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Anticoagulation Hub contains news and clinical review articles for physicians seeking the most up-to-date information on the rapidly evolving treatment options for preventing stroke, acute coronary events, deep vein thrombosis, and pulmonary embolism in at-risk patients. The Anticoagulation Hub is powered by Frontline Medical Communications.
Prenotification, unequivocal stroke promote ultra-fast door-to-needle time
BOSTON – Ultra-fast door-to-needle times of 10 minutes or less for intravenous acute ischemic stroke thrombolysis can be safely achieved in carefully selected cases, according to a review of cases at an Austrian teaching hospital.
Raffi Topakian, MD, and his colleagues at the Academic Teaching Hospital Wels-Grieskirchen in Wels, Austria, followed a multidisciplinary intervention to reinforce key components of the well-known Helsinki model of acute stroke care to improve the intravenous thrombolysis rate and the median door-to-needle time (DNT) at the teaching hospital and analyzed data from 361 patients who underwent intravenous thrombolysis (IVT) for stroke there between July 2014 and September 2016. The IVT rate increased from 19% to about 27% after intervention, and the DNT during the study period was 60 minutes or less in 316 patients (87.5%), 30 minutes or less in 181 patients (50.1%), and 10 minutes or less in 63 patients (17.5%).
“Over the study period, we reduced the DNT time from 49 minutes to 25 minutes. This was significant, and the door-to-needle times were astonishingly similar for the in-hours service and the out-of-hour service,” he said at the annual meeting of the American Academy of Neurology.
Further, the rate of prenotifications from emergency medical services rose from about 30% to 63% during the study period.
Patients with ultra-fast DNT vs. those with slower DNT were older, had more chronic heart failure, had more severe stroke (National Institutes of Health Stroke Scale score of 10 vs. 5), had more anterior circulation stroke and cardioembolic stroke, and had clear onset of stroke. Independent predictors of ultra-fast DNT included prenotification by EMS, anterior circulation syndrome, chronic heart failure, and having a stroke neurologist on duty, Dr. Topakian said.
“Ultra short DNTs can be achieved safely. The key is that we are prenotified by the EMS, that we can get all the relevant history details during transport, that there is a dedicated multidisciplinary stroke team and EMS staff, and that we have a seemingly unequivocal clinical scenario,” he said. “Out-of-hours DNT matched in-hours DNT, but the caveat is we’re talking about highly selected candidates; safety must not be sacrificed for the sake of speed, in all of our patients.”
Dr. Topakian has received personal compensation for activities with Novartis and Shire-Baxalta as an advisory board member; from Novartis, Pfizer, AbbVie, and Bayer for conference support; and from Pfizer as a speaker.
BOSTON – Ultra-fast door-to-needle times of 10 minutes or less for intravenous acute ischemic stroke thrombolysis can be safely achieved in carefully selected cases, according to a review of cases at an Austrian teaching hospital.
Raffi Topakian, MD, and his colleagues at the Academic Teaching Hospital Wels-Grieskirchen in Wels, Austria, followed a multidisciplinary intervention to reinforce key components of the well-known Helsinki model of acute stroke care to improve the intravenous thrombolysis rate and the median door-to-needle time (DNT) at the teaching hospital and analyzed data from 361 patients who underwent intravenous thrombolysis (IVT) for stroke there between July 2014 and September 2016. The IVT rate increased from 19% to about 27% after intervention, and the DNT during the study period was 60 minutes or less in 316 patients (87.5%), 30 minutes or less in 181 patients (50.1%), and 10 minutes or less in 63 patients (17.5%).
“Over the study period, we reduced the DNT time from 49 minutes to 25 minutes. This was significant, and the door-to-needle times were astonishingly similar for the in-hours service and the out-of-hour service,” he said at the annual meeting of the American Academy of Neurology.
Further, the rate of prenotifications from emergency medical services rose from about 30% to 63% during the study period.
Patients with ultra-fast DNT vs. those with slower DNT were older, had more chronic heart failure, had more severe stroke (National Institutes of Health Stroke Scale score of 10 vs. 5), had more anterior circulation stroke and cardioembolic stroke, and had clear onset of stroke. Independent predictors of ultra-fast DNT included prenotification by EMS, anterior circulation syndrome, chronic heart failure, and having a stroke neurologist on duty, Dr. Topakian said.
“Ultra short DNTs can be achieved safely. The key is that we are prenotified by the EMS, that we can get all the relevant history details during transport, that there is a dedicated multidisciplinary stroke team and EMS staff, and that we have a seemingly unequivocal clinical scenario,” he said. “Out-of-hours DNT matched in-hours DNT, but the caveat is we’re talking about highly selected candidates; safety must not be sacrificed for the sake of speed, in all of our patients.”
Dr. Topakian has received personal compensation for activities with Novartis and Shire-Baxalta as an advisory board member; from Novartis, Pfizer, AbbVie, and Bayer for conference support; and from Pfizer as a speaker.
BOSTON – Ultra-fast door-to-needle times of 10 minutes or less for intravenous acute ischemic stroke thrombolysis can be safely achieved in carefully selected cases, according to a review of cases at an Austrian teaching hospital.
Raffi Topakian, MD, and his colleagues at the Academic Teaching Hospital Wels-Grieskirchen in Wels, Austria, followed a multidisciplinary intervention to reinforce key components of the well-known Helsinki model of acute stroke care to improve the intravenous thrombolysis rate and the median door-to-needle time (DNT) at the teaching hospital and analyzed data from 361 patients who underwent intravenous thrombolysis (IVT) for stroke there between July 2014 and September 2016. The IVT rate increased from 19% to about 27% after intervention, and the DNT during the study period was 60 minutes or less in 316 patients (87.5%), 30 minutes or less in 181 patients (50.1%), and 10 minutes or less in 63 patients (17.5%).
“Over the study period, we reduced the DNT time from 49 minutes to 25 minutes. This was significant, and the door-to-needle times were astonishingly similar for the in-hours service and the out-of-hour service,” he said at the annual meeting of the American Academy of Neurology.
Further, the rate of prenotifications from emergency medical services rose from about 30% to 63% during the study period.
Patients with ultra-fast DNT vs. those with slower DNT were older, had more chronic heart failure, had more severe stroke (National Institutes of Health Stroke Scale score of 10 vs. 5), had more anterior circulation stroke and cardioembolic stroke, and had clear onset of stroke. Independent predictors of ultra-fast DNT included prenotification by EMS, anterior circulation syndrome, chronic heart failure, and having a stroke neurologist on duty, Dr. Topakian said.
“Ultra short DNTs can be achieved safely. The key is that we are prenotified by the EMS, that we can get all the relevant history details during transport, that there is a dedicated multidisciplinary stroke team and EMS staff, and that we have a seemingly unequivocal clinical scenario,” he said. “Out-of-hours DNT matched in-hours DNT, but the caveat is we’re talking about highly selected candidates; safety must not be sacrificed for the sake of speed, in all of our patients.”
Dr. Topakian has received personal compensation for activities with Novartis and Shire-Baxalta as an advisory board member; from Novartis, Pfizer, AbbVie, and Bayer for conference support; and from Pfizer as a speaker.
Key clinical point:
Major finding: Door-to-needle time of 10 minutes or less was achieved in 63 patients (17.5%).
Data source: A retrospective review of prospectively collected data from 361 patients.
Disclosures: Dr. Topakian has received personal compensation for activities with Novartis and Shire-Baxalta as an advisory board member; from Novartis, Pfizer, AbbVie, and Bayer for conference support; and from Pfizer as a speaker.
New-onset AF boosts bad HFrEF outcomes
WASHINGTON – New onset atrial fibrillation more than doubled the rate of adverse outcomes in patients with heart failure with reduced ejection fraction in a review of more than 15,000 such patients.
In 9,934 patients with heart failure with reduced ejection fraction (HFrEF) and no history of atrial fibrillation (AF), development of new-onset AF was linked with a greater than twofold increased risk of cardiovascular disease death or hospitalization for heart failure during follow-up, compared with HFrEF patients who did not initially have or later develop heart failure, after adjustment for several demographic and clinical variables, John J.V. McMurray, MD, said at the annual meeting of the American College of Cardiology. This difference for the primary endpoint of his analysis was statistically significant.
The 1,645 patients with paroxysmal AF at the start of their follow-up also had a significantly increased rate of cardiovascular death or heart failure hospitalization, but their increased risk when compared with HFrEF patients who didn’t develop AF was a much more modest 20% in his fully adjusted analysis. The patients who began follow-up with paroxysmal AF also had a relatively increased relative stroke rate of 33% when compared with HFrEF patients without AF at baseline who remained AF free, but the all-cause mortality rate among those with paroxysmal AF wasn’t significantly elevated, compared with the comparator group.
The 3,770 patients with persistent or permanent AF at baseline showed no statistically significant spike in their adverse event rates, compared with patients without AF, for any of the examined endpoints. The study group also included 66 patients with an undefined form of AF who weren’t included in these analyses.
“It’s the first episodes and paroxysmal episodes that cause trouble, and the trouble they cause is stroke,” Dr. McMurray said in an interview. Their stroke risk gets exacerbated in clinical practice, because these patients often don’t receive the stroke prevention they need in the form of anticoagulation treatment.
“We find over and over that patients with paroxysmal AF are not anticoagulated as frequently as they should be,” Dr. McMurray said. And HFrEF patients with a first AF episode need anticoagulation, too, as soon as AF is diagnosed, he advised.
He went a step further and speculated that the reason why HFrEF patients with new onset AF did so poorly in his analysis was because they already had several prior, brief AF episodes that had gone undetected. “Many of these patients probably had undiagnosed, clinically unapparent AF episodes” that then resulted in strokes, he suggested.
The upshot is that patients with HFrEF may need more aggressive monitoring for new-onset AF, possibly in the form of small, implanted arrhythmia-detection devices. Dr. McMurray said that he and other researchers are currently testing whether this hypothesis is correct. “We and others are now looking at this because these new data are convincing that new-onset AF is bad news [for HFrEF patients].”
In the analysis, “we looked only at clinically recognized and adjudicated new-onset AF. Goodness knows how many HFrEF patients are having unrecognized paroxysmal AF. Almost certainly there is a lot that is unrecognized” that potentially could be detected using a small implanted arrhythmia monitor, which could then lead to earlier anticoagulant treatment as well as possible treatment with antiarrhythmic drugs or with catheter ablation, Dr. McMurray said. Looking for undetected AF in HFrEF patients “is where the science is moving.”
The findings that Dr. McMurray reported are “something we should act on,” commented Adrian F. Hernandez, MD, professor of medicine and a cardiologist at Duke University in Durham, N.C. The comorbidity of AF in HFrEF patients requires “aggressive anticoagulation, and also a review of their heart failure medical treatment to be sure that is optimized, because AF could be a sign of worsening heart failure,” Dr. Hernandez said in an interview. “We may need to more aggressively get HFrEF patients with AF into normal sinus rhythm.”
When Mikhail Kosiborod, MD, treats HFrEF patients with a high risk for AF, such as patients with lower ejection fractions, a dilated left ventricle, or a dilated atrium, “I frequently do 30-day loop recordings in these patients because of their risk for incident AF,” Dr. Kosiborod said in an interview. “We don’t yet have convincing evidence for this, but it makes sense.”
Another finding from his analysis was that the HFrEF patients enrolled in these two trials did not get treatment with a mineralocorticoid receptor antagonist – spironolactone or eplerenone – “as often as they should,” with treatment rates of 44%-48%, compared with use of a beta-blocker in 92%-95% of patients. Treatment with eplerenone (Inspra) “has been shown to reduce the risk for new onset AF, so adding eplerenone or spironolactone is an important step that could be taken to try to prevent AF as well as treat the HFrEF and reduce mortality,” Dr. McMurray said.
PARADIGM-HF and ATMOSPHERE were funded by Novartis. Dr. McMurray has been a consultant to and has received travel and research support from Novartis, and he has received research and travel support from Amgen. Dr. Hernandez has received honoraria from Amgen, AstraZeneca, Janssen, Merck, and Novartis, and has received research support from Amgen, Bayer, Merck, and Portola. Dr. Kosiborod has been a consultant to several drug companies, and he has received research funding from AstraZeneca, Boehringer Ingelheim, Gilead, and Sanofi-Aventis.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
WASHINGTON – New onset atrial fibrillation more than doubled the rate of adverse outcomes in patients with heart failure with reduced ejection fraction in a review of more than 15,000 such patients.
In 9,934 patients with heart failure with reduced ejection fraction (HFrEF) and no history of atrial fibrillation (AF), development of new-onset AF was linked with a greater than twofold increased risk of cardiovascular disease death or hospitalization for heart failure during follow-up, compared with HFrEF patients who did not initially have or later develop heart failure, after adjustment for several demographic and clinical variables, John J.V. McMurray, MD, said at the annual meeting of the American College of Cardiology. This difference for the primary endpoint of his analysis was statistically significant.
The 1,645 patients with paroxysmal AF at the start of their follow-up also had a significantly increased rate of cardiovascular death or heart failure hospitalization, but their increased risk when compared with HFrEF patients who didn’t develop AF was a much more modest 20% in his fully adjusted analysis. The patients who began follow-up with paroxysmal AF also had a relatively increased relative stroke rate of 33% when compared with HFrEF patients without AF at baseline who remained AF free, but the all-cause mortality rate among those with paroxysmal AF wasn’t significantly elevated, compared with the comparator group.
The 3,770 patients with persistent or permanent AF at baseline showed no statistically significant spike in their adverse event rates, compared with patients without AF, for any of the examined endpoints. The study group also included 66 patients with an undefined form of AF who weren’t included in these analyses.
“It’s the first episodes and paroxysmal episodes that cause trouble, and the trouble they cause is stroke,” Dr. McMurray said in an interview. Their stroke risk gets exacerbated in clinical practice, because these patients often don’t receive the stroke prevention they need in the form of anticoagulation treatment.
“We find over and over that patients with paroxysmal AF are not anticoagulated as frequently as they should be,” Dr. McMurray said. And HFrEF patients with a first AF episode need anticoagulation, too, as soon as AF is diagnosed, he advised.
He went a step further and speculated that the reason why HFrEF patients with new onset AF did so poorly in his analysis was because they already had several prior, brief AF episodes that had gone undetected. “Many of these patients probably had undiagnosed, clinically unapparent AF episodes” that then resulted in strokes, he suggested.
The upshot is that patients with HFrEF may need more aggressive monitoring for new-onset AF, possibly in the form of small, implanted arrhythmia-detection devices. Dr. McMurray said that he and other researchers are currently testing whether this hypothesis is correct. “We and others are now looking at this because these new data are convincing that new-onset AF is bad news [for HFrEF patients].”
In the analysis, “we looked only at clinically recognized and adjudicated new-onset AF. Goodness knows how many HFrEF patients are having unrecognized paroxysmal AF. Almost certainly there is a lot that is unrecognized” that potentially could be detected using a small implanted arrhythmia monitor, which could then lead to earlier anticoagulant treatment as well as possible treatment with antiarrhythmic drugs or with catheter ablation, Dr. McMurray said. Looking for undetected AF in HFrEF patients “is where the science is moving.”
The findings that Dr. McMurray reported are “something we should act on,” commented Adrian F. Hernandez, MD, professor of medicine and a cardiologist at Duke University in Durham, N.C. The comorbidity of AF in HFrEF patients requires “aggressive anticoagulation, and also a review of their heart failure medical treatment to be sure that is optimized, because AF could be a sign of worsening heart failure,” Dr. Hernandez said in an interview. “We may need to more aggressively get HFrEF patients with AF into normal sinus rhythm.”
When Mikhail Kosiborod, MD, treats HFrEF patients with a high risk for AF, such as patients with lower ejection fractions, a dilated left ventricle, or a dilated atrium, “I frequently do 30-day loop recordings in these patients because of their risk for incident AF,” Dr. Kosiborod said in an interview. “We don’t yet have convincing evidence for this, but it makes sense.”
Another finding from his analysis was that the HFrEF patients enrolled in these two trials did not get treatment with a mineralocorticoid receptor antagonist – spironolactone or eplerenone – “as often as they should,” with treatment rates of 44%-48%, compared with use of a beta-blocker in 92%-95% of patients. Treatment with eplerenone (Inspra) “has been shown to reduce the risk for new onset AF, so adding eplerenone or spironolactone is an important step that could be taken to try to prevent AF as well as treat the HFrEF and reduce mortality,” Dr. McMurray said.
PARADIGM-HF and ATMOSPHERE were funded by Novartis. Dr. McMurray has been a consultant to and has received travel and research support from Novartis, and he has received research and travel support from Amgen. Dr. Hernandez has received honoraria from Amgen, AstraZeneca, Janssen, Merck, and Novartis, and has received research support from Amgen, Bayer, Merck, and Portola. Dr. Kosiborod has been a consultant to several drug companies, and he has received research funding from AstraZeneca, Boehringer Ingelheim, Gilead, and Sanofi-Aventis.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
WASHINGTON – New onset atrial fibrillation more than doubled the rate of adverse outcomes in patients with heart failure with reduced ejection fraction in a review of more than 15,000 such patients.
In 9,934 patients with heart failure with reduced ejection fraction (HFrEF) and no history of atrial fibrillation (AF), development of new-onset AF was linked with a greater than twofold increased risk of cardiovascular disease death or hospitalization for heart failure during follow-up, compared with HFrEF patients who did not initially have or later develop heart failure, after adjustment for several demographic and clinical variables, John J.V. McMurray, MD, said at the annual meeting of the American College of Cardiology. This difference for the primary endpoint of his analysis was statistically significant.
The 1,645 patients with paroxysmal AF at the start of their follow-up also had a significantly increased rate of cardiovascular death or heart failure hospitalization, but their increased risk when compared with HFrEF patients who didn’t develop AF was a much more modest 20% in his fully adjusted analysis. The patients who began follow-up with paroxysmal AF also had a relatively increased relative stroke rate of 33% when compared with HFrEF patients without AF at baseline who remained AF free, but the all-cause mortality rate among those with paroxysmal AF wasn’t significantly elevated, compared with the comparator group.
The 3,770 patients with persistent or permanent AF at baseline showed no statistically significant spike in their adverse event rates, compared with patients without AF, for any of the examined endpoints. The study group also included 66 patients with an undefined form of AF who weren’t included in these analyses.
“It’s the first episodes and paroxysmal episodes that cause trouble, and the trouble they cause is stroke,” Dr. McMurray said in an interview. Their stroke risk gets exacerbated in clinical practice, because these patients often don’t receive the stroke prevention they need in the form of anticoagulation treatment.
“We find over and over that patients with paroxysmal AF are not anticoagulated as frequently as they should be,” Dr. McMurray said. And HFrEF patients with a first AF episode need anticoagulation, too, as soon as AF is diagnosed, he advised.
He went a step further and speculated that the reason why HFrEF patients with new onset AF did so poorly in his analysis was because they already had several prior, brief AF episodes that had gone undetected. “Many of these patients probably had undiagnosed, clinically unapparent AF episodes” that then resulted in strokes, he suggested.
The upshot is that patients with HFrEF may need more aggressive monitoring for new-onset AF, possibly in the form of small, implanted arrhythmia-detection devices. Dr. McMurray said that he and other researchers are currently testing whether this hypothesis is correct. “We and others are now looking at this because these new data are convincing that new-onset AF is bad news [for HFrEF patients].”
In the analysis, “we looked only at clinically recognized and adjudicated new-onset AF. Goodness knows how many HFrEF patients are having unrecognized paroxysmal AF. Almost certainly there is a lot that is unrecognized” that potentially could be detected using a small implanted arrhythmia monitor, which could then lead to earlier anticoagulant treatment as well as possible treatment with antiarrhythmic drugs or with catheter ablation, Dr. McMurray said. Looking for undetected AF in HFrEF patients “is where the science is moving.”
The findings that Dr. McMurray reported are “something we should act on,” commented Adrian F. Hernandez, MD, professor of medicine and a cardiologist at Duke University in Durham, N.C. The comorbidity of AF in HFrEF patients requires “aggressive anticoagulation, and also a review of their heart failure medical treatment to be sure that is optimized, because AF could be a sign of worsening heart failure,” Dr. Hernandez said in an interview. “We may need to more aggressively get HFrEF patients with AF into normal sinus rhythm.”
When Mikhail Kosiborod, MD, treats HFrEF patients with a high risk for AF, such as patients with lower ejection fractions, a dilated left ventricle, or a dilated atrium, “I frequently do 30-day loop recordings in these patients because of their risk for incident AF,” Dr. Kosiborod said in an interview. “We don’t yet have convincing evidence for this, but it makes sense.”
Another finding from his analysis was that the HFrEF patients enrolled in these two trials did not get treatment with a mineralocorticoid receptor antagonist – spironolactone or eplerenone – “as often as they should,” with treatment rates of 44%-48%, compared with use of a beta-blocker in 92%-95% of patients. Treatment with eplerenone (Inspra) “has been shown to reduce the risk for new onset AF, so adding eplerenone or spironolactone is an important step that could be taken to try to prevent AF as well as treat the HFrEF and reduce mortality,” Dr. McMurray said.
PARADIGM-HF and ATMOSPHERE were funded by Novartis. Dr. McMurray has been a consultant to and has received travel and research support from Novartis, and he has received research and travel support from Amgen. Dr. Hernandez has received honoraria from Amgen, AstraZeneca, Janssen, Merck, and Novartis, and has received research support from Amgen, Bayer, Merck, and Portola. Dr. Kosiborod has been a consultant to several drug companies, and he has received research funding from AstraZeneca, Boehringer Ingelheim, Gilead, and Sanofi-Aventis.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
AT ACC 17
Key clinical point:
Major finding: Adverse outcomes were more than twice as frequent in HFrEF patients with incident atrial fibrillation, compared with those without AF.
Data source: Post hoc analysis of 15,415 heart failure patients enrolled in the PARADIGM-HF and ATMOSPHERE trials.
Disclosures: PARADIGM-HF and ATMOSPHERE were funded by Novartis. Dr. McMurray has been a consultant to and has received travel and research support from Novartis, and he has received research and travel support from Amgen.
‘Sobering’ high 10-year mortality post-MI after age 65
WASHINGTON – Patients who experience an acute MI at age 65 or older have unsettlingly high 5- and 10-year mortality in community practice settings despite excellent rates of evidence-based medications being prescribed at discharge, Ajar Kochar, MD, reported at the annual meeting of the American College of Cardiology.
This observation is based upon more than 22,000 patients aged 65 years or older treated for an acute MI during 2004-2006 at 344 U.S. hospitals participating in the CRUSADE registry. Their median age at the time of MI was 77 years. But 10-year all-cause mortality remained high even among relatively younger patients aged 65-74 whom one would expect to have a favorable long-term prognosis because they had additional survival-enhancing factors working in their favor, including having undergone coronary revascularization during their index hospitalization and surviving their first year post-MI, observed Dr. Kochar of the Duke Clinical Research Institute in Durham, N.C.
This unmet need will increasingly clamor for attention as the aging of the American population accelerates like a runaway freight train. By 2030, an estimated 20% of Americans will be aged 65 or older. That’s more than 71 million people. And more than half of all MIs occur in individuals above age 65, he noted.
Dr. Kochar presented a CRUSADE analysis which included 19,755 older Americans with a non–ST elevation MI (NSTEMI) and 2,540 with a STEMI. The overall group’s 1-year mortality was 24%, with a 5-year cumulative mortality of 51% and a whopping 10-year mortality of 72%.
According to the Centers for Disease Control and Prevention, the expected additional lifespan of someone who was 65 years old in 2015 is 19 years. In contrast, the median survival of patients in the CRUSADE registry who were 65-69 at the time of their MI was less than half of that, at 8.3 years.
Among the key findings from the CRUSADE analysis:
• Unadjusted 10-year all-cause mortality was significantly greater in patients with NSTEMI than STEMI, by a margin of 73% versus 60%. Notably, however, NSTEMI patients were far less likely to undergo coronary revascularization: 32% of them had percutaneous coronary intervention during their index hospitalization, and 8.7% underwent coronary artery bypass grafting, in contrast to rates of 65.5% for PCI and 8.0% for CABG in the STEMI patients. After adjustment for these and other differences in care, NSTEMI patients actually had a 7% lower risk of long-term mortality than the STEMI group.
• Even after limiting the analysis to the youngest elderly – patients aged 65-74 when their MI occurred – 10-year mortality remained high, at 53%.
• After excluding the 24% of patients who died within 1 year after MI, 10-year mortality was still quite high, at 63%. Dr. Kochar and his coinvestigators chose to reanalyze the data in this way because the 1-year mark is an important time point clinically, since it’s when decisions regarding extended dual-antiplatelet therapy are made.
Patients who underwent coronary revascularization during their index hospitalization had a much-improved long-term prognosis, compared with those with medical management only. The 10-year cumulative mortality rate was 57% in patients who had PCI, identical at 57% in those who received CABG, and 84% in medically managed patients.
Ninety-five percent of patients were discharged on aspirin, 94% on a beta blocker, 81% on a statin, and 73% on clopidogrel. Discharge prescriptions for statins and clopidogrel were more common for the STEMI group. Unfortunately, the CRUSADE registry doesn’t include data on long-term medication adherence or prescription refill rates.
Dr. Kochar named several potential strategies aimed at reducing the high long-term mortality rates in older patients with MI as documented in this study. These include structured efforts to improve adherence to evidence-based medications for secondary prevention, as well as making percutaneous revascularization more widely available for older patients with NSTEMI. He noted that while in 2004-2006, 32% of CRUSADE participants with NSTEMI underwent PCI during their index hospitalization, by 2011-2012 that rate had inched upward only to 36%.
Several physicians commented that the high long-term all-cause mortality rates in older CRUSADE participants may paint a grim picture, in part because the aged face growing risks of cancer and other noncardiovascular competing causes of death. But Dr. Kochar replied that while the lack of information on specific causes of death is a study limitation, he and his coinvestigators are convinced based upon data from other studies that most of the deaths in CRUSADE were cardiovascular in nature.
He reported having no financial conflicts regarding his study.
WASHINGTON – Patients who experience an acute MI at age 65 or older have unsettlingly high 5- and 10-year mortality in community practice settings despite excellent rates of evidence-based medications being prescribed at discharge, Ajar Kochar, MD, reported at the annual meeting of the American College of Cardiology.
This observation is based upon more than 22,000 patients aged 65 years or older treated for an acute MI during 2004-2006 at 344 U.S. hospitals participating in the CRUSADE registry. Their median age at the time of MI was 77 years. But 10-year all-cause mortality remained high even among relatively younger patients aged 65-74 whom one would expect to have a favorable long-term prognosis because they had additional survival-enhancing factors working in their favor, including having undergone coronary revascularization during their index hospitalization and surviving their first year post-MI, observed Dr. Kochar of the Duke Clinical Research Institute in Durham, N.C.
This unmet need will increasingly clamor for attention as the aging of the American population accelerates like a runaway freight train. By 2030, an estimated 20% of Americans will be aged 65 or older. That’s more than 71 million people. And more than half of all MIs occur in individuals above age 65, he noted.
Dr. Kochar presented a CRUSADE analysis which included 19,755 older Americans with a non–ST elevation MI (NSTEMI) and 2,540 with a STEMI. The overall group’s 1-year mortality was 24%, with a 5-year cumulative mortality of 51% and a whopping 10-year mortality of 72%.
According to the Centers for Disease Control and Prevention, the expected additional lifespan of someone who was 65 years old in 2015 is 19 years. In contrast, the median survival of patients in the CRUSADE registry who were 65-69 at the time of their MI was less than half of that, at 8.3 years.
Among the key findings from the CRUSADE analysis:
• Unadjusted 10-year all-cause mortality was significantly greater in patients with NSTEMI than STEMI, by a margin of 73% versus 60%. Notably, however, NSTEMI patients were far less likely to undergo coronary revascularization: 32% of them had percutaneous coronary intervention during their index hospitalization, and 8.7% underwent coronary artery bypass grafting, in contrast to rates of 65.5% for PCI and 8.0% for CABG in the STEMI patients. After adjustment for these and other differences in care, NSTEMI patients actually had a 7% lower risk of long-term mortality than the STEMI group.
• Even after limiting the analysis to the youngest elderly – patients aged 65-74 when their MI occurred – 10-year mortality remained high, at 53%.
• After excluding the 24% of patients who died within 1 year after MI, 10-year mortality was still quite high, at 63%. Dr. Kochar and his coinvestigators chose to reanalyze the data in this way because the 1-year mark is an important time point clinically, since it’s when decisions regarding extended dual-antiplatelet therapy are made.
Patients who underwent coronary revascularization during their index hospitalization had a much-improved long-term prognosis, compared with those with medical management only. The 10-year cumulative mortality rate was 57% in patients who had PCI, identical at 57% in those who received CABG, and 84% in medically managed patients.
Ninety-five percent of patients were discharged on aspirin, 94% on a beta blocker, 81% on a statin, and 73% on clopidogrel. Discharge prescriptions for statins and clopidogrel were more common for the STEMI group. Unfortunately, the CRUSADE registry doesn’t include data on long-term medication adherence or prescription refill rates.
Dr. Kochar named several potential strategies aimed at reducing the high long-term mortality rates in older patients with MI as documented in this study. These include structured efforts to improve adherence to evidence-based medications for secondary prevention, as well as making percutaneous revascularization more widely available for older patients with NSTEMI. He noted that while in 2004-2006, 32% of CRUSADE participants with NSTEMI underwent PCI during their index hospitalization, by 2011-2012 that rate had inched upward only to 36%.
Several physicians commented that the high long-term all-cause mortality rates in older CRUSADE participants may paint a grim picture, in part because the aged face growing risks of cancer and other noncardiovascular competing causes of death. But Dr. Kochar replied that while the lack of information on specific causes of death is a study limitation, he and his coinvestigators are convinced based upon data from other studies that most of the deaths in CRUSADE were cardiovascular in nature.
He reported having no financial conflicts regarding his study.
WASHINGTON – Patients who experience an acute MI at age 65 or older have unsettlingly high 5- and 10-year mortality in community practice settings despite excellent rates of evidence-based medications being prescribed at discharge, Ajar Kochar, MD, reported at the annual meeting of the American College of Cardiology.
This observation is based upon more than 22,000 patients aged 65 years or older treated for an acute MI during 2004-2006 at 344 U.S. hospitals participating in the CRUSADE registry. Their median age at the time of MI was 77 years. But 10-year all-cause mortality remained high even among relatively younger patients aged 65-74 whom one would expect to have a favorable long-term prognosis because they had additional survival-enhancing factors working in their favor, including having undergone coronary revascularization during their index hospitalization and surviving their first year post-MI, observed Dr. Kochar of the Duke Clinical Research Institute in Durham, N.C.
This unmet need will increasingly clamor for attention as the aging of the American population accelerates like a runaway freight train. By 2030, an estimated 20% of Americans will be aged 65 or older. That’s more than 71 million people. And more than half of all MIs occur in individuals above age 65, he noted.
Dr. Kochar presented a CRUSADE analysis which included 19,755 older Americans with a non–ST elevation MI (NSTEMI) and 2,540 with a STEMI. The overall group’s 1-year mortality was 24%, with a 5-year cumulative mortality of 51% and a whopping 10-year mortality of 72%.
According to the Centers for Disease Control and Prevention, the expected additional lifespan of someone who was 65 years old in 2015 is 19 years. In contrast, the median survival of patients in the CRUSADE registry who were 65-69 at the time of their MI was less than half of that, at 8.3 years.
Among the key findings from the CRUSADE analysis:
• Unadjusted 10-year all-cause mortality was significantly greater in patients with NSTEMI than STEMI, by a margin of 73% versus 60%. Notably, however, NSTEMI patients were far less likely to undergo coronary revascularization: 32% of them had percutaneous coronary intervention during their index hospitalization, and 8.7% underwent coronary artery bypass grafting, in contrast to rates of 65.5% for PCI and 8.0% for CABG in the STEMI patients. After adjustment for these and other differences in care, NSTEMI patients actually had a 7% lower risk of long-term mortality than the STEMI group.
• Even after limiting the analysis to the youngest elderly – patients aged 65-74 when their MI occurred – 10-year mortality remained high, at 53%.
• After excluding the 24% of patients who died within 1 year after MI, 10-year mortality was still quite high, at 63%. Dr. Kochar and his coinvestigators chose to reanalyze the data in this way because the 1-year mark is an important time point clinically, since it’s when decisions regarding extended dual-antiplatelet therapy are made.
Patients who underwent coronary revascularization during their index hospitalization had a much-improved long-term prognosis, compared with those with medical management only. The 10-year cumulative mortality rate was 57% in patients who had PCI, identical at 57% in those who received CABG, and 84% in medically managed patients.
Ninety-five percent of patients were discharged on aspirin, 94% on a beta blocker, 81% on a statin, and 73% on clopidogrel. Discharge prescriptions for statins and clopidogrel were more common for the STEMI group. Unfortunately, the CRUSADE registry doesn’t include data on long-term medication adherence or prescription refill rates.
Dr. Kochar named several potential strategies aimed at reducing the high long-term mortality rates in older patients with MI as documented in this study. These include structured efforts to improve adherence to evidence-based medications for secondary prevention, as well as making percutaneous revascularization more widely available for older patients with NSTEMI. He noted that while in 2004-2006, 32% of CRUSADE participants with NSTEMI underwent PCI during their index hospitalization, by 2011-2012 that rate had inched upward only to 36%.
Several physicians commented that the high long-term all-cause mortality rates in older CRUSADE participants may paint a grim picture, in part because the aged face growing risks of cancer and other noncardiovascular competing causes of death. But Dr. Kochar replied that while the lack of information on specific causes of death is a study limitation, he and his coinvestigators are convinced based upon data from other studies that most of the deaths in CRUSADE were cardiovascular in nature.
He reported having no financial conflicts regarding his study.
AT ACC 17
Key clinical point:
Major finding: The 10-year cumulative mortality rate in patients who had an MI at age 65-74 is 53%.
Data source: This was an analysis of 10-year cumulative mortality in more than 22,000 patients aged 65 or older treated for an acute MI during 2004-2006 at 344 U.S. community hospitals participating in the prospective CRUSADE registry.
Disclosures: The study presenter reported having no financial conflicts.
Marijuana abuse linked to increased MI risk
Washington – Marijuana abuse was independently associated with an eye-opening doubled risk of acute MI in a large, retrospective, age-matched cohort study, Ahmad Tarek Chami, MD, reported at the annual meeting of the American College of Cardiology.
The link was strongest by far in young adult marijuana abusers, with an adjusted 3.2-fold increased risk of MI in 25- to 29-year-olds with marijuana abuse noted in their medical records, compared with age-matched controls and a 4.56-fold greater risk among the 30- to 34-year-old cannabis abusers, according to Dr. Chami of Case Western Reserve University in Cleveland.
These data constitute a signal warranting further research. Public opinion regarding potheads has undergone a huge shift. Medical and/or recreational marijuana is now legal in 28 states and the District of Columbia. Surveys indicate that, in 2015, 8.3% of Americans aged 12 years and older had used marijuana during the previous month, and 13.5% had used it within the past year.
“Cardiologists and other physicians are more likely than ever before to encounter patients who use marijuana or even ask them to prescribe it,” Dr. Chami said.
The cannabis plant contains more than 60 cannabinoids. Although marijuana is widely prescribed for treatment of nausea, anorexia, neuropathic pain, glaucoma, seizure disorders, and other conditions, the long-term effects of marijuana on the cardiovascular system are largely unknown, he continued.
This ambiguity was the impetus for Dr. Chami’s study. In it, he utilized a database incorporating 26 health care systems across the United States with nearly 50 million patients, which is maintained by Explorys, an 8-year-old Cleveland-based company.
Dr. Chami identified 210,700 patients with cannabis abuse noted in their medical records, covering provider/patient encounters between October 2011 and September 2016. Their mean age was 36.8 years. The abusers were age-matched to 10,395,060 non–marijuana abuser controls.
The 5-year cumulative incidence of MI in this skewed–young patient population was significantly higher than in the marijuana abuser group: 1.28%, compared with 0.89%, for a 44% increase in relative risk.
However, the marijuana abusers also had a significantly higher burden of cardiovascular risk factors than did their non–cannabis abusing counterparts. They were 2.85 times more likely to have hypertension, 1.59 times more likely to be dyslipidemic, and 7.2 times more likely to be cigarette smokers, and they had a 2.8 times greater prevalence of diabetes. Of note, they were also 17.6 times more likely to have been diagnosed with alcohol abuse, and 61 times more likely to abuse cocaine.
In a multivariate analysis adjusted for these and other potential confounders, marijuana abuse remained independently associated with a 1.73-fold increased risk of acute MI. Moreover, after eliminating patients with known coronary artery disease, the strongest risk factor for MI, from the analysis, marijuana abuse was independently associated with a twofold increased risk of MI.
This was a retrospective study, one limitation of which was the standard caveat regarding the possibility of unrecognized confounders that couldn’t be taken into account.
Another study limitation is the uncertainty regarding the diagnosis of “cannabis abuser” in patients’ charts. The Explorys cloud-based database relies on ICD codes to capture data. It doesn’t include specific information on how much marijuana a patient who was labeled as an abuser was actually using. This limitation raises an unanswered question: Were young adults who abused marijuana at highest risk for MI because of heavier use, or are younger patients’ coronary arteries somehow more vulnerable to marijuana’s potential adverse cardiovascular effects?
Several audience members called Dr. Chami’s study “very provocative.” Aaron D. Kugelmass, MD, said that the fundamental question in his mind is whether the cardiovascular hazard of marijuana identified in this study is the result of the practice of smoking the raw product, usually associated with illicit marijuana abusers.
Today, legalized marijuana is often consumed in the form of edible products, tinctures, and other derivatives that don’t involve inhalation of smoke. Whether these alternative forms of consumption pose any cardiovascular risk is an important unresolved issue in this era of widespread decriminalization of cannabis, noted Dr. Kugelmass, chief of cardiology and medical director of the Heart and Vascular Center at Baystate Medical Center in Springfield, Mass.
Dr. Chami reported having no financial conflicts regarding his study.
Washington – Marijuana abuse was independently associated with an eye-opening doubled risk of acute MI in a large, retrospective, age-matched cohort study, Ahmad Tarek Chami, MD, reported at the annual meeting of the American College of Cardiology.
The link was strongest by far in young adult marijuana abusers, with an adjusted 3.2-fold increased risk of MI in 25- to 29-year-olds with marijuana abuse noted in their medical records, compared with age-matched controls and a 4.56-fold greater risk among the 30- to 34-year-old cannabis abusers, according to Dr. Chami of Case Western Reserve University in Cleveland.
These data constitute a signal warranting further research. Public opinion regarding potheads has undergone a huge shift. Medical and/or recreational marijuana is now legal in 28 states and the District of Columbia. Surveys indicate that, in 2015, 8.3% of Americans aged 12 years and older had used marijuana during the previous month, and 13.5% had used it within the past year.
“Cardiologists and other physicians are more likely than ever before to encounter patients who use marijuana or even ask them to prescribe it,” Dr. Chami said.
The cannabis plant contains more than 60 cannabinoids. Although marijuana is widely prescribed for treatment of nausea, anorexia, neuropathic pain, glaucoma, seizure disorders, and other conditions, the long-term effects of marijuana on the cardiovascular system are largely unknown, he continued.
This ambiguity was the impetus for Dr. Chami’s study. In it, he utilized a database incorporating 26 health care systems across the United States with nearly 50 million patients, which is maintained by Explorys, an 8-year-old Cleveland-based company.
Dr. Chami identified 210,700 patients with cannabis abuse noted in their medical records, covering provider/patient encounters between October 2011 and September 2016. Their mean age was 36.8 years. The abusers were age-matched to 10,395,060 non–marijuana abuser controls.
The 5-year cumulative incidence of MI in this skewed–young patient population was significantly higher than in the marijuana abuser group: 1.28%, compared with 0.89%, for a 44% increase in relative risk.
However, the marijuana abusers also had a significantly higher burden of cardiovascular risk factors than did their non–cannabis abusing counterparts. They were 2.85 times more likely to have hypertension, 1.59 times more likely to be dyslipidemic, and 7.2 times more likely to be cigarette smokers, and they had a 2.8 times greater prevalence of diabetes. Of note, they were also 17.6 times more likely to have been diagnosed with alcohol abuse, and 61 times more likely to abuse cocaine.
In a multivariate analysis adjusted for these and other potential confounders, marijuana abuse remained independently associated with a 1.73-fold increased risk of acute MI. Moreover, after eliminating patients with known coronary artery disease, the strongest risk factor for MI, from the analysis, marijuana abuse was independently associated with a twofold increased risk of MI.
This was a retrospective study, one limitation of which was the standard caveat regarding the possibility of unrecognized confounders that couldn’t be taken into account.
Another study limitation is the uncertainty regarding the diagnosis of “cannabis abuser” in patients’ charts. The Explorys cloud-based database relies on ICD codes to capture data. It doesn’t include specific information on how much marijuana a patient who was labeled as an abuser was actually using. This limitation raises an unanswered question: Were young adults who abused marijuana at highest risk for MI because of heavier use, or are younger patients’ coronary arteries somehow more vulnerable to marijuana’s potential adverse cardiovascular effects?
Several audience members called Dr. Chami’s study “very provocative.” Aaron D. Kugelmass, MD, said that the fundamental question in his mind is whether the cardiovascular hazard of marijuana identified in this study is the result of the practice of smoking the raw product, usually associated with illicit marijuana abusers.
Today, legalized marijuana is often consumed in the form of edible products, tinctures, and other derivatives that don’t involve inhalation of smoke. Whether these alternative forms of consumption pose any cardiovascular risk is an important unresolved issue in this era of widespread decriminalization of cannabis, noted Dr. Kugelmass, chief of cardiology and medical director of the Heart and Vascular Center at Baystate Medical Center in Springfield, Mass.
Dr. Chami reported having no financial conflicts regarding his study.
Washington – Marijuana abuse was independently associated with an eye-opening doubled risk of acute MI in a large, retrospective, age-matched cohort study, Ahmad Tarek Chami, MD, reported at the annual meeting of the American College of Cardiology.
The link was strongest by far in young adult marijuana abusers, with an adjusted 3.2-fold increased risk of MI in 25- to 29-year-olds with marijuana abuse noted in their medical records, compared with age-matched controls and a 4.56-fold greater risk among the 30- to 34-year-old cannabis abusers, according to Dr. Chami of Case Western Reserve University in Cleveland.
These data constitute a signal warranting further research. Public opinion regarding potheads has undergone a huge shift. Medical and/or recreational marijuana is now legal in 28 states and the District of Columbia. Surveys indicate that, in 2015, 8.3% of Americans aged 12 years and older had used marijuana during the previous month, and 13.5% had used it within the past year.
“Cardiologists and other physicians are more likely than ever before to encounter patients who use marijuana or even ask them to prescribe it,” Dr. Chami said.
The cannabis plant contains more than 60 cannabinoids. Although marijuana is widely prescribed for treatment of nausea, anorexia, neuropathic pain, glaucoma, seizure disorders, and other conditions, the long-term effects of marijuana on the cardiovascular system are largely unknown, he continued.
This ambiguity was the impetus for Dr. Chami’s study. In it, he utilized a database incorporating 26 health care systems across the United States with nearly 50 million patients, which is maintained by Explorys, an 8-year-old Cleveland-based company.
Dr. Chami identified 210,700 patients with cannabis abuse noted in their medical records, covering provider/patient encounters between October 2011 and September 2016. Their mean age was 36.8 years. The abusers were age-matched to 10,395,060 non–marijuana abuser controls.
The 5-year cumulative incidence of MI in this skewed–young patient population was significantly higher than in the marijuana abuser group: 1.28%, compared with 0.89%, for a 44% increase in relative risk.
However, the marijuana abusers also had a significantly higher burden of cardiovascular risk factors than did their non–cannabis abusing counterparts. They were 2.85 times more likely to have hypertension, 1.59 times more likely to be dyslipidemic, and 7.2 times more likely to be cigarette smokers, and they had a 2.8 times greater prevalence of diabetes. Of note, they were also 17.6 times more likely to have been diagnosed with alcohol abuse, and 61 times more likely to abuse cocaine.
In a multivariate analysis adjusted for these and other potential confounders, marijuana abuse remained independently associated with a 1.73-fold increased risk of acute MI. Moreover, after eliminating patients with known coronary artery disease, the strongest risk factor for MI, from the analysis, marijuana abuse was independently associated with a twofold increased risk of MI.
This was a retrospective study, one limitation of which was the standard caveat regarding the possibility of unrecognized confounders that couldn’t be taken into account.
Another study limitation is the uncertainty regarding the diagnosis of “cannabis abuser” in patients’ charts. The Explorys cloud-based database relies on ICD codes to capture data. It doesn’t include specific information on how much marijuana a patient who was labeled as an abuser was actually using. This limitation raises an unanswered question: Were young adults who abused marijuana at highest risk for MI because of heavier use, or are younger patients’ coronary arteries somehow more vulnerable to marijuana’s potential adverse cardiovascular effects?
Several audience members called Dr. Chami’s study “very provocative.” Aaron D. Kugelmass, MD, said that the fundamental question in his mind is whether the cardiovascular hazard of marijuana identified in this study is the result of the practice of smoking the raw product, usually associated with illicit marijuana abusers.
Today, legalized marijuana is often consumed in the form of edible products, tinctures, and other derivatives that don’t involve inhalation of smoke. Whether these alternative forms of consumption pose any cardiovascular risk is an important unresolved issue in this era of widespread decriminalization of cannabis, noted Dr. Kugelmass, chief of cardiology and medical director of the Heart and Vascular Center at Baystate Medical Center in Springfield, Mass.
Dr. Chami reported having no financial conflicts regarding his study.
At ACC 17
Key clinical point:
Major finding: Marijuana abuse was associated with a twofold increased risk of acute MI independent of cardiovascular risk factor levels.
Data source: A retrospective cohort study including 210,700 patients with cannabis abuse noted in their medical record and 10,395,060 age-matched controls.
Disclosures: The study presenter reported having no financial conflicts.
Dabigatran crushes warfarin for AF ablation
Washington – Uninterrupted dabigatran for periprocedural anticoagulation in patients undergoing catheter ablation for atrial fibrillation proved far superior to uninterrupted warfarin – the current standard – in the randomized multicenter RE-CIRCUIT trial, Hugh Calkins, MD, reported at the annual meeting of the American College of Cardiology.
The primary study endpoint – the incidence of major bleeding events from the time of the first femoral puncture at the procedure’s start through the subsequent 8 weeks – occurred in 1.6% of the dabigatran (Pradaxa) group and 6.9% of the warfarin group, for an absolute 5.9% reduction in risk and a 77% relative risk reduction favoring the novel anticoagulant.
“This trial will definitely affect my own practice, and I think it will quickly affect the practices of electrophysiologists around the world,” declared Dr. Calkins, professor of cardiology and medicine and director of the clinical electrophysiology laboratory and the arrhythmia service at Johns Hopkins University, Baltimore.
RE-CIRCUIT (Randomized Evaluation of Dabigatran Etexilate Compared to Warfarin in Pulmonary Vein Ablation: Assessment of an Uninterrupted Periprocedural Anticoagulation Strategy) was a multicenter, prospective, international trial conducted in 635 atrial fibrillation (AF) patients who underwent catheter ablation at 104 sites. The trial was of necessity open label because of the need for frequent adjustments of warfarin dosing; however, outcome assessment was carried out by a blinded panel of six cardiologists and three neurologists.
Standard practice among AF ablationists is to continue oral anticoagulation periprocedurally because prior studies have convincingly shown that periprocedural interruption of warfarin in an effort to reduce bleeding results in a sharply increased risk of periprocedural stroke. So participants in RE-CIRCUIT were randomized to 4-8 weeks of uninterrupted anticoagulation with either dabigatran at 150 mg b.i.d. or warfarin with a target international normalized ratio (INR) of 2.0-3.0 prior to the ablation procedure, during it, and for 8 weeks afterward, at which time an individualized decision was made as to whether to stop or continue the drug.
Major bleeding events were defined by the International Society on Thrombosis and Hemostatis criteria. Most of these bleeds occurred within the first day or two after the procedure. Pericardial tamponades and groin hematomas were significantly less common with dabigatran.
The incidence of minor bleeding events was similar, at around 18% in the two treatment arms. No strokes or systemic embolisms occurred in the study. One patient on warfarin experienced a transient ischemic attack.
Dr. Calkins elaborated on why RE-CIRCUIT will change clinical practice: “A stroke is a terrible thing during an AF procedure and cardiac tamponade is the most common cause of death from the procedure. And now we have high-quality data showing that if you perform this procedure on uninterrupted dabigatran, the risk of stroke and other systemic embolic events is extremely low, and the rate of major bleeding was 77% less.
“Plus, the logistics of warfarin are a pain,” he continued. “If the patient presents on the day of ablation with an INR that’s too high, the procedure is canceled, and if they present with an INR that’s too low and the procedure is carried out, it’s done so with an increased stroke risk.”
Dr. Calkins said he suspects the sharp reduction in major bleeding events during and after AF catheter ablation is a class effect shared by the other NOACs. Studies with those agents are ongoing. But for now, the unique availability of an immediate reversal agent in the form of idarucizumab (Praxbind) for dabigatran in the event of uncontrolled major bleeding is a source of reassurance for operators and patients alike. The antidote was never required in RE-CIRCUIT, though, the cardiologist noted.
Discussant William G. Stevenson, MD, called the trial “informative and helpful.”
“Something we’ve all been struggling with was that some concern was earlier raised that dabigatran might be associated with more thromboembolic events in this scenario. This study clearly refutes that concern,” observed Dr. Stevenson, director of the clinical cardiac electrophysiology program at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, both in Boston.
Dr. Stevenson wondered whether the outcome differences between the two study groups could be explained by differences in operator techniques and tools. That’s highly unlikely, Dr. Calkins replied. Randomization was done patient by patient, not center by center.
Then why the big difference in major bleeding complications? Dr. Stevenson asked.
“It may be that, if you poke a hole when a patient is on a more forgiving anticoagulant like dabigatran, the bleeding doesn’t persist and turn into a tamponade, whereas if you poke a hole on warfarin it turns into a bigger problem,” Dr. Calkins responded. “When you think about it, warfarin really impacts the whole coagulation cascade through factors VII, IX, and X, so multiple coagulation factors are rendered impotent, whereas dabigatran is a direct thrombin inhibitor, so you’re selectively knocking out just one component of the coagulation cascade. It provides more leeway in preventing a small hole from turning into a big effusion,” he said.
The RE-CIRCUIT trial was funded by Boehringer Ingelheim. Dr. Calkins reported receiving lecture fees from that company and from Medtronic, and serving as a consultant to Medtronic, Abbott Medical, and AtriCure.
Simultaneously with Dr. Calkins’ presentation at ACC 17, the RE-CIRCUIT study was published online (N Engl J Med. 2017 Mar 19. doi: 10.1056/NEJMoa1701005).
Washington – Uninterrupted dabigatran for periprocedural anticoagulation in patients undergoing catheter ablation for atrial fibrillation proved far superior to uninterrupted warfarin – the current standard – in the randomized multicenter RE-CIRCUIT trial, Hugh Calkins, MD, reported at the annual meeting of the American College of Cardiology.
The primary study endpoint – the incidence of major bleeding events from the time of the first femoral puncture at the procedure’s start through the subsequent 8 weeks – occurred in 1.6% of the dabigatran (Pradaxa) group and 6.9% of the warfarin group, for an absolute 5.9% reduction in risk and a 77% relative risk reduction favoring the novel anticoagulant.
“This trial will definitely affect my own practice, and I think it will quickly affect the practices of electrophysiologists around the world,” declared Dr. Calkins, professor of cardiology and medicine and director of the clinical electrophysiology laboratory and the arrhythmia service at Johns Hopkins University, Baltimore.
RE-CIRCUIT (Randomized Evaluation of Dabigatran Etexilate Compared to Warfarin in Pulmonary Vein Ablation: Assessment of an Uninterrupted Periprocedural Anticoagulation Strategy) was a multicenter, prospective, international trial conducted in 635 atrial fibrillation (AF) patients who underwent catheter ablation at 104 sites. The trial was of necessity open label because of the need for frequent adjustments of warfarin dosing; however, outcome assessment was carried out by a blinded panel of six cardiologists and three neurologists.
Standard practice among AF ablationists is to continue oral anticoagulation periprocedurally because prior studies have convincingly shown that periprocedural interruption of warfarin in an effort to reduce bleeding results in a sharply increased risk of periprocedural stroke. So participants in RE-CIRCUIT were randomized to 4-8 weeks of uninterrupted anticoagulation with either dabigatran at 150 mg b.i.d. or warfarin with a target international normalized ratio (INR) of 2.0-3.0 prior to the ablation procedure, during it, and for 8 weeks afterward, at which time an individualized decision was made as to whether to stop or continue the drug.
Major bleeding events were defined by the International Society on Thrombosis and Hemostatis criteria. Most of these bleeds occurred within the first day or two after the procedure. Pericardial tamponades and groin hematomas were significantly less common with dabigatran.
The incidence of minor bleeding events was similar, at around 18% in the two treatment arms. No strokes or systemic embolisms occurred in the study. One patient on warfarin experienced a transient ischemic attack.
Dr. Calkins elaborated on why RE-CIRCUIT will change clinical practice: “A stroke is a terrible thing during an AF procedure and cardiac tamponade is the most common cause of death from the procedure. And now we have high-quality data showing that if you perform this procedure on uninterrupted dabigatran, the risk of stroke and other systemic embolic events is extremely low, and the rate of major bleeding was 77% less.
“Plus, the logistics of warfarin are a pain,” he continued. “If the patient presents on the day of ablation with an INR that’s too high, the procedure is canceled, and if they present with an INR that’s too low and the procedure is carried out, it’s done so with an increased stroke risk.”
Dr. Calkins said he suspects the sharp reduction in major bleeding events during and after AF catheter ablation is a class effect shared by the other NOACs. Studies with those agents are ongoing. But for now, the unique availability of an immediate reversal agent in the form of idarucizumab (Praxbind) for dabigatran in the event of uncontrolled major bleeding is a source of reassurance for operators and patients alike. The antidote was never required in RE-CIRCUIT, though, the cardiologist noted.
Discussant William G. Stevenson, MD, called the trial “informative and helpful.”
“Something we’ve all been struggling with was that some concern was earlier raised that dabigatran might be associated with more thromboembolic events in this scenario. This study clearly refutes that concern,” observed Dr. Stevenson, director of the clinical cardiac electrophysiology program at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, both in Boston.
Dr. Stevenson wondered whether the outcome differences between the two study groups could be explained by differences in operator techniques and tools. That’s highly unlikely, Dr. Calkins replied. Randomization was done patient by patient, not center by center.
Then why the big difference in major bleeding complications? Dr. Stevenson asked.
“It may be that, if you poke a hole when a patient is on a more forgiving anticoagulant like dabigatran, the bleeding doesn’t persist and turn into a tamponade, whereas if you poke a hole on warfarin it turns into a bigger problem,” Dr. Calkins responded. “When you think about it, warfarin really impacts the whole coagulation cascade through factors VII, IX, and X, so multiple coagulation factors are rendered impotent, whereas dabigatran is a direct thrombin inhibitor, so you’re selectively knocking out just one component of the coagulation cascade. It provides more leeway in preventing a small hole from turning into a big effusion,” he said.
The RE-CIRCUIT trial was funded by Boehringer Ingelheim. Dr. Calkins reported receiving lecture fees from that company and from Medtronic, and serving as a consultant to Medtronic, Abbott Medical, and AtriCure.
Simultaneously with Dr. Calkins’ presentation at ACC 17, the RE-CIRCUIT study was published online (N Engl J Med. 2017 Mar 19. doi: 10.1056/NEJMoa1701005).
Washington – Uninterrupted dabigatran for periprocedural anticoagulation in patients undergoing catheter ablation for atrial fibrillation proved far superior to uninterrupted warfarin – the current standard – in the randomized multicenter RE-CIRCUIT trial, Hugh Calkins, MD, reported at the annual meeting of the American College of Cardiology.
The primary study endpoint – the incidence of major bleeding events from the time of the first femoral puncture at the procedure’s start through the subsequent 8 weeks – occurred in 1.6% of the dabigatran (Pradaxa) group and 6.9% of the warfarin group, for an absolute 5.9% reduction in risk and a 77% relative risk reduction favoring the novel anticoagulant.
“This trial will definitely affect my own practice, and I think it will quickly affect the practices of electrophysiologists around the world,” declared Dr. Calkins, professor of cardiology and medicine and director of the clinical electrophysiology laboratory and the arrhythmia service at Johns Hopkins University, Baltimore.
RE-CIRCUIT (Randomized Evaluation of Dabigatran Etexilate Compared to Warfarin in Pulmonary Vein Ablation: Assessment of an Uninterrupted Periprocedural Anticoagulation Strategy) was a multicenter, prospective, international trial conducted in 635 atrial fibrillation (AF) patients who underwent catheter ablation at 104 sites. The trial was of necessity open label because of the need for frequent adjustments of warfarin dosing; however, outcome assessment was carried out by a blinded panel of six cardiologists and three neurologists.
Standard practice among AF ablationists is to continue oral anticoagulation periprocedurally because prior studies have convincingly shown that periprocedural interruption of warfarin in an effort to reduce bleeding results in a sharply increased risk of periprocedural stroke. So participants in RE-CIRCUIT were randomized to 4-8 weeks of uninterrupted anticoagulation with either dabigatran at 150 mg b.i.d. or warfarin with a target international normalized ratio (INR) of 2.0-3.0 prior to the ablation procedure, during it, and for 8 weeks afterward, at which time an individualized decision was made as to whether to stop or continue the drug.
Major bleeding events were defined by the International Society on Thrombosis and Hemostatis criteria. Most of these bleeds occurred within the first day or two after the procedure. Pericardial tamponades and groin hematomas were significantly less common with dabigatran.
The incidence of minor bleeding events was similar, at around 18% in the two treatment arms. No strokes or systemic embolisms occurred in the study. One patient on warfarin experienced a transient ischemic attack.
Dr. Calkins elaborated on why RE-CIRCUIT will change clinical practice: “A stroke is a terrible thing during an AF procedure and cardiac tamponade is the most common cause of death from the procedure. And now we have high-quality data showing that if you perform this procedure on uninterrupted dabigatran, the risk of stroke and other systemic embolic events is extremely low, and the rate of major bleeding was 77% less.
“Plus, the logistics of warfarin are a pain,” he continued. “If the patient presents on the day of ablation with an INR that’s too high, the procedure is canceled, and if they present with an INR that’s too low and the procedure is carried out, it’s done so with an increased stroke risk.”
Dr. Calkins said he suspects the sharp reduction in major bleeding events during and after AF catheter ablation is a class effect shared by the other NOACs. Studies with those agents are ongoing. But for now, the unique availability of an immediate reversal agent in the form of idarucizumab (Praxbind) for dabigatran in the event of uncontrolled major bleeding is a source of reassurance for operators and patients alike. The antidote was never required in RE-CIRCUIT, though, the cardiologist noted.
Discussant William G. Stevenson, MD, called the trial “informative and helpful.”
“Something we’ve all been struggling with was that some concern was earlier raised that dabigatran might be associated with more thromboembolic events in this scenario. This study clearly refutes that concern,” observed Dr. Stevenson, director of the clinical cardiac electrophysiology program at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, both in Boston.
Dr. Stevenson wondered whether the outcome differences between the two study groups could be explained by differences in operator techniques and tools. That’s highly unlikely, Dr. Calkins replied. Randomization was done patient by patient, not center by center.
Then why the big difference in major bleeding complications? Dr. Stevenson asked.
“It may be that, if you poke a hole when a patient is on a more forgiving anticoagulant like dabigatran, the bleeding doesn’t persist and turn into a tamponade, whereas if you poke a hole on warfarin it turns into a bigger problem,” Dr. Calkins responded. “When you think about it, warfarin really impacts the whole coagulation cascade through factors VII, IX, and X, so multiple coagulation factors are rendered impotent, whereas dabigatran is a direct thrombin inhibitor, so you’re selectively knocking out just one component of the coagulation cascade. It provides more leeway in preventing a small hole from turning into a big effusion,” he said.
The RE-CIRCUIT trial was funded by Boehringer Ingelheim. Dr. Calkins reported receiving lecture fees from that company and from Medtronic, and serving as a consultant to Medtronic, Abbott Medical, and AtriCure.
Simultaneously with Dr. Calkins’ presentation at ACC 17, the RE-CIRCUIT study was published online (N Engl J Med. 2017 Mar 19. doi: 10.1056/NEJMoa1701005).
At ACC 17
Key clinical point:
Major finding: The incidence of major bleeding events in conjunction with catheter ablation of atrial fibrillation was reduced by 77% in patients on periprocedural dabigatran compared with those on warfarin.
Data source: A randomized multicenter prospective international trial of 635 patients who underwent catheter ablation for atrial fibrillation supported by uninterrupted oral anticoagulation.
Disclosures: The RE-CIRCUIT trial was funded by Boehringer Ingelheim. Dr. Calkins reported receiving lecture fees from that company and from Medtronic, and serving as a consultant to Medtronic, Abbott Medical, and AtriCure.
BNP flags high atrial fibrillation prevalence in ESUS stroke
HOUSTON – Following an embolic stroke of undetermined source, a patient’s serum level of brain natriuretic peptide may identify patients at high risk of having covert atrial fibrillation that warrants assessment by prolonged arrhythmia monitoring, based on a post hoc analysis of data collected from 373 patients.
The analysis showed that in older patients with a recent embolic stroke of undetermined source (ESUS) who had a serum brain natriuretic peptide (BNP) level of 100 pg/mL or greater, the prevalence of atrial fibrillation (AF) detected by up to 30 days of Holter monitoring was 33%. In contrast the AF prevalence was 4% among similar ESUS patients with a lower BNP level, Rolf Wachter, MD, said at the International Stroke Conference sponsored by the American Heart Association.
“This evidence is pretty compelling,” commented Hooman Kamel, MD, a neurologist at Weill Cornell Medicine in New York. “We already use other lab tests that have less evidence supporting their use than this, and checking BNP is a simple lab test.”
The results showed that monitoring identified AF in 5% of the control patients and in 14% of those who underwent extended monitoring, a statistically significant difference (Lancet Neurol. 2017 Apr;16[4]:282-90).
Dr. Wachter and his colleagues had baseline BNP measurements for 373 of the patients and analyzed the prevalence of AF based on these levels. The patients averaged 72 years old. Among those with BNP values of at least 100 pg/mL, prolonged arrhythmia monitoring found AF in 33%, while briefer, conventional monitoring found AF in about 4%. This meant that for every three patients receiving prolonged arrhythmia scrutiny in this subgroup, the assessment found one patient with AF. But among patients with a serum BNP of less than 100 pg/mL, prolonged arrhythmia assessment yielded a 10% rate of AF detection, compared with about 4% in the controls, meaning that for every 18 patients screened prolonged Holter monitoring detected one additional case of AF, he reported.
This relationship presumably exists because higher BNP levels identify patients with structural heart abnormalities, a subgroup at increased risk for AF, Dr. Wachter explained. He cautioned that, because this was a post hoc analysis, he would like to see the findings confirmed in prospective studies.
Dr. Wachter has been a speaker on behalf of Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, and Daiichi Sankyo and has received research support from Boehringer Ingelheim. The FIND-AFRANDOMISED trial received funding from Boehringer Ingelheim.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
HOUSTON – Following an embolic stroke of undetermined source, a patient’s serum level of brain natriuretic peptide may identify patients at high risk of having covert atrial fibrillation that warrants assessment by prolonged arrhythmia monitoring, based on a post hoc analysis of data collected from 373 patients.
The analysis showed that in older patients with a recent embolic stroke of undetermined source (ESUS) who had a serum brain natriuretic peptide (BNP) level of 100 pg/mL or greater, the prevalence of atrial fibrillation (AF) detected by up to 30 days of Holter monitoring was 33%. In contrast the AF prevalence was 4% among similar ESUS patients with a lower BNP level, Rolf Wachter, MD, said at the International Stroke Conference sponsored by the American Heart Association.
“This evidence is pretty compelling,” commented Hooman Kamel, MD, a neurologist at Weill Cornell Medicine in New York. “We already use other lab tests that have less evidence supporting their use than this, and checking BNP is a simple lab test.”
The results showed that monitoring identified AF in 5% of the control patients and in 14% of those who underwent extended monitoring, a statistically significant difference (Lancet Neurol. 2017 Apr;16[4]:282-90).
Dr. Wachter and his colleagues had baseline BNP measurements for 373 of the patients and analyzed the prevalence of AF based on these levels. The patients averaged 72 years old. Among those with BNP values of at least 100 pg/mL, prolonged arrhythmia monitoring found AF in 33%, while briefer, conventional monitoring found AF in about 4%. This meant that for every three patients receiving prolonged arrhythmia scrutiny in this subgroup, the assessment found one patient with AF. But among patients with a serum BNP of less than 100 pg/mL, prolonged arrhythmia assessment yielded a 10% rate of AF detection, compared with about 4% in the controls, meaning that for every 18 patients screened prolonged Holter monitoring detected one additional case of AF, he reported.
This relationship presumably exists because higher BNP levels identify patients with structural heart abnormalities, a subgroup at increased risk for AF, Dr. Wachter explained. He cautioned that, because this was a post hoc analysis, he would like to see the findings confirmed in prospective studies.
Dr. Wachter has been a speaker on behalf of Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, and Daiichi Sankyo and has received research support from Boehringer Ingelheim. The FIND-AFRANDOMISED trial received funding from Boehringer Ingelheim.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
HOUSTON – Following an embolic stroke of undetermined source, a patient’s serum level of brain natriuretic peptide may identify patients at high risk of having covert atrial fibrillation that warrants assessment by prolonged arrhythmia monitoring, based on a post hoc analysis of data collected from 373 patients.
The analysis showed that in older patients with a recent embolic stroke of undetermined source (ESUS) who had a serum brain natriuretic peptide (BNP) level of 100 pg/mL or greater, the prevalence of atrial fibrillation (AF) detected by up to 30 days of Holter monitoring was 33%. In contrast the AF prevalence was 4% among similar ESUS patients with a lower BNP level, Rolf Wachter, MD, said at the International Stroke Conference sponsored by the American Heart Association.
“This evidence is pretty compelling,” commented Hooman Kamel, MD, a neurologist at Weill Cornell Medicine in New York. “We already use other lab tests that have less evidence supporting their use than this, and checking BNP is a simple lab test.”
The results showed that monitoring identified AF in 5% of the control patients and in 14% of those who underwent extended monitoring, a statistically significant difference (Lancet Neurol. 2017 Apr;16[4]:282-90).
Dr. Wachter and his colleagues had baseline BNP measurements for 373 of the patients and analyzed the prevalence of AF based on these levels. The patients averaged 72 years old. Among those with BNP values of at least 100 pg/mL, prolonged arrhythmia monitoring found AF in 33%, while briefer, conventional monitoring found AF in about 4%. This meant that for every three patients receiving prolonged arrhythmia scrutiny in this subgroup, the assessment found one patient with AF. But among patients with a serum BNP of less than 100 pg/mL, prolonged arrhythmia assessment yielded a 10% rate of AF detection, compared with about 4% in the controls, meaning that for every 18 patients screened prolonged Holter monitoring detected one additional case of AF, he reported.
This relationship presumably exists because higher BNP levels identify patients with structural heart abnormalities, a subgroup at increased risk for AF, Dr. Wachter explained. He cautioned that, because this was a post hoc analysis, he would like to see the findings confirmed in prospective studies.
Dr. Wachter has been a speaker on behalf of Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, and Daiichi Sankyo and has received research support from Boehringer Ingelheim. The FIND-AFRANDOMISED trial received funding from Boehringer Ingelheim.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
AT THE INTERNATIONAL STROKE CONFERENCE
Key clinical point:
Major finding: Following ESUS, patients with a BNP of 100 pg/mL or greater had a 33% prevalence of AF.
Data source: A post hoc analysis of 373 German patients enrolled in the FIND-AFRANDOMISED trial.
Disclosures: Dr. Wachter has been a speaker on behalf of Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Pfizer, and Daiichi Sankyo and has received research support from Boehringer Ingelheim. The FIND-AFRANDOMISED trial received funding from Boehringer Ingelheim.
Stroke in AF patients often preceded by inadequate anticoagulation
Of the 94,474 ischemic strokes that occurred in a nationwide registry among patients with known atrial fibrillation, 84% were preceded by inadequate anticoagulation, according to a report published online March 14 in JAMA.
Fully 30% of the patients in this retrospective cohort study weren’t taking any form of antithrombotic therapy before their stroke, even though all of them had atrial fibrillation (AF) and most of them had additional risk factors as well. And although nearly 20,000 of the study participants were taking warfarin before their stroke, 64% of them were taking subtherapeutic doses, said Ying Xian, MD, PhD, of the department of neurology at the Duke Clinical Research Institute, Durham, N.C., and his associates.
These findings highlight tens of thousands of missed opportunities for preventing stroke simply by following existing guidelines, the investigators said.
In previous studies, researchers have consistently found underuse of oral anticoagulants in community practice. To examine current trends since the rapid adoption of non–vitamin-K antagonist oral anticoagulants (NOACs), Dr. Xian and his associates analyzed data from the AHA/ASA Get With the Guidelines-Stroke Registry. They determined the prevalence of antithrombotic treatment among AF patients who developed ischemic stroke, focusing on patients (mean age, 79.9 years) enrolled in the registry after being admitted for ischemic stroke to 1,622 participating U.S. hospitals during a 2.5-year period.
A total of 79,008 (83.6%) were not receiving therapeutic anticoagulation at the time of their stroke. This included 28,583 who were not taking any antithrombotic treatment, 12,751 who were taking subtherapeutic doses of warfarin (international normalized ratio,or INR, of less than 2 at the time of their stroke), and 37,674 who were taking only antiplatelet drugs when additional treatment was indicated, the investigators said (JAMA. 2017 Mar 14;317[10]:1057-67).
Among the minority of AF patients who were receiving therapeutic anticoagulation at the time of their stroke, 7,176 were taking adequate warfarin and 8,290 were taking adequate NOACs such as dabigatran (Pradaxa), rivaroxaban (Xarelto), and apixaban (Eliquis).
Stroke severity, as measured by median scores on the National Institutes of Health Stroke Scale, was significantly greater among patients receiving no antithrombotic medication, antiplatelet agents alone, or subtherapeutic levels of warfarin, compared with patients receiving therapeutic levels of warfarin or NOACs. Similarly, patients who had adequate anticoagulation before their stroke were significantly more likely to have better functional outcomes than those who did not. “These findings reinforce the importance of INR monitoring and dose adjustment to ... keep the INR in the therapeutic range,” Dr. Xian and his associates wrote.
The reasons why patients weren’t receiving adequate anticoagulation before their stroke – including any direct contraindications to treatment – were not available from the registry data. But such reasons are likely to persist after a stroke, and study clinicians were required to document such reasons in the medical records at hospital discharge. So the investigators examined reasons listed for not prescribing oral anticoagulation at hospital discharge in 58,084 patients.
A striking 38,249 AF patients (65.8%) in this large subgroup of study participants had no documented reason for not receiving oral anticoagulation, even after they were hospitalized for ischemic stroke and even though such documentation was “required.” Among the minority of patients whose records did show such reasons, the most common reason cited was bleeding risk (16.3%), followed by risk of falling (10.3%), the presence of a terminal illness (6.2%), patient or family refusal of the medication (4.3%), the patient’s impaired mental status (1.1%), adverse effects of the medication (1.0%), and allergy to the medication (0.6%).
This study was supported by the Patient-Centered Outcomes Research Institute. Dr. Xian reported that his institution received research funding from the American Heart Association, Daiichi Sankyo, Janssen, and Genentech. His associates reported ties to numerous industry sources.
Of the 94,474 ischemic strokes that occurred in a nationwide registry among patients with known atrial fibrillation, 84% were preceded by inadequate anticoagulation, according to a report published online March 14 in JAMA.
Fully 30% of the patients in this retrospective cohort study weren’t taking any form of antithrombotic therapy before their stroke, even though all of them had atrial fibrillation (AF) and most of them had additional risk factors as well. And although nearly 20,000 of the study participants were taking warfarin before their stroke, 64% of them were taking subtherapeutic doses, said Ying Xian, MD, PhD, of the department of neurology at the Duke Clinical Research Institute, Durham, N.C., and his associates.
These findings highlight tens of thousands of missed opportunities for preventing stroke simply by following existing guidelines, the investigators said.
In previous studies, researchers have consistently found underuse of oral anticoagulants in community practice. To examine current trends since the rapid adoption of non–vitamin-K antagonist oral anticoagulants (NOACs), Dr. Xian and his associates analyzed data from the AHA/ASA Get With the Guidelines-Stroke Registry. They determined the prevalence of antithrombotic treatment among AF patients who developed ischemic stroke, focusing on patients (mean age, 79.9 years) enrolled in the registry after being admitted for ischemic stroke to 1,622 participating U.S. hospitals during a 2.5-year period.
A total of 79,008 (83.6%) were not receiving therapeutic anticoagulation at the time of their stroke. This included 28,583 who were not taking any antithrombotic treatment, 12,751 who were taking subtherapeutic doses of warfarin (international normalized ratio,or INR, of less than 2 at the time of their stroke), and 37,674 who were taking only antiplatelet drugs when additional treatment was indicated, the investigators said (JAMA. 2017 Mar 14;317[10]:1057-67).
Among the minority of AF patients who were receiving therapeutic anticoagulation at the time of their stroke, 7,176 were taking adequate warfarin and 8,290 were taking adequate NOACs such as dabigatran (Pradaxa), rivaroxaban (Xarelto), and apixaban (Eliquis).
Stroke severity, as measured by median scores on the National Institutes of Health Stroke Scale, was significantly greater among patients receiving no antithrombotic medication, antiplatelet agents alone, or subtherapeutic levels of warfarin, compared with patients receiving therapeutic levels of warfarin or NOACs. Similarly, patients who had adequate anticoagulation before their stroke were significantly more likely to have better functional outcomes than those who did not. “These findings reinforce the importance of INR monitoring and dose adjustment to ... keep the INR in the therapeutic range,” Dr. Xian and his associates wrote.
The reasons why patients weren’t receiving adequate anticoagulation before their stroke – including any direct contraindications to treatment – were not available from the registry data. But such reasons are likely to persist after a stroke, and study clinicians were required to document such reasons in the medical records at hospital discharge. So the investigators examined reasons listed for not prescribing oral anticoagulation at hospital discharge in 58,084 patients.
A striking 38,249 AF patients (65.8%) in this large subgroup of study participants had no documented reason for not receiving oral anticoagulation, even after they were hospitalized for ischemic stroke and even though such documentation was “required.” Among the minority of patients whose records did show such reasons, the most common reason cited was bleeding risk (16.3%), followed by risk of falling (10.3%), the presence of a terminal illness (6.2%), patient or family refusal of the medication (4.3%), the patient’s impaired mental status (1.1%), adverse effects of the medication (1.0%), and allergy to the medication (0.6%).
This study was supported by the Patient-Centered Outcomes Research Institute. Dr. Xian reported that his institution received research funding from the American Heart Association, Daiichi Sankyo, Janssen, and Genentech. His associates reported ties to numerous industry sources.
Of the 94,474 ischemic strokes that occurred in a nationwide registry among patients with known atrial fibrillation, 84% were preceded by inadequate anticoagulation, according to a report published online March 14 in JAMA.
Fully 30% of the patients in this retrospective cohort study weren’t taking any form of antithrombotic therapy before their stroke, even though all of them had atrial fibrillation (AF) and most of them had additional risk factors as well. And although nearly 20,000 of the study participants were taking warfarin before their stroke, 64% of them were taking subtherapeutic doses, said Ying Xian, MD, PhD, of the department of neurology at the Duke Clinical Research Institute, Durham, N.C., and his associates.
These findings highlight tens of thousands of missed opportunities for preventing stroke simply by following existing guidelines, the investigators said.
In previous studies, researchers have consistently found underuse of oral anticoagulants in community practice. To examine current trends since the rapid adoption of non–vitamin-K antagonist oral anticoagulants (NOACs), Dr. Xian and his associates analyzed data from the AHA/ASA Get With the Guidelines-Stroke Registry. They determined the prevalence of antithrombotic treatment among AF patients who developed ischemic stroke, focusing on patients (mean age, 79.9 years) enrolled in the registry after being admitted for ischemic stroke to 1,622 participating U.S. hospitals during a 2.5-year period.
A total of 79,008 (83.6%) were not receiving therapeutic anticoagulation at the time of their stroke. This included 28,583 who were not taking any antithrombotic treatment, 12,751 who were taking subtherapeutic doses of warfarin (international normalized ratio,or INR, of less than 2 at the time of their stroke), and 37,674 who were taking only antiplatelet drugs when additional treatment was indicated, the investigators said (JAMA. 2017 Mar 14;317[10]:1057-67).
Among the minority of AF patients who were receiving therapeutic anticoagulation at the time of their stroke, 7,176 were taking adequate warfarin and 8,290 were taking adequate NOACs such as dabigatran (Pradaxa), rivaroxaban (Xarelto), and apixaban (Eliquis).
Stroke severity, as measured by median scores on the National Institutes of Health Stroke Scale, was significantly greater among patients receiving no antithrombotic medication, antiplatelet agents alone, or subtherapeutic levels of warfarin, compared with patients receiving therapeutic levels of warfarin or NOACs. Similarly, patients who had adequate anticoagulation before their stroke were significantly more likely to have better functional outcomes than those who did not. “These findings reinforce the importance of INR monitoring and dose adjustment to ... keep the INR in the therapeutic range,” Dr. Xian and his associates wrote.
The reasons why patients weren’t receiving adequate anticoagulation before their stroke – including any direct contraindications to treatment – were not available from the registry data. But such reasons are likely to persist after a stroke, and study clinicians were required to document such reasons in the medical records at hospital discharge. So the investigators examined reasons listed for not prescribing oral anticoagulation at hospital discharge in 58,084 patients.
A striking 38,249 AF patients (65.8%) in this large subgroup of study participants had no documented reason for not receiving oral anticoagulation, even after they were hospitalized for ischemic stroke and even though such documentation was “required.” Among the minority of patients whose records did show such reasons, the most common reason cited was bleeding risk (16.3%), followed by risk of falling (10.3%), the presence of a terminal illness (6.2%), patient or family refusal of the medication (4.3%), the patient’s impaired mental status (1.1%), adverse effects of the medication (1.0%), and allergy to the medication (0.6%).
This study was supported by the Patient-Centered Outcomes Research Institute. Dr. Xian reported that his institution received research funding from the American Heart Association, Daiichi Sankyo, Janssen, and Genentech. His associates reported ties to numerous industry sources.
FROM JAMA
Key clinical point: 84% of ischemic strokes that occurred in patients with known atrial fibrillation were preceded by inadequate anticoagulation.
Major finding: A total of 30% of AF patients were not taking any antithrombotic treatment before their ischemic stroke, 14% were taking subtherapeutic doses of warfarin, and 40% were taking only antiplatelet drugs when additional treatment was indicated.
Data source: A retrospective observational cohort study involving 94,474 patients with AF enrolled in a nationwide stroke outcomes registry.
Disclosures: This study was supported by the Patient-Centered Outcomes Research Institute. Dr. Xian reported that his institution received research funding from the American Heart Association, Daiichi Sankyo, Janssen, and Genentech. His associates reported ties to numerous industry sources.
Cannabis associated with increased risk of heart failure and stroke
Cannabis use was associated with an increased risk of cerebrovascular accidents and heart failure in a retrospective analysis of the Nationwide Inpatient Sample (NIS).
Aditi Kalla, MD, a cardiology fellow at Einstein Medical Center in Philadelphia, and her colleagues analyzed data from nearly 21 million adult patients aged 18-55 years from the NIS 2009-2010 database. Approximately 1.5% (316,397) were diagnosed as cannabis users.
Cannabis users also were more likely to report cardiac risk factors such as hypertension (19.9% vs. 15.7% of nonusers), tobacco use (47.2% vs. 11.4%), alcohol use (28.1% vs 3.8%), and obesity (7% vs. 6.5%). They were older, on average, with a mean age of 33 years, compared with 26 years, and were likely to be male (60%), Dr. Kalla noted during a press briefing held in advance of the annual meeting of the American College of Cardiology.
Using multivariate regression analysis to adjust for these traditional cardiovascular risk factors, the investigators found cannabis remained an independent predictor for heart failure, with an odds ratio of 1.1 (P less than .01) and cerebrovascular accident, with an OR of 1.24 (P less than .001).
“Even when we corrected for known risks, we still found a higher rate of both stroke and heart failure in these patients,” Dr. Kalla said. “That leads us to believe that there is something else going on besides just obesity or diet-related cardiovascular side effects.”
Dr. Kalla noted that an expert analysis published by the ACC in September 2016 linked cannabinoid receptor type 1 with atherogenesis.
Further research is needed on the topic of cannabis and cardiovascular effects, especially as the legalization of medical and recreational cannabis spreads across the country, Dr. Kalla said. “Decriminalization of cannabis has passed in several states, bringing the total count now up to 28 states, plus the District of Columbia. We now need to be more knowledgeable of the risks and benefits of cannabis, as patients in these states may inquire into the use of it, or even ask us for prescriptions for it.”
While the NIS provided a large and strong data set for this analysis, the number of cannabis users likely was underreported because cannabis was legal in just 14 states at the time, Dr. Kalla noted. The study also was limited by a lack of specific information regarding cannabis intake, method of intake (ingestion or smoking), quantity and frequency of use, and whether use was medical or recreational.
The information collected also excluded whether patients used marijuana for medical or recreational purpose and how it was taken, by smoking or ingestion.
ezimmerman@frontlinemedcom.com
On Twitter @EAZTweets
Cannabis use was associated with an increased risk of cerebrovascular accidents and heart failure in a retrospective analysis of the Nationwide Inpatient Sample (NIS).
Aditi Kalla, MD, a cardiology fellow at Einstein Medical Center in Philadelphia, and her colleagues analyzed data from nearly 21 million adult patients aged 18-55 years from the NIS 2009-2010 database. Approximately 1.5% (316,397) were diagnosed as cannabis users.
Cannabis users also were more likely to report cardiac risk factors such as hypertension (19.9% vs. 15.7% of nonusers), tobacco use (47.2% vs. 11.4%), alcohol use (28.1% vs 3.8%), and obesity (7% vs. 6.5%). They were older, on average, with a mean age of 33 years, compared with 26 years, and were likely to be male (60%), Dr. Kalla noted during a press briefing held in advance of the annual meeting of the American College of Cardiology.
Using multivariate regression analysis to adjust for these traditional cardiovascular risk factors, the investigators found cannabis remained an independent predictor for heart failure, with an odds ratio of 1.1 (P less than .01) and cerebrovascular accident, with an OR of 1.24 (P less than .001).
“Even when we corrected for known risks, we still found a higher rate of both stroke and heart failure in these patients,” Dr. Kalla said. “That leads us to believe that there is something else going on besides just obesity or diet-related cardiovascular side effects.”
Dr. Kalla noted that an expert analysis published by the ACC in September 2016 linked cannabinoid receptor type 1 with atherogenesis.
Further research is needed on the topic of cannabis and cardiovascular effects, especially as the legalization of medical and recreational cannabis spreads across the country, Dr. Kalla said. “Decriminalization of cannabis has passed in several states, bringing the total count now up to 28 states, plus the District of Columbia. We now need to be more knowledgeable of the risks and benefits of cannabis, as patients in these states may inquire into the use of it, or even ask us for prescriptions for it.”
While the NIS provided a large and strong data set for this analysis, the number of cannabis users likely was underreported because cannabis was legal in just 14 states at the time, Dr. Kalla noted. The study also was limited by a lack of specific information regarding cannabis intake, method of intake (ingestion or smoking), quantity and frequency of use, and whether use was medical or recreational.
The information collected also excluded whether patients used marijuana for medical or recreational purpose and how it was taken, by smoking or ingestion.
ezimmerman@frontlinemedcom.com
On Twitter @EAZTweets
Cannabis use was associated with an increased risk of cerebrovascular accidents and heart failure in a retrospective analysis of the Nationwide Inpatient Sample (NIS).
Aditi Kalla, MD, a cardiology fellow at Einstein Medical Center in Philadelphia, and her colleagues analyzed data from nearly 21 million adult patients aged 18-55 years from the NIS 2009-2010 database. Approximately 1.5% (316,397) were diagnosed as cannabis users.
Cannabis users also were more likely to report cardiac risk factors such as hypertension (19.9% vs. 15.7% of nonusers), tobacco use (47.2% vs. 11.4%), alcohol use (28.1% vs 3.8%), and obesity (7% vs. 6.5%). They were older, on average, with a mean age of 33 years, compared with 26 years, and were likely to be male (60%), Dr. Kalla noted during a press briefing held in advance of the annual meeting of the American College of Cardiology.
Using multivariate regression analysis to adjust for these traditional cardiovascular risk factors, the investigators found cannabis remained an independent predictor for heart failure, with an odds ratio of 1.1 (P less than .01) and cerebrovascular accident, with an OR of 1.24 (P less than .001).
“Even when we corrected for known risks, we still found a higher rate of both stroke and heart failure in these patients,” Dr. Kalla said. “That leads us to believe that there is something else going on besides just obesity or diet-related cardiovascular side effects.”
Dr. Kalla noted that an expert analysis published by the ACC in September 2016 linked cannabinoid receptor type 1 with atherogenesis.
Further research is needed on the topic of cannabis and cardiovascular effects, especially as the legalization of medical and recreational cannabis spreads across the country, Dr. Kalla said. “Decriminalization of cannabis has passed in several states, bringing the total count now up to 28 states, plus the District of Columbia. We now need to be more knowledgeable of the risks and benefits of cannabis, as patients in these states may inquire into the use of it, or even ask us for prescriptions for it.”
While the NIS provided a large and strong data set for this analysis, the number of cannabis users likely was underreported because cannabis was legal in just 14 states at the time, Dr. Kalla noted. The study also was limited by a lack of specific information regarding cannabis intake, method of intake (ingestion or smoking), quantity and frequency of use, and whether use was medical or recreational.
The information collected also excluded whether patients used marijuana for medical or recreational purpose and how it was taken, by smoking or ingestion.
ezimmerman@frontlinemedcom.com
On Twitter @EAZTweets
FROM ACC 17
Key clinical point:
Major finding: Cannabis users showed 26% increased risk (OR, 1.24) of stroke and 10% increased risk (OR, 1.1) of heart failure.
Data source: Retrospective study of over 20 million patients’ records aged 18-55 years gathered from the Nationwide Inpatient Sample 2009-2010 database.
Disclosures: Researchers reported no relevant conflicts of interest.
Anticoagulant resumption after ICH aids patients
HOUSTON – Even when patients on an oral anticoagulant have the dreaded complication of an intracerebral hemorrhage, resumption of their oral anticoagulation regimen appears to produce the best midterm outcomes, based on a meta-analysis of data from more than 1,000 patients collected in three observational studies.
Resumption of oral anticoagulation therapy (OAT) is a “major dilemma” when managing patients who developed an intracerebral hemorrhage (ICH) while on OAT, said Alessandro Biffi, MD, explaining why he performed this meta-analysis that he presented at the International Stroke Conference sponsored by the American Heart Association.
He used individual patient data collected from a total of 1,027 patients enrolled in any of three different observational studies: the German-wide Multicenter Analysis of Oral Anticoagulation Associated Intracerebral Hemorrhage (RETRACE) study, the MGH longitudinal ICH study, or the Ethnic/Racial Variations of Intracerebral Hemorrhage (ERICH) study. Overall 26% of the patients resumed OAT following their ICH, although the rate ranged from a low of 20% in one study to a high of 42% in another. The vast majority of patients received a vitamin K antagonist as their anticoagulant; very few received a new oral anticoagulant.
Using propensity score matching to compare similar patients who resumed or stayed off OAT, Dr. Biffi found that, during the year following the index ICH, mortality was 71%-74% lower among patients who resumed OAT. Recurrent all-cause stroke was 49%-55% lower with resumed OAT, and favorable functional outcomes (a score of 0-3 on the modified Rankin scale) were more than fourfold higher with OAT resumption, he reported.
Dr. Biffi calculated these relative rates, both for patients with a lumbar location of their ICH and for those with a nonlumbar location, and found that location had no influence on responsiveness to OAT. Patients with an index ICH in a lumbar location had a trend toward more recurrent ICH on OAT, a 26% higher rate relative to patients not resumed on OAT, but this difference fell short of statistical significance.
The only factor he found that linked with whether or not patients resumed OAT was the severity of their index ICH. The more severe their bleed, the less likely were patients to resume. Aside from that, “there is a lot of variation in practice,” he said. “We are gathering additional data” to try to further address this question.
Dr. Biffi had no disclosures.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
Resuming oral anticoagulation following an intracerebral hemorrhage is one of the most vexing problems today in vascular neurology. It’s a situation that often happens, and it will grow increasingly more common as the number of patients with atrial fibrillation escalates and even more people start oral anticoagulation.
It’s also very important to remember that patients like these who need oral anticoagulation but now have a history of ICH must have all their other cardiovascular disease risk factors very well controlled: their blood pressure, their diabetes, their smoking, etc. Oral anticoagulation may be important for these patients, but tight risk factor control is even more important.
I agree with Dr. Biffi that a prospective, randomized trial is the best way to get more information to help guide resuming oral anticoagulation. Observational studies are significantly limited by ascertainment bias, and for these patients there are also many variables – at least a dozen – that can influence whether or not a patient resumes oral anticoagulation. Dr. Biffi’s findings are interesting, but the limitations of his data prevent the results from being truly compelling.
It would be very helpful to have data from a trial that randomized ICH patients who required anticoagulation to a full-dose NOAC, a reduced-dose NOAC, or aspirin and see which group had the best long-term outcome. Whatever the results, it would change practice. It’s intriguing to speculate that a reduced-dose NOAC might provide adequate ischemic protection with a reduced risk for more bleeding.
Mark J. Alberts, MD , is chief of neurology at Hartford (Conn.) Hospital. He had no disclosures. He made these comments in an interview and during a press conference.
Resuming oral anticoagulation following an intracerebral hemorrhage is one of the most vexing problems today in vascular neurology. It’s a situation that often happens, and it will grow increasingly more common as the number of patients with atrial fibrillation escalates and even more people start oral anticoagulation.
It’s also very important to remember that patients like these who need oral anticoagulation but now have a history of ICH must have all their other cardiovascular disease risk factors very well controlled: their blood pressure, their diabetes, their smoking, etc. Oral anticoagulation may be important for these patients, but tight risk factor control is even more important.
I agree with Dr. Biffi that a prospective, randomized trial is the best way to get more information to help guide resuming oral anticoagulation. Observational studies are significantly limited by ascertainment bias, and for these patients there are also many variables – at least a dozen – that can influence whether or not a patient resumes oral anticoagulation. Dr. Biffi’s findings are interesting, but the limitations of his data prevent the results from being truly compelling.
It would be very helpful to have data from a trial that randomized ICH patients who required anticoagulation to a full-dose NOAC, a reduced-dose NOAC, or aspirin and see which group had the best long-term outcome. Whatever the results, it would change practice. It’s intriguing to speculate that a reduced-dose NOAC might provide adequate ischemic protection with a reduced risk for more bleeding.
Mark J. Alberts, MD , is chief of neurology at Hartford (Conn.) Hospital. He had no disclosures. He made these comments in an interview and during a press conference.
Resuming oral anticoagulation following an intracerebral hemorrhage is one of the most vexing problems today in vascular neurology. It’s a situation that often happens, and it will grow increasingly more common as the number of patients with atrial fibrillation escalates and even more people start oral anticoagulation.
It’s also very important to remember that patients like these who need oral anticoagulation but now have a history of ICH must have all their other cardiovascular disease risk factors very well controlled: their blood pressure, their diabetes, their smoking, etc. Oral anticoagulation may be important for these patients, but tight risk factor control is even more important.
I agree with Dr. Biffi that a prospective, randomized trial is the best way to get more information to help guide resuming oral anticoagulation. Observational studies are significantly limited by ascertainment bias, and for these patients there are also many variables – at least a dozen – that can influence whether or not a patient resumes oral anticoagulation. Dr. Biffi’s findings are interesting, but the limitations of his data prevent the results from being truly compelling.
It would be very helpful to have data from a trial that randomized ICH patients who required anticoagulation to a full-dose NOAC, a reduced-dose NOAC, or aspirin and see which group had the best long-term outcome. Whatever the results, it would change practice. It’s intriguing to speculate that a reduced-dose NOAC might provide adequate ischemic protection with a reduced risk for more bleeding.
Mark J. Alberts, MD , is chief of neurology at Hartford (Conn.) Hospital. He had no disclosures. He made these comments in an interview and during a press conference.
HOUSTON – Even when patients on an oral anticoagulant have the dreaded complication of an intracerebral hemorrhage, resumption of their oral anticoagulation regimen appears to produce the best midterm outcomes, based on a meta-analysis of data from more than 1,000 patients collected in three observational studies.
Resumption of oral anticoagulation therapy (OAT) is a “major dilemma” when managing patients who developed an intracerebral hemorrhage (ICH) while on OAT, said Alessandro Biffi, MD, explaining why he performed this meta-analysis that he presented at the International Stroke Conference sponsored by the American Heart Association.
He used individual patient data collected from a total of 1,027 patients enrolled in any of three different observational studies: the German-wide Multicenter Analysis of Oral Anticoagulation Associated Intracerebral Hemorrhage (RETRACE) study, the MGH longitudinal ICH study, or the Ethnic/Racial Variations of Intracerebral Hemorrhage (ERICH) study. Overall 26% of the patients resumed OAT following their ICH, although the rate ranged from a low of 20% in one study to a high of 42% in another. The vast majority of patients received a vitamin K antagonist as their anticoagulant; very few received a new oral anticoagulant.
Using propensity score matching to compare similar patients who resumed or stayed off OAT, Dr. Biffi found that, during the year following the index ICH, mortality was 71%-74% lower among patients who resumed OAT. Recurrent all-cause stroke was 49%-55% lower with resumed OAT, and favorable functional outcomes (a score of 0-3 on the modified Rankin scale) were more than fourfold higher with OAT resumption, he reported.
Dr. Biffi calculated these relative rates, both for patients with a lumbar location of their ICH and for those with a nonlumbar location, and found that location had no influence on responsiveness to OAT. Patients with an index ICH in a lumbar location had a trend toward more recurrent ICH on OAT, a 26% higher rate relative to patients not resumed on OAT, but this difference fell short of statistical significance.
The only factor he found that linked with whether or not patients resumed OAT was the severity of their index ICH. The more severe their bleed, the less likely were patients to resume. Aside from that, “there is a lot of variation in practice,” he said. “We are gathering additional data” to try to further address this question.
Dr. Biffi had no disclosures.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
HOUSTON – Even when patients on an oral anticoagulant have the dreaded complication of an intracerebral hemorrhage, resumption of their oral anticoagulation regimen appears to produce the best midterm outcomes, based on a meta-analysis of data from more than 1,000 patients collected in three observational studies.
Resumption of oral anticoagulation therapy (OAT) is a “major dilemma” when managing patients who developed an intracerebral hemorrhage (ICH) while on OAT, said Alessandro Biffi, MD, explaining why he performed this meta-analysis that he presented at the International Stroke Conference sponsored by the American Heart Association.
He used individual patient data collected from a total of 1,027 patients enrolled in any of three different observational studies: the German-wide Multicenter Analysis of Oral Anticoagulation Associated Intracerebral Hemorrhage (RETRACE) study, the MGH longitudinal ICH study, or the Ethnic/Racial Variations of Intracerebral Hemorrhage (ERICH) study. Overall 26% of the patients resumed OAT following their ICH, although the rate ranged from a low of 20% in one study to a high of 42% in another. The vast majority of patients received a vitamin K antagonist as their anticoagulant; very few received a new oral anticoagulant.
Using propensity score matching to compare similar patients who resumed or stayed off OAT, Dr. Biffi found that, during the year following the index ICH, mortality was 71%-74% lower among patients who resumed OAT. Recurrent all-cause stroke was 49%-55% lower with resumed OAT, and favorable functional outcomes (a score of 0-3 on the modified Rankin scale) were more than fourfold higher with OAT resumption, he reported.
Dr. Biffi calculated these relative rates, both for patients with a lumbar location of their ICH and for those with a nonlumbar location, and found that location had no influence on responsiveness to OAT. Patients with an index ICH in a lumbar location had a trend toward more recurrent ICH on OAT, a 26% higher rate relative to patients not resumed on OAT, but this difference fell short of statistical significance.
The only factor he found that linked with whether or not patients resumed OAT was the severity of their index ICH. The more severe their bleed, the less likely were patients to resume. Aside from that, “there is a lot of variation in practice,” he said. “We are gathering additional data” to try to further address this question.
Dr. Biffi had no disclosures.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
AT THE INTERNATIONAL STROKE CONFERENCE
Key clinical point:
Major finding: One-year mortality was 71%-74% lower among patients who resumed oral anticoagulation relative to those who did not.
Data source: Meta-analysis of data from 1,027 patients collected in three observational studies.
Disclosures: Dr. Biffi had no disclosures.
Prolonged dual-antiplatelet therapy after PCI challenged
WASHINGTON – Guidelines were recently modified to permit shorter duration of dual-antiplatelet therapy (DAPT) after percutaneous coronary intervention, but a series of ongoing trials are evaluating whether DAPT can be abandoned altogether in many if not most percutaneous coronary intervention (PCI) patients, according to a review of this major potential change in direction presented at CRT 2017 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
“The 1-year duration of dual-antiplatelet therapy post PCI with a drug eluting stent is based on anecdotal historical data,” asserted Patrick W. Serruys, MD, PhD, professor of cardiology, Imperial College, London. Citing several sets of data consistent with the conclusion that single agents provide adequate protection against thrombus formation but reduced risk of bleeding relative to DAPT, he suggested that it is now critical to challenge the old standard.
It has long been understood that greater protection against thrombus formation with more aggressive antiplatelet therapy is purchased with a higher risk of bleeding, but there appears to be a fundamental change in orientation. Several new pieces of evidence, including data showing that shorter duration of DAPT is as good as longer duration, has placed this trade-off in doubt at least over the longer term.
To some degree, the current standard was based on the premise that thrombotic events are more important than bleeding events, according to Usman Baber, MD, assistant professor of cardiology, Icahn School of Medicine at Mount Sinai, New York. He said, “That thought process really dominated thinking for many years, but this is completely unsupported by the data.” Instead, he noted that hazard ratios after thrombotic and bleeding events are almost identical, but the risk of death after bleeding is more persistent, while risk of ischemic events typically diminishes after an initial peak.
There is no shortage of studies that have attempted to determine the ideal combination and duration of antiplatelet therapies after PCI, but the heterogeneity of study design has prohibited definitive conclusions. In particular, Dr. Serruys suggested that there is no level 1 evidence confirming the value of adding aspirin, which he emphasized has a relatively nonspecific effect, over that of P2Y12 inhibitor alone.
In the design phase of the GLOBAL LEADERS trial, Dr. Serruys recounted, he first argued for a design in which aspirin was eliminated altogether and then for a protocol with only a single week of aspirin, but was met with strong objections each time. In the end, the experimental protocol calls for 1 month of aspirin plus ticagrelor before patients are continued on ticagrelor alone. This is being compared with the current standard, which is aspirin plus ticagrelor or clopidogrel for 12 months followed by another 12 months of aspirin alone.
GLOBAL LEADERS is an all-comers trial in which patients are randomized before PCI. All patients at the 131 participating centers in 18 countries are receiving the same stent (BioMatrix Flex). The primary endpoint is all-cause mortality, and enrollment is completed. The results are expected in November of this year.
There are numerous other studies addressing the same question. Like GLOBAL LEADERS, the TWILIGHT trial is also investigator-initiated and is near the halfway mark for a 9,000-patient enrollment. In this study, patients are being randomized to aspirin plus ticagrelor or ticagrelor alone after they have achieved a successful placement of a drug-eluting stent. This trial, however, is restricted to those with diabetes, chronic kidney disease, or other high-risk features. The primary endpoint is major bleeding. Completion is expected in 2019.
The SMART-CHOICE trial is enrolling roughly 5,000 PCI patients receiving a drug-eluting stent. Patients are being randomized to a P2Y12 antagonist monotherapy plus aspirin or the P2Y12 antagonist alone. The primary endpoint is a composite of major adverse cardiovascular events as well as major bleeding events.
After the STOP DAPT trial showed that 3 months of DAPT after PCI was as safe as prolonged DAPT in patients receiving a everolimus-eluting chromium-cobalt stent (Cardiovasc Interv Ther. 2016;31:196-209), the same group of Japanese investigators conceived the STOP-DAPT2 trial. In this trial, 3,000 patients are being randomized a standard DAPT or clopidogrel monotherapy beginning 1 month after PCI. The primary outcome is similar to that of SMART-CHOICE.
In yet another trial cited by Dr. Serruys, patients will receive DAPT only if the PCI outcome is considered suboptimal. For those judged to have a good result, patients will receive ticagrelor alone. Outcomes at the end of 1 year will be monitored.
The movement toward antiplatelet monotherapy is driven by recognition that “the need to mitigate the risk of bleeding is an important as the need to mitigate thrombosis,” Dr. Baber explained. Like Dr. Serruys, he believes it is important to challenge the standard.
“By testing single, specific, and potent antiplatelet therapy and getting rid of the old and nonspecific platelet drug called acetylsalicylic acid, we may be able to simplify risk management after PCI,” agreed Dr. Serruys. If, as expected, the GLOBAL LEADERS and other monotherapy antiplatelet trials meet their endpoints, it will mean a major evolution in postprocedural risk management.
Dr. Serruys reported no financial relationships to disclose.
WASHINGTON – Guidelines were recently modified to permit shorter duration of dual-antiplatelet therapy (DAPT) after percutaneous coronary intervention, but a series of ongoing trials are evaluating whether DAPT can be abandoned altogether in many if not most percutaneous coronary intervention (PCI) patients, according to a review of this major potential change in direction presented at CRT 2017 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
“The 1-year duration of dual-antiplatelet therapy post PCI with a drug eluting stent is based on anecdotal historical data,” asserted Patrick W. Serruys, MD, PhD, professor of cardiology, Imperial College, London. Citing several sets of data consistent with the conclusion that single agents provide adequate protection against thrombus formation but reduced risk of bleeding relative to DAPT, he suggested that it is now critical to challenge the old standard.
It has long been understood that greater protection against thrombus formation with more aggressive antiplatelet therapy is purchased with a higher risk of bleeding, but there appears to be a fundamental change in orientation. Several new pieces of evidence, including data showing that shorter duration of DAPT is as good as longer duration, has placed this trade-off in doubt at least over the longer term.
To some degree, the current standard was based on the premise that thrombotic events are more important than bleeding events, according to Usman Baber, MD, assistant professor of cardiology, Icahn School of Medicine at Mount Sinai, New York. He said, “That thought process really dominated thinking for many years, but this is completely unsupported by the data.” Instead, he noted that hazard ratios after thrombotic and bleeding events are almost identical, but the risk of death after bleeding is more persistent, while risk of ischemic events typically diminishes after an initial peak.
There is no shortage of studies that have attempted to determine the ideal combination and duration of antiplatelet therapies after PCI, but the heterogeneity of study design has prohibited definitive conclusions. In particular, Dr. Serruys suggested that there is no level 1 evidence confirming the value of adding aspirin, which he emphasized has a relatively nonspecific effect, over that of P2Y12 inhibitor alone.
In the design phase of the GLOBAL LEADERS trial, Dr. Serruys recounted, he first argued for a design in which aspirin was eliminated altogether and then for a protocol with only a single week of aspirin, but was met with strong objections each time. In the end, the experimental protocol calls for 1 month of aspirin plus ticagrelor before patients are continued on ticagrelor alone. This is being compared with the current standard, which is aspirin plus ticagrelor or clopidogrel for 12 months followed by another 12 months of aspirin alone.
GLOBAL LEADERS is an all-comers trial in which patients are randomized before PCI. All patients at the 131 participating centers in 18 countries are receiving the same stent (BioMatrix Flex). The primary endpoint is all-cause mortality, and enrollment is completed. The results are expected in November of this year.
There are numerous other studies addressing the same question. Like GLOBAL LEADERS, the TWILIGHT trial is also investigator-initiated and is near the halfway mark for a 9,000-patient enrollment. In this study, patients are being randomized to aspirin plus ticagrelor or ticagrelor alone after they have achieved a successful placement of a drug-eluting stent. This trial, however, is restricted to those with diabetes, chronic kidney disease, or other high-risk features. The primary endpoint is major bleeding. Completion is expected in 2019.
The SMART-CHOICE trial is enrolling roughly 5,000 PCI patients receiving a drug-eluting stent. Patients are being randomized to a P2Y12 antagonist monotherapy plus aspirin or the P2Y12 antagonist alone. The primary endpoint is a composite of major adverse cardiovascular events as well as major bleeding events.
After the STOP DAPT trial showed that 3 months of DAPT after PCI was as safe as prolonged DAPT in patients receiving a everolimus-eluting chromium-cobalt stent (Cardiovasc Interv Ther. 2016;31:196-209), the same group of Japanese investigators conceived the STOP-DAPT2 trial. In this trial, 3,000 patients are being randomized a standard DAPT or clopidogrel monotherapy beginning 1 month after PCI. The primary outcome is similar to that of SMART-CHOICE.
In yet another trial cited by Dr. Serruys, patients will receive DAPT only if the PCI outcome is considered suboptimal. For those judged to have a good result, patients will receive ticagrelor alone. Outcomes at the end of 1 year will be monitored.
The movement toward antiplatelet monotherapy is driven by recognition that “the need to mitigate the risk of bleeding is an important as the need to mitigate thrombosis,” Dr. Baber explained. Like Dr. Serruys, he believes it is important to challenge the standard.
“By testing single, specific, and potent antiplatelet therapy and getting rid of the old and nonspecific platelet drug called acetylsalicylic acid, we may be able to simplify risk management after PCI,” agreed Dr. Serruys. If, as expected, the GLOBAL LEADERS and other monotherapy antiplatelet trials meet their endpoints, it will mean a major evolution in postprocedural risk management.
Dr. Serruys reported no financial relationships to disclose.
WASHINGTON – Guidelines were recently modified to permit shorter duration of dual-antiplatelet therapy (DAPT) after percutaneous coronary intervention, but a series of ongoing trials are evaluating whether DAPT can be abandoned altogether in many if not most percutaneous coronary intervention (PCI) patients, according to a review of this major potential change in direction presented at CRT 2017 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
“The 1-year duration of dual-antiplatelet therapy post PCI with a drug eluting stent is based on anecdotal historical data,” asserted Patrick W. Serruys, MD, PhD, professor of cardiology, Imperial College, London. Citing several sets of data consistent with the conclusion that single agents provide adequate protection against thrombus formation but reduced risk of bleeding relative to DAPT, he suggested that it is now critical to challenge the old standard.
It has long been understood that greater protection against thrombus formation with more aggressive antiplatelet therapy is purchased with a higher risk of bleeding, but there appears to be a fundamental change in orientation. Several new pieces of evidence, including data showing that shorter duration of DAPT is as good as longer duration, has placed this trade-off in doubt at least over the longer term.
To some degree, the current standard was based on the premise that thrombotic events are more important than bleeding events, according to Usman Baber, MD, assistant professor of cardiology, Icahn School of Medicine at Mount Sinai, New York. He said, “That thought process really dominated thinking for many years, but this is completely unsupported by the data.” Instead, he noted that hazard ratios after thrombotic and bleeding events are almost identical, but the risk of death after bleeding is more persistent, while risk of ischemic events typically diminishes after an initial peak.
There is no shortage of studies that have attempted to determine the ideal combination and duration of antiplatelet therapies after PCI, but the heterogeneity of study design has prohibited definitive conclusions. In particular, Dr. Serruys suggested that there is no level 1 evidence confirming the value of adding aspirin, which he emphasized has a relatively nonspecific effect, over that of P2Y12 inhibitor alone.
In the design phase of the GLOBAL LEADERS trial, Dr. Serruys recounted, he first argued for a design in which aspirin was eliminated altogether and then for a protocol with only a single week of aspirin, but was met with strong objections each time. In the end, the experimental protocol calls for 1 month of aspirin plus ticagrelor before patients are continued on ticagrelor alone. This is being compared with the current standard, which is aspirin plus ticagrelor or clopidogrel for 12 months followed by another 12 months of aspirin alone.
GLOBAL LEADERS is an all-comers trial in which patients are randomized before PCI. All patients at the 131 participating centers in 18 countries are receiving the same stent (BioMatrix Flex). The primary endpoint is all-cause mortality, and enrollment is completed. The results are expected in November of this year.
There are numerous other studies addressing the same question. Like GLOBAL LEADERS, the TWILIGHT trial is also investigator-initiated and is near the halfway mark for a 9,000-patient enrollment. In this study, patients are being randomized to aspirin plus ticagrelor or ticagrelor alone after they have achieved a successful placement of a drug-eluting stent. This trial, however, is restricted to those with diabetes, chronic kidney disease, or other high-risk features. The primary endpoint is major bleeding. Completion is expected in 2019.
The SMART-CHOICE trial is enrolling roughly 5,000 PCI patients receiving a drug-eluting stent. Patients are being randomized to a P2Y12 antagonist monotherapy plus aspirin or the P2Y12 antagonist alone. The primary endpoint is a composite of major adverse cardiovascular events as well as major bleeding events.
After the STOP DAPT trial showed that 3 months of DAPT after PCI was as safe as prolonged DAPT in patients receiving a everolimus-eluting chromium-cobalt stent (Cardiovasc Interv Ther. 2016;31:196-209), the same group of Japanese investigators conceived the STOP-DAPT2 trial. In this trial, 3,000 patients are being randomized a standard DAPT or clopidogrel monotherapy beginning 1 month after PCI. The primary outcome is similar to that of SMART-CHOICE.
In yet another trial cited by Dr. Serruys, patients will receive DAPT only if the PCI outcome is considered suboptimal. For those judged to have a good result, patients will receive ticagrelor alone. Outcomes at the end of 1 year will be monitored.
The movement toward antiplatelet monotherapy is driven by recognition that “the need to mitigate the risk of bleeding is an important as the need to mitigate thrombosis,” Dr. Baber explained. Like Dr. Serruys, he believes it is important to challenge the standard.
“By testing single, specific, and potent antiplatelet therapy and getting rid of the old and nonspecific platelet drug called acetylsalicylic acid, we may be able to simplify risk management after PCI,” agreed Dr. Serruys. If, as expected, the GLOBAL LEADERS and other monotherapy antiplatelet trials meet their endpoints, it will mean a major evolution in postprocedural risk management.
Dr. Serruys reported no financial relationships to disclose.
EXPERT ANALYSIS FROM CRT 2017