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Benefit of dabigatran over warfarin persists in AF patient subgroups undergoing PCI
ANAHEIM, CALIF. – The benefit of dabigatran dual therapy versus warfarin triple therapy after percutaneous coronary intervention in patients with atrial fibrillation was consistent whether patients had drug-eluting or bare-metal stents, concomitant treatment with ticagrelor or clopidogrel, or acute coronary syndrome or stable disease as the indication for PCI, according to a subgroup analysis of the RE-DUAL PCI trial.
The trial, presented at the American Heart Association scientific sessions, randomized 2,725 patients to triple therapy with warfarin plus a P2Y12 inhibitor (clopidogrel or ticagrelor) and aspirin – the triple therapy group – or dabigatran 110 mg or 150 mg twice daily plus clopidogrel or ticagrelor – the dual therapy groups (N Engl J Med. 2017 Oct 19;377[16]:1513-24).
After a mean follow-up 14 months, the incidence of the major or clinically relevant nonmajor bleeding was 15.4% in the 110-mg dual-therapy group (hazard ratio, 0.52; 95% CI, 0.42-0.63; P less than .001) and 20.2% in the 150-mg dual-therapy group (HR, 0.72; 95% CI, 0.58-0.88; P less than .001), versus about 26% with triple-therapy.
The incidence of the composite efficacy endpoint – death, unplanned revascularization, myocardial infarction, stroke, or systemic embolism – was 13.7% in the two dual-therapy groups versus 13.4% with triple-therapy (HR, 1.04; 95% CI, 0.84-1.29; P = .005).
The investigators found consistent results when they analyzed their prespecified subgroups.
Drug-eluting stents were placed in 83% of patients; the rest had bare metal stents (BMS). The groups were well-balanced, except BMS patients were again more likely to be new to oral anticoagulation. Bleeding, thromboembolic events, and mortality were consistent with the main results regardless of the stent type, Most of the subjects were on clopidogrel, with just 12% on ticagrelor in both the dabigatran and warfarin groups. Ticagrelor patients were more likely to have ACS as their PCI indication and be new to oral anticoagulation. Ticagrelor patients were also more clinically complex, with a higher bleeding risk. Even so, they had relative bleeding risk reduction and efficacy results with dabigatran that were consistent with the overall finding, Dr. Oldgren said.
Patients were eligible for RE-DUAL PCI (Evaluation of Dual Therapy with Dabigatran vs. Triple Therapy with Warfarin in Patients with AF That Undergo a PCI with Stenting) if they had nonvalvular atrial fibrillation and a successful PCI within 120 hours. Those with bioprosthetic or mechanical heart valves, severe renal insufficiency, or other major comorbidities were excluded.
The trial was funded by Boehringer Ingelheim, the maker of dabigatran. Several investigators were employees. Dr. Oldgren is an adviser to Boehringer Ingelheim. Other authors reported financial ties to the company as well.
ANAHEIM, CALIF. – The benefit of dabigatran dual therapy versus warfarin triple therapy after percutaneous coronary intervention in patients with atrial fibrillation was consistent whether patients had drug-eluting or bare-metal stents, concomitant treatment with ticagrelor or clopidogrel, or acute coronary syndrome or stable disease as the indication for PCI, according to a subgroup analysis of the RE-DUAL PCI trial.
The trial, presented at the American Heart Association scientific sessions, randomized 2,725 patients to triple therapy with warfarin plus a P2Y12 inhibitor (clopidogrel or ticagrelor) and aspirin – the triple therapy group – or dabigatran 110 mg or 150 mg twice daily plus clopidogrel or ticagrelor – the dual therapy groups (N Engl J Med. 2017 Oct 19;377[16]:1513-24).
After a mean follow-up 14 months, the incidence of the major or clinically relevant nonmajor bleeding was 15.4% in the 110-mg dual-therapy group (hazard ratio, 0.52; 95% CI, 0.42-0.63; P less than .001) and 20.2% in the 150-mg dual-therapy group (HR, 0.72; 95% CI, 0.58-0.88; P less than .001), versus about 26% with triple-therapy.
The incidence of the composite efficacy endpoint – death, unplanned revascularization, myocardial infarction, stroke, or systemic embolism – was 13.7% in the two dual-therapy groups versus 13.4% with triple-therapy (HR, 1.04; 95% CI, 0.84-1.29; P = .005).
The investigators found consistent results when they analyzed their prespecified subgroups.
Drug-eluting stents were placed in 83% of patients; the rest had bare metal stents (BMS). The groups were well-balanced, except BMS patients were again more likely to be new to oral anticoagulation. Bleeding, thromboembolic events, and mortality were consistent with the main results regardless of the stent type, Most of the subjects were on clopidogrel, with just 12% on ticagrelor in both the dabigatran and warfarin groups. Ticagrelor patients were more likely to have ACS as their PCI indication and be new to oral anticoagulation. Ticagrelor patients were also more clinically complex, with a higher bleeding risk. Even so, they had relative bleeding risk reduction and efficacy results with dabigatran that were consistent with the overall finding, Dr. Oldgren said.
Patients were eligible for RE-DUAL PCI (Evaluation of Dual Therapy with Dabigatran vs. Triple Therapy with Warfarin in Patients with AF That Undergo a PCI with Stenting) if they had nonvalvular atrial fibrillation and a successful PCI within 120 hours. Those with bioprosthetic or mechanical heart valves, severe renal insufficiency, or other major comorbidities were excluded.
The trial was funded by Boehringer Ingelheim, the maker of dabigatran. Several investigators were employees. Dr. Oldgren is an adviser to Boehringer Ingelheim. Other authors reported financial ties to the company as well.
ANAHEIM, CALIF. – The benefit of dabigatran dual therapy versus warfarin triple therapy after percutaneous coronary intervention in patients with atrial fibrillation was consistent whether patients had drug-eluting or bare-metal stents, concomitant treatment with ticagrelor or clopidogrel, or acute coronary syndrome or stable disease as the indication for PCI, according to a subgroup analysis of the RE-DUAL PCI trial.
The trial, presented at the American Heart Association scientific sessions, randomized 2,725 patients to triple therapy with warfarin plus a P2Y12 inhibitor (clopidogrel or ticagrelor) and aspirin – the triple therapy group – or dabigatran 110 mg or 150 mg twice daily plus clopidogrel or ticagrelor – the dual therapy groups (N Engl J Med. 2017 Oct 19;377[16]:1513-24).
After a mean follow-up 14 months, the incidence of the major or clinically relevant nonmajor bleeding was 15.4% in the 110-mg dual-therapy group (hazard ratio, 0.52; 95% CI, 0.42-0.63; P less than .001) and 20.2% in the 150-mg dual-therapy group (HR, 0.72; 95% CI, 0.58-0.88; P less than .001), versus about 26% with triple-therapy.
The incidence of the composite efficacy endpoint – death, unplanned revascularization, myocardial infarction, stroke, or systemic embolism – was 13.7% in the two dual-therapy groups versus 13.4% with triple-therapy (HR, 1.04; 95% CI, 0.84-1.29; P = .005).
The investigators found consistent results when they analyzed their prespecified subgroups.
Drug-eluting stents were placed in 83% of patients; the rest had bare metal stents (BMS). The groups were well-balanced, except BMS patients were again more likely to be new to oral anticoagulation. Bleeding, thromboembolic events, and mortality were consistent with the main results regardless of the stent type, Most of the subjects were on clopidogrel, with just 12% on ticagrelor in both the dabigatran and warfarin groups. Ticagrelor patients were more likely to have ACS as their PCI indication and be new to oral anticoagulation. Ticagrelor patients were also more clinically complex, with a higher bleeding risk. Even so, they had relative bleeding risk reduction and efficacy results with dabigatran that were consistent with the overall finding, Dr. Oldgren said.
Patients were eligible for RE-DUAL PCI (Evaluation of Dual Therapy with Dabigatran vs. Triple Therapy with Warfarin in Patients with AF That Undergo a PCI with Stenting) if they had nonvalvular atrial fibrillation and a successful PCI within 120 hours. Those with bioprosthetic or mechanical heart valves, severe renal insufficiency, or other major comorbidities were excluded.
The trial was funded by Boehringer Ingelheim, the maker of dabigatran. Several investigators were employees. Dr. Oldgren is an adviser to Boehringer Ingelheim. Other authors reported financial ties to the company as well.
AT THE AHA SCIENTIFIC SESSIONS
Key clinical point:
Major finding: After a mean follow-up of 14 months, the incidence of major or clinically relevant nonmajor bleeding was 15.4% in the 110-mg dual-therapy group (HR, 0.52; 95% CI, 0.42-0.63, P less than .001) and 20.2% in the 150-mg dual-therapy group (HR, 0.72; 95% CI, 0.58-0.88; P less than .001), versus about 26% with triple-therapy.
Data source: Subgroup analysis of RE-DUAL PCI trial
Disclosures: The trial was funded by Boehringer Ingelheim, the maker of dabigatran. Several investigators were employees. Authors disclosed various financial ties to the company.
VA, Kaiser lauded for hypertension control
At a time when the Department of Veterans Affairs is criticized for the care it delivers, and when some also see it threatened by privatization, it was refreshing to hear the VA praised for the quality of its hypertension care, a model for success in a new era of reduced blood pressure treatment targets and revised hypertension guidelines that classify millions more Americans as having hypertension.
“In systems of care, like the VA and Kaiser Permanente Northern California, we are doing much better with hypertension control, reaching control rates greater than 90%,” Paul Whelton, MD, said in November during a talk at the American Heart Association scientific sessions in Anaheim, Calif. In a separate report at the same meeting, Dr. Whelton, a professor of public health at Tulane University in New Orleans, first presented the new hypertension diagnosis and management guidelines, produced by the American College of Cardiology/American Heart Association panel that he chaired (J Am Coll Cardiol. 2017 Nov 13. doi: 10.1016/j.jacc.2017.11.006).
He again stressed that the VA and Kaiser are doing “remarkably well” when it came to controlling hypertension in the vast majority of their patients.
That assessment seems especially appropriate for Kaiser Permanente Northern California, Oakland, Calif. Data from an audit of Kaiser’s hypertension registry showed that during 2000-2013 the percentage of patients with hypertension at their goal blood pressure rose from 44% in 2000 to 90% in 2013 (J Clin Hypertension. 2016 April;18[4]:260-1). The two Kaiser researchers who reported these findings attributed the rise in control rates to a hypertension treatment program that Kaiser Permanente Northern California put into practice starting in 2000.
Current success in the VA Health System is harder to pin down and put in the Kaiser ballpark. The most up-to-date audit I could find was a 2012 report from a team of VA researchers who reviewed control rates of more than half a million hypertensive veterans at 15 VA medical centers during 2000-2010. They found that, during that 11-year period, the percentage of hypertensive patients with their blood pressure controlled to their target level had risen from 46% in 2000 to 76% in 2010 (Circulation. 2012 May 22;125[20]:2462-68).
While this 76% rate of control in 2010 is short of the 90% rate in Kaiser in 2013, it’s still not shabby. To put the 76% control rate in perspective, consider data reported at the AHA meeting from TargetBP, a national program begun in late 2015 to aid all U.S. health care programs in improving their hypertension control rates: This data showed that, among 310 participating programs that filed 2016 control-rate data with TargetBP, the average control rate was 66%. Specifically, of those 310 reporting programs, 191 (62%) had control rates that exceeded 70%, with an average control rate among these more successful programs of 76%.
As-yet-unpublished data collected by the VA show that other centers in the system beyond those 15 included in the study discussed above have also recently reached a similar control level of about 75%, said Vasilios Papademetriou, MD, a professor of medicine at Georgetown University and the director of the Interventional Hypertension and Vascular Medicine Program at the VA Medical Center in Washington. Plus, certain VA centers are now up to an 85% control rate, he added in an interview. “Blood pressure control rates have been exceptionally good in the VA medical system,” he declared. Dr. Papademetriou attributed the rising control rates to a concerted hypertension program the VA instituted starting in the early 2000s.
“The VA has had some physicians who have championed this issue, and they have built computer-based systems to identify patients with uncontrolled hypertension, and then they plug these patients into their care algorithms,” commented Donald M. Lloyd-Jones, MD, a professor and chairman of preventive medicine at Northwestern University in Chicago. “Often, when there are champions, things change,” he noted.
William C. Cushman, MD, a hypertension specialist who is chief of preventive medicine for the VA Medical Center in Memphis and professor of preventive medicine at the University of Tennessee, also in Memphis, highlighted several steps the VA took that have helped fuel the program’s success in controlling blood pressure.
Dr. Cushman couldn’t resist adding that this successful approach to hypertension management is now threatened by potential changes to the VA system that could take some patients out of the existing program and move them to privatized medical care. “If that happens, patients will not get the same comprehensive care” that until now has produced such high rates of hypertension control, he warned.
[email protected]
On Twitter @mitchelzoler
At a time when the Department of Veterans Affairs is criticized for the care it delivers, and when some also see it threatened by privatization, it was refreshing to hear the VA praised for the quality of its hypertension care, a model for success in a new era of reduced blood pressure treatment targets and revised hypertension guidelines that classify millions more Americans as having hypertension.
“In systems of care, like the VA and Kaiser Permanente Northern California, we are doing much better with hypertension control, reaching control rates greater than 90%,” Paul Whelton, MD, said in November during a talk at the American Heart Association scientific sessions in Anaheim, Calif. In a separate report at the same meeting, Dr. Whelton, a professor of public health at Tulane University in New Orleans, first presented the new hypertension diagnosis and management guidelines, produced by the American College of Cardiology/American Heart Association panel that he chaired (J Am Coll Cardiol. 2017 Nov 13. doi: 10.1016/j.jacc.2017.11.006).
He again stressed that the VA and Kaiser are doing “remarkably well” when it came to controlling hypertension in the vast majority of their patients.
That assessment seems especially appropriate for Kaiser Permanente Northern California, Oakland, Calif. Data from an audit of Kaiser’s hypertension registry showed that during 2000-2013 the percentage of patients with hypertension at their goal blood pressure rose from 44% in 2000 to 90% in 2013 (J Clin Hypertension. 2016 April;18[4]:260-1). The two Kaiser researchers who reported these findings attributed the rise in control rates to a hypertension treatment program that Kaiser Permanente Northern California put into practice starting in 2000.
Current success in the VA Health System is harder to pin down and put in the Kaiser ballpark. The most up-to-date audit I could find was a 2012 report from a team of VA researchers who reviewed control rates of more than half a million hypertensive veterans at 15 VA medical centers during 2000-2010. They found that, during that 11-year period, the percentage of hypertensive patients with their blood pressure controlled to their target level had risen from 46% in 2000 to 76% in 2010 (Circulation. 2012 May 22;125[20]:2462-68).
While this 76% rate of control in 2010 is short of the 90% rate in Kaiser in 2013, it’s still not shabby. To put the 76% control rate in perspective, consider data reported at the AHA meeting from TargetBP, a national program begun in late 2015 to aid all U.S. health care programs in improving their hypertension control rates: This data showed that, among 310 participating programs that filed 2016 control-rate data with TargetBP, the average control rate was 66%. Specifically, of those 310 reporting programs, 191 (62%) had control rates that exceeded 70%, with an average control rate among these more successful programs of 76%.
As-yet-unpublished data collected by the VA show that other centers in the system beyond those 15 included in the study discussed above have also recently reached a similar control level of about 75%, said Vasilios Papademetriou, MD, a professor of medicine at Georgetown University and the director of the Interventional Hypertension and Vascular Medicine Program at the VA Medical Center in Washington. Plus, certain VA centers are now up to an 85% control rate, he added in an interview. “Blood pressure control rates have been exceptionally good in the VA medical system,” he declared. Dr. Papademetriou attributed the rising control rates to a concerted hypertension program the VA instituted starting in the early 2000s.
“The VA has had some physicians who have championed this issue, and they have built computer-based systems to identify patients with uncontrolled hypertension, and then they plug these patients into their care algorithms,” commented Donald M. Lloyd-Jones, MD, a professor and chairman of preventive medicine at Northwestern University in Chicago. “Often, when there are champions, things change,” he noted.
William C. Cushman, MD, a hypertension specialist who is chief of preventive medicine for the VA Medical Center in Memphis and professor of preventive medicine at the University of Tennessee, also in Memphis, highlighted several steps the VA took that have helped fuel the program’s success in controlling blood pressure.
Dr. Cushman couldn’t resist adding that this successful approach to hypertension management is now threatened by potential changes to the VA system that could take some patients out of the existing program and move them to privatized medical care. “If that happens, patients will not get the same comprehensive care” that until now has produced such high rates of hypertension control, he warned.
[email protected]
On Twitter @mitchelzoler
At a time when the Department of Veterans Affairs is criticized for the care it delivers, and when some also see it threatened by privatization, it was refreshing to hear the VA praised for the quality of its hypertension care, a model for success in a new era of reduced blood pressure treatment targets and revised hypertension guidelines that classify millions more Americans as having hypertension.
“In systems of care, like the VA and Kaiser Permanente Northern California, we are doing much better with hypertension control, reaching control rates greater than 90%,” Paul Whelton, MD, said in November during a talk at the American Heart Association scientific sessions in Anaheim, Calif. In a separate report at the same meeting, Dr. Whelton, a professor of public health at Tulane University in New Orleans, first presented the new hypertension diagnosis and management guidelines, produced by the American College of Cardiology/American Heart Association panel that he chaired (J Am Coll Cardiol. 2017 Nov 13. doi: 10.1016/j.jacc.2017.11.006).
He again stressed that the VA and Kaiser are doing “remarkably well” when it came to controlling hypertension in the vast majority of their patients.
That assessment seems especially appropriate for Kaiser Permanente Northern California, Oakland, Calif. Data from an audit of Kaiser’s hypertension registry showed that during 2000-2013 the percentage of patients with hypertension at their goal blood pressure rose from 44% in 2000 to 90% in 2013 (J Clin Hypertension. 2016 April;18[4]:260-1). The two Kaiser researchers who reported these findings attributed the rise in control rates to a hypertension treatment program that Kaiser Permanente Northern California put into practice starting in 2000.
Current success in the VA Health System is harder to pin down and put in the Kaiser ballpark. The most up-to-date audit I could find was a 2012 report from a team of VA researchers who reviewed control rates of more than half a million hypertensive veterans at 15 VA medical centers during 2000-2010. They found that, during that 11-year period, the percentage of hypertensive patients with their blood pressure controlled to their target level had risen from 46% in 2000 to 76% in 2010 (Circulation. 2012 May 22;125[20]:2462-68).
While this 76% rate of control in 2010 is short of the 90% rate in Kaiser in 2013, it’s still not shabby. To put the 76% control rate in perspective, consider data reported at the AHA meeting from TargetBP, a national program begun in late 2015 to aid all U.S. health care programs in improving their hypertension control rates: This data showed that, among 310 participating programs that filed 2016 control-rate data with TargetBP, the average control rate was 66%. Specifically, of those 310 reporting programs, 191 (62%) had control rates that exceeded 70%, with an average control rate among these more successful programs of 76%.
As-yet-unpublished data collected by the VA show that other centers in the system beyond those 15 included in the study discussed above have also recently reached a similar control level of about 75%, said Vasilios Papademetriou, MD, a professor of medicine at Georgetown University and the director of the Interventional Hypertension and Vascular Medicine Program at the VA Medical Center in Washington. Plus, certain VA centers are now up to an 85% control rate, he added in an interview. “Blood pressure control rates have been exceptionally good in the VA medical system,” he declared. Dr. Papademetriou attributed the rising control rates to a concerted hypertension program the VA instituted starting in the early 2000s.
“The VA has had some physicians who have championed this issue, and they have built computer-based systems to identify patients with uncontrolled hypertension, and then they plug these patients into their care algorithms,” commented Donald M. Lloyd-Jones, MD, a professor and chairman of preventive medicine at Northwestern University in Chicago. “Often, when there are champions, things change,” he noted.
William C. Cushman, MD, a hypertension specialist who is chief of preventive medicine for the VA Medical Center in Memphis and professor of preventive medicine at the University of Tennessee, also in Memphis, highlighted several steps the VA took that have helped fuel the program’s success in controlling blood pressure.
Dr. Cushman couldn’t resist adding that this successful approach to hypertension management is now threatened by potential changes to the VA system that could take some patients out of the existing program and move them to privatized medical care. “If that happens, patients will not get the same comprehensive care” that until now has produced such high rates of hypertension control, he warned.
[email protected]
On Twitter @mitchelzoler
VIDEO: Team approach boosts effective blood pressure control
ANAHEIM, CALIF. – Using a multidisciplinary team of clinicians “could be one of the most effective measures we have to improve blood pressure control,” Tracy Y. Wang, MD, said in a video interview during the American Heart Association scientific sessions.
Speaking a day after the release of revised guidelines for the prevention, detection, evaluation, and management of high blood pressure in adults (J Am Coll Cardiol. 2017 Nov 13;doi: 10.1016/j.jacc.2017.11.006), Dr. Wang particularly highlighted the strong recommendation the guidelines made for a team-based approach for managing hypertension.
“I’m absolutely ecstatic that team management is embedded firmly in the new guidelines,” commented Dr. Wang, a cardiologist at Duke University in Durham, N.C. who has studied methods to optimize evidence-based treatment of cardiovascular diseases. “Endorsement of a team approach for blood pressure control was long overdue,” she said.
Dr. Wang discussed some approaches she believes would help better integrate team-based care into the routine management of patients with hypertension.
Dr. Wang has received honoraria from AstraZeneca, Eli Lilly, and Premier, and she has received research funding from several companies.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @mitchelzoler
ANAHEIM, CALIF. – Using a multidisciplinary team of clinicians “could be one of the most effective measures we have to improve blood pressure control,” Tracy Y. Wang, MD, said in a video interview during the American Heart Association scientific sessions.
Speaking a day after the release of revised guidelines for the prevention, detection, evaluation, and management of high blood pressure in adults (J Am Coll Cardiol. 2017 Nov 13;doi: 10.1016/j.jacc.2017.11.006), Dr. Wang particularly highlighted the strong recommendation the guidelines made for a team-based approach for managing hypertension.
“I’m absolutely ecstatic that team management is embedded firmly in the new guidelines,” commented Dr. Wang, a cardiologist at Duke University in Durham, N.C. who has studied methods to optimize evidence-based treatment of cardiovascular diseases. “Endorsement of a team approach for blood pressure control was long overdue,” she said.
Dr. Wang discussed some approaches she believes would help better integrate team-based care into the routine management of patients with hypertension.
Dr. Wang has received honoraria from AstraZeneca, Eli Lilly, and Premier, and she has received research funding from several companies.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @mitchelzoler
ANAHEIM, CALIF. – Using a multidisciplinary team of clinicians “could be one of the most effective measures we have to improve blood pressure control,” Tracy Y. Wang, MD, said in a video interview during the American Heart Association scientific sessions.
Speaking a day after the release of revised guidelines for the prevention, detection, evaluation, and management of high blood pressure in adults (J Am Coll Cardiol. 2017 Nov 13;doi: 10.1016/j.jacc.2017.11.006), Dr. Wang particularly highlighted the strong recommendation the guidelines made for a team-based approach for managing hypertension.
“I’m absolutely ecstatic that team management is embedded firmly in the new guidelines,” commented Dr. Wang, a cardiologist at Duke University in Durham, N.C. who has studied methods to optimize evidence-based treatment of cardiovascular diseases. “Endorsement of a team approach for blood pressure control was long overdue,” she said.
Dr. Wang discussed some approaches she believes would help better integrate team-based care into the routine management of patients with hypertension.
Dr. Wang has received honoraria from AstraZeneca, Eli Lilly, and Premier, and she has received research funding from several companies.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
[email protected]
On Twitter @mitchelzoler
EXPERT ANALYSIS FROM THE AHA SCIENTIFIC SESSIONS
Empagliflozin’s heart failure benefits linked to volume drop
ANAHEIM, CALIF. – When results from the EMPA-REG OUTCOME trial came out 2 years ago and showed a dramatic decrease in heart failure hospitalizations and deaths linked to treatment with the oral diabetes drug empagliflozin, some experts suggested that a completely hypothetical effect of empagliflozin on reducing fluid volume may have largely caused these unexpected clinical benefits.
New analyses of the trial results show this hypothesis may be at least partially correct.
Results from a post hoc analysis of data collected in Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME) suggest that perhaps half the heart failure benefit was attributable to what appears to have been a roughly 7% drop in plasma volume in patients treated with empagliflozin (Jardiance), which began soon after treatment started and continued through the balance of the study, David Fitchett, MD, said at the American Heart Association scientific sessions.
“Markers of change in plasma volume were important mediators of the reduction in risk of hospitalization for heart failure or death from heart failure,” said Dr Fitchett, a cardiologist at St. Michael’s Hospital in Toronto and a coinvestigator of EMPA-REG OUTCOME (N Engl J Med. 2015 Nov 26;373[22]:2117-28).
The analysis also showed that a “modest” effect from a reduction in uric acid might explain about 20%-25% of the observed heart failure benefit, he reported. In contrast, none of the traditional cardiovascular disease risk factors examined in the analysis – including lipids, blood pressure, obesity, and hemoglobin A1c – appeared to have any relationship to the heart failure effects of empagliflozin.
Dr. Fitchett and his associates assessed the possible impact of a list of potential mediators with a statistical method that performed an unadjusted, univariate analysis of the time-dependent change in each of several variables relative to the observed changes in heart failure outcomes.
This analysis showed that on-treatment changes in two markers of plasma volume, hematocrit and hemoglobin, each showed changes that appeared to mediate about half of the heart failure effects. A third marker of plasma volume, albumin level, appeared to mediate about a quarter of the heart failure effects.
The changes in both hematocrit and hemoglobin first appeared within a few weeks of treatment onset, and soon reached a plateau that remained sustained through the balance of the study. For example, during the first 12 weeks of treatment, the average hematocrit level rose from about 41% at baseline to about 44%. This 3% net rise corresponds to about a 7% drop in plasma volume, Dr. Fitchett said.
In addition to reflecting a potentially beneficial decrease in fluid volume, this effect would also boost the oxygen-carrying capacity of a patient’s blood that could be beneficial for patients with ischemic heart disease and those with reduced left ventricular function, he noted.
The EMPA-REG OUTCOME trial was sponsored by Boehringer Ingelheim and Eli Lilly, which jointly market empagliflozin (Jardiance). Dr. Fitchett has received honoraria from those companies and also from Amgen, AstraZeneca, Merck, and Sanofi.
[email protected]
On Twitter @mitchelzoler
ANAHEIM, CALIF. – When results from the EMPA-REG OUTCOME trial came out 2 years ago and showed a dramatic decrease in heart failure hospitalizations and deaths linked to treatment with the oral diabetes drug empagliflozin, some experts suggested that a completely hypothetical effect of empagliflozin on reducing fluid volume may have largely caused these unexpected clinical benefits.
New analyses of the trial results show this hypothesis may be at least partially correct.
Results from a post hoc analysis of data collected in Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME) suggest that perhaps half the heart failure benefit was attributable to what appears to have been a roughly 7% drop in plasma volume in patients treated with empagliflozin (Jardiance), which began soon after treatment started and continued through the balance of the study, David Fitchett, MD, said at the American Heart Association scientific sessions.
“Markers of change in plasma volume were important mediators of the reduction in risk of hospitalization for heart failure or death from heart failure,” said Dr Fitchett, a cardiologist at St. Michael’s Hospital in Toronto and a coinvestigator of EMPA-REG OUTCOME (N Engl J Med. 2015 Nov 26;373[22]:2117-28).
The analysis also showed that a “modest” effect from a reduction in uric acid might explain about 20%-25% of the observed heart failure benefit, he reported. In contrast, none of the traditional cardiovascular disease risk factors examined in the analysis – including lipids, blood pressure, obesity, and hemoglobin A1c – appeared to have any relationship to the heart failure effects of empagliflozin.
Dr. Fitchett and his associates assessed the possible impact of a list of potential mediators with a statistical method that performed an unadjusted, univariate analysis of the time-dependent change in each of several variables relative to the observed changes in heart failure outcomes.
This analysis showed that on-treatment changes in two markers of plasma volume, hematocrit and hemoglobin, each showed changes that appeared to mediate about half of the heart failure effects. A third marker of plasma volume, albumin level, appeared to mediate about a quarter of the heart failure effects.
The changes in both hematocrit and hemoglobin first appeared within a few weeks of treatment onset, and soon reached a plateau that remained sustained through the balance of the study. For example, during the first 12 weeks of treatment, the average hematocrit level rose from about 41% at baseline to about 44%. This 3% net rise corresponds to about a 7% drop in plasma volume, Dr. Fitchett said.
In addition to reflecting a potentially beneficial decrease in fluid volume, this effect would also boost the oxygen-carrying capacity of a patient’s blood that could be beneficial for patients with ischemic heart disease and those with reduced left ventricular function, he noted.
The EMPA-REG OUTCOME trial was sponsored by Boehringer Ingelheim and Eli Lilly, which jointly market empagliflozin (Jardiance). Dr. Fitchett has received honoraria from those companies and also from Amgen, AstraZeneca, Merck, and Sanofi.
[email protected]
On Twitter @mitchelzoler
ANAHEIM, CALIF. – When results from the EMPA-REG OUTCOME trial came out 2 years ago and showed a dramatic decrease in heart failure hospitalizations and deaths linked to treatment with the oral diabetes drug empagliflozin, some experts suggested that a completely hypothetical effect of empagliflozin on reducing fluid volume may have largely caused these unexpected clinical benefits.
New analyses of the trial results show this hypothesis may be at least partially correct.
Results from a post hoc analysis of data collected in Empagliflozin Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME) suggest that perhaps half the heart failure benefit was attributable to what appears to have been a roughly 7% drop in plasma volume in patients treated with empagliflozin (Jardiance), which began soon after treatment started and continued through the balance of the study, David Fitchett, MD, said at the American Heart Association scientific sessions.
“Markers of change in plasma volume were important mediators of the reduction in risk of hospitalization for heart failure or death from heart failure,” said Dr Fitchett, a cardiologist at St. Michael’s Hospital in Toronto and a coinvestigator of EMPA-REG OUTCOME (N Engl J Med. 2015 Nov 26;373[22]:2117-28).
The analysis also showed that a “modest” effect from a reduction in uric acid might explain about 20%-25% of the observed heart failure benefit, he reported. In contrast, none of the traditional cardiovascular disease risk factors examined in the analysis – including lipids, blood pressure, obesity, and hemoglobin A1c – appeared to have any relationship to the heart failure effects of empagliflozin.
Dr. Fitchett and his associates assessed the possible impact of a list of potential mediators with a statistical method that performed an unadjusted, univariate analysis of the time-dependent change in each of several variables relative to the observed changes in heart failure outcomes.
This analysis showed that on-treatment changes in two markers of plasma volume, hematocrit and hemoglobin, each showed changes that appeared to mediate about half of the heart failure effects. A third marker of plasma volume, albumin level, appeared to mediate about a quarter of the heart failure effects.
The changes in both hematocrit and hemoglobin first appeared within a few weeks of treatment onset, and soon reached a plateau that remained sustained through the balance of the study. For example, during the first 12 weeks of treatment, the average hematocrit level rose from about 41% at baseline to about 44%. This 3% net rise corresponds to about a 7% drop in plasma volume, Dr. Fitchett said.
In addition to reflecting a potentially beneficial decrease in fluid volume, this effect would also boost the oxygen-carrying capacity of a patient’s blood that could be beneficial for patients with ischemic heart disease and those with reduced left ventricular function, he noted.
The EMPA-REG OUTCOME trial was sponsored by Boehringer Ingelheim and Eli Lilly, which jointly market empagliflozin (Jardiance). Dr. Fitchett has received honoraria from those companies and also from Amgen, AstraZeneca, Merck, and Sanofi.
[email protected]
On Twitter @mitchelzoler
AT THE AHA SCIENTIFIC SESSIONS
Key clinical point: About according to post hoc analysis of the EMPA-REG OUTCOME study.
Major finding: About half of the observed heart failure benefit was tied to a roughly 3% rise in average hematocrit level.
Data source: Post hoc analysis of data from the 7,028 patients enrolled in the EMPA-REG OUTCOME trial.
Disclosures: The EMPA-REG OUTCOME trial was sponsored by Boehringer Ingelheim and Eli Lilly, the two companies that market empagliflozin (Jardiance). Dr. Fitchett has received honoraria from those companies and also from Amgen, AstraZeneca, Merck, and Sanofi.
Aim for BP a bit above SPRINT
ANAHEIM – If blood pressure isn’t measured the way it was in the SPRINT trial, it shouldn’t be treated all the way down to the SPRINT target of less than 120 mm Hg; it’s best to aim a little higher, according to investigators from Kaiser Permanente of Northern California.
SPRINT (the Systolic Blood Pressure Intervention Trial) found that treating hypertension to below 120 mm Hg – as opposed to below 140 mm Hg – reduced the risk of cardiovascular events and death, but blood pressure wasn’t measured the way it usually is in standard practice. Among other differences, SPRINT subjects rested for 5 minutes beforehand, sometimes unobserved, and then three automated measurements were taken and averaged (N Engl J Med. 2015 Nov 26;373[22]:2103-16).
In a review of 73,522 hypertensive patients, the Kaiser investigators found that those treated to a mean systolic BP (SBP) of 122 mm Hg – based on standard office measurement – actually had worse outcomes than did those treated to a mean of 132 mm Hg, with a greater incidence of cardiovascular events, hypotension, electrolyte abnormalities, and other problems.
“The way SPRINT measured BP was systematically different than the BPs we rely on to treat patients in clinical practice. We think that, unless you are going to implement a SPRINT-like protocol, aiming for a slightly higher target of around a mean of 130-132 mm Hg will achieve optimal outcomes. You are likely achieving a SPRINT BP of around 120-125 mm Hg,” said Alan Go, MD, director of the comprehensive clinical research unit at Kaiser Permanente of Northern California, Oakland.
Meanwhile, “if you [treat] to 120 mm Hg, you are probably getting around a SPRINT 114 mm Hg. That runs the risk of hypotension, which we did see. There is also the potential for coronary ischemia because you are no longer providing adequate coronary perfusion,” he said at the American Heart Association scientific sessions.
In their “SPRINT to translation” study, Dr. Go and his team reviewed Kaiser’s electronic medical records to identify patients with baseline BPs of 130-180 mm Hg who met SPRINT criteria and then evaluated how they fared over about 6 years of blood pressure management, with at least one BP taken every 6 months; 7,213 patients were treated to an SBP of 140-149 mm Hg and a mean of 143 mm Hg; 44,847 were treated to an SBP of 126-139 mm Hg and a mean of 132 mm Hg; and 21,462 were treated to 115-125 mm Hg and a mean of 122 mm Hg.
After extensive adjustment for potential confounders, patients treated to 140-149 mm Hg, versus those treated to 126-139 mm Hg, had a 70% increased risk of the composite outcome of acute MI, unstable angina, heart failure, stroke, and cardiovascular death, and a 28% increased risk of all-cause mortality. They also had an increased risk of acute kidney injury, electrolyte abnormalities, and other problems.
More surprisingly, patients treated to 115-125 mm Hg, again versus those treated to 126-139 mm Hg, also had an increased risk of the composite outcome of 9%. They had lower rates of MI and ischemic stroke, but higher rates of heart failure and cardiovascular death. There was also a 17% increased risk of acute kidney injury and a 51% increased risk of hypotension requiring ED or hospital treatment, as well as more electrolyte abnormalities.
The 115-125 mm Hg group also had a 48% increased risk of all-cause mortality. The magnitude of the increase suggests that low blood pressure was a secondary effect of terminal illness in some cases, but Dr. Go didn’t think that was the entire explanation.
The participants had a mean age of 70 years; 63% were women and 75% were white. As in SPRINT, patients with baseline heart failure, stroke, systolic dysfunction, diabetes, end-stage renal disease, and cancer were among those excluded.
There was no external funding for the work, and the investigators didn’t have any disclosures.
ANAHEIM – If blood pressure isn’t measured the way it was in the SPRINT trial, it shouldn’t be treated all the way down to the SPRINT target of less than 120 mm Hg; it’s best to aim a little higher, according to investigators from Kaiser Permanente of Northern California.
SPRINT (the Systolic Blood Pressure Intervention Trial) found that treating hypertension to below 120 mm Hg – as opposed to below 140 mm Hg – reduced the risk of cardiovascular events and death, but blood pressure wasn’t measured the way it usually is in standard practice. Among other differences, SPRINT subjects rested for 5 minutes beforehand, sometimes unobserved, and then three automated measurements were taken and averaged (N Engl J Med. 2015 Nov 26;373[22]:2103-16).
In a review of 73,522 hypertensive patients, the Kaiser investigators found that those treated to a mean systolic BP (SBP) of 122 mm Hg – based on standard office measurement – actually had worse outcomes than did those treated to a mean of 132 mm Hg, with a greater incidence of cardiovascular events, hypotension, electrolyte abnormalities, and other problems.
“The way SPRINT measured BP was systematically different than the BPs we rely on to treat patients in clinical practice. We think that, unless you are going to implement a SPRINT-like protocol, aiming for a slightly higher target of around a mean of 130-132 mm Hg will achieve optimal outcomes. You are likely achieving a SPRINT BP of around 120-125 mm Hg,” said Alan Go, MD, director of the comprehensive clinical research unit at Kaiser Permanente of Northern California, Oakland.
Meanwhile, “if you [treat] to 120 mm Hg, you are probably getting around a SPRINT 114 mm Hg. That runs the risk of hypotension, which we did see. There is also the potential for coronary ischemia because you are no longer providing adequate coronary perfusion,” he said at the American Heart Association scientific sessions.
In their “SPRINT to translation” study, Dr. Go and his team reviewed Kaiser’s electronic medical records to identify patients with baseline BPs of 130-180 mm Hg who met SPRINT criteria and then evaluated how they fared over about 6 years of blood pressure management, with at least one BP taken every 6 months; 7,213 patients were treated to an SBP of 140-149 mm Hg and a mean of 143 mm Hg; 44,847 were treated to an SBP of 126-139 mm Hg and a mean of 132 mm Hg; and 21,462 were treated to 115-125 mm Hg and a mean of 122 mm Hg.
After extensive adjustment for potential confounders, patients treated to 140-149 mm Hg, versus those treated to 126-139 mm Hg, had a 70% increased risk of the composite outcome of acute MI, unstable angina, heart failure, stroke, and cardiovascular death, and a 28% increased risk of all-cause mortality. They also had an increased risk of acute kidney injury, electrolyte abnormalities, and other problems.
More surprisingly, patients treated to 115-125 mm Hg, again versus those treated to 126-139 mm Hg, also had an increased risk of the composite outcome of 9%. They had lower rates of MI and ischemic stroke, but higher rates of heart failure and cardiovascular death. There was also a 17% increased risk of acute kidney injury and a 51% increased risk of hypotension requiring ED or hospital treatment, as well as more electrolyte abnormalities.
The 115-125 mm Hg group also had a 48% increased risk of all-cause mortality. The magnitude of the increase suggests that low blood pressure was a secondary effect of terminal illness in some cases, but Dr. Go didn’t think that was the entire explanation.
The participants had a mean age of 70 years; 63% were women and 75% were white. As in SPRINT, patients with baseline heart failure, stroke, systolic dysfunction, diabetes, end-stage renal disease, and cancer were among those excluded.
There was no external funding for the work, and the investigators didn’t have any disclosures.
ANAHEIM – If blood pressure isn’t measured the way it was in the SPRINT trial, it shouldn’t be treated all the way down to the SPRINT target of less than 120 mm Hg; it’s best to aim a little higher, according to investigators from Kaiser Permanente of Northern California.
SPRINT (the Systolic Blood Pressure Intervention Trial) found that treating hypertension to below 120 mm Hg – as opposed to below 140 mm Hg – reduced the risk of cardiovascular events and death, but blood pressure wasn’t measured the way it usually is in standard practice. Among other differences, SPRINT subjects rested for 5 minutes beforehand, sometimes unobserved, and then three automated measurements were taken and averaged (N Engl J Med. 2015 Nov 26;373[22]:2103-16).
In a review of 73,522 hypertensive patients, the Kaiser investigators found that those treated to a mean systolic BP (SBP) of 122 mm Hg – based on standard office measurement – actually had worse outcomes than did those treated to a mean of 132 mm Hg, with a greater incidence of cardiovascular events, hypotension, electrolyte abnormalities, and other problems.
“The way SPRINT measured BP was systematically different than the BPs we rely on to treat patients in clinical practice. We think that, unless you are going to implement a SPRINT-like protocol, aiming for a slightly higher target of around a mean of 130-132 mm Hg will achieve optimal outcomes. You are likely achieving a SPRINT BP of around 120-125 mm Hg,” said Alan Go, MD, director of the comprehensive clinical research unit at Kaiser Permanente of Northern California, Oakland.
Meanwhile, “if you [treat] to 120 mm Hg, you are probably getting around a SPRINT 114 mm Hg. That runs the risk of hypotension, which we did see. There is also the potential for coronary ischemia because you are no longer providing adequate coronary perfusion,” he said at the American Heart Association scientific sessions.
In their “SPRINT to translation” study, Dr. Go and his team reviewed Kaiser’s electronic medical records to identify patients with baseline BPs of 130-180 mm Hg who met SPRINT criteria and then evaluated how they fared over about 6 years of blood pressure management, with at least one BP taken every 6 months; 7,213 patients were treated to an SBP of 140-149 mm Hg and a mean of 143 mm Hg; 44,847 were treated to an SBP of 126-139 mm Hg and a mean of 132 mm Hg; and 21,462 were treated to 115-125 mm Hg and a mean of 122 mm Hg.
After extensive adjustment for potential confounders, patients treated to 140-149 mm Hg, versus those treated to 126-139 mm Hg, had a 70% increased risk of the composite outcome of acute MI, unstable angina, heart failure, stroke, and cardiovascular death, and a 28% increased risk of all-cause mortality. They also had an increased risk of acute kidney injury, electrolyte abnormalities, and other problems.
More surprisingly, patients treated to 115-125 mm Hg, again versus those treated to 126-139 mm Hg, also had an increased risk of the composite outcome of 9%. They had lower rates of MI and ischemic stroke, but higher rates of heart failure and cardiovascular death. There was also a 17% increased risk of acute kidney injury and a 51% increased risk of hypotension requiring ED or hospital treatment, as well as more electrolyte abnormalities.
The 115-125 mm Hg group also had a 48% increased risk of all-cause mortality. The magnitude of the increase suggests that low blood pressure was a secondary effect of terminal illness in some cases, but Dr. Go didn’t think that was the entire explanation.
The participants had a mean age of 70 years; 63% were women and 75% were white. As in SPRINT, patients with baseline heart failure, stroke, systolic dysfunction, diabetes, end-stage renal disease, and cancer were among those excluded.
There was no external funding for the work, and the investigators didn’t have any disclosures.
AT THE AHA SCIENTIFIC SESSIONS
Key clinical point:
Major finding: Cardiovascular events were 9% more likely in patients treated to 115-125 mm Hg vs. those treated to 126-139 mm Hg.
Data source: Review of 73,522 hypertensive patients at Kaiser Permanente of Northern California
Disclosures: There was no external funding for the work, and the investigators had no disclosures.
Observing BP measurement made no difference in SPRINT
ANAHEIM, CALIF. – More than half of the BP measurements of patients in the SPRINT trial were at least partially attended by clinic staff, but those efforts made no difference in outcomes, according to a survey presented by SPRINT investigators at the American Heart Association scientific sessions.
“It really didn’t matter” whether measurements were observed or not; blood pressure control and outcomes – fewer deaths and cardiovascular events when hypertension was treated to below 120 mm Hg instead of below 140 mm Hg – were largely the same either way, said the survey’s lead investigator Karen C. Johnson, MD, professor of women’s health and preventive medicine at the University of Tennessee in Memphis. 
What did matter were the other measures SPRINT [Systolic Blood Pressure Intervention Trial] took to ensure accurate blood pressure measurement, including patients resting for 5 minutes; three automated readings taken afterward then averaged; proper cuff size; feet flat on the floor while patients sat; arms at proper level, and no talking, texting, or filling out forms during the reading, Dr. Johnson said (N Engl J Med. 2015 Nov 26;373[22]:2103-16).
“If you do [those things], then it doesn’t matter if somebody is in the room or not; you can treat to the levels we are talking about,” said William Cushman, MD, professor of medicine and physiology at the university, and also a SPRINT investigator. 
Although the SPRINT researchers hadn’t addressed the issue before the AHA meeting, it’s been widely thought, and even reported in some places, that blood pressures in the trial were unattended. The misperception has led to anxiety about how to apply SPRINT to everyday practice, since few clinics are set up to have patients sit alone for 5 or 10 minutes for a blood pressure.
To address the concern, the SPRINT team surveyed study sites after the trial ended. It turned out that 4,082 subjects were at sites where patients were usually left alone for both the 5-minute rest period and the three BP readings, and 2,247 were at sites where staff usually attended both; 1,746 were at sites that left patients alone for the rest period only; and 570 were at sites where patients were alone only for the BP readings.
Observation had no impact on blood pressure. In the intensive arm, participants achieved and maintained an average systolic BP of about 120 mm Hg in all four groups. In the standard treatment arm, that average was about 135 mm Hg in all four groups. “When we look at the number of medications used, they were very similar in all four blood pressure groups,” with intensive treatment patients taking an average of one extra drug, Dr. Johnson said.
Intensive treatment, versus standard treatment, reduced cardiovascular events to a similar extent in patients who were alone for the entire blood pressure reading (by 38%) and those who were accompanied throughout (by 36%). For reasons that are not clear, intensive treatment did not significantly reduce risk among subjects who were observed during rest or observed for blood pressure readings. Both groups had lower Framingham 10-year cardiovascular disease risk scores, which may have been a confounder.
Meanwhile, the rate of adverse events and total mortality – lower with intensive treatment – did not vary by observation, Dr. Johnson said.
The survey excluded 716 subjects at 14 study sites who could not be classified into one of the four BP observation categories.
SPRINT was sponsored by the National Institutes of Health. Doctors Johnson and Cushman didn’t have any disclosures.
ANAHEIM, CALIF. – More than half of the BP measurements of patients in the SPRINT trial were at least partially attended by clinic staff, but those efforts made no difference in outcomes, according to a survey presented by SPRINT investigators at the American Heart Association scientific sessions.
“It really didn’t matter” whether measurements were observed or not; blood pressure control and outcomes – fewer deaths and cardiovascular events when hypertension was treated to below 120 mm Hg instead of below 140 mm Hg – were largely the same either way, said the survey’s lead investigator Karen C. Johnson, MD, professor of women’s health and preventive medicine at the University of Tennessee in Memphis.
What did matter were the other measures SPRINT [Systolic Blood Pressure Intervention Trial] took to ensure accurate blood pressure measurement, including patients resting for 5 minutes; three automated readings taken afterward then averaged; proper cuff size; feet flat on the floor while patients sat; arms at proper level, and no talking, texting, or filling out forms during the reading, Dr. Johnson said (N Engl J Med. 2015 Nov 26;373[22]:2103-16).
“If you do [those things], then it doesn’t matter if somebody is in the room or not; you can treat to the levels we are talking about,” said William Cushman, MD, professor of medicine and physiology at the university, and also a SPRINT investigator.
Although the SPRINT researchers hadn’t addressed the issue before the AHA meeting, it’s been widely thought, and even reported in some places, that blood pressures in the trial were unattended. The misperception has led to anxiety about how to apply SPRINT to everyday practice, since few clinics are set up to have patients sit alone for 5 or 10 minutes for a blood pressure.
To address the concern, the SPRINT team surveyed study sites after the trial ended. It turned out that 4,082 subjects were at sites where patients were usually left alone for both the 5-minute rest period and the three BP readings, and 2,247 were at sites where staff usually attended both; 1,746 were at sites that left patients alone for the rest period only; and 570 were at sites where patients were alone only for the BP readings.
Observation had no impact on blood pressure. In the intensive arm, participants achieved and maintained an average systolic BP of about 120 mm Hg in all four groups. In the standard treatment arm, that average was about 135 mm Hg in all four groups. “When we look at the number of medications used, they were very similar in all four blood pressure groups,” with intensive treatment patients taking an average of one extra drug, Dr. Johnson said.
Intensive treatment, versus standard treatment, reduced cardiovascular events to a similar extent in patients who were alone for the entire blood pressure reading (by 38%) and those who were accompanied throughout (by 36%). For reasons that are not clear, intensive treatment did not significantly reduce risk among subjects who were observed during rest or observed for blood pressure readings. Both groups had lower Framingham 10-year cardiovascular disease risk scores, which may have been a confounder.
Meanwhile, the rate of adverse events and total mortality – lower with intensive treatment – did not vary by observation, Dr. Johnson said.
The survey excluded 716 subjects at 14 study sites who could not be classified into one of the four BP observation categories.
SPRINT was sponsored by the National Institutes of Health. Doctors Johnson and Cushman didn’t have any disclosures.
ANAHEIM, CALIF. – More than half of the BP measurements of patients in the SPRINT trial were at least partially attended by clinic staff, but those efforts made no difference in outcomes, according to a survey presented by SPRINT investigators at the American Heart Association scientific sessions.
“It really didn’t matter” whether measurements were observed or not; blood pressure control and outcomes – fewer deaths and cardiovascular events when hypertension was treated to below 120 mm Hg instead of below 140 mm Hg – were largely the same either way, said the survey’s lead investigator Karen C. Johnson, MD, professor of women’s health and preventive medicine at the University of Tennessee in Memphis.
What did matter were the other measures SPRINT [Systolic Blood Pressure Intervention Trial] took to ensure accurate blood pressure measurement, including patients resting for 5 minutes; three automated readings taken afterward then averaged; proper cuff size; feet flat on the floor while patients sat; arms at proper level, and no talking, texting, or filling out forms during the reading, Dr. Johnson said (N Engl J Med. 2015 Nov 26;373[22]:2103-16).
“If you do [those things], then it doesn’t matter if somebody is in the room or not; you can treat to the levels we are talking about,” said William Cushman, MD, professor of medicine and physiology at the university, and also a SPRINT investigator.
Although the SPRINT researchers hadn’t addressed the issue before the AHA meeting, it’s been widely thought, and even reported in some places, that blood pressures in the trial were unattended. The misperception has led to anxiety about how to apply SPRINT to everyday practice, since few clinics are set up to have patients sit alone for 5 or 10 minutes for a blood pressure.
To address the concern, the SPRINT team surveyed study sites after the trial ended. It turned out that 4,082 subjects were at sites where patients were usually left alone for both the 5-minute rest period and the three BP readings, and 2,247 were at sites where staff usually attended both; 1,746 were at sites that left patients alone for the rest period only; and 570 were at sites where patients were alone only for the BP readings.
Observation had no impact on blood pressure. In the intensive arm, participants achieved and maintained an average systolic BP of about 120 mm Hg in all four groups. In the standard treatment arm, that average was about 135 mm Hg in all four groups. “When we look at the number of medications used, they were very similar in all four blood pressure groups,” with intensive treatment patients taking an average of one extra drug, Dr. Johnson said.
Intensive treatment, versus standard treatment, reduced cardiovascular events to a similar extent in patients who were alone for the entire blood pressure reading (by 38%) and those who were accompanied throughout (by 36%). For reasons that are not clear, intensive treatment did not significantly reduce risk among subjects who were observed during rest or observed for blood pressure readings. Both groups had lower Framingham 10-year cardiovascular disease risk scores, which may have been a confounder.
Meanwhile, the rate of adverse events and total mortality – lower with intensive treatment – did not vary by observation, Dr. Johnson said.
The survey excluded 716 subjects at 14 study sites who could not be classified into one of the four BP observation categories.
SPRINT was sponsored by the National Institutes of Health. Doctors Johnson and Cushman didn’t have any disclosures.
AT THE AHA SCIENTIFIC SESSIONS
Key clinical point:
Major finding: Blood pressure and CV event reductions were similar in the 4,082 subjects at sites where patients were usually left alone for both the 5-minute rest period and the three BP readings, the 2,247 patients at sites where staff usually attended both, the 1,746 at sites that left patients alone for the rest period only, and the 570 at sites where patients were alone only for the BP readings.
Data source: A survey of SPRINT study sites.
Disclosures: SPRINT was sponsored by the National Institutes of Health. The presenter had no disclosures.
VIDEO: Canakinumab’s cardiovascular benefits linked with hsCRP cuts
ANAHEIM, CALIF. – Targeting the anti-inflammatory drug canakinumab to cardiovascular disease patients with a robust response to a single dose may be an effective way to enhance the cost benefit of this novel treatment that is effective but also expensive.
A post hoc analysis of data collected in the ground-breaking CANTOS trial showed that among patients with a robust anti-inflammatory response to their first dose of canakinumab, the 4-year rate of major adverse cardiovascular events fell by 25% compared with patients who received placebo, a much higher relative risk reduction compared with all canakinumab recipients in the study. In this responsive subgroup, which constituted 55% of all patients assessed after their first dose, canakinumab also cut both cardiovascular death and all-cause death by 31% each relative to placebo, statistically significant reductions that had not been seen in the trial’s primary analysis that included all drug recipients, Paul M. Ridker, MD, said at the American Heart Association scientific sessions.
“The current analysis suggests that the magnitude of hsCRP [high sensitivity C-reactive protein] reduction following a single dose of canakinumab may provide a simple clinical method to identify individuals most likely to accrue the largest cardiovascular and cancer benefits from continued treatment.” The findings have importance “for patient selection, cost-effectiveness, and personalized medicine” as researchers and clinicians begin using anti-inflammatory drugs such as canakinumab to treat cardiovascular disease patients, said Dr. Ridker, professor of medicine at Harvard Medical School and director of the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital, both in Boston.
“The magnitude of the hsCRP reduction” after the first dose “is telling us who benefits most,” Dr. Ridker said in a video interview.
The Canakinumab Anti-inflammatory Thrombosis Outcome Study (CANTOS) enrolled patients with a history of a MI and a “residual” inflammatory risk based on having an hsCRP level above 2 mg/L at baseline despite receiving optimized standard treatments and having a median LDL cholesterol level of 82 mg/dL. Dr. Ridker and his associates reported the study’s primary outcome results in August at the European Society of Cardiology meeting and in a simultaneously-published article (N Engl J Med. 2017 Sept 21; 377[12]:1119-31).
For the current analyses they defined a robust anti-inflammatory response as CANTOS patients who maintained an hsCRP level below 2 mg/L when measured 3 months after their first canakinumab dose. When the researchers divided all canakinumab recipients into tertiles based on their achieved hsCRP level after one dose, those with the lowest level, less than 1.2 mg/L, also had the best outcome, with a 4-year rate of major adverse cardiovascular events that was 29% lower than the placebo patients. Patients in the middle tertile of achieved hsCRP, from 1.2 up to but not including 2.6 mg/L, showed a smaller but still statistically significant relative 17% reduction in events, while patients with the tertile with the highest hsCRP levels following one canakinumab dose had essentially no difference in their outcomes compared with placebo-treated control patients.
These findings suggest that for hsCRP, “lower is better,” Dr. Ridker noted. “It’s similar to where we were in 1994” when trial results showed how LDL levels related to cardiovascular disease events and the potential that statin treatment held had for reducing event rates.
The new analyses included three additional notable findings:
• The main serious adverse effect from canakinumab treatment, fatal infections, which occurred at a small but significantly higher rate than in control patients, had a similar incidence of about one episode/300 patient years regardless of whether the achieved hsCRP level fell below 2 mg/L or remained above that level. The placebo rate of fatal infections was about one for every 500 patient years.
• The substantially reduced incidence of lung cancer seen in the primary CANTOS results also tracked with achieved hsCRP. Patients with an achieved hsCRP that was below the median for all treated patients had a 71% cut in new-onset lung cancer compared with controls, while patients with hsCRP levels that fell above the median showed no significant difference compared with control patients.
• All three doses of canakinumab tested in CANTOS – 50 mg, 150 mg, and 300 mg administered by subcutaneous injection once every 3 months – produced a drop in hsCRP to below 2 mg/L in some patients, but the rate at which patients reached this level differed depending on dose: 44% among patients who received the lowest dose, 55% of those who received a 150-mg dose, and 65% among those on the highest dose.
But this “responder analysis” of patients who received canakinumab received a strong cautionary caveat from Robert M. Califf, MD, professor of medicine and vice chancellor for health data sciences at Duke University in Durham, N.C.
“Beware of responder analyses,” Dr. Califf said during a talk at the meeting in which he commented on the new CANTOS findings. “There is a long history in cardiology of being misled” by responder analyses, he said.
Dr. Ridker added that the mechanism that determines whether patients have a robust or modest response to canakinumab remains unclear, although it likely depends on genetic factors. He also noted that research being done by himself and others is investigating the efficacy of other anti-inflammatory drugs that could potentially cut cardiovascular disease rates, including methotrexate and colchicine.
Canakinumab (Ilaris) had Food and Drug Administration marketing approval to treat systemic juvenile idiopathic arthritis and pediatric fever syndromes. Concurrently with the meeting report, the results appeared in an article online (Lancet 2017 Nov 13. doi: 10.1016/S0140-6736[17]32814-3).
CANTOS was sponsored by Novartis, the company that markets canakinumab. Dr. Ridker has been a consultant to Novartis and was lead investigator of CANTOS. He also holds patents on using hsCRP to assess cardiovascular disease risk. Dr. Califf is an adviser to Verily Health Sciences.
[email protected]
On Twitter @mitchelzoler
CANTOS is a landmark trial for showing the importance of inflammation in causing cardiovascular disease events. The new analyses from CANTOS strengthen the biological premise of the study and better address some concerns about the magnitude of benefit raised following the first report of the CANTOS findings. We now see an increased effect on major cardiovascular disease events and, for the first time, an impact from treatment on cardiovascular death and all-cause death in the subgroup of patients with a robust anti-inflammatory response to the drug. This shows the possibility of an enhanced benefit-to-risk balance by focusing canakinumab treatment on responsive patients.
New anti-inflammatory agents now in development offer the prospect for oral drugs that could have similar benefits, and by targeting such treatments to selected patients we can envision using an anti-inflammatory strategy for primary prevention of cardiovascular disease events as well as for secondary prevention. We can also anticipate studies that will show how to better integrate anti-inflammatory interventions with lipid-lowering drugs, as well as selected drugs used to treat diabetes.
The data from CANTOS has opened a new world of possibilities related to anti-inflammatory treatments for preventing and treating cardiovascular diseases.
Ira Tabas, MD , is professor of medicine, cell biology, and physiology at Columbia University in New York. He had no disclosures. He made these comments as designated discussant for Dr. Ridker’s report.
CANTOS is a landmark trial for showing the importance of inflammation in causing cardiovascular disease events. The new analyses from CANTOS strengthen the biological premise of the study and better address some concerns about the magnitude of benefit raised following the first report of the CANTOS findings. We now see an increased effect on major cardiovascular disease events and, for the first time, an impact from treatment on cardiovascular death and all-cause death in the subgroup of patients with a robust anti-inflammatory response to the drug. This shows the possibility of an enhanced benefit-to-risk balance by focusing canakinumab treatment on responsive patients.
New anti-inflammatory agents now in development offer the prospect for oral drugs that could have similar benefits, and by targeting such treatments to selected patients we can envision using an anti-inflammatory strategy for primary prevention of cardiovascular disease events as well as for secondary prevention. We can also anticipate studies that will show how to better integrate anti-inflammatory interventions with lipid-lowering drugs, as well as selected drugs used to treat diabetes.
The data from CANTOS has opened a new world of possibilities related to anti-inflammatory treatments for preventing and treating cardiovascular diseases.
Ira Tabas, MD , is professor of medicine, cell biology, and physiology at Columbia University in New York. He had no disclosures. He made these comments as designated discussant for Dr. Ridker’s report.
CANTOS is a landmark trial for showing the importance of inflammation in causing cardiovascular disease events. The new analyses from CANTOS strengthen the biological premise of the study and better address some concerns about the magnitude of benefit raised following the first report of the CANTOS findings. We now see an increased effect on major cardiovascular disease events and, for the first time, an impact from treatment on cardiovascular death and all-cause death in the subgroup of patients with a robust anti-inflammatory response to the drug. This shows the possibility of an enhanced benefit-to-risk balance by focusing canakinumab treatment on responsive patients.
New anti-inflammatory agents now in development offer the prospect for oral drugs that could have similar benefits, and by targeting such treatments to selected patients we can envision using an anti-inflammatory strategy for primary prevention of cardiovascular disease events as well as for secondary prevention. We can also anticipate studies that will show how to better integrate anti-inflammatory interventions with lipid-lowering drugs, as well as selected drugs used to treat diabetes.
The data from CANTOS has opened a new world of possibilities related to anti-inflammatory treatments for preventing and treating cardiovascular diseases.
Ira Tabas, MD , is professor of medicine, cell biology, and physiology at Columbia University in New York. He had no disclosures. He made these comments as designated discussant for Dr. Ridker’s report.
ANAHEIM, CALIF. – Targeting the anti-inflammatory drug canakinumab to cardiovascular disease patients with a robust response to a single dose may be an effective way to enhance the cost benefit of this novel treatment that is effective but also expensive.
A post hoc analysis of data collected in the ground-breaking CANTOS trial showed that among patients with a robust anti-inflammatory response to their first dose of canakinumab, the 4-year rate of major adverse cardiovascular events fell by 25% compared with patients who received placebo, a much higher relative risk reduction compared with all canakinumab recipients in the study. In this responsive subgroup, which constituted 55% of all patients assessed after their first dose, canakinumab also cut both cardiovascular death and all-cause death by 31% each relative to placebo, statistically significant reductions that had not been seen in the trial’s primary analysis that included all drug recipients, Paul M. Ridker, MD, said at the American Heart Association scientific sessions.
“The current analysis suggests that the magnitude of hsCRP [high sensitivity C-reactive protein] reduction following a single dose of canakinumab may provide a simple clinical method to identify individuals most likely to accrue the largest cardiovascular and cancer benefits from continued treatment.” The findings have importance “for patient selection, cost-effectiveness, and personalized medicine” as researchers and clinicians begin using anti-inflammatory drugs such as canakinumab to treat cardiovascular disease patients, said Dr. Ridker, professor of medicine at Harvard Medical School and director of the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital, both in Boston.
“The magnitude of the hsCRP reduction” after the first dose “is telling us who benefits most,” Dr. Ridker said in a video interview.
The Canakinumab Anti-inflammatory Thrombosis Outcome Study (CANTOS) enrolled patients with a history of a MI and a “residual” inflammatory risk based on having an hsCRP level above 2 mg/L at baseline despite receiving optimized standard treatments and having a median LDL cholesterol level of 82 mg/dL. Dr. Ridker and his associates reported the study’s primary outcome results in August at the European Society of Cardiology meeting and in a simultaneously-published article (N Engl J Med. 2017 Sept 21; 377[12]:1119-31).
For the current analyses they defined a robust anti-inflammatory response as CANTOS patients who maintained an hsCRP level below 2 mg/L when measured 3 months after their first canakinumab dose. When the researchers divided all canakinumab recipients into tertiles based on their achieved hsCRP level after one dose, those with the lowest level, less than 1.2 mg/L, also had the best outcome, with a 4-year rate of major adverse cardiovascular events that was 29% lower than the placebo patients. Patients in the middle tertile of achieved hsCRP, from 1.2 up to but not including 2.6 mg/L, showed a smaller but still statistically significant relative 17% reduction in events, while patients with the tertile with the highest hsCRP levels following one canakinumab dose had essentially no difference in their outcomes compared with placebo-treated control patients.
These findings suggest that for hsCRP, “lower is better,” Dr. Ridker noted. “It’s similar to where we were in 1994” when trial results showed how LDL levels related to cardiovascular disease events and the potential that statin treatment held had for reducing event rates.
The new analyses included three additional notable findings:
• The main serious adverse effect from canakinumab treatment, fatal infections, which occurred at a small but significantly higher rate than in control patients, had a similar incidence of about one episode/300 patient years regardless of whether the achieved hsCRP level fell below 2 mg/L or remained above that level. The placebo rate of fatal infections was about one for every 500 patient years.
• The substantially reduced incidence of lung cancer seen in the primary CANTOS results also tracked with achieved hsCRP. Patients with an achieved hsCRP that was below the median for all treated patients had a 71% cut in new-onset lung cancer compared with controls, while patients with hsCRP levels that fell above the median showed no significant difference compared with control patients.
• All three doses of canakinumab tested in CANTOS – 50 mg, 150 mg, and 300 mg administered by subcutaneous injection once every 3 months – produced a drop in hsCRP to below 2 mg/L in some patients, but the rate at which patients reached this level differed depending on dose: 44% among patients who received the lowest dose, 55% of those who received a 150-mg dose, and 65% among those on the highest dose.
But this “responder analysis” of patients who received canakinumab received a strong cautionary caveat from Robert M. Califf, MD, professor of medicine and vice chancellor for health data sciences at Duke University in Durham, N.C.
“Beware of responder analyses,” Dr. Califf said during a talk at the meeting in which he commented on the new CANTOS findings. “There is a long history in cardiology of being misled” by responder analyses, he said.
Dr. Ridker added that the mechanism that determines whether patients have a robust or modest response to canakinumab remains unclear, although it likely depends on genetic factors. He also noted that research being done by himself and others is investigating the efficacy of other anti-inflammatory drugs that could potentially cut cardiovascular disease rates, including methotrexate and colchicine.
Canakinumab (Ilaris) had Food and Drug Administration marketing approval to treat systemic juvenile idiopathic arthritis and pediatric fever syndromes. Concurrently with the meeting report, the results appeared in an article online (Lancet 2017 Nov 13. doi: 10.1016/S0140-6736[17]32814-3).
CANTOS was sponsored by Novartis, the company that markets canakinumab. Dr. Ridker has been a consultant to Novartis and was lead investigator of CANTOS. He also holds patents on using hsCRP to assess cardiovascular disease risk. Dr. Califf is an adviser to Verily Health Sciences.
[email protected]
On Twitter @mitchelzoler
ANAHEIM, CALIF. – Targeting the anti-inflammatory drug canakinumab to cardiovascular disease patients with a robust response to a single dose may be an effective way to enhance the cost benefit of this novel treatment that is effective but also expensive.
A post hoc analysis of data collected in the ground-breaking CANTOS trial showed that among patients with a robust anti-inflammatory response to their first dose of canakinumab, the 4-year rate of major adverse cardiovascular events fell by 25% compared with patients who received placebo, a much higher relative risk reduction compared with all canakinumab recipients in the study. In this responsive subgroup, which constituted 55% of all patients assessed after their first dose, canakinumab also cut both cardiovascular death and all-cause death by 31% each relative to placebo, statistically significant reductions that had not been seen in the trial’s primary analysis that included all drug recipients, Paul M. Ridker, MD, said at the American Heart Association scientific sessions.
“The current analysis suggests that the magnitude of hsCRP [high sensitivity C-reactive protein] reduction following a single dose of canakinumab may provide a simple clinical method to identify individuals most likely to accrue the largest cardiovascular and cancer benefits from continued treatment.” The findings have importance “for patient selection, cost-effectiveness, and personalized medicine” as researchers and clinicians begin using anti-inflammatory drugs such as canakinumab to treat cardiovascular disease patients, said Dr. Ridker, professor of medicine at Harvard Medical School and director of the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital, both in Boston.
“The magnitude of the hsCRP reduction” after the first dose “is telling us who benefits most,” Dr. Ridker said in a video interview.
The Canakinumab Anti-inflammatory Thrombosis Outcome Study (CANTOS) enrolled patients with a history of a MI and a “residual” inflammatory risk based on having an hsCRP level above 2 mg/L at baseline despite receiving optimized standard treatments and having a median LDL cholesterol level of 82 mg/dL. Dr. Ridker and his associates reported the study’s primary outcome results in August at the European Society of Cardiology meeting and in a simultaneously-published article (N Engl J Med. 2017 Sept 21; 377[12]:1119-31).
For the current analyses they defined a robust anti-inflammatory response as CANTOS patients who maintained an hsCRP level below 2 mg/L when measured 3 months after their first canakinumab dose. When the researchers divided all canakinumab recipients into tertiles based on their achieved hsCRP level after one dose, those with the lowest level, less than 1.2 mg/L, also had the best outcome, with a 4-year rate of major adverse cardiovascular events that was 29% lower than the placebo patients. Patients in the middle tertile of achieved hsCRP, from 1.2 up to but not including 2.6 mg/L, showed a smaller but still statistically significant relative 17% reduction in events, while patients with the tertile with the highest hsCRP levels following one canakinumab dose had essentially no difference in their outcomes compared with placebo-treated control patients.
These findings suggest that for hsCRP, “lower is better,” Dr. Ridker noted. “It’s similar to where we were in 1994” when trial results showed how LDL levels related to cardiovascular disease events and the potential that statin treatment held had for reducing event rates.
The new analyses included three additional notable findings:
• The main serious adverse effect from canakinumab treatment, fatal infections, which occurred at a small but significantly higher rate than in control patients, had a similar incidence of about one episode/300 patient years regardless of whether the achieved hsCRP level fell below 2 mg/L or remained above that level. The placebo rate of fatal infections was about one for every 500 patient years.
• The substantially reduced incidence of lung cancer seen in the primary CANTOS results also tracked with achieved hsCRP. Patients with an achieved hsCRP that was below the median for all treated patients had a 71% cut in new-onset lung cancer compared with controls, while patients with hsCRP levels that fell above the median showed no significant difference compared with control patients.
• All three doses of canakinumab tested in CANTOS – 50 mg, 150 mg, and 300 mg administered by subcutaneous injection once every 3 months – produced a drop in hsCRP to below 2 mg/L in some patients, but the rate at which patients reached this level differed depending on dose: 44% among patients who received the lowest dose, 55% of those who received a 150-mg dose, and 65% among those on the highest dose.
But this “responder analysis” of patients who received canakinumab received a strong cautionary caveat from Robert M. Califf, MD, professor of medicine and vice chancellor for health data sciences at Duke University in Durham, N.C.
“Beware of responder analyses,” Dr. Califf said during a talk at the meeting in which he commented on the new CANTOS findings. “There is a long history in cardiology of being misled” by responder analyses, he said.
Dr. Ridker added that the mechanism that determines whether patients have a robust or modest response to canakinumab remains unclear, although it likely depends on genetic factors. He also noted that research being done by himself and others is investigating the efficacy of other anti-inflammatory drugs that could potentially cut cardiovascular disease rates, including methotrexate and colchicine.
Canakinumab (Ilaris) had Food and Drug Administration marketing approval to treat systemic juvenile idiopathic arthritis and pediatric fever syndromes. Concurrently with the meeting report, the results appeared in an article online (Lancet 2017 Nov 13. doi: 10.1016/S0140-6736[17]32814-3).
CANTOS was sponsored by Novartis, the company that markets canakinumab. Dr. Ridker has been a consultant to Novartis and was lead investigator of CANTOS. He also holds patents on using hsCRP to assess cardiovascular disease risk. Dr. Califf is an adviser to Verily Health Sciences.
[email protected]
On Twitter @mitchelzoler
AT THE AHA SCIENTIFIC SESSIONS
Key clinical point:
Major finding: Patients with a strong hsCRP canakinumab response had a 25% drop in cardiovascular disease events compared with controls.
Data source: Post hoc analyses of data collected in CANTOS, a multicenter trial with 10,061 patients.
Disclosures: CANTOS was sponsored by Novartis, the company that markets canakinumab (Ilaris). Dr. Ridker has been a consultant to Novartis and was lead investigator of CANTOS. He also holds patents on using hsCRP to assess cardiovascular disease risk. Dr. Califf is an adviser to Verily Health Sciences.
ACC survey: Burnout pervasive in cardiologists
ANAHEIM, CALIF. – A disturbingly high 27% of U.S. cardiologists reported currently feeling burnout in the American College of Cardiology’s third Professional Life Survey, Laxmi S. Mehta, MD, said at the American Heart Association scientific sessions.
A gender gap existed: The prevalence of burnout was 29% greater among female cardiologists than their male counterparts, by a margin of 31%-24%.
“These are the doctors who are taking care of people’s hearts, and we know that when you’re burned out, there are higher rates of medical errors and the quality of care is poorer. So this is problematic,” she said in an interview.
Burnout had a negative effect on career satisfaction: While 94% of cardiologists in the nonburnout group professed they were satisfied with their career, that was the case for only 74% of cardiologists who felt burnout. Just 56% percent of the burnout group said they would recommend cardiology as a career, compared with 80% of the practitioners who felt no burnout.
The 2015 ACC survey was completed by 2,313 U.S. cardiologists, 964 of whom were women. The first round of results, which focused on career satisfaction and racial and gender discrimination in the workplace, have been published (J Am Coll Cardiol. 2017 Jan 31;69[4]:452-62). The survey included the validated 10-question Mini Z burnout assessment, the results of which were the focus of the new analysis.
The 27% of cardiologists in the burnout group fell into three subcategories, the largest of which comprised those who reported feeling at least one burnout symptom of physical or mental exhaustion. Those who said their burnout symptoms don’t go away and that they think about their work frustrations frequently made up a smaller group. Just a few percent of survey participants fell into the completely burned out category.
Only 51% of the burnout group were satisfied with their financial compensation, compared with 68% of the nonburnout group. Sixty-one percent of the burnout group felt they were treated fairly at their job, as did 86% of the cardiologists who felt burnout. Half of the cardiologists with burnout reported experiencing past discrimination, compared with 37% of the nonburnout group. And 40% of the burnout group felt their family responsibilities hindered career advancement, a sentiment expressed by 22% of the nonburnout group.
EMR “pajama time” cited as a major burden
Two-thirds of cardiologists with constant burnout symptoms or complete burnout cited excessive time spent completing their electronic medical records as a significant contributing factor.
“The electronic medical record ends up taking over our personal time,” according to Dr. Mehta. “We call it ‘pajama time’ because many of us are doing the charts or responding to patients at midnight, on vacation, at meetings like this. There is no separation, and that’s a problem.”
What can be done to reduce burnout
The 2015 Professional Life Survey was the third one in 20 years. Compared with the earlier two, the most recent survey painted a picture of an aging workforce that is less likely to be in private practice. The survey – the first one to assess burnout within the specialty – was carried out by the ACC Women in Cardiology Leadership Council. Armed with the survey results, the ACC leadership is now in the process of redefining the organization’s mission statement to incorporate a new emphasis on providing for physician health and well-being in addition to the more traditional goals of improving the quality and reducing the cost of care.
“Many cardiologists are working a lot harder than they used to, with less personal time. We need to work on mechanisms to reduce burnout by reducing the burdens put on them. The survey data help because they show the cardiology profession, and hopefully hospital administrators, the importance of making a better work environment. That’s the hope,” Dr. Mehta said.
She reported having no financial conflicts of interest regarding the survey.
ANAHEIM, CALIF. – A disturbingly high 27% of U.S. cardiologists reported currently feeling burnout in the American College of Cardiology’s third Professional Life Survey, Laxmi S. Mehta, MD, said at the American Heart Association scientific sessions.
A gender gap existed: The prevalence of burnout was 29% greater among female cardiologists than their male counterparts, by a margin of 31%-24%.
“These are the doctors who are taking care of people’s hearts, and we know that when you’re burned out, there are higher rates of medical errors and the quality of care is poorer. So this is problematic,” she said in an interview.
Burnout had a negative effect on career satisfaction: While 94% of cardiologists in the nonburnout group professed they were satisfied with their career, that was the case for only 74% of cardiologists who felt burnout. Just 56% percent of the burnout group said they would recommend cardiology as a career, compared with 80% of the practitioners who felt no burnout.
The 2015 ACC survey was completed by 2,313 U.S. cardiologists, 964 of whom were women. The first round of results, which focused on career satisfaction and racial and gender discrimination in the workplace, have been published (J Am Coll Cardiol. 2017 Jan 31;69[4]:452-62). The survey included the validated 10-question Mini Z burnout assessment, the results of which were the focus of the new analysis.
The 27% of cardiologists in the burnout group fell into three subcategories, the largest of which comprised those who reported feeling at least one burnout symptom of physical or mental exhaustion. Those who said their burnout symptoms don’t go away and that they think about their work frustrations frequently made up a smaller group. Just a few percent of survey participants fell into the completely burned out category.
Only 51% of the burnout group were satisfied with their financial compensation, compared with 68% of the nonburnout group. Sixty-one percent of the burnout group felt they were treated fairly at their job, as did 86% of the cardiologists who felt burnout. Half of the cardiologists with burnout reported experiencing past discrimination, compared with 37% of the nonburnout group. And 40% of the burnout group felt their family responsibilities hindered career advancement, a sentiment expressed by 22% of the nonburnout group.
EMR “pajama time” cited as a major burden
Two-thirds of cardiologists with constant burnout symptoms or complete burnout cited excessive time spent completing their electronic medical records as a significant contributing factor.
“The electronic medical record ends up taking over our personal time,” according to Dr. Mehta. “We call it ‘pajama time’ because many of us are doing the charts or responding to patients at midnight, on vacation, at meetings like this. There is no separation, and that’s a problem.”
What can be done to reduce burnout
The 2015 Professional Life Survey was the third one in 20 years. Compared with the earlier two, the most recent survey painted a picture of an aging workforce that is less likely to be in private practice. The survey – the first one to assess burnout within the specialty – was carried out by the ACC Women in Cardiology Leadership Council. Armed with the survey results, the ACC leadership is now in the process of redefining the organization’s mission statement to incorporate a new emphasis on providing for physician health and well-being in addition to the more traditional goals of improving the quality and reducing the cost of care.
“Many cardiologists are working a lot harder than they used to, with less personal time. We need to work on mechanisms to reduce burnout by reducing the burdens put on them. The survey data help because they show the cardiology profession, and hopefully hospital administrators, the importance of making a better work environment. That’s the hope,” Dr. Mehta said.
She reported having no financial conflicts of interest regarding the survey.
ANAHEIM, CALIF. – A disturbingly high 27% of U.S. cardiologists reported currently feeling burnout in the American College of Cardiology’s third Professional Life Survey, Laxmi S. Mehta, MD, said at the American Heart Association scientific sessions.
A gender gap existed: The prevalence of burnout was 29% greater among female cardiologists than their male counterparts, by a margin of 31%-24%.
“These are the doctors who are taking care of people’s hearts, and we know that when you’re burned out, there are higher rates of medical errors and the quality of care is poorer. So this is problematic,” she said in an interview.
Burnout had a negative effect on career satisfaction: While 94% of cardiologists in the nonburnout group professed they were satisfied with their career, that was the case for only 74% of cardiologists who felt burnout. Just 56% percent of the burnout group said they would recommend cardiology as a career, compared with 80% of the practitioners who felt no burnout.
The 2015 ACC survey was completed by 2,313 U.S. cardiologists, 964 of whom were women. The first round of results, which focused on career satisfaction and racial and gender discrimination in the workplace, have been published (J Am Coll Cardiol. 2017 Jan 31;69[4]:452-62). The survey included the validated 10-question Mini Z burnout assessment, the results of which were the focus of the new analysis.
The 27% of cardiologists in the burnout group fell into three subcategories, the largest of which comprised those who reported feeling at least one burnout symptom of physical or mental exhaustion. Those who said their burnout symptoms don’t go away and that they think about their work frustrations frequently made up a smaller group. Just a few percent of survey participants fell into the completely burned out category.
Only 51% of the burnout group were satisfied with their financial compensation, compared with 68% of the nonburnout group. Sixty-one percent of the burnout group felt they were treated fairly at their job, as did 86% of the cardiologists who felt burnout. Half of the cardiologists with burnout reported experiencing past discrimination, compared with 37% of the nonburnout group. And 40% of the burnout group felt their family responsibilities hindered career advancement, a sentiment expressed by 22% of the nonburnout group.
EMR “pajama time” cited as a major burden
Two-thirds of cardiologists with constant burnout symptoms or complete burnout cited excessive time spent completing their electronic medical records as a significant contributing factor.
“The electronic medical record ends up taking over our personal time,” according to Dr. Mehta. “We call it ‘pajama time’ because many of us are doing the charts or responding to patients at midnight, on vacation, at meetings like this. There is no separation, and that’s a problem.”
What can be done to reduce burnout
The 2015 Professional Life Survey was the third one in 20 years. Compared with the earlier two, the most recent survey painted a picture of an aging workforce that is less likely to be in private practice. The survey – the first one to assess burnout within the specialty – was carried out by the ACC Women in Cardiology Leadership Council. Armed with the survey results, the ACC leadership is now in the process of redefining the organization’s mission statement to incorporate a new emphasis on providing for physician health and well-being in addition to the more traditional goals of improving the quality and reducing the cost of care.
“Many cardiologists are working a lot harder than they used to, with less personal time. We need to work on mechanisms to reduce burnout by reducing the burdens put on them. The survey data help because they show the cardiology profession, and hopefully hospital administrators, the importance of making a better work environment. That’s the hope,” Dr. Mehta said.
She reported having no financial conflicts of interest regarding the survey.
AT THE AHA SCIENTIFIC SESSIONS
Key clinical point:
Major finding: There is a noticeable gender gap in U.S. cardiologist burnout.
Data source: This survey of 2,313 U.S. cardiologists addressed burnout and career satisfaction within the profession.
Disclosures: The presenter reported having no financial conflicts of interest regarding the survey, conducted by the American College of Cardiology.
Heart failure readmission penalties linked with rise in deaths
ANAHEIM, CALIF. – Evidence continues to mount that Medicare’s penalization of hospitals with excess heart failure readmissions has cut readmissions but at the apparent price of more deaths.
During the penalty phase of the Hospital Readmission Reduction Program (HRRP), which started in Oct. 2012, 30-day all-cause mortality following a heart failure hospitalization was 18% higher compared with the adjusted rate during 2006-2010, based on Medicare data from 2006-2014 that underwent “extensive” risk adjustment using prospectively-collected clinical data, Gregg C. Fonarow, MD, and his associates reported in a poster at the American Heart Association scientific sessions. During the same 2012-2014 period with imposed penalties, 30-day all-cause readmissions following an index heart failure hospitalization fell by a risk-adjusted 9% compared to the era just before the HRRP. Both the drop in readmissions and rise in deaths were statistically significant.
A similar pattern existed for the risk-adjusted readmissions and mortality rates during the year following the index hospitalization: readmissions fell by 8% compared with the time before the program but deaths rose by a relative 10%, also statistically significant differences.
“This is urgent and alarming. The Centers for Medicare & Medicaid Services needs to revamp the program to exclude heart failure patients and take steps to mitigate the damage,” Dr. Fonarow said in an interview. He estimated that the uptick in mortality following heart failure hospitalizations is causing 5,000-10,000 excess annual deaths among U.S. heart failure patients that are directly attributable to the HRRP. Similar effects have not been seen for patients with an index hospitalization of pneumonia or acute MI, two other targets of the HRRP, he noted.
The HRRP “currently has penalties for readmissions that are 15-fold higher than for mortality. They need to penalize equally, and they need to get at the gaming that hospitals are doing” to shift outcomes away from readmissions even if it means more patients will die. Heart failure patients “who need hospitalization are being denied admission by hospitals out of fear of the readmissions penalty,” said Dr. Fonarow, professor and co-chief of cardiology at the University of California, Los Angeles. “Seeing increased mortality linked with implementation of the penalty is completely unacceptable.”
Although a prior report used similar Medicare data from 2008-2014 to initially find this inverse association, that analysis relied entirely on administrative data collected in Medicare records to perform risk adjustments (JAMA. 2017 July 17;318[3]:270-8). The new analysis reported by Dr. Fonarow and his associates combined the Medicare data with detailed clinical records for the same patients collected by the Get With the Guidelines--Heart Failure program. The extensive clinical data that the researchers used for risk-adjustment allowed for a more reliable attribution to the HRRP of readmission and mortality differences between the two time periods. Despite the extensive risk adjustment “we see exactly the same result” as initially reported, Dr. Fonarow said.
The findings “remind us that it is very important to look at the unintended consequences” of interventions that might initially seem reasonable, commented Lynne Warner Stevenson, MD, professor and director of cardiomyopathy at Vanderbilt University in Nashville, Tenn.
Concurrent with the presentation at the meeting the results also appeared in an article published online (JAMA Cardiol. 2017 Nov 12;doi:10.1001/jamacardio.2017.4265).
A separate analysis of data collected in the Get With the Guidelines--Heart Failure during 2005-2009 showed that within the past decade the 5-year survival of U.S. hospitalized heart failure patients has remained dismally low, and similar regardless of whether patients had heart failure with reduced ejection fraction (HFrEF, 46% of all heart failure patients in the analysis), heart failure with preserved ejection fraction (HFpEF, also 46% of patients), or the in-between patients who had heart failure with borderline ejection fraction (HFbEF, an ejection fraction of 41%-49%, in 8% of patients).
The results, from 39,982 patients, showed a 75% mortality rate during 5-years of follow-up, with similar mortality rates regardless of the patient’s ejection-fraction level, reported Dr. Fonarow and his associates in a separate poster. In every age group examined, patients with heart failure had dramatically reduced life expectancies compared with the general population. For example, among heart failure patients aged 65-69 years in the study, median survival was less than 4 years compared with a 19-year expected median survival for people in the general U.S. population in the same age range.
These very low survival rates of heart failure patients initially hospitalized for heart failure during the relatively recent era of 2005-2009 “is a call to action to prevent heart failure,” said Dr. Fonarow.
The poor prognosis most heart failure patients face should also spur aggressive treatment of HFrEF patients with all proven treatments, Dr. Fonarow said. It should also spur more effort to find effective treatments for HFpEF, which currently has no clearly-proven effective treatment.
These results also appeared in a report simultaneously published online (J Amer Coll Cardiol. 2017 Nov 12;doi: 10.1016/j.jacc.2017.08.074).
[email protected]
On Twitter @mitchelzoler
ANAHEIM, CALIF. – Evidence continues to mount that Medicare’s penalization of hospitals with excess heart failure readmissions has cut readmissions but at the apparent price of more deaths.
During the penalty phase of the Hospital Readmission Reduction Program (HRRP), which started in Oct. 2012, 30-day all-cause mortality following a heart failure hospitalization was 18% higher compared with the adjusted rate during 2006-2010, based on Medicare data from 2006-2014 that underwent “extensive” risk adjustment using prospectively-collected clinical data, Gregg C. Fonarow, MD, and his associates reported in a poster at the American Heart Association scientific sessions. During the same 2012-2014 period with imposed penalties, 30-day all-cause readmissions following an index heart failure hospitalization fell by a risk-adjusted 9% compared to the era just before the HRRP. Both the drop in readmissions and rise in deaths were statistically significant.
A similar pattern existed for the risk-adjusted readmissions and mortality rates during the year following the index hospitalization: readmissions fell by 8% compared with the time before the program but deaths rose by a relative 10%, also statistically significant differences.
“This is urgent and alarming. The Centers for Medicare & Medicaid Services needs to revamp the program to exclude heart failure patients and take steps to mitigate the damage,” Dr. Fonarow said in an interview. He estimated that the uptick in mortality following heart failure hospitalizations is causing 5,000-10,000 excess annual deaths among U.S. heart failure patients that are directly attributable to the HRRP. Similar effects have not been seen for patients with an index hospitalization of pneumonia or acute MI, two other targets of the HRRP, he noted.
The HRRP “currently has penalties for readmissions that are 15-fold higher than for mortality. They need to penalize equally, and they need to get at the gaming that hospitals are doing” to shift outcomes away from readmissions even if it means more patients will die. Heart failure patients “who need hospitalization are being denied admission by hospitals out of fear of the readmissions penalty,” said Dr. Fonarow, professor and co-chief of cardiology at the University of California, Los Angeles. “Seeing increased mortality linked with implementation of the penalty is completely unacceptable.”
Although a prior report used similar Medicare data from 2008-2014 to initially find this inverse association, that analysis relied entirely on administrative data collected in Medicare records to perform risk adjustments (JAMA. 2017 July 17;318[3]:270-8). The new analysis reported by Dr. Fonarow and his associates combined the Medicare data with detailed clinical records for the same patients collected by the Get With the Guidelines--Heart Failure program. The extensive clinical data that the researchers used for risk-adjustment allowed for a more reliable attribution to the HRRP of readmission and mortality differences between the two time periods. Despite the extensive risk adjustment “we see exactly the same result” as initially reported, Dr. Fonarow said.
The findings “remind us that it is very important to look at the unintended consequences” of interventions that might initially seem reasonable, commented Lynne Warner Stevenson, MD, professor and director of cardiomyopathy at Vanderbilt University in Nashville, Tenn.
Concurrent with the presentation at the meeting the results also appeared in an article published online (JAMA Cardiol. 2017 Nov 12;doi:10.1001/jamacardio.2017.4265).
A separate analysis of data collected in the Get With the Guidelines--Heart Failure during 2005-2009 showed that within the past decade the 5-year survival of U.S. hospitalized heart failure patients has remained dismally low, and similar regardless of whether patients had heart failure with reduced ejection fraction (HFrEF, 46% of all heart failure patients in the analysis), heart failure with preserved ejection fraction (HFpEF, also 46% of patients), or the in-between patients who had heart failure with borderline ejection fraction (HFbEF, an ejection fraction of 41%-49%, in 8% of patients).
The results, from 39,982 patients, showed a 75% mortality rate during 5-years of follow-up, with similar mortality rates regardless of the patient’s ejection-fraction level, reported Dr. Fonarow and his associates in a separate poster. In every age group examined, patients with heart failure had dramatically reduced life expectancies compared with the general population. For example, among heart failure patients aged 65-69 years in the study, median survival was less than 4 years compared with a 19-year expected median survival for people in the general U.S. population in the same age range.
These very low survival rates of heart failure patients initially hospitalized for heart failure during the relatively recent era of 2005-2009 “is a call to action to prevent heart failure,” said Dr. Fonarow.
The poor prognosis most heart failure patients face should also spur aggressive treatment of HFrEF patients with all proven treatments, Dr. Fonarow said. It should also spur more effort to find effective treatments for HFpEF, which currently has no clearly-proven effective treatment.
These results also appeared in a report simultaneously published online (J Amer Coll Cardiol. 2017 Nov 12;doi: 10.1016/j.jacc.2017.08.074).
[email protected]
On Twitter @mitchelzoler
ANAHEIM, CALIF. – Evidence continues to mount that Medicare’s penalization of hospitals with excess heart failure readmissions has cut readmissions but at the apparent price of more deaths.
During the penalty phase of the Hospital Readmission Reduction Program (HRRP), which started in Oct. 2012, 30-day all-cause mortality following a heart failure hospitalization was 18% higher compared with the adjusted rate during 2006-2010, based on Medicare data from 2006-2014 that underwent “extensive” risk adjustment using prospectively-collected clinical data, Gregg C. Fonarow, MD, and his associates reported in a poster at the American Heart Association scientific sessions. During the same 2012-2014 period with imposed penalties, 30-day all-cause readmissions following an index heart failure hospitalization fell by a risk-adjusted 9% compared to the era just before the HRRP. Both the drop in readmissions and rise in deaths were statistically significant.
A similar pattern existed for the risk-adjusted readmissions and mortality rates during the year following the index hospitalization: readmissions fell by 8% compared with the time before the program but deaths rose by a relative 10%, also statistically significant differences.
“This is urgent and alarming. The Centers for Medicare & Medicaid Services needs to revamp the program to exclude heart failure patients and take steps to mitigate the damage,” Dr. Fonarow said in an interview. He estimated that the uptick in mortality following heart failure hospitalizations is causing 5,000-10,000 excess annual deaths among U.S. heart failure patients that are directly attributable to the HRRP. Similar effects have not been seen for patients with an index hospitalization of pneumonia or acute MI, two other targets of the HRRP, he noted.
The HRRP “currently has penalties for readmissions that are 15-fold higher than for mortality. They need to penalize equally, and they need to get at the gaming that hospitals are doing” to shift outcomes away from readmissions even if it means more patients will die. Heart failure patients “who need hospitalization are being denied admission by hospitals out of fear of the readmissions penalty,” said Dr. Fonarow, professor and co-chief of cardiology at the University of California, Los Angeles. “Seeing increased mortality linked with implementation of the penalty is completely unacceptable.”
Although a prior report used similar Medicare data from 2008-2014 to initially find this inverse association, that analysis relied entirely on administrative data collected in Medicare records to perform risk adjustments (JAMA. 2017 July 17;318[3]:270-8). The new analysis reported by Dr. Fonarow and his associates combined the Medicare data with detailed clinical records for the same patients collected by the Get With the Guidelines--Heart Failure program. The extensive clinical data that the researchers used for risk-adjustment allowed for a more reliable attribution to the HRRP of readmission and mortality differences between the two time periods. Despite the extensive risk adjustment “we see exactly the same result” as initially reported, Dr. Fonarow said.
The findings “remind us that it is very important to look at the unintended consequences” of interventions that might initially seem reasonable, commented Lynne Warner Stevenson, MD, professor and director of cardiomyopathy at Vanderbilt University in Nashville, Tenn.
Concurrent with the presentation at the meeting the results also appeared in an article published online (JAMA Cardiol. 2017 Nov 12;doi:10.1001/jamacardio.2017.4265).
A separate analysis of data collected in the Get With the Guidelines--Heart Failure during 2005-2009 showed that within the past decade the 5-year survival of U.S. hospitalized heart failure patients has remained dismally low, and similar regardless of whether patients had heart failure with reduced ejection fraction (HFrEF, 46% of all heart failure patients in the analysis), heart failure with preserved ejection fraction (HFpEF, also 46% of patients), or the in-between patients who had heart failure with borderline ejection fraction (HFbEF, an ejection fraction of 41%-49%, in 8% of patients).
The results, from 39,982 patients, showed a 75% mortality rate during 5-years of follow-up, with similar mortality rates regardless of the patient’s ejection-fraction level, reported Dr. Fonarow and his associates in a separate poster. In every age group examined, patients with heart failure had dramatically reduced life expectancies compared with the general population. For example, among heart failure patients aged 65-69 years in the study, median survival was less than 4 years compared with a 19-year expected median survival for people in the general U.S. population in the same age range.
These very low survival rates of heart failure patients initially hospitalized for heart failure during the relatively recent era of 2005-2009 “is a call to action to prevent heart failure,” said Dr. Fonarow.
The poor prognosis most heart failure patients face should also spur aggressive treatment of HFrEF patients with all proven treatments, Dr. Fonarow said. It should also spur more effort to find effective treatments for HFpEF, which currently has no clearly-proven effective treatment.
These results also appeared in a report simultaneously published online (J Amer Coll Cardiol. 2017 Nov 12;doi: 10.1016/j.jacc.2017.08.074).
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AT THE AHA SCIENTIFIC SESSIONS
Key clinical point:
Major finding: Risk-adjusted 30-day readmissions fell by a relative 9% during the reduction program but relative mortality rose by 18%.
Data source: Review of 115,245 Medicare beneficiaries with heart failure treated at hospitals in the Get With the Guidelines--Heart Failure program.
Disclosures: Dr. Fonarow has been a consultant to Amgen, Janssen, Medtronic, Novartis, and St. Jude. Dr. Stevenson has been a consultant to Abbott, has received travel support from St. Jude, and has received research funding and food from Novartis.
Restrictive transfusion strategy safe in cardiac surgery
ANAHEIM, CALIF. – Waiting to transfuse heart surgery patients until their hemoglobin drops below 7.5 g/dL is just as safe as transfusing them when their hemoglobin drops below 9.5 g/dL, and it saves a lot of blood, according to the TRICS III randomized, noninferiority trial of nearly 5,000 patients undergoing cardiac surgery with cardiopulmonary bypass.
Cardiac surgeons have been moving to more restrictive transfusion policies following reports of worse postoperative survival when patients are transfused. However, there are concerns about safety and uncertainty over whether it’s the transfusions themselves that are problematic or whether transfused patients do worse because they are sicker to begin with. The Transfusion Requirements in Cardiac Surgery (TRICS) III trial removes some of the doubt: “A restrictive transfusion strategy is as effective and safe as a liberal strategy in patients undergoing cardiac surgery,” said lead investigator C. David Mazer, MD, a professor in the department of anesthesia at the University of Toronto.
Overall, 11.4% in the restrictive-threshold group and 12.5% in the liberal-threshold group met the study’s composite primary outcome of death from any cause, MI, stroke, and new-onset renal failure with dialysis (P less than .001 for noninferiority). There were no statistically significant between-group differences in the individual components of the composite outcome. Mortality was 3% in the restrictive group and 3.6% in the liberal group, a 15% reduction for the restrictive group.
About 52% of the patients in the restrictive arm, compared with 72.6% in the liberal arm, were transfused. When transfused, patients in the restrictive arm received a median of 2 units of red cells; liberal-arm patients received a median of 3 units. The overall cost difference was roughly $3 million, Dr. Mazer said at the American Heart Association scientific sessions.
There were no statistically significant differences in secondary outcomes. Restrictive patients were on mechanical ventilation for a median of 0.38 days and in the ICU for a median of 2.1 days; patients in the liberal arm were ventilated for a median of 0.36 days and in the ICU for a median of 1.9 days. The median hospital stay was 8 days in both groups.
Unexpectedly, patients 75 years and older did better with the restrictive transfusion strategy, with a 30% lower risk of the composite outcome. “Many people think the older you are, the higher your hemoglobin should be, and the more liberal you should be with transfusions. We didn’t find that. [It] challenges current beliefs and may be considered to be hypothesis generating; at a minimum, it highlights that a restrictive transfusion strategy appears to be safe in elderly patients,” Dr. Mazer said.
The participants were a mean of 72 years old, and 35% were women. The majority in both arms underwent coronary artery bypass surgery, valve surgery, or both. Heart transplants were excluded from the study. The trial was conducted in 19 countries, including China and India, but “the results were remarkably consistent independent of where the sites were,” he said.
Results of the TRICS III trial were published simultaneously with Dr. Mazer’s presentation (N Engl J Med. 2017 Nov 12. doi: 10.1056/NEJMoa1711818).
The trial was funded by the Canadian Institutes of Health Research, among others. Dr. Mazer reported personal fees from Amgen, Boehringer Ingelheim, Octapharma, and Pharmascience, as well as grants and personal fees from Fresenius Kabi.
This is an extremely important study. There have been multiple other trials, and, unfortunately, results have been quite equivocal. It’s incumbent upon us to figure out the best transfusion strategy, especially in cardiac surgery, since it is associated with a large amount of blood utilization. Also, there’ve been projections for a significant lack of blood supply in the future.
While the overall results showed no significant difference in outcomes between the groups, there was a numerical benefit evident in the restrictive group for the composite outcome, as well as all components of the main primary outcome except MI. This is not entirely unexpected, but we are really looking at the short-term effects here. I’m hoping that the longer-term outcomes will be evaluated, because they are extremely important.
Frank Sellke, MD , is chief of cardiothoracic surgery at Brown University in Providence, R.I. He made his comments after the study was presented at the American Heart Association scientific sessions. He was not involved with the work.
This is an extremely important study. There have been multiple other trials, and, unfortunately, results have been quite equivocal. It’s incumbent upon us to figure out the best transfusion strategy, especially in cardiac surgery, since it is associated with a large amount of blood utilization. Also, there’ve been projections for a significant lack of blood supply in the future.
While the overall results showed no significant difference in outcomes between the groups, there was a numerical benefit evident in the restrictive group for the composite outcome, as well as all components of the main primary outcome except MI. This is not entirely unexpected, but we are really looking at the short-term effects here. I’m hoping that the longer-term outcomes will be evaluated, because they are extremely important.
Frank Sellke, MD , is chief of cardiothoracic surgery at Brown University in Providence, R.I. He made his comments after the study was presented at the American Heart Association scientific sessions. He was not involved with the work.
This is an extremely important study. There have been multiple other trials, and, unfortunately, results have been quite equivocal. It’s incumbent upon us to figure out the best transfusion strategy, especially in cardiac surgery, since it is associated with a large amount of blood utilization. Also, there’ve been projections for a significant lack of blood supply in the future.
While the overall results showed no significant difference in outcomes between the groups, there was a numerical benefit evident in the restrictive group for the composite outcome, as well as all components of the main primary outcome except MI. This is not entirely unexpected, but we are really looking at the short-term effects here. I’m hoping that the longer-term outcomes will be evaluated, because they are extremely important.
Frank Sellke, MD , is chief of cardiothoracic surgery at Brown University in Providence, R.I. He made his comments after the study was presented at the American Heart Association scientific sessions. He was not involved with the work.
ANAHEIM, CALIF. – Waiting to transfuse heart surgery patients until their hemoglobin drops below 7.5 g/dL is just as safe as transfusing them when their hemoglobin drops below 9.5 g/dL, and it saves a lot of blood, according to the TRICS III randomized, noninferiority trial of nearly 5,000 patients undergoing cardiac surgery with cardiopulmonary bypass.
Cardiac surgeons have been moving to more restrictive transfusion policies following reports of worse postoperative survival when patients are transfused. However, there are concerns about safety and uncertainty over whether it’s the transfusions themselves that are problematic or whether transfused patients do worse because they are sicker to begin with. The Transfusion Requirements in Cardiac Surgery (TRICS) III trial removes some of the doubt: “A restrictive transfusion strategy is as effective and safe as a liberal strategy in patients undergoing cardiac surgery,” said lead investigator C. David Mazer, MD, a professor in the department of anesthesia at the University of Toronto.
Overall, 11.4% in the restrictive-threshold group and 12.5% in the liberal-threshold group met the study’s composite primary outcome of death from any cause, MI, stroke, and new-onset renal failure with dialysis (P less than .001 for noninferiority). There were no statistically significant between-group differences in the individual components of the composite outcome. Mortality was 3% in the restrictive group and 3.6% in the liberal group, a 15% reduction for the restrictive group.
About 52% of the patients in the restrictive arm, compared with 72.6% in the liberal arm, were transfused. When transfused, patients in the restrictive arm received a median of 2 units of red cells; liberal-arm patients received a median of 3 units. The overall cost difference was roughly $3 million, Dr. Mazer said at the American Heart Association scientific sessions.
There were no statistically significant differences in secondary outcomes. Restrictive patients were on mechanical ventilation for a median of 0.38 days and in the ICU for a median of 2.1 days; patients in the liberal arm were ventilated for a median of 0.36 days and in the ICU for a median of 1.9 days. The median hospital stay was 8 days in both groups.
Unexpectedly, patients 75 years and older did better with the restrictive transfusion strategy, with a 30% lower risk of the composite outcome. “Many people think the older you are, the higher your hemoglobin should be, and the more liberal you should be with transfusions. We didn’t find that. [It] challenges current beliefs and may be considered to be hypothesis generating; at a minimum, it highlights that a restrictive transfusion strategy appears to be safe in elderly patients,” Dr. Mazer said.
The participants were a mean of 72 years old, and 35% were women. The majority in both arms underwent coronary artery bypass surgery, valve surgery, or both. Heart transplants were excluded from the study. The trial was conducted in 19 countries, including China and India, but “the results were remarkably consistent independent of where the sites were,” he said.
Results of the TRICS III trial were published simultaneously with Dr. Mazer’s presentation (N Engl J Med. 2017 Nov 12. doi: 10.1056/NEJMoa1711818).
The trial was funded by the Canadian Institutes of Health Research, among others. Dr. Mazer reported personal fees from Amgen, Boehringer Ingelheim, Octapharma, and Pharmascience, as well as grants and personal fees from Fresenius Kabi.
ANAHEIM, CALIF. – Waiting to transfuse heart surgery patients until their hemoglobin drops below 7.5 g/dL is just as safe as transfusing them when their hemoglobin drops below 9.5 g/dL, and it saves a lot of blood, according to the TRICS III randomized, noninferiority trial of nearly 5,000 patients undergoing cardiac surgery with cardiopulmonary bypass.
Cardiac surgeons have been moving to more restrictive transfusion policies following reports of worse postoperative survival when patients are transfused. However, there are concerns about safety and uncertainty over whether it’s the transfusions themselves that are problematic or whether transfused patients do worse because they are sicker to begin with. The Transfusion Requirements in Cardiac Surgery (TRICS) III trial removes some of the doubt: “A restrictive transfusion strategy is as effective and safe as a liberal strategy in patients undergoing cardiac surgery,” said lead investigator C. David Mazer, MD, a professor in the department of anesthesia at the University of Toronto.
Overall, 11.4% in the restrictive-threshold group and 12.5% in the liberal-threshold group met the study’s composite primary outcome of death from any cause, MI, stroke, and new-onset renal failure with dialysis (P less than .001 for noninferiority). There were no statistically significant between-group differences in the individual components of the composite outcome. Mortality was 3% in the restrictive group and 3.6% in the liberal group, a 15% reduction for the restrictive group.
About 52% of the patients in the restrictive arm, compared with 72.6% in the liberal arm, were transfused. When transfused, patients in the restrictive arm received a median of 2 units of red cells; liberal-arm patients received a median of 3 units. The overall cost difference was roughly $3 million, Dr. Mazer said at the American Heart Association scientific sessions.
There were no statistically significant differences in secondary outcomes. Restrictive patients were on mechanical ventilation for a median of 0.38 days and in the ICU for a median of 2.1 days; patients in the liberal arm were ventilated for a median of 0.36 days and in the ICU for a median of 1.9 days. The median hospital stay was 8 days in both groups.
Unexpectedly, patients 75 years and older did better with the restrictive transfusion strategy, with a 30% lower risk of the composite outcome. “Many people think the older you are, the higher your hemoglobin should be, and the more liberal you should be with transfusions. We didn’t find that. [It] challenges current beliefs and may be considered to be hypothesis generating; at a minimum, it highlights that a restrictive transfusion strategy appears to be safe in elderly patients,” Dr. Mazer said.
The participants were a mean of 72 years old, and 35% were women. The majority in both arms underwent coronary artery bypass surgery, valve surgery, or both. Heart transplants were excluded from the study. The trial was conducted in 19 countries, including China and India, but “the results were remarkably consistent independent of where the sites were,” he said.
Results of the TRICS III trial were published simultaneously with Dr. Mazer’s presentation (N Engl J Med. 2017 Nov 12. doi: 10.1056/NEJMoa1711818).
The trial was funded by the Canadian Institutes of Health Research, among others. Dr. Mazer reported personal fees from Amgen, Boehringer Ingelheim, Octapharma, and Pharmascience, as well as grants and personal fees from Fresenius Kabi.
AT THE AHA SCIENTIFIC SESSIONS
Key clinical point:
Major finding: Overall, 11.4% in the restrictive-threshold group, versus 12.5% in the liberal-threshold group, met the study’s composite primary outcome of death from any cause, myocardial infarction, stroke, or new-onset renal failure with dialysis.
Data source: TRICS III, a randomized, noninferiority trial with almost 5,000 participants
Disclosures: TRICS III was funded by the Canadian Institutes of Health Research, among others. The lead investigator reported personal fees from Amgen, Boehringer Ingelheim, Octapharma, and Pharmascience, as well as grants and personal fees from Fresenius Kabi.