in real-world clinical settings during the pandemic differed in practice from how we had prepared in theory,” lead author Catherine Butler, MD, told Medscape Medical News. Insufficient dialysis treatment time, staff shortages, and routine supply scarcity are examples “for which there was not an established plan or approach for appropriate allocation.”

“This left frontline clinicians to determine what constituted an acceptable standard of care and to make difficult allocation decisions at the bedside,” added Butler, acting instructor in the Division of Nephrology at the University of Washington in Seattle and a research fellow at the VA Health Services Research and Development Seattle-Denver Center of Innovation.

The investigators conducted semistructured interviews in April and May with 61 clinicians and health leaders. Mean age was 46 years, 63% were women, and participants practiced in 15 states. Most participants hailed from locations hard-hit by the pandemic at the time, including Seattle, New York City, and New Orleans.
 

Triage tribulations

The qualitative study included comments from respondents on three major themes that emerged: planning for crisis capacity, adapting to resource limitation, and the multiple unprecedented barriers to care delivery.

Overall, planning and support from institutional leaders varied. One provider said, “Talking to administration, and they just seemed really disengaged with the problem. We asked multiple times if there was a triage command center or a plan for what would occur if we got to the point where we had to triage resources. They said there was, but they wouldn’t provide it to us.”

Another had a more positive experience. “The biggest deal in the ethics world in the last 2 months has been preparing in case we need to triage. So, we have a very detailed, elaborate, well thought-out triage policy … that was done at the highest levels of the system.”

Clinicians said they participate on triage teams – despite the moral weight and likely emotional burden – out of a sense of duty.

Interestingly, some providers on these teams also reported a reluctance to reveal their participation to colleagues. “I didn’t feel like I should tell anybody … even some of my close friends who are physicians and nurses here … that I’ve been asked to be on this [triage team],” one respondent said. “I didn’t feel like I should make it known.”
 

Adapting to scarce resources

Multiple providers said they faced difficult care decisions because of limited dialysis or supply shortages. “They felt that this patient had the greatest likelihood of benefiting from most aggressive therapy. … I think there was probably like 5 or 6 patients in the ICU … and then you had this 35-year-old with no comorbidities,” one respondent said. “That’s who the ICU dialyzed, and I couldn’t really disagree.”

“I emailed all of [my colleagues], and I said ‘Help! We need X, we need CRRT [continuous renal replacement therapy] machines, we need dialysates,’ “ another responded.

“One of the attendings had a tweet when we were running out of CRRT. He had a tweet about, ‘Can anybody give us supplies for CRRT?’ So, it got to that. You do anything. You get really desperate,” the clinician said.

Other providers reported getting innovative under the circumstances. “My partner’s son, he actually borrowed a couple of 3D printers. He printed some of these face shields, and then they got the formula, or the specifics as to how to make this particular connection to connect to a dialysis machine to generate dialysate. So, he also printed some of those from the 3D printer.”
 

Dire situations with dialysis

Another respondent understood the focus on ventilators and ICU beds throughout the crisis, but said “no one has acknowledged that dialysis has been one of the most, if not the most, limited resources.”

Another clinician expressed surprise at a decision made in the face of limited availability of traditional dialysis. “A month ago, people said we were going to do acute peritoneal dialysis [PD]. And I said, ‘No, we’re not going to do acute PD. PD, it’s not that great for acute patients, sick people in the ICUs. I don’t think we’re going to do PD.’

“Three days later we were doing acute PD. I mean, that was unbelievable!”

Some institutions rationed dialysis therapy. “We went through the entire list at the beginning of the week and [said], this person has to dialyze these days, this person would probably benefit from a dialysis session, a third group person we could probably just string along and medically manage if we needed to,” one provider said.

Another respondent reported a different strategy. “No one was not getting dialysis, but there were a lot of people getting minimal dialysis. Even though people were getting treated, resources were very stretched.”
 

Changing family dynamics

COVID-19 has naturally changed how clinicians speak with families. One respondent recalled looking at the ICU physician and being like, ‘Have you talked to the son this week?’ And she’s like, ‘Oh my God, no. … Did you talk to the son?’ I’m like, ‘Oh my God, no.’ “

They realized, the respondent added, “that none of us had called the family because it’s just not in your workflow. You’re so used to the family being there.”

Multiple providers also feared a conversation with family regarding necessary changes to care given the limitation of resources during the pandemic.

“Most families have been actually very understanding. This is a crisis, and we’re in a pandemic, and we’re all doing things we wouldn’t normally do.”

Another respondent said, “We were pretty honest about how resources were limited and how we were doing with this COVID-19 surge. And I think we talked about how the usual ability to provide aggressive dialysis was not the case with COVID-19. There was a lot of understanding, sometimes to my surprise. I would think people would be more upset when hearing something like that.”

Many clinicians facing these challenges experience moral distress, the researchers noted.

“Early in the pandemic, it became quickly apparent that possible resource limitation, such as scarce ventilators, was a major ethical concern. There was robust debate and discussion published in medical journals and the popular press about how to appropriately allocate health care resources,” the University of Washington’s Butler said.

“Transparency, accountability, and standardized processes for rationing these resources in ‘crisis capacity’ settings were seen as key to avoiding the impact of implicit bias and moral distress for clinicians,” she added.
 

Lessons learned

In terms of potential solutions that could mitigate these challenges in the future, health care leaders “could develop standardized protocols or guidelines for allocating a broader range of potentially scarce health care resources even before ‘crisis capacity’ is declared,” Butler said.

Furthermore, no frontline worker should have to go it alone. “Medical ethicists and/or other clinicians familiar with ethical considerations in settings of scarce health care resources might provide bedside consultation and collaborate with frontline providers who must grapple with the impact of more subtle forms of resource limitation on clinical decision-making.”

The study was partially funded by grants from the National Institute of Diabetes and Digestive and Kidney Diseases and a COVID-19 Research Award from the University of Washington Institute of Translational Health Sciences given to Butler.
 

This article first appeared on Medscape.com.