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Flu activity hits seasonal high
Influenza activity increased for the third consecutive week and has now reached its highest point for the 2018-2019 flu season, according to the Centers for Disease Control and Prevention.
The proportion of outpatient visits for influenza-like illness (ILI) hit 4.3% for the week ending Feb. 2, which topped the previous high of 4.0% that was reached in late December (the national baseline rate is 2.2%). Outpatient ILI visits then dipped down to 3.1% after 2 weeks of decreases before rising again in mid-January, the CDC’s influenza division reported Feb. 8.
Season-high activity also was seen at the state level for the week ending Feb. 2. There were 18 states at level 10 on the CDC’s 1-10 scale of ILI activity, which was up from 16 the week before, and a total of 24 states were in the high range from 8-10, compared with 23 for the previous week. The geographic spread of influenza was reported as widespread in 47 states and Puerto Rico, the CDC said.
Four flu-related pediatric deaths were reported during the week ending Feb. 2, two of which occurred the previous week, which brings the total for the 2018-2019 season to 28, the CDC said.
There were 158 flu-related deaths among all ages during the week ending Jan. 26 – the latest for which such data are available – with reporting almost 75% complete. The previous week saw 177 overall flu deaths, with reporting for that week over 90% complete. During the corresponding weeks of the very severe 2017-2018 flu season, the overall death totals were 1,448 and 1,626, CDC data show.
Influenza activity increased for the third consecutive week and has now reached its highest point for the 2018-2019 flu season, according to the Centers for Disease Control and Prevention.
The proportion of outpatient visits for influenza-like illness (ILI) hit 4.3% for the week ending Feb. 2, which topped the previous high of 4.0% that was reached in late December (the national baseline rate is 2.2%). Outpatient ILI visits then dipped down to 3.1% after 2 weeks of decreases before rising again in mid-January, the CDC’s influenza division reported Feb. 8.
Season-high activity also was seen at the state level for the week ending Feb. 2. There were 18 states at level 10 on the CDC’s 1-10 scale of ILI activity, which was up from 16 the week before, and a total of 24 states were in the high range from 8-10, compared with 23 for the previous week. The geographic spread of influenza was reported as widespread in 47 states and Puerto Rico, the CDC said.
Four flu-related pediatric deaths were reported during the week ending Feb. 2, two of which occurred the previous week, which brings the total for the 2018-2019 season to 28, the CDC said.
There were 158 flu-related deaths among all ages during the week ending Jan. 26 – the latest for which such data are available – with reporting almost 75% complete. The previous week saw 177 overall flu deaths, with reporting for that week over 90% complete. During the corresponding weeks of the very severe 2017-2018 flu season, the overall death totals were 1,448 and 1,626, CDC data show.
Influenza activity increased for the third consecutive week and has now reached its highest point for the 2018-2019 flu season, according to the Centers for Disease Control and Prevention.
The proportion of outpatient visits for influenza-like illness (ILI) hit 4.3% for the week ending Feb. 2, which topped the previous high of 4.0% that was reached in late December (the national baseline rate is 2.2%). Outpatient ILI visits then dipped down to 3.1% after 2 weeks of decreases before rising again in mid-January, the CDC’s influenza division reported Feb. 8.
Season-high activity also was seen at the state level for the week ending Feb. 2. There were 18 states at level 10 on the CDC’s 1-10 scale of ILI activity, which was up from 16 the week before, and a total of 24 states were in the high range from 8-10, compared with 23 for the previous week. The geographic spread of influenza was reported as widespread in 47 states and Puerto Rico, the CDC said.
Four flu-related pediatric deaths were reported during the week ending Feb. 2, two of which occurred the previous week, which brings the total for the 2018-2019 season to 28, the CDC said.
There were 158 flu-related deaths among all ages during the week ending Jan. 26 – the latest for which such data are available – with reporting almost 75% complete. The previous week saw 177 overall flu deaths, with reporting for that week over 90% complete. During the corresponding weeks of the very severe 2017-2018 flu season, the overall death totals were 1,448 and 1,626, CDC data show.
SGLT2 inhibitors morph into HF drugs
SNOWMASS, COLO. – The oral sodium-glucose cotransporter-2 (SGLT2) inhibitors are the focus of a slew of ongoing phase 3 clinical trials in patients with symptomatic heart failure but no diabetes.
“We have a wide array of exciting opportunities to modify cardiovascular risk with agents that were initially developed for the therapy of diabetes. I think we’re increasingly moving to an age where these agents are actually cardiovascular drugs that happen to lower blood glucose, rather than the other way around, which is how they were initially conceived,” Akshay S. Desai, MD, observed at the Annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.
These are each multi-thousand-patient trials, variously due to be completed in 2019-2021. Of note, several of them are restricted to nondiabetic patients with heart failure with preserved ejection fraction (HFpEF), a common, serious, understudied, extremely high-cost disease sorely in need of effective pharmacotherapies, added Dr. Desai, director of the cardiomyopathy and heart failure program at Brigham and Women’s Hospital and a cardiologist at Harvard Medical School, Boston.
All of these placebo-controlled trials have as their composite primary endpoint cardiovascular death and heart failure hospitalization.
EMPEROR-Preserved has randomized 4,126 patients with HFpEF to empagliflozin (Jardiance) or placebo, while EMPEROR-Reduced involves 2,850 patients with heart failure with reduced ejection fraction (HFrEF). Both are due to be completed in 2020.
In addition, the DELIVER trial is focused on 4,700 HFpEF patients randomized to dapagliflozin (Farxiga) or placebo, while Dapa-HF employs the SGLT2 inhibitor in a study of 4,500 patients with HFrEF. Dapa-HF will be completed by late 2019. DELIVER wraps up in mid-2021.
Again, remarkably, none of the participants in these trials has diabetes. All have symptomatic heart failure with elevated N-terminal pro b-type natriuretic peptide levels. The impetus for this ongoing round of studies was the impressive reduction in the risk of hospitalization for heart failure seen in the pivotal trials that earned the SGLT2 inhibitors empagliflozin, canagliflozin (Invokana), and dapagliflozin marketing approval for treatment of type 2 diabetes from the Food and Drug Administration.
Dr. Desai called attention to a new systematic review and meta-analysis of cardiovascular outcomes in randomized, placebo-controlled trials of SGLT2 inhibitors in more than 34,000 patients with type 2 diabetes. The conclusion: These drugs impressively reduced the risk of heart failure hospitalization by 32% in patients with a baseline history of heart failure and similarly by 29% in those with no such history. Also notable was the 45% reduction in the risk of progression of renal disease regardless of whether patients had atherosclerotic cardiovascular disease (Lancet. 2019 Jan 5;393[10166]:31-9).
Only one of the ongoing round of phase 3 trials of SGLT2 inhibitors in heart failure is being conducted in patients with comorbid type 2 diabetes: the 4,000-subject SOLOIST-WHF trial. This study features the investigational dual inhibitor of SGLT1 and 2, sotagliflozin, with a primary outcome of cardiovascular death or heart failure hospitalization. Results are expected in early 2021.
What the latest guidelines say
The 2018 American Diabetes Association/European Association for the Study of Diabetes joint consensus statement on management of hyperglycemia in type 2 diabetes reflects an appreciation of the cardiovascular benefits of the SGLT2 inhibitors as well as the injectable glucagon-like peptide-1 receptor (GLP-1) agonists, which have shown significant reductions in major adverse cardiovascular events in pivotal trials including LEADER, HARMONY, and REWIND, albeit without the impressive reduction in heart failure hospitalizations documented with the SGLT2 inhibitors.
The consensus statement emphasizes that aggressive lifestyle modification advice is step No. 1, with the first-line medication being metformin titrated to a target of 1,000 mg twice daily. For patients with clinical heart failure or chronic kidney disease and atherosclerotic cardiovascular heart disease, the next drug recommended is an SGLT2 inhibitor with proven cardiovascular benefit. A GLP-1 agonist is recommended as the first injectable medication, ahead of insulin.
Who will take the lead in this new treatment strategy?
Dr. Desai presented data showing that overall utilization of SGLT2 inhibitors and GLP-1 agonists is going up, but not as steeply as it should.
“Cardiologists need to take a more active role,” he declared.
“It’s increasingly clear that, if we’re interested in modifying cardiovascular outcomes, we need to take ownership of this problem, much as we’ve done for lipids and hypertension, because modulating cardiovascular risk is our job,” Dr. Desai asserted. “These drugs may have modest influence on glycemic control, but the primary goal with these agents is to influence cardiovascular outcomes – and if we leave that job to our colleagues, then it often is just a can that gets kicked down the road.”
As a practical matter in prescribing SGLT2 inhibitors and GLP-1 agonists, he emphasized the value of partnering with a primary care physician, endocrinologist, and/or pharmacist by creating pathways for accelerated referral for pharmacologic teaching and, in the case of GLP-1 agonists, injection-related instruction. Pharmacists are often particularly helpful in obtaining prior authorization and financial approval for these medications, and they are familiar with drug discounts and vouchers.
“A great way to jump start collaboration is to provide the patient with a prescription before leaving your office. I think often what we do is just suggest it to the patient, and then a year later they come back and nothing has changed,” the cardiologist said.
Dr. Desai reported serving as a paid consultant to more than half a dozen pharmaceutical or medical device companies.
SNOWMASS, COLO. – The oral sodium-glucose cotransporter-2 (SGLT2) inhibitors are the focus of a slew of ongoing phase 3 clinical trials in patients with symptomatic heart failure but no diabetes.
“We have a wide array of exciting opportunities to modify cardiovascular risk with agents that were initially developed for the therapy of diabetes. I think we’re increasingly moving to an age where these agents are actually cardiovascular drugs that happen to lower blood glucose, rather than the other way around, which is how they were initially conceived,” Akshay S. Desai, MD, observed at the Annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.
These are each multi-thousand-patient trials, variously due to be completed in 2019-2021. Of note, several of them are restricted to nondiabetic patients with heart failure with preserved ejection fraction (HFpEF), a common, serious, understudied, extremely high-cost disease sorely in need of effective pharmacotherapies, added Dr. Desai, director of the cardiomyopathy and heart failure program at Brigham and Women’s Hospital and a cardiologist at Harvard Medical School, Boston.
All of these placebo-controlled trials have as their composite primary endpoint cardiovascular death and heart failure hospitalization.
EMPEROR-Preserved has randomized 4,126 patients with HFpEF to empagliflozin (Jardiance) or placebo, while EMPEROR-Reduced involves 2,850 patients with heart failure with reduced ejection fraction (HFrEF). Both are due to be completed in 2020.
In addition, the DELIVER trial is focused on 4,700 HFpEF patients randomized to dapagliflozin (Farxiga) or placebo, while Dapa-HF employs the SGLT2 inhibitor in a study of 4,500 patients with HFrEF. Dapa-HF will be completed by late 2019. DELIVER wraps up in mid-2021.
Again, remarkably, none of the participants in these trials has diabetes. All have symptomatic heart failure with elevated N-terminal pro b-type natriuretic peptide levels. The impetus for this ongoing round of studies was the impressive reduction in the risk of hospitalization for heart failure seen in the pivotal trials that earned the SGLT2 inhibitors empagliflozin, canagliflozin (Invokana), and dapagliflozin marketing approval for treatment of type 2 diabetes from the Food and Drug Administration.
Dr. Desai called attention to a new systematic review and meta-analysis of cardiovascular outcomes in randomized, placebo-controlled trials of SGLT2 inhibitors in more than 34,000 patients with type 2 diabetes. The conclusion: These drugs impressively reduced the risk of heart failure hospitalization by 32% in patients with a baseline history of heart failure and similarly by 29% in those with no such history. Also notable was the 45% reduction in the risk of progression of renal disease regardless of whether patients had atherosclerotic cardiovascular disease (Lancet. 2019 Jan 5;393[10166]:31-9).
Only one of the ongoing round of phase 3 trials of SGLT2 inhibitors in heart failure is being conducted in patients with comorbid type 2 diabetes: the 4,000-subject SOLOIST-WHF trial. This study features the investigational dual inhibitor of SGLT1 and 2, sotagliflozin, with a primary outcome of cardiovascular death or heart failure hospitalization. Results are expected in early 2021.
What the latest guidelines say
The 2018 American Diabetes Association/European Association for the Study of Diabetes joint consensus statement on management of hyperglycemia in type 2 diabetes reflects an appreciation of the cardiovascular benefits of the SGLT2 inhibitors as well as the injectable glucagon-like peptide-1 receptor (GLP-1) agonists, which have shown significant reductions in major adverse cardiovascular events in pivotal trials including LEADER, HARMONY, and REWIND, albeit without the impressive reduction in heart failure hospitalizations documented with the SGLT2 inhibitors.
The consensus statement emphasizes that aggressive lifestyle modification advice is step No. 1, with the first-line medication being metformin titrated to a target of 1,000 mg twice daily. For patients with clinical heart failure or chronic kidney disease and atherosclerotic cardiovascular heart disease, the next drug recommended is an SGLT2 inhibitor with proven cardiovascular benefit. A GLP-1 agonist is recommended as the first injectable medication, ahead of insulin.
Who will take the lead in this new treatment strategy?
Dr. Desai presented data showing that overall utilization of SGLT2 inhibitors and GLP-1 agonists is going up, but not as steeply as it should.
“Cardiologists need to take a more active role,” he declared.
“It’s increasingly clear that, if we’re interested in modifying cardiovascular outcomes, we need to take ownership of this problem, much as we’ve done for lipids and hypertension, because modulating cardiovascular risk is our job,” Dr. Desai asserted. “These drugs may have modest influence on glycemic control, but the primary goal with these agents is to influence cardiovascular outcomes – and if we leave that job to our colleagues, then it often is just a can that gets kicked down the road.”
As a practical matter in prescribing SGLT2 inhibitors and GLP-1 agonists, he emphasized the value of partnering with a primary care physician, endocrinologist, and/or pharmacist by creating pathways for accelerated referral for pharmacologic teaching and, in the case of GLP-1 agonists, injection-related instruction. Pharmacists are often particularly helpful in obtaining prior authorization and financial approval for these medications, and they are familiar with drug discounts and vouchers.
“A great way to jump start collaboration is to provide the patient with a prescription before leaving your office. I think often what we do is just suggest it to the patient, and then a year later they come back and nothing has changed,” the cardiologist said.
Dr. Desai reported serving as a paid consultant to more than half a dozen pharmaceutical or medical device companies.
SNOWMASS, COLO. – The oral sodium-glucose cotransporter-2 (SGLT2) inhibitors are the focus of a slew of ongoing phase 3 clinical trials in patients with symptomatic heart failure but no diabetes.
“We have a wide array of exciting opportunities to modify cardiovascular risk with agents that were initially developed for the therapy of diabetes. I think we’re increasingly moving to an age where these agents are actually cardiovascular drugs that happen to lower blood glucose, rather than the other way around, which is how they were initially conceived,” Akshay S. Desai, MD, observed at the Annual Cardiovascular Conference at Snowmass sponsored by the American College of Cardiology.
These are each multi-thousand-patient trials, variously due to be completed in 2019-2021. Of note, several of them are restricted to nondiabetic patients with heart failure with preserved ejection fraction (HFpEF), a common, serious, understudied, extremely high-cost disease sorely in need of effective pharmacotherapies, added Dr. Desai, director of the cardiomyopathy and heart failure program at Brigham and Women’s Hospital and a cardiologist at Harvard Medical School, Boston.
All of these placebo-controlled trials have as their composite primary endpoint cardiovascular death and heart failure hospitalization.
EMPEROR-Preserved has randomized 4,126 patients with HFpEF to empagliflozin (Jardiance) or placebo, while EMPEROR-Reduced involves 2,850 patients with heart failure with reduced ejection fraction (HFrEF). Both are due to be completed in 2020.
In addition, the DELIVER trial is focused on 4,700 HFpEF patients randomized to dapagliflozin (Farxiga) or placebo, while Dapa-HF employs the SGLT2 inhibitor in a study of 4,500 patients with HFrEF. Dapa-HF will be completed by late 2019. DELIVER wraps up in mid-2021.
Again, remarkably, none of the participants in these trials has diabetes. All have symptomatic heart failure with elevated N-terminal pro b-type natriuretic peptide levels. The impetus for this ongoing round of studies was the impressive reduction in the risk of hospitalization for heart failure seen in the pivotal trials that earned the SGLT2 inhibitors empagliflozin, canagliflozin (Invokana), and dapagliflozin marketing approval for treatment of type 2 diabetes from the Food and Drug Administration.
Dr. Desai called attention to a new systematic review and meta-analysis of cardiovascular outcomes in randomized, placebo-controlled trials of SGLT2 inhibitors in more than 34,000 patients with type 2 diabetes. The conclusion: These drugs impressively reduced the risk of heart failure hospitalization by 32% in patients with a baseline history of heart failure and similarly by 29% in those with no such history. Also notable was the 45% reduction in the risk of progression of renal disease regardless of whether patients had atherosclerotic cardiovascular disease (Lancet. 2019 Jan 5;393[10166]:31-9).
Only one of the ongoing round of phase 3 trials of SGLT2 inhibitors in heart failure is being conducted in patients with comorbid type 2 diabetes: the 4,000-subject SOLOIST-WHF trial. This study features the investigational dual inhibitor of SGLT1 and 2, sotagliflozin, with a primary outcome of cardiovascular death or heart failure hospitalization. Results are expected in early 2021.
What the latest guidelines say
The 2018 American Diabetes Association/European Association for the Study of Diabetes joint consensus statement on management of hyperglycemia in type 2 diabetes reflects an appreciation of the cardiovascular benefits of the SGLT2 inhibitors as well as the injectable glucagon-like peptide-1 receptor (GLP-1) agonists, which have shown significant reductions in major adverse cardiovascular events in pivotal trials including LEADER, HARMONY, and REWIND, albeit without the impressive reduction in heart failure hospitalizations documented with the SGLT2 inhibitors.
The consensus statement emphasizes that aggressive lifestyle modification advice is step No. 1, with the first-line medication being metformin titrated to a target of 1,000 mg twice daily. For patients with clinical heart failure or chronic kidney disease and atherosclerotic cardiovascular heart disease, the next drug recommended is an SGLT2 inhibitor with proven cardiovascular benefit. A GLP-1 agonist is recommended as the first injectable medication, ahead of insulin.
Who will take the lead in this new treatment strategy?
Dr. Desai presented data showing that overall utilization of SGLT2 inhibitors and GLP-1 agonists is going up, but not as steeply as it should.
“Cardiologists need to take a more active role,” he declared.
“It’s increasingly clear that, if we’re interested in modifying cardiovascular outcomes, we need to take ownership of this problem, much as we’ve done for lipids and hypertension, because modulating cardiovascular risk is our job,” Dr. Desai asserted. “These drugs may have modest influence on glycemic control, but the primary goal with these agents is to influence cardiovascular outcomes – and if we leave that job to our colleagues, then it often is just a can that gets kicked down the road.”
As a practical matter in prescribing SGLT2 inhibitors and GLP-1 agonists, he emphasized the value of partnering with a primary care physician, endocrinologist, and/or pharmacist by creating pathways for accelerated referral for pharmacologic teaching and, in the case of GLP-1 agonists, injection-related instruction. Pharmacists are often particularly helpful in obtaining prior authorization and financial approval for these medications, and they are familiar with drug discounts and vouchers.
“A great way to jump start collaboration is to provide the patient with a prescription before leaving your office. I think often what we do is just suggest it to the patient, and then a year later they come back and nothing has changed,” the cardiologist said.
Dr. Desai reported serving as a paid consultant to more than half a dozen pharmaceutical or medical device companies.
EXPERT ANALYSIS FROM ACC SNOWMASS 2019
Cilostazol plus aspirin or clopidogrel reduces the risk of recurrent stroke
HONOLULU – The combination also entails a similar risk of major bleeding, compared with aspirin and clopidogrel alone, according to results from the Cilostazol Stroke Prevention Study for Antiplatelet Combination (CSPS.com).
Dual-antiplatelet therapy with aspirin and clopidogrel reduced the rate of recurrent stroke in previous studies. The benefit of this drug combination is relatively short-lived, however, and long-term concomitant use of aspirin and clopidogrel entails a risk of major bleeding. Other data have indicated that cilostazol, which is approved by the Food and Drug Administration to alleviate intermittent claudication in patients with peripheral vascular disease, prevents stroke recurrence without increasing the incidence of serious bleeding, compared with aspirin, said Kazunori Toyoda, MD, PhD, who presented the results of the CSPS.com trial at the International Stroke Conference sponsored by the American Heart Association.
Dr. Toyoda of the National Cerebral and Cardiovascular Center in Osaka, Japan, and his colleagues randomized 1,879 high-risk patients at 8-180 days after the onset of noncardioembolic ischemic stroke identified on MRI to receive 81 or 100 mg aspirin or 50 or 75 mg clopidogrel alone, or a combination of cilostazol 100 mg twice daily with aspirin or clopidogrel. They conducted their open-label, parallel-group trial at 292 sites in Japan from December 2013 through March 2017.
To be considered at high risk, participants had to meet one or more of the following criteria: 50% or greater stenosis of a major intracranial artery, 50% or greater stenosis of an extracranial artery, and two or more vascular risk factors. The trial’s primary efficacy outcome was the first recurrence of ischemic stroke. Safety outcomes included severe or life-threatening bleeding.
The investigators ended the trial early because of a delay in recruiting patients. They enrolled 1,884 and randomized 1,879 of an anticipated 4,000 patients. At randomization, 41% in the dual-therapy group received aspirin and 59% clopidogrel, and in the monotherapy group, 40% received aspirin and 60% clopidogrel. Baseline characteristics were similar between the treatment groups. The population’s mean age was 70. Approximately 30% of patients were women.
During a median follow-up period of 17 months, ischemic stroke recurred in 29 of 932 patients receiving dual therapy including cilostazol for an annual rate of 2.2% and in 64 of 947 patients receiving monotherapy for an annual rate of 4.5% (hazard ratio, 0.49; 95% confidence interval, 0.31-0.76; P = .001). Severe or life-threatening bleeding occurred in 8 patients (0.6% per year) receiving dual therapy and 13 patients (0.9% per year) receiving monotherapy (HR, 0.66; 95% CI, 0.27-1.60; P = .354).
The study was funded by Otsuka Pharmaceutical, which manufactures cilostazol. Dr. Toyoda reported receiving support from Bayer Yakuhin, Daiichi Sankyo, Bristol-Myers Squibb, and Nippon Boehringer Ingelheim.
SOURCE: Toyoda K et al. ISC 2019, Abstract LB3.
HONOLULU – The combination also entails a similar risk of major bleeding, compared with aspirin and clopidogrel alone, according to results from the Cilostazol Stroke Prevention Study for Antiplatelet Combination (CSPS.com).
Dual-antiplatelet therapy with aspirin and clopidogrel reduced the rate of recurrent stroke in previous studies. The benefit of this drug combination is relatively short-lived, however, and long-term concomitant use of aspirin and clopidogrel entails a risk of major bleeding. Other data have indicated that cilostazol, which is approved by the Food and Drug Administration to alleviate intermittent claudication in patients with peripheral vascular disease, prevents stroke recurrence without increasing the incidence of serious bleeding, compared with aspirin, said Kazunori Toyoda, MD, PhD, who presented the results of the CSPS.com trial at the International Stroke Conference sponsored by the American Heart Association.
Dr. Toyoda of the National Cerebral and Cardiovascular Center in Osaka, Japan, and his colleagues randomized 1,879 high-risk patients at 8-180 days after the onset of noncardioembolic ischemic stroke identified on MRI to receive 81 or 100 mg aspirin or 50 or 75 mg clopidogrel alone, or a combination of cilostazol 100 mg twice daily with aspirin or clopidogrel. They conducted their open-label, parallel-group trial at 292 sites in Japan from December 2013 through March 2017.
To be considered at high risk, participants had to meet one or more of the following criteria: 50% or greater stenosis of a major intracranial artery, 50% or greater stenosis of an extracranial artery, and two or more vascular risk factors. The trial’s primary efficacy outcome was the first recurrence of ischemic stroke. Safety outcomes included severe or life-threatening bleeding.
The investigators ended the trial early because of a delay in recruiting patients. They enrolled 1,884 and randomized 1,879 of an anticipated 4,000 patients. At randomization, 41% in the dual-therapy group received aspirin and 59% clopidogrel, and in the monotherapy group, 40% received aspirin and 60% clopidogrel. Baseline characteristics were similar between the treatment groups. The population’s mean age was 70. Approximately 30% of patients were women.
During a median follow-up period of 17 months, ischemic stroke recurred in 29 of 932 patients receiving dual therapy including cilostazol for an annual rate of 2.2% and in 64 of 947 patients receiving monotherapy for an annual rate of 4.5% (hazard ratio, 0.49; 95% confidence interval, 0.31-0.76; P = .001). Severe or life-threatening bleeding occurred in 8 patients (0.6% per year) receiving dual therapy and 13 patients (0.9% per year) receiving monotherapy (HR, 0.66; 95% CI, 0.27-1.60; P = .354).
The study was funded by Otsuka Pharmaceutical, which manufactures cilostazol. Dr. Toyoda reported receiving support from Bayer Yakuhin, Daiichi Sankyo, Bristol-Myers Squibb, and Nippon Boehringer Ingelheim.
SOURCE: Toyoda K et al. ISC 2019, Abstract LB3.
HONOLULU – The combination also entails a similar risk of major bleeding, compared with aspirin and clopidogrel alone, according to results from the Cilostazol Stroke Prevention Study for Antiplatelet Combination (CSPS.com).
Dual-antiplatelet therapy with aspirin and clopidogrel reduced the rate of recurrent stroke in previous studies. The benefit of this drug combination is relatively short-lived, however, and long-term concomitant use of aspirin and clopidogrel entails a risk of major bleeding. Other data have indicated that cilostazol, which is approved by the Food and Drug Administration to alleviate intermittent claudication in patients with peripheral vascular disease, prevents stroke recurrence without increasing the incidence of serious bleeding, compared with aspirin, said Kazunori Toyoda, MD, PhD, who presented the results of the CSPS.com trial at the International Stroke Conference sponsored by the American Heart Association.
Dr. Toyoda of the National Cerebral and Cardiovascular Center in Osaka, Japan, and his colleagues randomized 1,879 high-risk patients at 8-180 days after the onset of noncardioembolic ischemic stroke identified on MRI to receive 81 or 100 mg aspirin or 50 or 75 mg clopidogrel alone, or a combination of cilostazol 100 mg twice daily with aspirin or clopidogrel. They conducted their open-label, parallel-group trial at 292 sites in Japan from December 2013 through March 2017.
To be considered at high risk, participants had to meet one or more of the following criteria: 50% or greater stenosis of a major intracranial artery, 50% or greater stenosis of an extracranial artery, and two or more vascular risk factors. The trial’s primary efficacy outcome was the first recurrence of ischemic stroke. Safety outcomes included severe or life-threatening bleeding.
The investigators ended the trial early because of a delay in recruiting patients. They enrolled 1,884 and randomized 1,879 of an anticipated 4,000 patients. At randomization, 41% in the dual-therapy group received aspirin and 59% clopidogrel, and in the monotherapy group, 40% received aspirin and 60% clopidogrel. Baseline characteristics were similar between the treatment groups. The population’s mean age was 70. Approximately 30% of patients were women.
During a median follow-up period of 17 months, ischemic stroke recurred in 29 of 932 patients receiving dual therapy including cilostazol for an annual rate of 2.2% and in 64 of 947 patients receiving monotherapy for an annual rate of 4.5% (hazard ratio, 0.49; 95% confidence interval, 0.31-0.76; P = .001). Severe or life-threatening bleeding occurred in 8 patients (0.6% per year) receiving dual therapy and 13 patients (0.9% per year) receiving monotherapy (HR, 0.66; 95% CI, 0.27-1.60; P = .354).
The study was funded by Otsuka Pharmaceutical, which manufactures cilostazol. Dr. Toyoda reported receiving support from Bayer Yakuhin, Daiichi Sankyo, Bristol-Myers Squibb, and Nippon Boehringer Ingelheim.
SOURCE: Toyoda K et al. ISC 2019, Abstract LB3.
REPORTING FROM ISC
Key clinical point: Treating patients at high risk of recurrent stroke with cilostazol and aspirin or clopidogrel reduced the risk of recurrent stroke more than either aspirin or clopidogrel alone and was just as safe.
Major finding: Dual therapy with cilostazol and aspirin or clopidogrel reduced the risk of recurrent stroke by approximately half, compared with aspirin or clopidogrel alone.
Study details: A multicenter, randomized, open-label, parallel-group trial including 1,879 patients at high risk of recurrent stroke.
Disclosures: Otsuka Pharmaceutical funded the study. The presenter reported receiving support from Bayer Yakuhin, Daiichi Sankyo, Bristol-Myers Squibb, and Nippon Boehringer Ingelheim.
Source: Toyoda K et al. ISC 2019, Abstract LB3.
Intensive insulin added no benefit for hyperglycemia after ischemic stroke
HONOLULU – In patients who were hyperglycemic following an acute ischemic stroke, intensive insulin control using a continuous insulin drip and an aggressive blood glucose target of 80-130 mg/dL provided no incremental benefit in clinical outcome, compared with a more standard approach of serial, subcutaneous insulin injections and a moderate blood glucose target in a multicenter, U.S. trial with more than 1,100 patients.
The results also highlighted the potential downside to aggressive insulin treatment, with an associated 2.6% incidence of severe hypoglycemia, defined as blood glucose falling below 40 mg/dL, Karen C. Johnston, MD, said at the International Stroke Conference sponsored by the American Heart Association.
“Our data suggest that subcutaneously administered insulin with a target blood glucose level of less than 180 mg/dL is the preferred treatment” because it produces similar efficacy without causing any episodes of severe hypoglycemia, concluded Dr. Johnston, professor and chair of neurology at the University of Virginia in Charlottesville. “There should be no further debate” over the potential superiority of a glucose target substantially below 180 mg/dL, she added in an interview.
Continuing to use a glucose target of less than 180 mg/dL and treating patients with subcutaneous insulin injections every 6 hours to achieve this will mean substantially less resource use and precludes the need for keeping patients in intensive care beds as is needed with an insulin drip, Dr. Johnston noted. A treatment target of less than 180 mg/dL is also consistent with the most recent American Heart Association stroke treatment guidelines, which listed a blood glucose target of 140-180 mg/dL as a class IIa recommendation (Stroke. 2018 March;49[3]:e66-99).
The SHINE (Stroke Hyperglycemia Insulin Network Effort) trial enrolled 1,151 adults diagnosed with an acute ischemic stroke at 63 U.S. centers during 2012-2018, excluding patients with type 1 diabetes. Patients had to enter the study within 12 hours of their last known well time, and with an elevated blood glucose level, above 110 mg/dL in patients with type 2 diabetes or at or above 150 mg/dL in other patients. The median glucose level of enrolled patients was about 188 mg/dL. Enrolled patients averaged 66 years old, and about 80% had type 2 diabetes. The median time from last known well to randomization was just over 7 hours. Almost two-thirds of the patients received thrombolytic treatment, and about 13% underwent thrombectomy.
During up to 72 hours of treatment following enrollment the patients in the standard-treatment arm showed a fairly steady average blood glucose level of 179 mg/dL; patients in the intensive arm showed a steady average of 118 mg/dL.
The study’s primary end point was the percentage of patients with a favorable outcome 90 days after enrollment based on their modified Rankin scale score at that time, with the scores that qualified for this end point varying depending on stroke severity at baseline. The percentage of patients achieving this was 20.5% among the intensive patients and 21.6% among those who received standard insulin treatment, a difference that was not statistically significant.
The findings left open the question of how to better manage acute ischemic stroke patients who present with hyperglycemia.
“Hyperglycemic stroke patients have worse outcomes than stroke patients without hyperglycemia. More aggressively treating the hyperglycemia did not help these patients, We need to figure out what will help them,” Dr. Johnson said.
SOURCE: Johnston KC et al. ISC 2019, Abstract LB1.
SHINE was a well-designed trial that was run with a high degree of rigor, and its results advance the field. The results left no doubt that the result was neutral, that , while resulting in an excess of severe hypoglycemia episodes.
Using a less intensive insulin regimen that does not require a continuous drip is easier. The question of how aggressive treatment needs to be when managing glucose in acute ischemic stroke patients is something that U.S. clinicians who care for stroke patients argue about virtually daily. At my center, Cedars-Sinai in Los Angeles, we have recently used an approach that blended standard insulin treatment with more aggressive treatment. The SHINE results may not be practice changing, but they will be argument changing. The new results will make a difference. We will now stop arguing. We now know what we need to do.
Patrick D. Lyden, MD , is professor and chair of neurology at Cedars-Sinai Medical Center in Los Angeles. He had no relevant disclosures. He made these comments in an interview.
SHINE was a well-designed trial that was run with a high degree of rigor, and its results advance the field. The results left no doubt that the result was neutral, that , while resulting in an excess of severe hypoglycemia episodes.
Using a less intensive insulin regimen that does not require a continuous drip is easier. The question of how aggressive treatment needs to be when managing glucose in acute ischemic stroke patients is something that U.S. clinicians who care for stroke patients argue about virtually daily. At my center, Cedars-Sinai in Los Angeles, we have recently used an approach that blended standard insulin treatment with more aggressive treatment. The SHINE results may not be practice changing, but they will be argument changing. The new results will make a difference. We will now stop arguing. We now know what we need to do.
Patrick D. Lyden, MD , is professor and chair of neurology at Cedars-Sinai Medical Center in Los Angeles. He had no relevant disclosures. He made these comments in an interview.
SHINE was a well-designed trial that was run with a high degree of rigor, and its results advance the field. The results left no doubt that the result was neutral, that , while resulting in an excess of severe hypoglycemia episodes.
Using a less intensive insulin regimen that does not require a continuous drip is easier. The question of how aggressive treatment needs to be when managing glucose in acute ischemic stroke patients is something that U.S. clinicians who care for stroke patients argue about virtually daily. At my center, Cedars-Sinai in Los Angeles, we have recently used an approach that blended standard insulin treatment with more aggressive treatment. The SHINE results may not be practice changing, but they will be argument changing. The new results will make a difference. We will now stop arguing. We now know what we need to do.
Patrick D. Lyden, MD , is professor and chair of neurology at Cedars-Sinai Medical Center in Los Angeles. He had no relevant disclosures. He made these comments in an interview.
HONOLULU – In patients who were hyperglycemic following an acute ischemic stroke, intensive insulin control using a continuous insulin drip and an aggressive blood glucose target of 80-130 mg/dL provided no incremental benefit in clinical outcome, compared with a more standard approach of serial, subcutaneous insulin injections and a moderate blood glucose target in a multicenter, U.S. trial with more than 1,100 patients.
The results also highlighted the potential downside to aggressive insulin treatment, with an associated 2.6% incidence of severe hypoglycemia, defined as blood glucose falling below 40 mg/dL, Karen C. Johnston, MD, said at the International Stroke Conference sponsored by the American Heart Association.
“Our data suggest that subcutaneously administered insulin with a target blood glucose level of less than 180 mg/dL is the preferred treatment” because it produces similar efficacy without causing any episodes of severe hypoglycemia, concluded Dr. Johnston, professor and chair of neurology at the University of Virginia in Charlottesville. “There should be no further debate” over the potential superiority of a glucose target substantially below 180 mg/dL, she added in an interview.
Continuing to use a glucose target of less than 180 mg/dL and treating patients with subcutaneous insulin injections every 6 hours to achieve this will mean substantially less resource use and precludes the need for keeping patients in intensive care beds as is needed with an insulin drip, Dr. Johnston noted. A treatment target of less than 180 mg/dL is also consistent with the most recent American Heart Association stroke treatment guidelines, which listed a blood glucose target of 140-180 mg/dL as a class IIa recommendation (Stroke. 2018 March;49[3]:e66-99).
The SHINE (Stroke Hyperglycemia Insulin Network Effort) trial enrolled 1,151 adults diagnosed with an acute ischemic stroke at 63 U.S. centers during 2012-2018, excluding patients with type 1 diabetes. Patients had to enter the study within 12 hours of their last known well time, and with an elevated blood glucose level, above 110 mg/dL in patients with type 2 diabetes or at or above 150 mg/dL in other patients. The median glucose level of enrolled patients was about 188 mg/dL. Enrolled patients averaged 66 years old, and about 80% had type 2 diabetes. The median time from last known well to randomization was just over 7 hours. Almost two-thirds of the patients received thrombolytic treatment, and about 13% underwent thrombectomy.
During up to 72 hours of treatment following enrollment the patients in the standard-treatment arm showed a fairly steady average blood glucose level of 179 mg/dL; patients in the intensive arm showed a steady average of 118 mg/dL.
The study’s primary end point was the percentage of patients with a favorable outcome 90 days after enrollment based on their modified Rankin scale score at that time, with the scores that qualified for this end point varying depending on stroke severity at baseline. The percentage of patients achieving this was 20.5% among the intensive patients and 21.6% among those who received standard insulin treatment, a difference that was not statistically significant.
The findings left open the question of how to better manage acute ischemic stroke patients who present with hyperglycemia.
“Hyperglycemic stroke patients have worse outcomes than stroke patients without hyperglycemia. More aggressively treating the hyperglycemia did not help these patients, We need to figure out what will help them,” Dr. Johnson said.
SOURCE: Johnston KC et al. ISC 2019, Abstract LB1.
HONOLULU – In patients who were hyperglycemic following an acute ischemic stroke, intensive insulin control using a continuous insulin drip and an aggressive blood glucose target of 80-130 mg/dL provided no incremental benefit in clinical outcome, compared with a more standard approach of serial, subcutaneous insulin injections and a moderate blood glucose target in a multicenter, U.S. trial with more than 1,100 patients.
The results also highlighted the potential downside to aggressive insulin treatment, with an associated 2.6% incidence of severe hypoglycemia, defined as blood glucose falling below 40 mg/dL, Karen C. Johnston, MD, said at the International Stroke Conference sponsored by the American Heart Association.
“Our data suggest that subcutaneously administered insulin with a target blood glucose level of less than 180 mg/dL is the preferred treatment” because it produces similar efficacy without causing any episodes of severe hypoglycemia, concluded Dr. Johnston, professor and chair of neurology at the University of Virginia in Charlottesville. “There should be no further debate” over the potential superiority of a glucose target substantially below 180 mg/dL, she added in an interview.
Continuing to use a glucose target of less than 180 mg/dL and treating patients with subcutaneous insulin injections every 6 hours to achieve this will mean substantially less resource use and precludes the need for keeping patients in intensive care beds as is needed with an insulin drip, Dr. Johnston noted. A treatment target of less than 180 mg/dL is also consistent with the most recent American Heart Association stroke treatment guidelines, which listed a blood glucose target of 140-180 mg/dL as a class IIa recommendation (Stroke. 2018 March;49[3]:e66-99).
The SHINE (Stroke Hyperglycemia Insulin Network Effort) trial enrolled 1,151 adults diagnosed with an acute ischemic stroke at 63 U.S. centers during 2012-2018, excluding patients with type 1 diabetes. Patients had to enter the study within 12 hours of their last known well time, and with an elevated blood glucose level, above 110 mg/dL in patients with type 2 diabetes or at or above 150 mg/dL in other patients. The median glucose level of enrolled patients was about 188 mg/dL. Enrolled patients averaged 66 years old, and about 80% had type 2 diabetes. The median time from last known well to randomization was just over 7 hours. Almost two-thirds of the patients received thrombolytic treatment, and about 13% underwent thrombectomy.
During up to 72 hours of treatment following enrollment the patients in the standard-treatment arm showed a fairly steady average blood glucose level of 179 mg/dL; patients in the intensive arm showed a steady average of 118 mg/dL.
The study’s primary end point was the percentage of patients with a favorable outcome 90 days after enrollment based on their modified Rankin scale score at that time, with the scores that qualified for this end point varying depending on stroke severity at baseline. The percentage of patients achieving this was 20.5% among the intensive patients and 21.6% among those who received standard insulin treatment, a difference that was not statistically significant.
The findings left open the question of how to better manage acute ischemic stroke patients who present with hyperglycemia.
“Hyperglycemic stroke patients have worse outcomes than stroke patients without hyperglycemia. More aggressively treating the hyperglycemia did not help these patients, We need to figure out what will help them,” Dr. Johnson said.
SOURCE: Johnston KC et al. ISC 2019, Abstract LB1.
REPORTING FROM ISC 2019
Key clinical point: Aggressive insulin management of hyperglycemia following an ischemic stroke gave no clinical benefit, compared with a standard approach.
Major finding: After 90 days, favorable outcomes occurred in 21% of patients on aggressive insulin treatment and 22% on standard treatment.
Study details: SHINE, a multicenter, randomized trial with 1,151 acute ischemic stroke patients.
Disclosures: SHINE received no commercial funding. Dr. Johnston had no disclosures.
Source: Johnston KC et al. ISC 2019, Abstract LB1.
Benefiting from an egalitarian hospital culture
Cultural change linked to improved outcomes
Health care experts have long known of a link between patient outcomes and a hospital’s organizational culture, according to an article in the New York Times by Pauline W. Chen, MD.
“Heart attack patients who are treated at hospitals where nurses feel powerless and senior management is only sporadically involved in patient care tend to fare more poorly than patients hospitalized at institutions where nurses are asked regularly for their input and chief executives hold regular meetings with clinicians to review patient results,” she wrote.
But there is hope for change, Dr. Chen noted, and it’s demonstrable, citing a group of researchers that has written about strategies targeting hospital organizational culture called “Leadership Saves Lives.” The researchers showed hospitals could create significant cultural changes, which could impact patient outcomes, in just 2 years.
“Leadership Saves Lives requires that each hospital create a ‘Guiding Coalition,’ a group of staff members from across the entire institution. The coalition members participate in regular workshops, discussions, and national forums on ways hospitals might improve, then help their respective hospital translate newfound ideas and information into clinical practice,” she wrote.
The researchers monitored heart attack patients to assess the effect of Leadership Saves Lives in 10 hospitals that had below average patient outcomes. Over 2 years, all 10 hospitals changed significantly, but 6 hospitals experienced particularly profound cultural transformations.
“The staff of these hospitals spoke of an institutional shift from ‘because I said so’ to ‘focusing on the why’s,’ ” Dr. Chen wrote. “Instead of accepting that every heart attack patient had to undergo certain testing or take specific drugs because the chief of the department or administrator had previously established such clinical protocols, for example, it became more important to provide the data that proved such rituals were actually helpful. Staff members in these hospitals also said they received, and appreciated, increased support from senior management and a newfound freedom to voice opinions in ‘more of an equal role, no matter what position you are.’ ”
The degree of an institution’s cultural change was directly linked to patient outcomes, the researchers found. Indeed, hospitals that made more substantial changes in their work culture realized larger and more sustained drops in heart attack mortality rates.
References
1. Chen PW. A More Egalitarian Hospital Culture Is Better for Everyone. New York Times. https://www.nytimes.com/2018/05/31/well/live/doctors-patients-hospital-culture-better-health.html. Published May 31, 2018. Accessed June 1, 2018.
2. Curry LA et al. Organizational culture change in U.S. hospitals: A mixed methods longitudinal intervention study. Implementation Science. 2015 Mar 7. doi: 10.1186/s13012-015-0218-0. Accessed June 18, 2018.
Cultural change linked to improved outcomes
Cultural change linked to improved outcomes
Health care experts have long known of a link between patient outcomes and a hospital’s organizational culture, according to an article in the New York Times by Pauline W. Chen, MD.
“Heart attack patients who are treated at hospitals where nurses feel powerless and senior management is only sporadically involved in patient care tend to fare more poorly than patients hospitalized at institutions where nurses are asked regularly for their input and chief executives hold regular meetings with clinicians to review patient results,” she wrote.
But there is hope for change, Dr. Chen noted, and it’s demonstrable, citing a group of researchers that has written about strategies targeting hospital organizational culture called “Leadership Saves Lives.” The researchers showed hospitals could create significant cultural changes, which could impact patient outcomes, in just 2 years.
“Leadership Saves Lives requires that each hospital create a ‘Guiding Coalition,’ a group of staff members from across the entire institution. The coalition members participate in regular workshops, discussions, and national forums on ways hospitals might improve, then help their respective hospital translate newfound ideas and information into clinical practice,” she wrote.
The researchers monitored heart attack patients to assess the effect of Leadership Saves Lives in 10 hospitals that had below average patient outcomes. Over 2 years, all 10 hospitals changed significantly, but 6 hospitals experienced particularly profound cultural transformations.
“The staff of these hospitals spoke of an institutional shift from ‘because I said so’ to ‘focusing on the why’s,’ ” Dr. Chen wrote. “Instead of accepting that every heart attack patient had to undergo certain testing or take specific drugs because the chief of the department or administrator had previously established such clinical protocols, for example, it became more important to provide the data that proved such rituals were actually helpful. Staff members in these hospitals also said they received, and appreciated, increased support from senior management and a newfound freedom to voice opinions in ‘more of an equal role, no matter what position you are.’ ”
The degree of an institution’s cultural change was directly linked to patient outcomes, the researchers found. Indeed, hospitals that made more substantial changes in their work culture realized larger and more sustained drops in heart attack mortality rates.
References
1. Chen PW. A More Egalitarian Hospital Culture Is Better for Everyone. New York Times. https://www.nytimes.com/2018/05/31/well/live/doctors-patients-hospital-culture-better-health.html. Published May 31, 2018. Accessed June 1, 2018.
2. Curry LA et al. Organizational culture change in U.S. hospitals: A mixed methods longitudinal intervention study. Implementation Science. 2015 Mar 7. doi: 10.1186/s13012-015-0218-0. Accessed June 18, 2018.
Health care experts have long known of a link between patient outcomes and a hospital’s organizational culture, according to an article in the New York Times by Pauline W. Chen, MD.
“Heart attack patients who are treated at hospitals where nurses feel powerless and senior management is only sporadically involved in patient care tend to fare more poorly than patients hospitalized at institutions where nurses are asked regularly for their input and chief executives hold regular meetings with clinicians to review patient results,” she wrote.
But there is hope for change, Dr. Chen noted, and it’s demonstrable, citing a group of researchers that has written about strategies targeting hospital organizational culture called “Leadership Saves Lives.” The researchers showed hospitals could create significant cultural changes, which could impact patient outcomes, in just 2 years.
“Leadership Saves Lives requires that each hospital create a ‘Guiding Coalition,’ a group of staff members from across the entire institution. The coalition members participate in regular workshops, discussions, and national forums on ways hospitals might improve, then help their respective hospital translate newfound ideas and information into clinical practice,” she wrote.
The researchers monitored heart attack patients to assess the effect of Leadership Saves Lives in 10 hospitals that had below average patient outcomes. Over 2 years, all 10 hospitals changed significantly, but 6 hospitals experienced particularly profound cultural transformations.
“The staff of these hospitals spoke of an institutional shift from ‘because I said so’ to ‘focusing on the why’s,’ ” Dr. Chen wrote. “Instead of accepting that every heart attack patient had to undergo certain testing or take specific drugs because the chief of the department or administrator had previously established such clinical protocols, for example, it became more important to provide the data that proved such rituals were actually helpful. Staff members in these hospitals also said they received, and appreciated, increased support from senior management and a newfound freedom to voice opinions in ‘more of an equal role, no matter what position you are.’ ”
The degree of an institution’s cultural change was directly linked to patient outcomes, the researchers found. Indeed, hospitals that made more substantial changes in their work culture realized larger and more sustained drops in heart attack mortality rates.
References
1. Chen PW. A More Egalitarian Hospital Culture Is Better for Everyone. New York Times. https://www.nytimes.com/2018/05/31/well/live/doctors-patients-hospital-culture-better-health.html. Published May 31, 2018. Accessed June 1, 2018.
2. Curry LA et al. Organizational culture change in U.S. hospitals: A mixed methods longitudinal intervention study. Implementation Science. 2015 Mar 7. doi: 10.1186/s13012-015-0218-0. Accessed June 18, 2018.
Public insurance income limits and hospitalizations for low-income children
Vulnerable populations at greater risk
Background: Medicaid and the Children’s Health Insurance Program (CHIP) provide health care to over 30 million children in the United States.1,2 As a result, low-income children have had increased access to health care, of all forms, which has increased the utilization of primary care and decreased unnecessary ED visits and hospitalizations. However, this comes at a high cost, both at the state and national level. Medicaid currently subsidizes more than 50% of every state’s public insurance program, spending about $100 billion/year in health care payments for children.3 Given this hefty price tag, there have been myriad strategies proposed to help decrease these costs. One such strategy, includes decreasing enrollment in public insurance through decreasing income eligibility thresholds. As a result, many children from low-income families would lose their public insurance and be eligible for commercial insurance only. Consequently, this would place an undue financial burden on these families and the health care systems that care for them. Furthermore, it is anticipated that poor health care outcomes would increase in these vulnerable populations.
Study design: Retrospective cohort study using 2014 State Inpatient Databases.
Setting: Pediatric hospitalizations (aged less than 18 years) from 14 states during 2014 with public insurance listed as the primary payer. This encompassed about 30% of family households in the United States in 2014.
Synopsis: Simulations were done at three different thresholds of the federal poverty level (FPL), including less than 100%, less than 200% and less than 300%. Of the families included, 43% lived below 300%, 27% below 200% and 11% below 100% of the FPL. Of note, public insurance FPL eligibility limits tended to be lower in states with a greater percentage of the population being below 300% of the FPL. The results, of these reductions, were as follows:
- If reduced to less than 300% of the FPL, about 155,000 hospitalizations became ineligible for reimbursement. The median per-hospitalization estimated costs ranged from approximately $6,000 to approximately $10,000, accumulating $1.2 billion in estimated costs.
- If reduced to less than 200% of the FPL, about 440,000 hospitalizations became ineligible for reimbursement. The median per-hospitalization estimated costs ranged from approximately $2,000 to approximately $10,000, accumulating $3.1 billion in estimated costs.
- If reduced to less than 100% of the FPL, about 650,000 hospitalizations became ineligible for reimbursement. The median per-hospitalization estimated costs ranged from approximately $2,000 to approximately $10,000, accumulating $4.4 billion in estimated costs.
If these reductions occurred, healthy newborns would be disproportionately affected by them, which is important to note because newborn hospitalization is one of the fastest-rising costs in pediatric care. In fact, it can range from approximately $700 to approximately $2,000 per hospitalization, which may represent a huge financial strain for families that are unable to secure commercial insurance. Furthermore, with the average hospitalization of non-newborns ranging from $3,000 to $10,000, it is likely that this cost would constitute a fairly large percentage of a low income family’s annual income, which may represent an untenable financial burden.
Thus, if these families are unable to obtain commercial insurance and/or pay these debts, the financial burden will shift to the institutions that care for these vulnerable populations.
Bottom line: If public insurance eligibility thresholds were decreased, a large number of pediatric hospitalizations would become ineligible for coverage, which would shift the costs to families and institutions that are already financially strained and likely result in poor health care outcomes for some of our most vulnerable pediatric patients.
Citation: Bettenhausen JL et al. The effect of lowering public insurance income limits on hospitalizations for low-income children. Pediatrics. 2018 Aug. doi: 10.1542/peds.2017-3486.
Dr. Darden is a pediatric hospitalist at Phoenix Children’s Hospital and clinical assistant professor, University of Arizona, Phoenix.
References
1. The Henry J. Kaiser Family Foundation. Total Medicaid Spending. 2016. Available at: http://kff.org/medicaid/state-indicator/total-medicaid-spending/.
2. Medicaid and CHIP Payment and Access Commission. Trends in Medicaid Spending. 2016. Available at https://www.macpac.gov/wp-content/uploads/2016/06/Trends-in-Medicaid-Spending.pdf.
3. Medicaid and CHIP Payment and Access Commission. Medicaid’s share of state budgets. 2017. Available at: https://www.macpac.gov/subtopic/medicaids-share-of-state-budgets/.
Vulnerable populations at greater risk
Vulnerable populations at greater risk
Background: Medicaid and the Children’s Health Insurance Program (CHIP) provide health care to over 30 million children in the United States.1,2 As a result, low-income children have had increased access to health care, of all forms, which has increased the utilization of primary care and decreased unnecessary ED visits and hospitalizations. However, this comes at a high cost, both at the state and national level. Medicaid currently subsidizes more than 50% of every state’s public insurance program, spending about $100 billion/year in health care payments for children.3 Given this hefty price tag, there have been myriad strategies proposed to help decrease these costs. One such strategy, includes decreasing enrollment in public insurance through decreasing income eligibility thresholds. As a result, many children from low-income families would lose their public insurance and be eligible for commercial insurance only. Consequently, this would place an undue financial burden on these families and the health care systems that care for them. Furthermore, it is anticipated that poor health care outcomes would increase in these vulnerable populations.
Study design: Retrospective cohort study using 2014 State Inpatient Databases.
Setting: Pediatric hospitalizations (aged less than 18 years) from 14 states during 2014 with public insurance listed as the primary payer. This encompassed about 30% of family households in the United States in 2014.
Synopsis: Simulations were done at three different thresholds of the federal poverty level (FPL), including less than 100%, less than 200% and less than 300%. Of the families included, 43% lived below 300%, 27% below 200% and 11% below 100% of the FPL. Of note, public insurance FPL eligibility limits tended to be lower in states with a greater percentage of the population being below 300% of the FPL. The results, of these reductions, were as follows:
- If reduced to less than 300% of the FPL, about 155,000 hospitalizations became ineligible for reimbursement. The median per-hospitalization estimated costs ranged from approximately $6,000 to approximately $10,000, accumulating $1.2 billion in estimated costs.
- If reduced to less than 200% of the FPL, about 440,000 hospitalizations became ineligible for reimbursement. The median per-hospitalization estimated costs ranged from approximately $2,000 to approximately $10,000, accumulating $3.1 billion in estimated costs.
- If reduced to less than 100% of the FPL, about 650,000 hospitalizations became ineligible for reimbursement. The median per-hospitalization estimated costs ranged from approximately $2,000 to approximately $10,000, accumulating $4.4 billion in estimated costs.
If these reductions occurred, healthy newborns would be disproportionately affected by them, which is important to note because newborn hospitalization is one of the fastest-rising costs in pediatric care. In fact, it can range from approximately $700 to approximately $2,000 per hospitalization, which may represent a huge financial strain for families that are unable to secure commercial insurance. Furthermore, with the average hospitalization of non-newborns ranging from $3,000 to $10,000, it is likely that this cost would constitute a fairly large percentage of a low income family’s annual income, which may represent an untenable financial burden.
Thus, if these families are unable to obtain commercial insurance and/or pay these debts, the financial burden will shift to the institutions that care for these vulnerable populations.
Bottom line: If public insurance eligibility thresholds were decreased, a large number of pediatric hospitalizations would become ineligible for coverage, which would shift the costs to families and institutions that are already financially strained and likely result in poor health care outcomes for some of our most vulnerable pediatric patients.
Citation: Bettenhausen JL et al. The effect of lowering public insurance income limits on hospitalizations for low-income children. Pediatrics. 2018 Aug. doi: 10.1542/peds.2017-3486.
Dr. Darden is a pediatric hospitalist at Phoenix Children’s Hospital and clinical assistant professor, University of Arizona, Phoenix.
References
1. The Henry J. Kaiser Family Foundation. Total Medicaid Spending. 2016. Available at: http://kff.org/medicaid/state-indicator/total-medicaid-spending/.
2. Medicaid and CHIP Payment and Access Commission. Trends in Medicaid Spending. 2016. Available at https://www.macpac.gov/wp-content/uploads/2016/06/Trends-in-Medicaid-Spending.pdf.
3. Medicaid and CHIP Payment and Access Commission. Medicaid’s share of state budgets. 2017. Available at: https://www.macpac.gov/subtopic/medicaids-share-of-state-budgets/.
Background: Medicaid and the Children’s Health Insurance Program (CHIP) provide health care to over 30 million children in the United States.1,2 As a result, low-income children have had increased access to health care, of all forms, which has increased the utilization of primary care and decreased unnecessary ED visits and hospitalizations. However, this comes at a high cost, both at the state and national level. Medicaid currently subsidizes more than 50% of every state’s public insurance program, spending about $100 billion/year in health care payments for children.3 Given this hefty price tag, there have been myriad strategies proposed to help decrease these costs. One such strategy, includes decreasing enrollment in public insurance through decreasing income eligibility thresholds. As a result, many children from low-income families would lose their public insurance and be eligible for commercial insurance only. Consequently, this would place an undue financial burden on these families and the health care systems that care for them. Furthermore, it is anticipated that poor health care outcomes would increase in these vulnerable populations.
Study design: Retrospective cohort study using 2014 State Inpatient Databases.
Setting: Pediatric hospitalizations (aged less than 18 years) from 14 states during 2014 with public insurance listed as the primary payer. This encompassed about 30% of family households in the United States in 2014.
Synopsis: Simulations were done at three different thresholds of the federal poverty level (FPL), including less than 100%, less than 200% and less than 300%. Of the families included, 43% lived below 300%, 27% below 200% and 11% below 100% of the FPL. Of note, public insurance FPL eligibility limits tended to be lower in states with a greater percentage of the population being below 300% of the FPL. The results, of these reductions, were as follows:
- If reduced to less than 300% of the FPL, about 155,000 hospitalizations became ineligible for reimbursement. The median per-hospitalization estimated costs ranged from approximately $6,000 to approximately $10,000, accumulating $1.2 billion in estimated costs.
- If reduced to less than 200% of the FPL, about 440,000 hospitalizations became ineligible for reimbursement. The median per-hospitalization estimated costs ranged from approximately $2,000 to approximately $10,000, accumulating $3.1 billion in estimated costs.
- If reduced to less than 100% of the FPL, about 650,000 hospitalizations became ineligible for reimbursement. The median per-hospitalization estimated costs ranged from approximately $2,000 to approximately $10,000, accumulating $4.4 billion in estimated costs.
If these reductions occurred, healthy newborns would be disproportionately affected by them, which is important to note because newborn hospitalization is one of the fastest-rising costs in pediatric care. In fact, it can range from approximately $700 to approximately $2,000 per hospitalization, which may represent a huge financial strain for families that are unable to secure commercial insurance. Furthermore, with the average hospitalization of non-newborns ranging from $3,000 to $10,000, it is likely that this cost would constitute a fairly large percentage of a low income family’s annual income, which may represent an untenable financial burden.
Thus, if these families are unable to obtain commercial insurance and/or pay these debts, the financial burden will shift to the institutions that care for these vulnerable populations.
Bottom line: If public insurance eligibility thresholds were decreased, a large number of pediatric hospitalizations would become ineligible for coverage, which would shift the costs to families and institutions that are already financially strained and likely result in poor health care outcomes for some of our most vulnerable pediatric patients.
Citation: Bettenhausen JL et al. The effect of lowering public insurance income limits on hospitalizations for low-income children. Pediatrics. 2018 Aug. doi: 10.1542/peds.2017-3486.
Dr. Darden is a pediatric hospitalist at Phoenix Children’s Hospital and clinical assistant professor, University of Arizona, Phoenix.
References
1. The Henry J. Kaiser Family Foundation. Total Medicaid Spending. 2016. Available at: http://kff.org/medicaid/state-indicator/total-medicaid-spending/.
2. Medicaid and CHIP Payment and Access Commission. Trends in Medicaid Spending. 2016. Available at https://www.macpac.gov/wp-content/uploads/2016/06/Trends-in-Medicaid-Spending.pdf.
3. Medicaid and CHIP Payment and Access Commission. Medicaid’s share of state budgets. 2017. Available at: https://www.macpac.gov/subtopic/medicaids-share-of-state-budgets/.
Statins cut vascular events in elderly patients
Statin therapy appears to reduce the risk of major vascular events for patients of all age groups, but there is less evidence that older patients with evidence of occlusive vascular disease benefit from the treatment, according to a recent meta-analysis of 28 trials from the Cholesterol Treatment Trialists’ Collaboration published in The Lancet.
Statins are “useful and affordable drug[s] that reduce heart attacks and strokes in older patients. Until now there has been an evidence gap and we wanted to look at their efficacy and safety in older people,” Jordan Fulcher, BSc (Med), MBBS, from the Cholesterol Treatment Trialists’ (CTT) Collaboration and the University of Sydney stated in a press release. “Our analysis indicates that major cardiovascular events were reduced by about a fifth, per mmol/L lower LDL cholesterol, by statin therapy across all age groups. Despite previous concerns, we found no adverse effect on cancer or nonvascular mortality in any age group.”
The researchers examined 186,854 participants from 28 CTT trials undergoing statin therapy, of whom 14,483 (8%) were older than 75 years. Patients were divided into six groups based on age and examined the risk of major cardiovascular events such as stroke, coronary revascularization and major coronary events, as well as the incidence of cancer and vascular mortality.
Among all age groups, there was a significant reduction in major vascular events, with a 21% proportional per 1.0-mmol/L reduction in LDL cholesterol (risk ratio, 0.79; 95% confidence interval, 0.77-0.81) among patients receiving statin therapy or a more intensive statin regimen, and there was a 24% proportional reduction (RR, 0.76; 95% CI, 0.73-0.79) of major coronary events per 1.0-mmol/L reduction in LDL cholesterol, with older age resulting in a lower proportional reduction of major coronary events (P = .009). The researchers also found a proportional reduction of coronary revascularization procedures by 25% (RR, 0.75; 95% CI, 0.73-0.78) and stroke by 16% (RR, 0.84; 95% CI, 0.80-0.89) among patients of any age group receiving statin therapy or more intensive statin regimen, with no significant differences between age groups.
There was a 12% proportional reduction in vascular mortality per 1.0-mmol/L reduction in LDL cholesterol (RR, 0.88; 95% CI, 0.85-0.91), but this statistic did not remain significant after the researchers excluded four trials that included patients with heart failure or who were receiving renal dialysis. After excluding these trials from the overall analysis, the researchers found the smaller proportional reductions persisted for older patients for major coronary events (P = .01) but was no longer significant for major vascular events.
The researchers noted their study was limited by the highly selected patient population, low percentage of patients older than 75 years, including trials with efficacy endpoints where some nonserious adverse events may not have been recorded, and not including some trials in the meta-analysis if they were not part of the CTT.
This study was funded by Australian National Health and Medical Research Council, National Institute for Health Research Oxford Biomedical Research Centre, UK Medical Research Council, and British Heart Foundation. The authors have reported personal fees, grants, and consulting fees from Abbott, Aegerion, Amgen, Arisaph, AstraZeneca, Bayer, Beckmann, Berlin-Chemie, Boehringer Ingelheim, Daiichi Sankyo, Dalcor, DuPont, Esperion, GlaxoSmithKline, ISIS Pharmaceuticals, Kowa, Mylan, Pfizer, Roche, Sanofi, Singulex, The Medicines Company, and Vatera Capital, as well as the British Heart Foundation, Cancer Research UK, National Institute for Health Research Oxford Biomedical Research Centre, Medical Research Council, Nuffield Department of Population Health, Weill Cornell Medicine, and UK Biobank.
SOURCE: Fulcher J et al. Lancet. 2019;393:407-15.
Statin therapy is often discontinued for older patients who have concomitant disease or other considerations, but it should still be considered in older patients when the benefits outweigh the risks, Bernard M.Y. Cheung, PhD, and Karen S.L. Lam, MD, wrote in a related editorial.
“Even if the relative risk reduction in people older than 75 years is less than expected, statin therapy might still be justified by a high baseline cardiovascular risk, which is usually present in older people,” they said.
One explanation for the decreased relative risk reduction among older patients from the results by Fulcher et al. in the Cholesterol Treatment Trialists’ (CTT) Collaboration trial could have been the inclusion of older patients with cardiac and renal failure, and treating patients with lower cardiac risk or lowering LDL cholesterol in patients at risk of cardiovascular events can help prevent major vascular events later.
Ultimately, no drug is harmless and the risk and benefits must be weighed before making a decision to use statins with older patients just as they would in any other patient population. “The challenge for the health-care profession and the media is to convey risks and benefits in ways that patients can understand, enabling them to make an informed choice,” the authors wrote.
Dr. Cheung and Dr. Lam are from the department of medicine at Queen Mary Hospital, University of Hong Kong in Hong Kong Special Administrative Region, China. They had no relevant disclosures.
Statin therapy is often discontinued for older patients who have concomitant disease or other considerations, but it should still be considered in older patients when the benefits outweigh the risks, Bernard M.Y. Cheung, PhD, and Karen S.L. Lam, MD, wrote in a related editorial.
“Even if the relative risk reduction in people older than 75 years is less than expected, statin therapy might still be justified by a high baseline cardiovascular risk, which is usually present in older people,” they said.
One explanation for the decreased relative risk reduction among older patients from the results by Fulcher et al. in the Cholesterol Treatment Trialists’ (CTT) Collaboration trial could have been the inclusion of older patients with cardiac and renal failure, and treating patients with lower cardiac risk or lowering LDL cholesterol in patients at risk of cardiovascular events can help prevent major vascular events later.
Ultimately, no drug is harmless and the risk and benefits must be weighed before making a decision to use statins with older patients just as they would in any other patient population. “The challenge for the health-care profession and the media is to convey risks and benefits in ways that patients can understand, enabling them to make an informed choice,” the authors wrote.
Dr. Cheung and Dr. Lam are from the department of medicine at Queen Mary Hospital, University of Hong Kong in Hong Kong Special Administrative Region, China. They had no relevant disclosures.
Statin therapy is often discontinued for older patients who have concomitant disease or other considerations, but it should still be considered in older patients when the benefits outweigh the risks, Bernard M.Y. Cheung, PhD, and Karen S.L. Lam, MD, wrote in a related editorial.
“Even if the relative risk reduction in people older than 75 years is less than expected, statin therapy might still be justified by a high baseline cardiovascular risk, which is usually present in older people,” they said.
One explanation for the decreased relative risk reduction among older patients from the results by Fulcher et al. in the Cholesterol Treatment Trialists’ (CTT) Collaboration trial could have been the inclusion of older patients with cardiac and renal failure, and treating patients with lower cardiac risk or lowering LDL cholesterol in patients at risk of cardiovascular events can help prevent major vascular events later.
Ultimately, no drug is harmless and the risk and benefits must be weighed before making a decision to use statins with older patients just as they would in any other patient population. “The challenge for the health-care profession and the media is to convey risks and benefits in ways that patients can understand, enabling them to make an informed choice,” the authors wrote.
Dr. Cheung and Dr. Lam are from the department of medicine at Queen Mary Hospital, University of Hong Kong in Hong Kong Special Administrative Region, China. They had no relevant disclosures.
Statin therapy appears to reduce the risk of major vascular events for patients of all age groups, but there is less evidence that older patients with evidence of occlusive vascular disease benefit from the treatment, according to a recent meta-analysis of 28 trials from the Cholesterol Treatment Trialists’ Collaboration published in The Lancet.
Statins are “useful and affordable drug[s] that reduce heart attacks and strokes in older patients. Until now there has been an evidence gap and we wanted to look at their efficacy and safety in older people,” Jordan Fulcher, BSc (Med), MBBS, from the Cholesterol Treatment Trialists’ (CTT) Collaboration and the University of Sydney stated in a press release. “Our analysis indicates that major cardiovascular events were reduced by about a fifth, per mmol/L lower LDL cholesterol, by statin therapy across all age groups. Despite previous concerns, we found no adverse effect on cancer or nonvascular mortality in any age group.”
The researchers examined 186,854 participants from 28 CTT trials undergoing statin therapy, of whom 14,483 (8%) were older than 75 years. Patients were divided into six groups based on age and examined the risk of major cardiovascular events such as stroke, coronary revascularization and major coronary events, as well as the incidence of cancer and vascular mortality.
Among all age groups, there was a significant reduction in major vascular events, with a 21% proportional per 1.0-mmol/L reduction in LDL cholesterol (risk ratio, 0.79; 95% confidence interval, 0.77-0.81) among patients receiving statin therapy or a more intensive statin regimen, and there was a 24% proportional reduction (RR, 0.76; 95% CI, 0.73-0.79) of major coronary events per 1.0-mmol/L reduction in LDL cholesterol, with older age resulting in a lower proportional reduction of major coronary events (P = .009). The researchers also found a proportional reduction of coronary revascularization procedures by 25% (RR, 0.75; 95% CI, 0.73-0.78) and stroke by 16% (RR, 0.84; 95% CI, 0.80-0.89) among patients of any age group receiving statin therapy or more intensive statin regimen, with no significant differences between age groups.
There was a 12% proportional reduction in vascular mortality per 1.0-mmol/L reduction in LDL cholesterol (RR, 0.88; 95% CI, 0.85-0.91), but this statistic did not remain significant after the researchers excluded four trials that included patients with heart failure or who were receiving renal dialysis. After excluding these trials from the overall analysis, the researchers found the smaller proportional reductions persisted for older patients for major coronary events (P = .01) but was no longer significant for major vascular events.
The researchers noted their study was limited by the highly selected patient population, low percentage of patients older than 75 years, including trials with efficacy endpoints where some nonserious adverse events may not have been recorded, and not including some trials in the meta-analysis if they were not part of the CTT.
This study was funded by Australian National Health and Medical Research Council, National Institute for Health Research Oxford Biomedical Research Centre, UK Medical Research Council, and British Heart Foundation. The authors have reported personal fees, grants, and consulting fees from Abbott, Aegerion, Amgen, Arisaph, AstraZeneca, Bayer, Beckmann, Berlin-Chemie, Boehringer Ingelheim, Daiichi Sankyo, Dalcor, DuPont, Esperion, GlaxoSmithKline, ISIS Pharmaceuticals, Kowa, Mylan, Pfizer, Roche, Sanofi, Singulex, The Medicines Company, and Vatera Capital, as well as the British Heart Foundation, Cancer Research UK, National Institute for Health Research Oxford Biomedical Research Centre, Medical Research Council, Nuffield Department of Population Health, Weill Cornell Medicine, and UK Biobank.
SOURCE: Fulcher J et al. Lancet. 2019;393:407-15.
Statin therapy appears to reduce the risk of major vascular events for patients of all age groups, but there is less evidence that older patients with evidence of occlusive vascular disease benefit from the treatment, according to a recent meta-analysis of 28 trials from the Cholesterol Treatment Trialists’ Collaboration published in The Lancet.
Statins are “useful and affordable drug[s] that reduce heart attacks and strokes in older patients. Until now there has been an evidence gap and we wanted to look at their efficacy and safety in older people,” Jordan Fulcher, BSc (Med), MBBS, from the Cholesterol Treatment Trialists’ (CTT) Collaboration and the University of Sydney stated in a press release. “Our analysis indicates that major cardiovascular events were reduced by about a fifth, per mmol/L lower LDL cholesterol, by statin therapy across all age groups. Despite previous concerns, we found no adverse effect on cancer or nonvascular mortality in any age group.”
The researchers examined 186,854 participants from 28 CTT trials undergoing statin therapy, of whom 14,483 (8%) were older than 75 years. Patients were divided into six groups based on age and examined the risk of major cardiovascular events such as stroke, coronary revascularization and major coronary events, as well as the incidence of cancer and vascular mortality.
Among all age groups, there was a significant reduction in major vascular events, with a 21% proportional per 1.0-mmol/L reduction in LDL cholesterol (risk ratio, 0.79; 95% confidence interval, 0.77-0.81) among patients receiving statin therapy or a more intensive statin regimen, and there was a 24% proportional reduction (RR, 0.76; 95% CI, 0.73-0.79) of major coronary events per 1.0-mmol/L reduction in LDL cholesterol, with older age resulting in a lower proportional reduction of major coronary events (P = .009). The researchers also found a proportional reduction of coronary revascularization procedures by 25% (RR, 0.75; 95% CI, 0.73-0.78) and stroke by 16% (RR, 0.84; 95% CI, 0.80-0.89) among patients of any age group receiving statin therapy or more intensive statin regimen, with no significant differences between age groups.
There was a 12% proportional reduction in vascular mortality per 1.0-mmol/L reduction in LDL cholesterol (RR, 0.88; 95% CI, 0.85-0.91), but this statistic did not remain significant after the researchers excluded four trials that included patients with heart failure or who were receiving renal dialysis. After excluding these trials from the overall analysis, the researchers found the smaller proportional reductions persisted for older patients for major coronary events (P = .01) but was no longer significant for major vascular events.
The researchers noted their study was limited by the highly selected patient population, low percentage of patients older than 75 years, including trials with efficacy endpoints where some nonserious adverse events may not have been recorded, and not including some trials in the meta-analysis if they were not part of the CTT.
This study was funded by Australian National Health and Medical Research Council, National Institute for Health Research Oxford Biomedical Research Centre, UK Medical Research Council, and British Heart Foundation. The authors have reported personal fees, grants, and consulting fees from Abbott, Aegerion, Amgen, Arisaph, AstraZeneca, Bayer, Beckmann, Berlin-Chemie, Boehringer Ingelheim, Daiichi Sankyo, Dalcor, DuPont, Esperion, GlaxoSmithKline, ISIS Pharmaceuticals, Kowa, Mylan, Pfizer, Roche, Sanofi, Singulex, The Medicines Company, and Vatera Capital, as well as the British Heart Foundation, Cancer Research UK, National Institute for Health Research Oxford Biomedical Research Centre, Medical Research Council, Nuffield Department of Population Health, Weill Cornell Medicine, and UK Biobank.
SOURCE: Fulcher J et al. Lancet. 2019;393:407-15.
FROM THE LANCET
Key clinical point: but patients older than 75 years with occlusive vascular disease have a smaller reduction in major coronary events.
Major finding: Major vascular coronary events were reduced by 24% (risk ratio, 0.76; 95% confidence interval, 0.73-0.79) with a decrease in the reduction of coronary events among patients older than 75 years. Study details: A meta-analysis of 28 trials with 186,854 individuals undergoing statin therapy from the Cholesterol Treatment Trialists’ Collaboration.
Disclosures: This study was funded by Australian National Health and Medical Research Council, National Institute for Health Research Oxford Biomedical Research Centre, UK Medical Research Council, and British Heart Foundation. The authors have reported personal fees, grants, and consulting fees from Abbott, Aegerion, Amgen, Arisaph, AstraZeneca, Bayer, Beckmann, Berlin-Chemie, Boehringer Ingelheim, Daiichi Sankyo, Dalcor, DuPont, Esperion, GlaxoSmithKline, ISIS Pharmaceuticals, Kowa, Mylan, Pfizer, Roche, Sanofi, Singulex, The Medicines Company, and Vatera Capital, as well as the British Heart Foundation, Cancer Research UK, National Institute for Health Research Oxford Biomedical Research Centre, Medical Research Council, Nuffield Department of Population Health, Weill Cornell Medicine, and UK Biobank.
Source: Fulcher J et al. Lancet. 2019;393:407-15.
When is it safe to resume anticoagulation in my patient with hemorrhagic stroke?
Balancing risk is critical to decision making
Department of Medicine, Massachusetts General Hospital, Boston
Case
A 75 year-old woman with a history of hypertension, diabetes mellitus, heart failure and nonvalvular atrial fibrillation (CHA2DS2-VASc score, 8) on anticoagulation is admitted with weakness and dysarthria. Exam is notable for hypertension and right-sided hemiparesis. CT of the head shows an intraparenchymal hemorrhage in the left putamen. Her anticoagulation is reversed and blood pressure well controlled. She is discharged 12 days later.
Brief overview of the issue
Intracranial hemorrhage (ICH) is the second most common cause of stroke and is associated with high morbidity and mortality.1 It is estimated that 10%-15% of spontaneous ICH cases occur in patients on therapeutic anticoagulation for atrial fibrillation.2 As our population ages and more people develop atrial fibrillation, anticoagulation for primary or secondary prevention of embolic stroke also will likely increase, placing more people at risk for ICH. Even stringently controlled therapeutic international normalized ratios (INRs) between 2 and 3 may double the risk of ICH.3
Patients with ICH require close monitoring and treatment, including blood pressure control, reversal of anticoagulation, reduction of intracranial pressure and, at times, neurosurgery.4 Although anticoagulation is discontinued and reversed at the onset of ICH, no clear consensus exists as to when it is safe to resume it. Although anticoagulation decreases the risk of stroke/thromboembolism, it may also increase the amount of bleeding associated with the initial ICH or lead to its recurrence.
Factors that may contribute to rebleeding include uncontrolled hypertension, advanced age, time to resumption of anticoagulation, and lobar location of ICH (i.e., in cerebral cortex and/or underlying white matter).5 Traditionally, lobar ICH has high incidence of cerebral amyloid angiopathy and has been associated with higher bleeding rates than has deep ICH (i.e., involving the thalami, basal ganglia, cerebellum, or brainstem) where cerebral amyloid angiopathy is rare and ICH is usually from hypertensive vessel disease. However, in patients with active thromboembolic disease, high-risk atrial fibrillation, and mechanical valves, withholding anticoagulation could place them at high risk of stroke.
Two questions should be addressed in the case presented: Is it safe to restart therapeutic anticoagulation; and if so, what is the optimal time interval between ICH and reinitiation of anticoagulation?
Overview of the data
There is limited guidance from major professional societies regarding the reinitiation of anticoagulation and the optimal timing of safely resuming anticoagulation in patients with prior ICH.
Current European Stroke Organization guidelines provide no specific recommendations for anticoagulation resumption after ICH.7 The American Heart Association/American Stroke Association guideline has a class IIA (weak) recommendation to avoid anticoagulation in spontaneous lobar ICH and a class IIB (very weak) recommendation to consider resuming anticoagulation in nonlobar ICH on a case-by-case basis.4
Two recent meta-analyses have examined outcomes of resuming anticoagulation after ICH. In a meta-analysis of 5,300 patients with nonlobar ICH involving eight retrospective studies, Murthy et al. evaluated the risk of thromboembolic events (described as a composite outcome of MI and stroke) and the risk of recurrent ICH.8 They reported that resumption of therapeutic anticoagulation was associated with a decrease in the rate of thromboembolic events (6.7% vs. 17.6%; risk ratio, 0.35; 95% confidence interval, 0.25-0.45) with no significant change in the rate of repeat ICH (8.7% vs. 7.8%).
A second meta-analysis of three retrospective trials conducted by Biffi et al. examined anticoagulation resumption in 1,012 patients with ICH solely in the setting of thromboprophylaxis for nonvalvular atrial fibrillation.9 Reinitiation of anticoagulation after ICH was associated with decreased mortality (hazard ratio, 0.27; 95% CI, 0.19-0.40; P less than .0001), improved functional outcome (HR, 4.15; 95% CI, 2.92-5.90; P less than .0001), and reduction in all-cause stroke recurrence (HR 0.47; 95% CI, 0.36-0.64; P less than .0001). There was no significant difference in the rate of recurrent ICH when anticoagulation was resumed. Despite the notion that patients with cerebral amyloid angiopathy are at high risk of rebleeding, this positive association still held irrespective of lobar vs. nonlobar location of ICH.
Collectively, these studies suggest that resumption of anticoagulation may be effective in decreasing the rates of thromboembolism, as well as provide a functional and mortality benefit without increasing the risk of rebleeding, irrespective of the location of the bleed.
Less is known about the optimal timing of resumption of therapeutic anticoagulation, with data ranging from 72 hours to 30 weeks.10 The American Heart Association/American Stroke Association has a class IIB (very weak) recommendation to avoid anticoagulation for at least 4 weeks in patients without mechanical heart valves.4 The median time to resumption of therapeutic anticoagulation in aforementioned meta-analyses ranged from 10 to 44 days.8,9
A recent observational study of 2,619 ICH survivors explored the relationship between the timing of reinitiation of anticoagulation and the incidence of thrombotic events (defined as ischemic stroke or death because of MI or systemic arterial thromboembolism) and hemorrhagic events (defined as recurrent ICH or bleeding event leading to death) occurring at least 28 days after initial ICH in patients with atrial fibrillation.11
A decrease in thrombotic events was demonstrated if anticoagulation was started 4-16 weeks after ICH. However, when anticoagulation was started more than 16 weeks after ICH, no benefit was seen. Additionally, there was no significant difference in hemorrhagic events between men and women who resumed anticoagulation. In patients with high venous thromboembolism risk based on CHA2DS2-VASc score, resumption of anticoagulation was associated with a decreased predicted incidence of vascular death and nonfatal stroke, with the greatest benefit observed when anticoagulation was started at 7-8 weeks after ICH.
Unfortunately, published literature to date on anticoagulation after ICH is based entirely on retrospective studies – not randomized, controlled studies – making it more likely that anticoagulation would have been resumed in healthier patients, not those left debilitated by the ICH.
Furthermore, information on the location and size of the hemorrhages – which may serve as another confounding factor – often has not been reported. This is important since patients with smaller hemorrhages in less precarious areas also may be more likely to have resumption of anticoagulation. Another limitation of the current literature is that warfarin is the most common anticoagulant studied, with few studies involving the increasingly prescribed newer direct oral anticoagulants. It is also important to stress that a causal relationship between use of anticoagulants and certain outcomes or adverse effects following ICH may be more difficult to invoke in the absence of randomized controlled study designs.
Application of the data to our patient
Resumption of anticoagulation in our patient with ICH requires balancing the risk of hemorrhage expansion and recurrent ICH with the risk of thromboembolic disease.
Our patient is at higher risk of bleeding because of her advanced age, but adequate control of her blood pressure and nonlobar location of her ICH in the basal ganglia also may decrease her risk of recurrent ICH. Her high CHA2DS2-VASc score places her at high risk of thromboembolic event and stroke, making it more likely for reinitiation of anticoagulation to confer a mortality benefit.
Based on AHA guidelines,4 we should wait at least 4 weeks, or possibly wait until weeks 7-8 after ICH when the greatest benefit may be expected based on prediction models.11
Bottom line
It would likely be safe to resume anticoagulation 4-8 weeks after ICH in our patient.
Dr. Gibson, Dr. Restrepo, Dr. Sasidhara, and Dr. Manian are hospitalists at Massachusetts General Hospital, Boston.
References
1. An SJ et al. Epidemiology, risk factors, and clinical features of intracerebral hemorrhage: An update. J Stroke. 2017 Jan;19:3-10.
2. Horstmann S et al. Intracerebral hemorrhage during anticoagulation with vitamin K antagonists: a consecutive observational study. J Neurol. 2013 Aug;260:2046-51.
3. Rosand J et al. The effect of warfarin and intensity of anticoagulation on outcome of intracerebral hemorrhage. Arch Intern Med. 2004 Apr 26;164:880-4.
4. Hemphill JC et al. Guidelines for the management of spontaneous intracerebral hemorrhage. Stroke. 2015 Jul;46:2032-60.
5. Aguillar MI et al. Update in intracerebral hemorrhage. Neurohospitalist. 2011;1:148-59.
6. Hill MD et al. Rate of stroke recurrence in patients with primary intracerebral hemorrhage. Stroke. 2000;31:123-7.
7. Steiner T et al. European Stroke Organization (ESO) guidelines for the management of spontaneous cerebral hemorrhage. Int J Stroke. 2014;9:840-55.
8. Murthy SB et al. Restarting anticoagulation therapy after intracranial hemorrhage: A systematic review and meta-analysis. Stroke. 2017 Jun;48:1594-600.
9. Biffi A et al. Oral anticoagulation and functional outcome after intracerebral hemorrhage. Ann Neurol. 2017 Nov;82:755-65.
10. Witt DM. What to do after the bleed: Resuming anticoagulation after major bleeding. Hematology Am Soc Hematol Educ Program. 2016 Dec 2;206:620-4.
11. Pennlert J et al. Optimal timing of anticoagulant treatment after intracerebral hemorrhage in patients with atrial fibrillation. Stroke. 2017 Feb;48:314-20.
Key Points
- Robust scientific data on when to resume anticoagulation after ICH does not exist.
- Retrospective studies have shown that anticoagulation resumption after 4-8 weeks decreases the risk of thromboembolic events, decreases mortality, and improves functional status following ICH with no significant change in the risk of its recurrence.
- Prospective, randomized controlled trials are needed to explore risks/benefits of anticoagulation resumption and better define its optimal timing in relation to ICH.
Quiz
Which of the following is false regarding ICH?
A. Lobar ICHs are usually associated with cerebral amyloid angiopathy which are prone to bleeding.
B. Randomized, controlled studies have helped guide the decision as to when to resume anticoagulation in patients with ICH.
C. Current guidelines suggest deferring therapeutic anticoagulation for at least 4 weeks following ICH.
D. Resumption of anticoagulation after 4-8 weeks does not lead to increased risk of rebleeding in patients with prior ICH.
The false answer is B: Current recommendations regarding resumption of anticoagulation in patients with ICH are based solely on retrospective observational studies; there are no randomized, control trials to date.
A is true: In contrast to hypertensive vessel disease associated with deep ICH, lobar hemorrhages are usually associated with cerebral amyloid angiopathy, which are more prone to bleeding.
C is true: The AHA/ASA has a class IIB recommendation to avoid anticoagulation for at least 4 weeks after ICH in patients without mechanical heart valves.
D is true: Several studies have shown that resumption of anticoagulation 4-8 weeks after ICH does not increase the risk of rebleeding.
Balancing risk is critical to decision making
Balancing risk is critical to decision making
Department of Medicine, Massachusetts General Hospital, Boston
Case
A 75 year-old woman with a history of hypertension, diabetes mellitus, heart failure and nonvalvular atrial fibrillation (CHA2DS2-VASc score, 8) on anticoagulation is admitted with weakness and dysarthria. Exam is notable for hypertension and right-sided hemiparesis. CT of the head shows an intraparenchymal hemorrhage in the left putamen. Her anticoagulation is reversed and blood pressure well controlled. She is discharged 12 days later.
Brief overview of the issue
Intracranial hemorrhage (ICH) is the second most common cause of stroke and is associated with high morbidity and mortality.1 It is estimated that 10%-15% of spontaneous ICH cases occur in patients on therapeutic anticoagulation for atrial fibrillation.2 As our population ages and more people develop atrial fibrillation, anticoagulation for primary or secondary prevention of embolic stroke also will likely increase, placing more people at risk for ICH. Even stringently controlled therapeutic international normalized ratios (INRs) between 2 and 3 may double the risk of ICH.3
Patients with ICH require close monitoring and treatment, including blood pressure control, reversal of anticoagulation, reduction of intracranial pressure and, at times, neurosurgery.4 Although anticoagulation is discontinued and reversed at the onset of ICH, no clear consensus exists as to when it is safe to resume it. Although anticoagulation decreases the risk of stroke/thromboembolism, it may also increase the amount of bleeding associated with the initial ICH or lead to its recurrence.
Factors that may contribute to rebleeding include uncontrolled hypertension, advanced age, time to resumption of anticoagulation, and lobar location of ICH (i.e., in cerebral cortex and/or underlying white matter).5 Traditionally, lobar ICH has high incidence of cerebral amyloid angiopathy and has been associated with higher bleeding rates than has deep ICH (i.e., involving the thalami, basal ganglia, cerebellum, or brainstem) where cerebral amyloid angiopathy is rare and ICH is usually from hypertensive vessel disease. However, in patients with active thromboembolic disease, high-risk atrial fibrillation, and mechanical valves, withholding anticoagulation could place them at high risk of stroke.
Two questions should be addressed in the case presented: Is it safe to restart therapeutic anticoagulation; and if so, what is the optimal time interval between ICH and reinitiation of anticoagulation?
Overview of the data
There is limited guidance from major professional societies regarding the reinitiation of anticoagulation and the optimal timing of safely resuming anticoagulation in patients with prior ICH.
Current European Stroke Organization guidelines provide no specific recommendations for anticoagulation resumption after ICH.7 The American Heart Association/American Stroke Association guideline has a class IIA (weak) recommendation to avoid anticoagulation in spontaneous lobar ICH and a class IIB (very weak) recommendation to consider resuming anticoagulation in nonlobar ICH on a case-by-case basis.4
Two recent meta-analyses have examined outcomes of resuming anticoagulation after ICH. In a meta-analysis of 5,300 patients with nonlobar ICH involving eight retrospective studies, Murthy et al. evaluated the risk of thromboembolic events (described as a composite outcome of MI and stroke) and the risk of recurrent ICH.8 They reported that resumption of therapeutic anticoagulation was associated with a decrease in the rate of thromboembolic events (6.7% vs. 17.6%; risk ratio, 0.35; 95% confidence interval, 0.25-0.45) with no significant change in the rate of repeat ICH (8.7% vs. 7.8%).
A second meta-analysis of three retrospective trials conducted by Biffi et al. examined anticoagulation resumption in 1,012 patients with ICH solely in the setting of thromboprophylaxis for nonvalvular atrial fibrillation.9 Reinitiation of anticoagulation after ICH was associated with decreased mortality (hazard ratio, 0.27; 95% CI, 0.19-0.40; P less than .0001), improved functional outcome (HR, 4.15; 95% CI, 2.92-5.90; P less than .0001), and reduction in all-cause stroke recurrence (HR 0.47; 95% CI, 0.36-0.64; P less than .0001). There was no significant difference in the rate of recurrent ICH when anticoagulation was resumed. Despite the notion that patients with cerebral amyloid angiopathy are at high risk of rebleeding, this positive association still held irrespective of lobar vs. nonlobar location of ICH.
Collectively, these studies suggest that resumption of anticoagulation may be effective in decreasing the rates of thromboembolism, as well as provide a functional and mortality benefit without increasing the risk of rebleeding, irrespective of the location of the bleed.
Less is known about the optimal timing of resumption of therapeutic anticoagulation, with data ranging from 72 hours to 30 weeks.10 The American Heart Association/American Stroke Association has a class IIB (very weak) recommendation to avoid anticoagulation for at least 4 weeks in patients without mechanical heart valves.4 The median time to resumption of therapeutic anticoagulation in aforementioned meta-analyses ranged from 10 to 44 days.8,9
A recent observational study of 2,619 ICH survivors explored the relationship between the timing of reinitiation of anticoagulation and the incidence of thrombotic events (defined as ischemic stroke or death because of MI or systemic arterial thromboembolism) and hemorrhagic events (defined as recurrent ICH or bleeding event leading to death) occurring at least 28 days after initial ICH in patients with atrial fibrillation.11
A decrease in thrombotic events was demonstrated if anticoagulation was started 4-16 weeks after ICH. However, when anticoagulation was started more than 16 weeks after ICH, no benefit was seen. Additionally, there was no significant difference in hemorrhagic events between men and women who resumed anticoagulation. In patients with high venous thromboembolism risk based on CHA2DS2-VASc score, resumption of anticoagulation was associated with a decreased predicted incidence of vascular death and nonfatal stroke, with the greatest benefit observed when anticoagulation was started at 7-8 weeks after ICH.
Unfortunately, published literature to date on anticoagulation after ICH is based entirely on retrospective studies – not randomized, controlled studies – making it more likely that anticoagulation would have been resumed in healthier patients, not those left debilitated by the ICH.
Furthermore, information on the location and size of the hemorrhages – which may serve as another confounding factor – often has not been reported. This is important since patients with smaller hemorrhages in less precarious areas also may be more likely to have resumption of anticoagulation. Another limitation of the current literature is that warfarin is the most common anticoagulant studied, with few studies involving the increasingly prescribed newer direct oral anticoagulants. It is also important to stress that a causal relationship between use of anticoagulants and certain outcomes or adverse effects following ICH may be more difficult to invoke in the absence of randomized controlled study designs.
Application of the data to our patient
Resumption of anticoagulation in our patient with ICH requires balancing the risk of hemorrhage expansion and recurrent ICH with the risk of thromboembolic disease.
Our patient is at higher risk of bleeding because of her advanced age, but adequate control of her blood pressure and nonlobar location of her ICH in the basal ganglia also may decrease her risk of recurrent ICH. Her high CHA2DS2-VASc score places her at high risk of thromboembolic event and stroke, making it more likely for reinitiation of anticoagulation to confer a mortality benefit.
Based on AHA guidelines,4 we should wait at least 4 weeks, or possibly wait until weeks 7-8 after ICH when the greatest benefit may be expected based on prediction models.11
Bottom line
It would likely be safe to resume anticoagulation 4-8 weeks after ICH in our patient.
Dr. Gibson, Dr. Restrepo, Dr. Sasidhara, and Dr. Manian are hospitalists at Massachusetts General Hospital, Boston.
References
1. An SJ et al. Epidemiology, risk factors, and clinical features of intracerebral hemorrhage: An update. J Stroke. 2017 Jan;19:3-10.
2. Horstmann S et al. Intracerebral hemorrhage during anticoagulation with vitamin K antagonists: a consecutive observational study. J Neurol. 2013 Aug;260:2046-51.
3. Rosand J et al. The effect of warfarin and intensity of anticoagulation on outcome of intracerebral hemorrhage. Arch Intern Med. 2004 Apr 26;164:880-4.
4. Hemphill JC et al. Guidelines for the management of spontaneous intracerebral hemorrhage. Stroke. 2015 Jul;46:2032-60.
5. Aguillar MI et al. Update in intracerebral hemorrhage. Neurohospitalist. 2011;1:148-59.
6. Hill MD et al. Rate of stroke recurrence in patients with primary intracerebral hemorrhage. Stroke. 2000;31:123-7.
7. Steiner T et al. European Stroke Organization (ESO) guidelines for the management of spontaneous cerebral hemorrhage. Int J Stroke. 2014;9:840-55.
8. Murthy SB et al. Restarting anticoagulation therapy after intracranial hemorrhage: A systematic review and meta-analysis. Stroke. 2017 Jun;48:1594-600.
9. Biffi A et al. Oral anticoagulation and functional outcome after intracerebral hemorrhage. Ann Neurol. 2017 Nov;82:755-65.
10. Witt DM. What to do after the bleed: Resuming anticoagulation after major bleeding. Hematology Am Soc Hematol Educ Program. 2016 Dec 2;206:620-4.
11. Pennlert J et al. Optimal timing of anticoagulant treatment after intracerebral hemorrhage in patients with atrial fibrillation. Stroke. 2017 Feb;48:314-20.
Key Points
- Robust scientific data on when to resume anticoagulation after ICH does not exist.
- Retrospective studies have shown that anticoagulation resumption after 4-8 weeks decreases the risk of thromboembolic events, decreases mortality, and improves functional status following ICH with no significant change in the risk of its recurrence.
- Prospective, randomized controlled trials are needed to explore risks/benefits of anticoagulation resumption and better define its optimal timing in relation to ICH.
Quiz
Which of the following is false regarding ICH?
A. Lobar ICHs are usually associated with cerebral amyloid angiopathy which are prone to bleeding.
B. Randomized, controlled studies have helped guide the decision as to when to resume anticoagulation in patients with ICH.
C. Current guidelines suggest deferring therapeutic anticoagulation for at least 4 weeks following ICH.
D. Resumption of anticoagulation after 4-8 weeks does not lead to increased risk of rebleeding in patients with prior ICH.
The false answer is B: Current recommendations regarding resumption of anticoagulation in patients with ICH are based solely on retrospective observational studies; there are no randomized, control trials to date.
A is true: In contrast to hypertensive vessel disease associated with deep ICH, lobar hemorrhages are usually associated with cerebral amyloid angiopathy, which are more prone to bleeding.
C is true: The AHA/ASA has a class IIB recommendation to avoid anticoagulation for at least 4 weeks after ICH in patients without mechanical heart valves.
D is true: Several studies have shown that resumption of anticoagulation 4-8 weeks after ICH does not increase the risk of rebleeding.
Department of Medicine, Massachusetts General Hospital, Boston
Case
A 75 year-old woman with a history of hypertension, diabetes mellitus, heart failure and nonvalvular atrial fibrillation (CHA2DS2-VASc score, 8) on anticoagulation is admitted with weakness and dysarthria. Exam is notable for hypertension and right-sided hemiparesis. CT of the head shows an intraparenchymal hemorrhage in the left putamen. Her anticoagulation is reversed and blood pressure well controlled. She is discharged 12 days later.
Brief overview of the issue
Intracranial hemorrhage (ICH) is the second most common cause of stroke and is associated with high morbidity and mortality.1 It is estimated that 10%-15% of spontaneous ICH cases occur in patients on therapeutic anticoagulation for atrial fibrillation.2 As our population ages and more people develop atrial fibrillation, anticoagulation for primary or secondary prevention of embolic stroke also will likely increase, placing more people at risk for ICH. Even stringently controlled therapeutic international normalized ratios (INRs) between 2 and 3 may double the risk of ICH.3
Patients with ICH require close monitoring and treatment, including blood pressure control, reversal of anticoagulation, reduction of intracranial pressure and, at times, neurosurgery.4 Although anticoagulation is discontinued and reversed at the onset of ICH, no clear consensus exists as to when it is safe to resume it. Although anticoagulation decreases the risk of stroke/thromboembolism, it may also increase the amount of bleeding associated with the initial ICH or lead to its recurrence.
Factors that may contribute to rebleeding include uncontrolled hypertension, advanced age, time to resumption of anticoagulation, and lobar location of ICH (i.e., in cerebral cortex and/or underlying white matter).5 Traditionally, lobar ICH has high incidence of cerebral amyloid angiopathy and has been associated with higher bleeding rates than has deep ICH (i.e., involving the thalami, basal ganglia, cerebellum, or brainstem) where cerebral amyloid angiopathy is rare and ICH is usually from hypertensive vessel disease. However, in patients with active thromboembolic disease, high-risk atrial fibrillation, and mechanical valves, withholding anticoagulation could place them at high risk of stroke.
Two questions should be addressed in the case presented: Is it safe to restart therapeutic anticoagulation; and if so, what is the optimal time interval between ICH and reinitiation of anticoagulation?
Overview of the data
There is limited guidance from major professional societies regarding the reinitiation of anticoagulation and the optimal timing of safely resuming anticoagulation in patients with prior ICH.
Current European Stroke Organization guidelines provide no specific recommendations for anticoagulation resumption after ICH.7 The American Heart Association/American Stroke Association guideline has a class IIA (weak) recommendation to avoid anticoagulation in spontaneous lobar ICH and a class IIB (very weak) recommendation to consider resuming anticoagulation in nonlobar ICH on a case-by-case basis.4
Two recent meta-analyses have examined outcomes of resuming anticoagulation after ICH. In a meta-analysis of 5,300 patients with nonlobar ICH involving eight retrospective studies, Murthy et al. evaluated the risk of thromboembolic events (described as a composite outcome of MI and stroke) and the risk of recurrent ICH.8 They reported that resumption of therapeutic anticoagulation was associated with a decrease in the rate of thromboembolic events (6.7% vs. 17.6%; risk ratio, 0.35; 95% confidence interval, 0.25-0.45) with no significant change in the rate of repeat ICH (8.7% vs. 7.8%).
A second meta-analysis of three retrospective trials conducted by Biffi et al. examined anticoagulation resumption in 1,012 patients with ICH solely in the setting of thromboprophylaxis for nonvalvular atrial fibrillation.9 Reinitiation of anticoagulation after ICH was associated with decreased mortality (hazard ratio, 0.27; 95% CI, 0.19-0.40; P less than .0001), improved functional outcome (HR, 4.15; 95% CI, 2.92-5.90; P less than .0001), and reduction in all-cause stroke recurrence (HR 0.47; 95% CI, 0.36-0.64; P less than .0001). There was no significant difference in the rate of recurrent ICH when anticoagulation was resumed. Despite the notion that patients with cerebral amyloid angiopathy are at high risk of rebleeding, this positive association still held irrespective of lobar vs. nonlobar location of ICH.
Collectively, these studies suggest that resumption of anticoagulation may be effective in decreasing the rates of thromboembolism, as well as provide a functional and mortality benefit without increasing the risk of rebleeding, irrespective of the location of the bleed.
Less is known about the optimal timing of resumption of therapeutic anticoagulation, with data ranging from 72 hours to 30 weeks.10 The American Heart Association/American Stroke Association has a class IIB (very weak) recommendation to avoid anticoagulation for at least 4 weeks in patients without mechanical heart valves.4 The median time to resumption of therapeutic anticoagulation in aforementioned meta-analyses ranged from 10 to 44 days.8,9
A recent observational study of 2,619 ICH survivors explored the relationship between the timing of reinitiation of anticoagulation and the incidence of thrombotic events (defined as ischemic stroke or death because of MI or systemic arterial thromboembolism) and hemorrhagic events (defined as recurrent ICH or bleeding event leading to death) occurring at least 28 days after initial ICH in patients with atrial fibrillation.11
A decrease in thrombotic events was demonstrated if anticoagulation was started 4-16 weeks after ICH. However, when anticoagulation was started more than 16 weeks after ICH, no benefit was seen. Additionally, there was no significant difference in hemorrhagic events between men and women who resumed anticoagulation. In patients with high venous thromboembolism risk based on CHA2DS2-VASc score, resumption of anticoagulation was associated with a decreased predicted incidence of vascular death and nonfatal stroke, with the greatest benefit observed when anticoagulation was started at 7-8 weeks after ICH.
Unfortunately, published literature to date on anticoagulation after ICH is based entirely on retrospective studies – not randomized, controlled studies – making it more likely that anticoagulation would have been resumed in healthier patients, not those left debilitated by the ICH.
Furthermore, information on the location and size of the hemorrhages – which may serve as another confounding factor – often has not been reported. This is important since patients with smaller hemorrhages in less precarious areas also may be more likely to have resumption of anticoagulation. Another limitation of the current literature is that warfarin is the most common anticoagulant studied, with few studies involving the increasingly prescribed newer direct oral anticoagulants. It is also important to stress that a causal relationship between use of anticoagulants and certain outcomes or adverse effects following ICH may be more difficult to invoke in the absence of randomized controlled study designs.
Application of the data to our patient
Resumption of anticoagulation in our patient with ICH requires balancing the risk of hemorrhage expansion and recurrent ICH with the risk of thromboembolic disease.
Our patient is at higher risk of bleeding because of her advanced age, but adequate control of her blood pressure and nonlobar location of her ICH in the basal ganglia also may decrease her risk of recurrent ICH. Her high CHA2DS2-VASc score places her at high risk of thromboembolic event and stroke, making it more likely for reinitiation of anticoagulation to confer a mortality benefit.
Based on AHA guidelines,4 we should wait at least 4 weeks, or possibly wait until weeks 7-8 after ICH when the greatest benefit may be expected based on prediction models.11
Bottom line
It would likely be safe to resume anticoagulation 4-8 weeks after ICH in our patient.
Dr. Gibson, Dr. Restrepo, Dr. Sasidhara, and Dr. Manian are hospitalists at Massachusetts General Hospital, Boston.
References
1. An SJ et al. Epidemiology, risk factors, and clinical features of intracerebral hemorrhage: An update. J Stroke. 2017 Jan;19:3-10.
2. Horstmann S et al. Intracerebral hemorrhage during anticoagulation with vitamin K antagonists: a consecutive observational study. J Neurol. 2013 Aug;260:2046-51.
3. Rosand J et al. The effect of warfarin and intensity of anticoagulation on outcome of intracerebral hemorrhage. Arch Intern Med. 2004 Apr 26;164:880-4.
4. Hemphill JC et al. Guidelines for the management of spontaneous intracerebral hemorrhage. Stroke. 2015 Jul;46:2032-60.
5. Aguillar MI et al. Update in intracerebral hemorrhage. Neurohospitalist. 2011;1:148-59.
6. Hill MD et al. Rate of stroke recurrence in patients with primary intracerebral hemorrhage. Stroke. 2000;31:123-7.
7. Steiner T et al. European Stroke Organization (ESO) guidelines for the management of spontaneous cerebral hemorrhage. Int J Stroke. 2014;9:840-55.
8. Murthy SB et al. Restarting anticoagulation therapy after intracranial hemorrhage: A systematic review and meta-analysis. Stroke. 2017 Jun;48:1594-600.
9. Biffi A et al. Oral anticoagulation and functional outcome after intracerebral hemorrhage. Ann Neurol. 2017 Nov;82:755-65.
10. Witt DM. What to do after the bleed: Resuming anticoagulation after major bleeding. Hematology Am Soc Hematol Educ Program. 2016 Dec 2;206:620-4.
11. Pennlert J et al. Optimal timing of anticoagulant treatment after intracerebral hemorrhage in patients with atrial fibrillation. Stroke. 2017 Feb;48:314-20.
Key Points
- Robust scientific data on when to resume anticoagulation after ICH does not exist.
- Retrospective studies have shown that anticoagulation resumption after 4-8 weeks decreases the risk of thromboembolic events, decreases mortality, and improves functional status following ICH with no significant change in the risk of its recurrence.
- Prospective, randomized controlled trials are needed to explore risks/benefits of anticoagulation resumption and better define its optimal timing in relation to ICH.
Quiz
Which of the following is false regarding ICH?
A. Lobar ICHs are usually associated with cerebral amyloid angiopathy which are prone to bleeding.
B. Randomized, controlled studies have helped guide the decision as to when to resume anticoagulation in patients with ICH.
C. Current guidelines suggest deferring therapeutic anticoagulation for at least 4 weeks following ICH.
D. Resumption of anticoagulation after 4-8 weeks does not lead to increased risk of rebleeding in patients with prior ICH.
The false answer is B: Current recommendations regarding resumption of anticoagulation in patients with ICH are based solely on retrospective observational studies; there are no randomized, control trials to date.
A is true: In contrast to hypertensive vessel disease associated with deep ICH, lobar hemorrhages are usually associated with cerebral amyloid angiopathy, which are more prone to bleeding.
C is true: The AHA/ASA has a class IIB recommendation to avoid anticoagulation for at least 4 weeks after ICH in patients without mechanical heart valves.
D is true: Several studies have shown that resumption of anticoagulation 4-8 weeks after ICH does not increase the risk of rebleeding.
Positive FIT test should prompt colonoscopy
Patients who test positive on a fecal immunochemical test (FIT), even after a recent colonoscopy, should be offered a repeat colonoscopy. That is the conclusion following a review of 2,228 subjects who were FIT positive, which revealed a greater risk of colorectal cancer (CRC) and advanced colorectal neoplasia (ACRN) the longer the gap since the last colonoscopy. The findings support the recommendations of the U.S. Multi-Society Task Force on CRC Screening to offer repeat colonoscopies to FIT-positive patients, even if they recently underwent a colonoscopy.
That recommendation was based on low-quality supporting evidence, and there is currently little agreement about whether annual FIT should be performed along with colonoscopy.
The researchers set out to detect the frequency of CRC and ACRN among patients with a positive FIT test. They analyzed data from the National Cancer Screening Program in Korea, which offers an annual FIT for adults aged 50 years and older as an initial screening, followed by a colonoscopy in case of a positive result.
The researchers analyzed data from 52,376 individuals who underwent FIT at a single center in Korea during January 2013–July 2017. They excluded patients with a history of CRC or colorectal surgery, inflammatory bowel disease, or poor bowel preparation.
FIT-positive and FIT-negative patients were divided into three groups based on the length of time since their last colonoscopy: less than 3 years, 3-10 years, or more than 10 years or no colonoscopy.
Compared with FIT-negative subjects, FIT-positive individuals were more likely to be diagnosed with any colorectal neoplasia (61.3% vs. 51.8%; P less than .001), ACRN (20.0% vs. 10.3%; P less than .001), and CRC (5.0% vs. 1.9%; P less than .001).
A total of 6% of subjects had a positive FIT result, and data from 2,228 were analyzed after exclusions. They were compared with 6,135 participants who had negative FIT results but underwent a colonoscopy.
Of patients with a positive FIT result, 23.1% had a colonoscopy less than 3 years before, 19.2% had one 3-10 years prior, and 57.8% had a colonoscopy more than 10 years earlier or had never had one.
The more-than-10-year group had a higher frequency of colorectal neoplasia, ACRN, or CRC (26.0%) than did the 3-10-year group (12.6%), and the less-than-3-year group (10.9%; P less than .001 for all). A similar trend was seen for CRC: 7.2%, 1.6%, and 2.1%, respectively (P less than .001).
Of the 6,135 FIT-negative participants, 22.2% were in the less-than-3-years group, 28.9% 3-10 years, and 48.8% more-than-10 years-or-never group. The more-than-10-years group had a higher frequency of ACRN (14.7%) than did the 3-10-year group (0.4%) and the 0-3-year group (0.7%, P less than .001).
Among FIT-positive patients, the more-than-10-year group was at higher risk of ACRN diagnosis during follow-up colonoscopy than was the less-than-3-year group (adjusted OR, 3.63; 95% confidence interval, 2.48-5.31), but not compared with the 3-10-year group (aOR, 1.17; 95% CI, 0.71-1.93). The more-than-10-year group also was at greater risk of a CRC diagnosis than was the less-than-3-year group (aOR, 3.66; 95% CI, 1.74-7.73). There was no significant difference in CRC risk between the less-than-3-year group and the 3-10-year group (aOR, 0.58; 95% CI, 0.17-1.93).
The authors suggest that CRC and ACRN found in patients who had a colonoscopy in the past 3 years are likely to be lesions that were missed in the previous exam, rather than new, fast-growing lesions. That suggests that FIT may help catch lesions that were missed during earlier screenings, though just 2.1% of the less-than-3-year group and 1.6% of the 3-10-year group were diagnosed with CRC, and 10.9% and 12.6% with ACRN, respectively.
The authors conclude that it may not be appropriate to offer interval FIT to all patients, since it can lead to unnecessary colonoscopies. They call for more research to determine which categories of patients are most likely to benefit from interval FIT.
SOURCE: Kim NH et al. Gastrointest Endosc. 2019 Jan 23. doi: 10.1016/j.gie.2019.01.012.
Patients who test positive on a fecal immunochemical test (FIT), even after a recent colonoscopy, should be offered a repeat colonoscopy. That is the conclusion following a review of 2,228 subjects who were FIT positive, which revealed a greater risk of colorectal cancer (CRC) and advanced colorectal neoplasia (ACRN) the longer the gap since the last colonoscopy. The findings support the recommendations of the U.S. Multi-Society Task Force on CRC Screening to offer repeat colonoscopies to FIT-positive patients, even if they recently underwent a colonoscopy.
That recommendation was based on low-quality supporting evidence, and there is currently little agreement about whether annual FIT should be performed along with colonoscopy.
The researchers set out to detect the frequency of CRC and ACRN among patients with a positive FIT test. They analyzed data from the National Cancer Screening Program in Korea, which offers an annual FIT for adults aged 50 years and older as an initial screening, followed by a colonoscopy in case of a positive result.
The researchers analyzed data from 52,376 individuals who underwent FIT at a single center in Korea during January 2013–July 2017. They excluded patients with a history of CRC or colorectal surgery, inflammatory bowel disease, or poor bowel preparation.
FIT-positive and FIT-negative patients were divided into three groups based on the length of time since their last colonoscopy: less than 3 years, 3-10 years, or more than 10 years or no colonoscopy.
Compared with FIT-negative subjects, FIT-positive individuals were more likely to be diagnosed with any colorectal neoplasia (61.3% vs. 51.8%; P less than .001), ACRN (20.0% vs. 10.3%; P less than .001), and CRC (5.0% vs. 1.9%; P less than .001).
A total of 6% of subjects had a positive FIT result, and data from 2,228 were analyzed after exclusions. They were compared with 6,135 participants who had negative FIT results but underwent a colonoscopy.
Of patients with a positive FIT result, 23.1% had a colonoscopy less than 3 years before, 19.2% had one 3-10 years prior, and 57.8% had a colonoscopy more than 10 years earlier or had never had one.
The more-than-10-year group had a higher frequency of colorectal neoplasia, ACRN, or CRC (26.0%) than did the 3-10-year group (12.6%), and the less-than-3-year group (10.9%; P less than .001 for all). A similar trend was seen for CRC: 7.2%, 1.6%, and 2.1%, respectively (P less than .001).
Of the 6,135 FIT-negative participants, 22.2% were in the less-than-3-years group, 28.9% 3-10 years, and 48.8% more-than-10 years-or-never group. The more-than-10-years group had a higher frequency of ACRN (14.7%) than did the 3-10-year group (0.4%) and the 0-3-year group (0.7%, P less than .001).
Among FIT-positive patients, the more-than-10-year group was at higher risk of ACRN diagnosis during follow-up colonoscopy than was the less-than-3-year group (adjusted OR, 3.63; 95% confidence interval, 2.48-5.31), but not compared with the 3-10-year group (aOR, 1.17; 95% CI, 0.71-1.93). The more-than-10-year group also was at greater risk of a CRC diagnosis than was the less-than-3-year group (aOR, 3.66; 95% CI, 1.74-7.73). There was no significant difference in CRC risk between the less-than-3-year group and the 3-10-year group (aOR, 0.58; 95% CI, 0.17-1.93).
The authors suggest that CRC and ACRN found in patients who had a colonoscopy in the past 3 years are likely to be lesions that were missed in the previous exam, rather than new, fast-growing lesions. That suggests that FIT may help catch lesions that were missed during earlier screenings, though just 2.1% of the less-than-3-year group and 1.6% of the 3-10-year group were diagnosed with CRC, and 10.9% and 12.6% with ACRN, respectively.
The authors conclude that it may not be appropriate to offer interval FIT to all patients, since it can lead to unnecessary colonoscopies. They call for more research to determine which categories of patients are most likely to benefit from interval FIT.
SOURCE: Kim NH et al. Gastrointest Endosc. 2019 Jan 23. doi: 10.1016/j.gie.2019.01.012.
Patients who test positive on a fecal immunochemical test (FIT), even after a recent colonoscopy, should be offered a repeat colonoscopy. That is the conclusion following a review of 2,228 subjects who were FIT positive, which revealed a greater risk of colorectal cancer (CRC) and advanced colorectal neoplasia (ACRN) the longer the gap since the last colonoscopy. The findings support the recommendations of the U.S. Multi-Society Task Force on CRC Screening to offer repeat colonoscopies to FIT-positive patients, even if they recently underwent a colonoscopy.
That recommendation was based on low-quality supporting evidence, and there is currently little agreement about whether annual FIT should be performed along with colonoscopy.
The researchers set out to detect the frequency of CRC and ACRN among patients with a positive FIT test. They analyzed data from the National Cancer Screening Program in Korea, which offers an annual FIT for adults aged 50 years and older as an initial screening, followed by a colonoscopy in case of a positive result.
The researchers analyzed data from 52,376 individuals who underwent FIT at a single center in Korea during January 2013–July 2017. They excluded patients with a history of CRC or colorectal surgery, inflammatory bowel disease, or poor bowel preparation.
FIT-positive and FIT-negative patients were divided into three groups based on the length of time since their last colonoscopy: less than 3 years, 3-10 years, or more than 10 years or no colonoscopy.
Compared with FIT-negative subjects, FIT-positive individuals were more likely to be diagnosed with any colorectal neoplasia (61.3% vs. 51.8%; P less than .001), ACRN (20.0% vs. 10.3%; P less than .001), and CRC (5.0% vs. 1.9%; P less than .001).
A total of 6% of subjects had a positive FIT result, and data from 2,228 were analyzed after exclusions. They were compared with 6,135 participants who had negative FIT results but underwent a colonoscopy.
Of patients with a positive FIT result, 23.1% had a colonoscopy less than 3 years before, 19.2% had one 3-10 years prior, and 57.8% had a colonoscopy more than 10 years earlier or had never had one.
The more-than-10-year group had a higher frequency of colorectal neoplasia, ACRN, or CRC (26.0%) than did the 3-10-year group (12.6%), and the less-than-3-year group (10.9%; P less than .001 for all). A similar trend was seen for CRC: 7.2%, 1.6%, and 2.1%, respectively (P less than .001).
Of the 6,135 FIT-negative participants, 22.2% were in the less-than-3-years group, 28.9% 3-10 years, and 48.8% more-than-10 years-or-never group. The more-than-10-years group had a higher frequency of ACRN (14.7%) than did the 3-10-year group (0.4%) and the 0-3-year group (0.7%, P less than .001).
Among FIT-positive patients, the more-than-10-year group was at higher risk of ACRN diagnosis during follow-up colonoscopy than was the less-than-3-year group (adjusted OR, 3.63; 95% confidence interval, 2.48-5.31), but not compared with the 3-10-year group (aOR, 1.17; 95% CI, 0.71-1.93). The more-than-10-year group also was at greater risk of a CRC diagnosis than was the less-than-3-year group (aOR, 3.66; 95% CI, 1.74-7.73). There was no significant difference in CRC risk between the less-than-3-year group and the 3-10-year group (aOR, 0.58; 95% CI, 0.17-1.93).
The authors suggest that CRC and ACRN found in patients who had a colonoscopy in the past 3 years are likely to be lesions that were missed in the previous exam, rather than new, fast-growing lesions. That suggests that FIT may help catch lesions that were missed during earlier screenings, though just 2.1% of the less-than-3-year group and 1.6% of the 3-10-year group were diagnosed with CRC, and 10.9% and 12.6% with ACRN, respectively.
The authors conclude that it may not be appropriate to offer interval FIT to all patients, since it can lead to unnecessary colonoscopies. They call for more research to determine which categories of patients are most likely to benefit from interval FIT.
SOURCE: Kim NH et al. Gastrointest Endosc. 2019 Jan 23. doi: 10.1016/j.gie.2019.01.012.
FROM GASTROINTESTINAL ENDOSCOPY
Key clinical point: Positive findings are linked to greater CRC and advanced colorectal neoplasia risk.
Major finding: Regardless of time since last colonoscopy, CRC and ACRN frequencies were higher in FIT-positive subjects.
Study details: Retrospective analysis of 2,228 FIT-positive and 6,135 FIT-negative subjects
Disclosures: The study received no funding. The authors reported no conflicts of interest.
Source: Kim NH et al. Gastrointest Endosc. 2019 Jan 23. doi: 10.1016/j.gie.2019.01.012.
AHA report highlights CVD burden, declines in smoking, sleep importance
Almost half of U.S. adults now have some form of cardiovascular disease, according to the latest annual statistical update from the American Heart Association.
The prevalence is driven in part by the recently changed definition of hypertension, from 140/90 to 130/80 mm Hg, said authors of the American Heart Association Heart Disease and Stroke Statistics–2019 Update.
Cardiovascular disease (CVD) deaths are up, though smoking rates continue to decline, and adults are getting more exercise (Circulation. 2019;139. doi: 10.1161/CIR.0000000000000659).
The update includes a new section on sleep and cardiovascular health, an enhanced focus on social determinants of health, and further evidence-based approaches to behavior change, according to the update’s authors, led by chair Emelia J. Benjamin, MD, professor of medicine and epidemiology at Boston University, and vice chair Paul Muntner, PhD, professor of epidemiology at the University of Alabama, Birmingham.
High blood pressure is an “overwhelming presence” that drives heart disease and stroke and can’t be dismissed in the fight against cardiovascular disease, AHA President Ivor J. Benjamin, MD, said in a statement. “Eliminating high blood pressure could have a larger impact on CVD deaths than the elimination of all other risk factors among women, and all except smoking among men.”
Using data from 2013 to 2016, 46% of adults in the United States had hypertension, and in 2016 there were 82,735 deaths attributable primarily to high blood pressure, according to the update.
Total direct costs of hypertension could approach $221 billion by 2035, according to projections in the report.
After decades of decline, U.S. cardiovascular disease deaths increased to 840,678 in 2016, up from 836,546 in 2015, the report says.
Smoking rate declines represent some of the most significant improvements outlined in the report, according to an AHA news release.
Ninety-four percent of adolescents were nonsmokers in the 2015-2016 period, which is up from 76% in 1999-2000, according to the report. The proportion of adult nonsmokers increased to 79% in 2015-2016, up from 73% in 1999-2000.
The new chapter on the importance of sleep cites data from the Centers for Disease Control and Prevention that only 65.2% of Americans have a healthy sleep duration (at least 7 hours), with even lower rates among non-Hispanic blacks, native Hawaiians and Pacific Islanders, and multiracial non-Hispanic individuals.
Short sleep duration is associated with a higher risk of all-cause mortality, total CVD, and coronary heart disease, according to a meta-analysis cited in the report. Long sleep duration, defined as greater than 8 hours, also was associated with higher risk of all-cause mortality, total CVD, coronary heart disease, and stroke.
Members of the statistical update writing group reported disclosures related to the American Heart Association, National Institutes of Health, Amgen, Sanofi, Roche, Abbott, Biogen, Medtronic, and others.
SOURCE: Benjamin EJ et al. Circulation. 2019 Jan 31.
The latest statistics on heart disease and stroke include some metrics that indicate progress, and others that suggest opportunities for improvement.
Tobacco use continues to decline; however, among high school students, e-cigarette use is up to 11.3%, which is concerning.
One bright spot is that the proportion of inactive adults has dropped to 30% in 2016, down from 40% in 2007. Despite that improvement, however, the prevalence of obesity increased significantly over the decade, to the point where nearly 40% of adults are obese and 7.7% are severely obese.
Although 48% of U.S. adults now have cardiovascular disease, according to this latest update, the number drops to just 9% when hypertension is excluded. Even so, 9% represents more than 24.3 million Americans who have coronary artery disease, stroke, or heart failure.
The cost of cardiovascular disease is astronomical, exceeding $351 billion in 2014-1205, with costs projected to increase sharply for older adults over the next few decades.
Starting in 2020, the AHA will begin charting progress in CVD using a metric called health-adjusted life expectancy (HALE), which relies on morbidity and mortality patterns to reflect the number of years a person can expect to live. Patients and the general public may find this metric more understandable than statistics about death rates and cardiovascular risk factors.
Mariell Jessup, MD, is chief science and medical officer for the American Heart Association. Her view on the latest statistical update was derived from a commentary that accompanied the update.
The latest statistics on heart disease and stroke include some metrics that indicate progress, and others that suggest opportunities for improvement.
Tobacco use continues to decline; however, among high school students, e-cigarette use is up to 11.3%, which is concerning.
One bright spot is that the proportion of inactive adults has dropped to 30% in 2016, down from 40% in 2007. Despite that improvement, however, the prevalence of obesity increased significantly over the decade, to the point where nearly 40% of adults are obese and 7.7% are severely obese.
Although 48% of U.S. adults now have cardiovascular disease, according to this latest update, the number drops to just 9% when hypertension is excluded. Even so, 9% represents more than 24.3 million Americans who have coronary artery disease, stroke, or heart failure.
The cost of cardiovascular disease is astronomical, exceeding $351 billion in 2014-1205, with costs projected to increase sharply for older adults over the next few decades.
Starting in 2020, the AHA will begin charting progress in CVD using a metric called health-adjusted life expectancy (HALE), which relies on morbidity and mortality patterns to reflect the number of years a person can expect to live. Patients and the general public may find this metric more understandable than statistics about death rates and cardiovascular risk factors.
Mariell Jessup, MD, is chief science and medical officer for the American Heart Association. Her view on the latest statistical update was derived from a commentary that accompanied the update.
The latest statistics on heart disease and stroke include some metrics that indicate progress, and others that suggest opportunities for improvement.
Tobacco use continues to decline; however, among high school students, e-cigarette use is up to 11.3%, which is concerning.
One bright spot is that the proportion of inactive adults has dropped to 30% in 2016, down from 40% in 2007. Despite that improvement, however, the prevalence of obesity increased significantly over the decade, to the point where nearly 40% of adults are obese and 7.7% are severely obese.
Although 48% of U.S. adults now have cardiovascular disease, according to this latest update, the number drops to just 9% when hypertension is excluded. Even so, 9% represents more than 24.3 million Americans who have coronary artery disease, stroke, or heart failure.
The cost of cardiovascular disease is astronomical, exceeding $351 billion in 2014-1205, with costs projected to increase sharply for older adults over the next few decades.
Starting in 2020, the AHA will begin charting progress in CVD using a metric called health-adjusted life expectancy (HALE), which relies on morbidity and mortality patterns to reflect the number of years a person can expect to live. Patients and the general public may find this metric more understandable than statistics about death rates and cardiovascular risk factors.
Mariell Jessup, MD, is chief science and medical officer for the American Heart Association. Her view on the latest statistical update was derived from a commentary that accompanied the update.
Almost half of U.S. adults now have some form of cardiovascular disease, according to the latest annual statistical update from the American Heart Association.
The prevalence is driven in part by the recently changed definition of hypertension, from 140/90 to 130/80 mm Hg, said authors of the American Heart Association Heart Disease and Stroke Statistics–2019 Update.
Cardiovascular disease (CVD) deaths are up, though smoking rates continue to decline, and adults are getting more exercise (Circulation. 2019;139. doi: 10.1161/CIR.0000000000000659).
The update includes a new section on sleep and cardiovascular health, an enhanced focus on social determinants of health, and further evidence-based approaches to behavior change, according to the update’s authors, led by chair Emelia J. Benjamin, MD, professor of medicine and epidemiology at Boston University, and vice chair Paul Muntner, PhD, professor of epidemiology at the University of Alabama, Birmingham.
High blood pressure is an “overwhelming presence” that drives heart disease and stroke and can’t be dismissed in the fight against cardiovascular disease, AHA President Ivor J. Benjamin, MD, said in a statement. “Eliminating high blood pressure could have a larger impact on CVD deaths than the elimination of all other risk factors among women, and all except smoking among men.”
Using data from 2013 to 2016, 46% of adults in the United States had hypertension, and in 2016 there were 82,735 deaths attributable primarily to high blood pressure, according to the update.
Total direct costs of hypertension could approach $221 billion by 2035, according to projections in the report.
After decades of decline, U.S. cardiovascular disease deaths increased to 840,678 in 2016, up from 836,546 in 2015, the report says.
Smoking rate declines represent some of the most significant improvements outlined in the report, according to an AHA news release.
Ninety-four percent of adolescents were nonsmokers in the 2015-2016 period, which is up from 76% in 1999-2000, according to the report. The proportion of adult nonsmokers increased to 79% in 2015-2016, up from 73% in 1999-2000.
The new chapter on the importance of sleep cites data from the Centers for Disease Control and Prevention that only 65.2% of Americans have a healthy sleep duration (at least 7 hours), with even lower rates among non-Hispanic blacks, native Hawaiians and Pacific Islanders, and multiracial non-Hispanic individuals.
Short sleep duration is associated with a higher risk of all-cause mortality, total CVD, and coronary heart disease, according to a meta-analysis cited in the report. Long sleep duration, defined as greater than 8 hours, also was associated with higher risk of all-cause mortality, total CVD, coronary heart disease, and stroke.
Members of the statistical update writing group reported disclosures related to the American Heart Association, National Institutes of Health, Amgen, Sanofi, Roche, Abbott, Biogen, Medtronic, and others.
SOURCE: Benjamin EJ et al. Circulation. 2019 Jan 31.
Almost half of U.S. adults now have some form of cardiovascular disease, according to the latest annual statistical update from the American Heart Association.
The prevalence is driven in part by the recently changed definition of hypertension, from 140/90 to 130/80 mm Hg, said authors of the American Heart Association Heart Disease and Stroke Statistics–2019 Update.
Cardiovascular disease (CVD) deaths are up, though smoking rates continue to decline, and adults are getting more exercise (Circulation. 2019;139. doi: 10.1161/CIR.0000000000000659).
The update includes a new section on sleep and cardiovascular health, an enhanced focus on social determinants of health, and further evidence-based approaches to behavior change, according to the update’s authors, led by chair Emelia J. Benjamin, MD, professor of medicine and epidemiology at Boston University, and vice chair Paul Muntner, PhD, professor of epidemiology at the University of Alabama, Birmingham.
High blood pressure is an “overwhelming presence” that drives heart disease and stroke and can’t be dismissed in the fight against cardiovascular disease, AHA President Ivor J. Benjamin, MD, said in a statement. “Eliminating high blood pressure could have a larger impact on CVD deaths than the elimination of all other risk factors among women, and all except smoking among men.”
Using data from 2013 to 2016, 46% of adults in the United States had hypertension, and in 2016 there were 82,735 deaths attributable primarily to high blood pressure, according to the update.
Total direct costs of hypertension could approach $221 billion by 2035, according to projections in the report.
After decades of decline, U.S. cardiovascular disease deaths increased to 840,678 in 2016, up from 836,546 in 2015, the report says.
Smoking rate declines represent some of the most significant improvements outlined in the report, according to an AHA news release.
Ninety-four percent of adolescents were nonsmokers in the 2015-2016 period, which is up from 76% in 1999-2000, according to the report. The proportion of adult nonsmokers increased to 79% in 2015-2016, up from 73% in 1999-2000.
The new chapter on the importance of sleep cites data from the Centers for Disease Control and Prevention that only 65.2% of Americans have a healthy sleep duration (at least 7 hours), with even lower rates among non-Hispanic blacks, native Hawaiians and Pacific Islanders, and multiracial non-Hispanic individuals.
Short sleep duration is associated with a higher risk of all-cause mortality, total CVD, and coronary heart disease, according to a meta-analysis cited in the report. Long sleep duration, defined as greater than 8 hours, also was associated with higher risk of all-cause mortality, total CVD, coronary heart disease, and stroke.
Members of the statistical update writing group reported disclosures related to the American Heart Association, National Institutes of Health, Amgen, Sanofi, Roche, Abbott, Biogen, Medtronic, and others.
SOURCE: Benjamin EJ et al. Circulation. 2019 Jan 31.
FROM CIRCULATION