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Antidepressant therapy after MI, stroke cut CVD events
ORLANDO – Although cardiologists and neurologists aren’t typically the physicians who diagnose and treat major depressive disorder that’s newly identified in patients after MI or stroke, they’re the ones who’ll deal with the cardiovascular consequences if the mood disorder isn’t adequately treated.
That was a key message of a study presented by interventional cardiologist Sripal Bangalore, MD, at the annual meeting of the American College of Cardiology.
In his retrospective cohort study of 1,568 patients diagnosed with and treated for major depressive disorder (MDD) following an initial acute MI or stroke, antidepressant therapy deemed inadequate by either of two prespecified measures was associated during a mean follow-up of 2 years with a 20% higher risk of the primary endpoint – a composite of recurrent MI, stroke, angina, or heart failure – than the risk in patients who received what was judged to be adequate antidepressant pharmacotherapy. A precondition for study inclusion was that a patient could not have been taking any antidepressant during the year prior to the index MI or stroke.
The study utilized nationwide claims data from the Truven Health MarketScan Claims Database for 2010-2015. Depression therapy was considered adequate if during the first 90 days following diagnosis of MDD two conditions were met: a patient aged 65 or younger had to be on the equivalent of at least 20 mg of fluoxetine per day, or if older then on a fluoxetine-equivalent dose of at least 10 mg/day, and pharmacy records had to indicate the patient was covered by the antidepressant prescription for at least 72 of those 90 days.
The prevalence of inadequate antidepressant therapy for MDD by these criteria among these patients with known cardiovascular disease was eyebrow-raisingly high: fully 60%, noted Dr. Bangalore of New York University.
In a multivariate logistic regression analysis adjusted for baseline factors that could affect the propensity to receive adequate antidepressant care, Dr. Bangalore and his coinvestigators broke down the risks of insufficient antidepressant therapy associated with each of the individual components of the composite primary endpoint. The 1.2- and 1.95-fold increased risks of stroke and angina, respectively, were statistically significant. However, the 1.37-fold higher risk of MI and 1.14-fold greater risk of heart failure than in adequately treated patients with MDD, while trending in the same direction, didn’t achieve significance.
Dr. Bangalore reported serving as a consultant to Pfizer, which funded the study, as well as to Abbott, Gilead Sciences, and Merck.
ORLANDO – Although cardiologists and neurologists aren’t typically the physicians who diagnose and treat major depressive disorder that’s newly identified in patients after MI or stroke, they’re the ones who’ll deal with the cardiovascular consequences if the mood disorder isn’t adequately treated.
That was a key message of a study presented by interventional cardiologist Sripal Bangalore, MD, at the annual meeting of the American College of Cardiology.
In his retrospective cohort study of 1,568 patients diagnosed with and treated for major depressive disorder (MDD) following an initial acute MI or stroke, antidepressant therapy deemed inadequate by either of two prespecified measures was associated during a mean follow-up of 2 years with a 20% higher risk of the primary endpoint – a composite of recurrent MI, stroke, angina, or heart failure – than the risk in patients who received what was judged to be adequate antidepressant pharmacotherapy. A precondition for study inclusion was that a patient could not have been taking any antidepressant during the year prior to the index MI or stroke.
The study utilized nationwide claims data from the Truven Health MarketScan Claims Database for 2010-2015. Depression therapy was considered adequate if during the first 90 days following diagnosis of MDD two conditions were met: a patient aged 65 or younger had to be on the equivalent of at least 20 mg of fluoxetine per day, or if older then on a fluoxetine-equivalent dose of at least 10 mg/day, and pharmacy records had to indicate the patient was covered by the antidepressant prescription for at least 72 of those 90 days.
The prevalence of inadequate antidepressant therapy for MDD by these criteria among these patients with known cardiovascular disease was eyebrow-raisingly high: fully 60%, noted Dr. Bangalore of New York University.
In a multivariate logistic regression analysis adjusted for baseline factors that could affect the propensity to receive adequate antidepressant care, Dr. Bangalore and his coinvestigators broke down the risks of insufficient antidepressant therapy associated with each of the individual components of the composite primary endpoint. The 1.2- and 1.95-fold increased risks of stroke and angina, respectively, were statistically significant. However, the 1.37-fold higher risk of MI and 1.14-fold greater risk of heart failure than in adequately treated patients with MDD, while trending in the same direction, didn’t achieve significance.
Dr. Bangalore reported serving as a consultant to Pfizer, which funded the study, as well as to Abbott, Gilead Sciences, and Merck.
ORLANDO – Although cardiologists and neurologists aren’t typically the physicians who diagnose and treat major depressive disorder that’s newly identified in patients after MI or stroke, they’re the ones who’ll deal with the cardiovascular consequences if the mood disorder isn’t adequately treated.
That was a key message of a study presented by interventional cardiologist Sripal Bangalore, MD, at the annual meeting of the American College of Cardiology.
In his retrospective cohort study of 1,568 patients diagnosed with and treated for major depressive disorder (MDD) following an initial acute MI or stroke, antidepressant therapy deemed inadequate by either of two prespecified measures was associated during a mean follow-up of 2 years with a 20% higher risk of the primary endpoint – a composite of recurrent MI, stroke, angina, or heart failure – than the risk in patients who received what was judged to be adequate antidepressant pharmacotherapy. A precondition for study inclusion was that a patient could not have been taking any antidepressant during the year prior to the index MI or stroke.
The study utilized nationwide claims data from the Truven Health MarketScan Claims Database for 2010-2015. Depression therapy was considered adequate if during the first 90 days following diagnosis of MDD two conditions were met: a patient aged 65 or younger had to be on the equivalent of at least 20 mg of fluoxetine per day, or if older then on a fluoxetine-equivalent dose of at least 10 mg/day, and pharmacy records had to indicate the patient was covered by the antidepressant prescription for at least 72 of those 90 days.
The prevalence of inadequate antidepressant therapy for MDD by these criteria among these patients with known cardiovascular disease was eyebrow-raisingly high: fully 60%, noted Dr. Bangalore of New York University.
In a multivariate logistic regression analysis adjusted for baseline factors that could affect the propensity to receive adequate antidepressant care, Dr. Bangalore and his coinvestigators broke down the risks of insufficient antidepressant therapy associated with each of the individual components of the composite primary endpoint. The 1.2- and 1.95-fold increased risks of stroke and angina, respectively, were statistically significant. However, the 1.37-fold higher risk of MI and 1.14-fold greater risk of heart failure than in adequately treated patients with MDD, while trending in the same direction, didn’t achieve significance.
Dr. Bangalore reported serving as a consultant to Pfizer, which funded the study, as well as to Abbott, Gilead Sciences, and Merck.
REPORTING FROM ACC 2018
Key clinical point: Make sure patients with newly diagnosed depression post-MI or stroke are getting adequate antidepressant therapy from their primary care physician or psychiatrist.
Major finding: Patients with a first MI or stroke subsequently diagnosed with major depressive disorder were 20% more likely to experience a recurrent cardiovascular event if their antidepressant therapy was judged insufficient than if adequate.
Study details: This was a retrospective cohort study of health insurance claims data for 1,568 patients with an initial diagnosis of MI or stroke who were subsequently diagnosed with and treated for major depressive disorder.
Disclosures: The presenter reported serving as a consultant to Pfizer, which funded the study.
Ad hoc PCI dominates in elderly
ORLANDO – Ad hoc percutaneous coronary intervention is performed nearly six times more frequently than planned PCI in older patients undergoing elective PCI for stable coronary artery disease, according to a national study of Medicare claims data for 2009-2014.
The data showed no evident downside to ad hoc PCI in patients over age 65. Indeed, the ad hoc PCI strategy was associated with a significantly lower adjusted risk of in-hospital bleeding, compared with non–ad hoc PCI. The two approaches didn’t differ significantly in terms of in-hospital acute kidney injury or mortality, Kamil F. Faridi, MD, reported at the annual meeting of the American College of Cardiology.
In the past, concern had been voiced that ad hoc PCI – that is, PCI performed during the same session as diagnostic coronary angiography – doesn’t allow time for optimization of medical therapy prior to intervention, which might in theory result in worse outcomes. But such was not the case in a study of 169,434 patients age 65 years and up who underwent PCI for stable CAD with no evidence of acute coronary syndrome.
Moreover, ad hoc PCI offers several distinct advantages: a single vascular access, shorter net time in hospital, and lower cost, noted Dr. Faridi, of Beth Israel Deaconess Medical Center in Boston.
The proportion of elective PCIs that were performed on an ad hoc basis rose during the study years, from 77% in 2009 to 85% in 2014.
Patients who underwent ad hoc PCI were more likely to have angina symptoms before intervention. They were less likely to have peripheral vascular disease, heart failure, chronic kidney disease, complex lesion anatomy, or multivessel PCI than were patients who had planned PCI. Non–ad hoc PCI was more likely to occur at high-volume centers.
The in-hospital bleeding rate was 2.9% in the ad hoc PCI group, significantly lower than the 3.8% rate in the planned PCI patients. In an analysis adjusted for potential confounders, this translated to a 14% relative risk reduction. In-hospital acute kidney injury occurred in 8.0% of the ad hoc PCI group and 9.2% of the planned PCI group. The in-hospital mortality rate was 0.4% with ad hoc and 0.5% with planned PCI.
Dr. Faridi’s study was supported by the ACC National Cardiovascular Data Registry. He reported having no financial conflicts.
SOURCE: Faridi KF. ACC 2018, Abstract 1306-468/468
ORLANDO – Ad hoc percutaneous coronary intervention is performed nearly six times more frequently than planned PCI in older patients undergoing elective PCI for stable coronary artery disease, according to a national study of Medicare claims data for 2009-2014.
The data showed no evident downside to ad hoc PCI in patients over age 65. Indeed, the ad hoc PCI strategy was associated with a significantly lower adjusted risk of in-hospital bleeding, compared with non–ad hoc PCI. The two approaches didn’t differ significantly in terms of in-hospital acute kidney injury or mortality, Kamil F. Faridi, MD, reported at the annual meeting of the American College of Cardiology.
In the past, concern had been voiced that ad hoc PCI – that is, PCI performed during the same session as diagnostic coronary angiography – doesn’t allow time for optimization of medical therapy prior to intervention, which might in theory result in worse outcomes. But such was not the case in a study of 169,434 patients age 65 years and up who underwent PCI for stable CAD with no evidence of acute coronary syndrome.
Moreover, ad hoc PCI offers several distinct advantages: a single vascular access, shorter net time in hospital, and lower cost, noted Dr. Faridi, of Beth Israel Deaconess Medical Center in Boston.
The proportion of elective PCIs that were performed on an ad hoc basis rose during the study years, from 77% in 2009 to 85% in 2014.
Patients who underwent ad hoc PCI were more likely to have angina symptoms before intervention. They were less likely to have peripheral vascular disease, heart failure, chronic kidney disease, complex lesion anatomy, or multivessel PCI than were patients who had planned PCI. Non–ad hoc PCI was more likely to occur at high-volume centers.
The in-hospital bleeding rate was 2.9% in the ad hoc PCI group, significantly lower than the 3.8% rate in the planned PCI patients. In an analysis adjusted for potential confounders, this translated to a 14% relative risk reduction. In-hospital acute kidney injury occurred in 8.0% of the ad hoc PCI group and 9.2% of the planned PCI group. The in-hospital mortality rate was 0.4% with ad hoc and 0.5% with planned PCI.
Dr. Faridi’s study was supported by the ACC National Cardiovascular Data Registry. He reported having no financial conflicts.
SOURCE: Faridi KF. ACC 2018, Abstract 1306-468/468
ORLANDO – Ad hoc percutaneous coronary intervention is performed nearly six times more frequently than planned PCI in older patients undergoing elective PCI for stable coronary artery disease, according to a national study of Medicare claims data for 2009-2014.
The data showed no evident downside to ad hoc PCI in patients over age 65. Indeed, the ad hoc PCI strategy was associated with a significantly lower adjusted risk of in-hospital bleeding, compared with non–ad hoc PCI. The two approaches didn’t differ significantly in terms of in-hospital acute kidney injury or mortality, Kamil F. Faridi, MD, reported at the annual meeting of the American College of Cardiology.
In the past, concern had been voiced that ad hoc PCI – that is, PCI performed during the same session as diagnostic coronary angiography – doesn’t allow time for optimization of medical therapy prior to intervention, which might in theory result in worse outcomes. But such was not the case in a study of 169,434 patients age 65 years and up who underwent PCI for stable CAD with no evidence of acute coronary syndrome.
Moreover, ad hoc PCI offers several distinct advantages: a single vascular access, shorter net time in hospital, and lower cost, noted Dr. Faridi, of Beth Israel Deaconess Medical Center in Boston.
The proportion of elective PCIs that were performed on an ad hoc basis rose during the study years, from 77% in 2009 to 85% in 2014.
Patients who underwent ad hoc PCI were more likely to have angina symptoms before intervention. They were less likely to have peripheral vascular disease, heart failure, chronic kidney disease, complex lesion anatomy, or multivessel PCI than were patients who had planned PCI. Non–ad hoc PCI was more likely to occur at high-volume centers.
The in-hospital bleeding rate was 2.9% in the ad hoc PCI group, significantly lower than the 3.8% rate in the planned PCI patients. In an analysis adjusted for potential confounders, this translated to a 14% relative risk reduction. In-hospital acute kidney injury occurred in 8.0% of the ad hoc PCI group and 9.2% of the planned PCI group. The in-hospital mortality rate was 0.4% with ad hoc and 0.5% with planned PCI.
Dr. Faridi’s study was supported by the ACC National Cardiovascular Data Registry. He reported having no financial conflicts.
SOURCE: Faridi KF. ACC 2018, Abstract 1306-468/468
REPORTING FROM ACC 2018
Key clinical point: Ad hoc PCI in older patients has a lower bleeding risk than non–ad hoc PCI.
Major finding: Older patients undergoing ad hoc PCI for stable CAD were 14% less likely to experience significant in-hospital bleeding than were those undergoing planned PCI.
Study details: This was a retrospective study of nearly 170,000 patients age 65 years or older who underwent elective PCI for stable CAD.
Disclosures: The study was supported by the ACC National Cardiovascular Data Registry. The presenter reported having no financial conflicts.
Source: Faridi KF. ACC 2018, Abstract 1306-468/468
Cost-effectiveness battle: FFR vs. iFR in DEFINE-FLAIR trial
ORLANDO – The use of an instantaneous wave-free ratio (iFR)–guided strategy to identify physiologically significant coronary stenoses that warrant revascularization proved substantially more cost effective than did a fractional flow reserve (FFR)–based strategy in a prespecified secondary analysis of the randomized DEFINE-FLAIR trial, Manesh R. Patel, MD, reported at the annual meeting of the American College of Cardiology.
The difference in total health care costs over the course of a year of follow-up was $896 per patient in favor of the instantaneous wave-free ratio (iFR) approach, said Dr. Patel, a professor of medicine, the chief of the division of cardiology, and the chief of the division of clinical pharmacology at Duke University in Durham, N.C.
DEFINE-FLAIR was a multicenter study in which 2,492 patients with coronary artery disease were randomized to undergo either iFR- or FFR-guided coronary revascularization. It had previously been established that decision making regarding coronary revascularization or deferral that was guided by FFR leads to better patient outcomes than decision making guided by angiography alone.
DEFINE-FLAIR showed that iFR provides clinical benefits similar to those of FFR. The 1-year primary endpoint, a composite of all-cause mortality, nonfatal MI, or unplanned revascularization, occurred in 6.8% of the iFR group and 7.0% of the FFR group, while the revascularization rate was significantly lower in the iFR group, by a margin of 47.5% to 53.4% (N Engl J Med. 2017 May 11;376(19):1824-34).
Dr. Patel presented a formal study of total health care costs and quality of life in the two study arms through 1 year of follow-up. The cost of coronary physiologic assessment by iFR was lower because, unlike FFR, iFR doesn’t use adenosine for vasodilation. Plus, median procedural time was 4.5 minutes shorter in the iFR group, resulting in lower costs for staff time. After investigators added up the costs of balloons, stents, laboratory testing, and a year’s worth of primary care visits, specialty consults, and unplanned revascularization procedures, the total cost per patient was $7,442.23 in 2017 U.S. dollars in the iFR group and $8,243.39 in the FFR group.
Session cochair Christopher Granger, MD, was favorably impressed.
“With equal clinical outcomes, the iFR – in not using adenosine and by identifying fewer patients needing referral for coronary artery bypass surgery or percutaneous coronary intervention – had a better cost effectiveness by about $900. That’s pretty good,” commented Dr. Granger, a professor of medicine at Duke University.
“At the moment, there is a longer track record for FFR data than iFR data for outcomes, but this is a fairly strong finding in a large population in a well-conducted study, and it shows very positive favorable economic results,” the cardiologist added. “There is no doubt that this [iFR] does have streamlined work flow, lower cost, and the same outcomes. So I think this is actually quite a positive effect.”
Dr. Patel, in acknowledging that there is a spirited ongoing debate among some interventional cardiologists as to which coronary physiology assessment tool should be used, declared, “We should stop arguing about which one to use and just use more of it, first and foremost.”
“I couldn’t agree more,” Dr. Granger said. “Coronary physiology for best decision making, whichever index you decide to choose, will lead to better outcomes and lower cost.”
Dr. Patel estimated that, worldwide, coronary physiology assessment is used in cardiac catheterization laboratories in fewer than 20% of patients. Achieving a substantial increase in that number is a matter of physician education perhaps coupled with payer requirements that interventional cardiologists must demonstrate evidence of ischemia before performing percutaneous coronary intervention on a given coronary lesion. Also, the American College of Cardiology/American Heart Association guidelines, which at present give a Class IIa recommendation for the use of FFR in patients with an intermediate stenosis, probably need to be revisited in light of DEFINE-FLAIR.
“One might argue that the recommendation could be a little stronger. And we have other proven technologies now besides FFR,” he observed.
Dr. Patel reported receiving research grants from Philips Volcano, sponsor of the DEFINE-FLAIR trial, as well as from AstraZeneca, Bayer, Janssen, ProCyrion, and the National Heart, Lung, and Blood Institute. He serves as a consultant to AstraZeneca, Bayer, Janssen, and Medscape.
SOURCE: Patel MR et al. ACC 18, Abstract 402-09.
ORLANDO – The use of an instantaneous wave-free ratio (iFR)–guided strategy to identify physiologically significant coronary stenoses that warrant revascularization proved substantially more cost effective than did a fractional flow reserve (FFR)–based strategy in a prespecified secondary analysis of the randomized DEFINE-FLAIR trial, Manesh R. Patel, MD, reported at the annual meeting of the American College of Cardiology.
The difference in total health care costs over the course of a year of follow-up was $896 per patient in favor of the instantaneous wave-free ratio (iFR) approach, said Dr. Patel, a professor of medicine, the chief of the division of cardiology, and the chief of the division of clinical pharmacology at Duke University in Durham, N.C.
DEFINE-FLAIR was a multicenter study in which 2,492 patients with coronary artery disease were randomized to undergo either iFR- or FFR-guided coronary revascularization. It had previously been established that decision making regarding coronary revascularization or deferral that was guided by FFR leads to better patient outcomes than decision making guided by angiography alone.
DEFINE-FLAIR showed that iFR provides clinical benefits similar to those of FFR. The 1-year primary endpoint, a composite of all-cause mortality, nonfatal MI, or unplanned revascularization, occurred in 6.8% of the iFR group and 7.0% of the FFR group, while the revascularization rate was significantly lower in the iFR group, by a margin of 47.5% to 53.4% (N Engl J Med. 2017 May 11;376(19):1824-34).
Dr. Patel presented a formal study of total health care costs and quality of life in the two study arms through 1 year of follow-up. The cost of coronary physiologic assessment by iFR was lower because, unlike FFR, iFR doesn’t use adenosine for vasodilation. Plus, median procedural time was 4.5 minutes shorter in the iFR group, resulting in lower costs for staff time. After investigators added up the costs of balloons, stents, laboratory testing, and a year’s worth of primary care visits, specialty consults, and unplanned revascularization procedures, the total cost per patient was $7,442.23 in 2017 U.S. dollars in the iFR group and $8,243.39 in the FFR group.
Session cochair Christopher Granger, MD, was favorably impressed.
“With equal clinical outcomes, the iFR – in not using adenosine and by identifying fewer patients needing referral for coronary artery bypass surgery or percutaneous coronary intervention – had a better cost effectiveness by about $900. That’s pretty good,” commented Dr. Granger, a professor of medicine at Duke University.
“At the moment, there is a longer track record for FFR data than iFR data for outcomes, but this is a fairly strong finding in a large population in a well-conducted study, and it shows very positive favorable economic results,” the cardiologist added. “There is no doubt that this [iFR] does have streamlined work flow, lower cost, and the same outcomes. So I think this is actually quite a positive effect.”
Dr. Patel, in acknowledging that there is a spirited ongoing debate among some interventional cardiologists as to which coronary physiology assessment tool should be used, declared, “We should stop arguing about which one to use and just use more of it, first and foremost.”
“I couldn’t agree more,” Dr. Granger said. “Coronary physiology for best decision making, whichever index you decide to choose, will lead to better outcomes and lower cost.”
Dr. Patel estimated that, worldwide, coronary physiology assessment is used in cardiac catheterization laboratories in fewer than 20% of patients. Achieving a substantial increase in that number is a matter of physician education perhaps coupled with payer requirements that interventional cardiologists must demonstrate evidence of ischemia before performing percutaneous coronary intervention on a given coronary lesion. Also, the American College of Cardiology/American Heart Association guidelines, which at present give a Class IIa recommendation for the use of FFR in patients with an intermediate stenosis, probably need to be revisited in light of DEFINE-FLAIR.
“One might argue that the recommendation could be a little stronger. And we have other proven technologies now besides FFR,” he observed.
Dr. Patel reported receiving research grants from Philips Volcano, sponsor of the DEFINE-FLAIR trial, as well as from AstraZeneca, Bayer, Janssen, ProCyrion, and the National Heart, Lung, and Blood Institute. He serves as a consultant to AstraZeneca, Bayer, Janssen, and Medscape.
SOURCE: Patel MR et al. ACC 18, Abstract 402-09.
ORLANDO – The use of an instantaneous wave-free ratio (iFR)–guided strategy to identify physiologically significant coronary stenoses that warrant revascularization proved substantially more cost effective than did a fractional flow reserve (FFR)–based strategy in a prespecified secondary analysis of the randomized DEFINE-FLAIR trial, Manesh R. Patel, MD, reported at the annual meeting of the American College of Cardiology.
The difference in total health care costs over the course of a year of follow-up was $896 per patient in favor of the instantaneous wave-free ratio (iFR) approach, said Dr. Patel, a professor of medicine, the chief of the division of cardiology, and the chief of the division of clinical pharmacology at Duke University in Durham, N.C.
DEFINE-FLAIR was a multicenter study in which 2,492 patients with coronary artery disease were randomized to undergo either iFR- or FFR-guided coronary revascularization. It had previously been established that decision making regarding coronary revascularization or deferral that was guided by FFR leads to better patient outcomes than decision making guided by angiography alone.
DEFINE-FLAIR showed that iFR provides clinical benefits similar to those of FFR. The 1-year primary endpoint, a composite of all-cause mortality, nonfatal MI, or unplanned revascularization, occurred in 6.8% of the iFR group and 7.0% of the FFR group, while the revascularization rate was significantly lower in the iFR group, by a margin of 47.5% to 53.4% (N Engl J Med. 2017 May 11;376(19):1824-34).
Dr. Patel presented a formal study of total health care costs and quality of life in the two study arms through 1 year of follow-up. The cost of coronary physiologic assessment by iFR was lower because, unlike FFR, iFR doesn’t use adenosine for vasodilation. Plus, median procedural time was 4.5 minutes shorter in the iFR group, resulting in lower costs for staff time. After investigators added up the costs of balloons, stents, laboratory testing, and a year’s worth of primary care visits, specialty consults, and unplanned revascularization procedures, the total cost per patient was $7,442.23 in 2017 U.S. dollars in the iFR group and $8,243.39 in the FFR group.
Session cochair Christopher Granger, MD, was favorably impressed.
“With equal clinical outcomes, the iFR – in not using adenosine and by identifying fewer patients needing referral for coronary artery bypass surgery or percutaneous coronary intervention – had a better cost effectiveness by about $900. That’s pretty good,” commented Dr. Granger, a professor of medicine at Duke University.
“At the moment, there is a longer track record for FFR data than iFR data for outcomes, but this is a fairly strong finding in a large population in a well-conducted study, and it shows very positive favorable economic results,” the cardiologist added. “There is no doubt that this [iFR] does have streamlined work flow, lower cost, and the same outcomes. So I think this is actually quite a positive effect.”
Dr. Patel, in acknowledging that there is a spirited ongoing debate among some interventional cardiologists as to which coronary physiology assessment tool should be used, declared, “We should stop arguing about which one to use and just use more of it, first and foremost.”
“I couldn’t agree more,” Dr. Granger said. “Coronary physiology for best decision making, whichever index you decide to choose, will lead to better outcomes and lower cost.”
Dr. Patel estimated that, worldwide, coronary physiology assessment is used in cardiac catheterization laboratories in fewer than 20% of patients. Achieving a substantial increase in that number is a matter of physician education perhaps coupled with payer requirements that interventional cardiologists must demonstrate evidence of ischemia before performing percutaneous coronary intervention on a given coronary lesion. Also, the American College of Cardiology/American Heart Association guidelines, which at present give a Class IIa recommendation for the use of FFR in patients with an intermediate stenosis, probably need to be revisited in light of DEFINE-FLAIR.
“One might argue that the recommendation could be a little stronger. And we have other proven technologies now besides FFR,” he observed.
Dr. Patel reported receiving research grants from Philips Volcano, sponsor of the DEFINE-FLAIR trial, as well as from AstraZeneca, Bayer, Janssen, ProCyrion, and the National Heart, Lung, and Blood Institute. He serves as a consultant to AstraZeneca, Bayer, Janssen, and Medscape.
SOURCE: Patel MR et al. ACC 18, Abstract 402-09.
REPORTING FROM ACC 2018
Key clinical point:
Major finding: A coronary revascularization strategy guided by physiologic information provided by instantaneous wave-free ratio resulted in $896 less in health care costs per patient over 1 year of follow-up than a fractional flow reserve–guided strategy had.
Study details: This was a prespecified analysis of all health care costs during 1 year of follow-up in the 2,492-patient randomized DEFINE-FLAIR study.
Disclosures: The study presenter reported receiving a research grant from Philips Volcano, sponsor of the DEFINE-FLAIR trial.
Source: Patel MR et al. ACC 18, Abstract 402-09.
Apixaban prevails in study of 163,000 DOAC users
ORLANDO – Apixaban outperformed both rivaroxaban and dabigatran in a retrospective, observational study of real-world prescribing of direct oral anticoagulants in nearly 163,000 U.S. patients with nonvalvular atrial fibrillation, Steven B. Deitelzweig, MD, reported at the annual meeting of the American College of Cardiology.
This ongoing study, known as ARISTOPHANES (Anticoagulants for Reduction in Stroke: Observational Pooled Analysis on Health Outcomes and Experience of Patients), is the largest real-world analysis of direct oral anticoagulants (DOACs) to date. Unlike most of the previous observational studies of DOACs, which used a single insurance claims database, ARISTOPHANES pools data from Medicare and four large U.S. commercial insurance claims databases that collectively cover more than 180 million Americans.
This was a study of real-world prescribing. Unlike in randomized trials, where everyone is on a standard-dose DOAC, lower-dose therapy was common. It was prescribed for 21% of patients on apixaban, 15% on dabigatran, and 24% on rivaroxaban.
ARISTOPHANES results
The biggest difference in outcome was between patients on apixaban and those on dabigatran. The incidence of stroke/systemic embolism in 27,096 patients on apixaban (Eliquis) was 1.01% in 360 days, for a statistically significant 31% reduction in risk relative to the 1.42% incidence rate in 27,096 extensively matched patients on dabigatran (Pradaxa). The 360-day incidence of major bleeding was 2.7% in the apixaban group and 3.3% in those on dabigatran, for a 23% relative risk reduction. In the apixaban/rivaroxaban comparison, which included 62,619 patients in each group, the incidence of stroke/systemic embolism was 1.21% with apixaban and 1.42% with rivaroxaban, for a 27% relative risk reduction. Major bleeding occurred in 3.1% of the apixaban group and 5.3% of those on rivaroxaban, for a 46% reduction in risk favoring apixaban.
In a comparison of 27,538 patients on dabigatran and an equal number of rivaroxaban, the 360-day cumulative incidence of stroke/systemic embolism was 1.40% with dabigatran versus 1.23% with rivaroxaban, while the major bleeding rate was 3.28% in the dabigatran group and 4.76% with rivaroxaban.
Dr. Deitelzweig was quick to acknowledge the major limitation of ARISTOPHANES.
“Only associations can be drawn from a nonrandomized, retrospective, observational study, not conclusions regarding causality, even though the cohorts were matched using propensity scoring,” he emphasized.
The critique
Session cochair Jeanne E. Poole, MD, professor of medicine and director of the clinical cardiac electrophysiology program at the University of Washington, Seattle, commented, “The problem, of course, with using these large databases is that you may not be able to find out important information, such as whether rivaroxaban was being taken appropriately with meals, which is frequently not the case. If it wasn’t, that decreases absorption and efficacy by 40%. That’s a limitation.”
Audience member James A. Reiffel, MD, rose to add that, in his view, another significant limitation of all real-world, observational analyses using claims data is that it’s not possible to know why physicians selected a given drug for a given patient. He used as an example a patient with atrial fibrillation and gastroesophageal reflux disease (GERD).
“People with GERD may be less likely to get dabigatran, and if they’re less likely to get dabigatran with GERD, maybe they’re less likely to get a GI bleed. I don’t know,” said Dr. Reiffel, professor of clinical medicine and director of the electrocardiography laboratory at Columbia University Medical Center, New York.
“We have to take all the real-world analyses with a little grain of salt,” he added.
Dr. Deitelzweig replied, “This study is not meant to be the be-all and end-all.”
That being said, he noted that although randomized trials have shown that DOACs are at least as effective and safe as warfarin for stroke prevention in atrial fibrillation, there have been no randomized, head-to-head clinical trials comparing them, nor are any such studies likely to be done for the foreseeable future. Yet physicians and their patients are hungry for comparative effectiveness data, even if it doesn’t rise to the status of level I evidence.
ARISTOPHANES is sponsored by Bristol-Myers Squibb and Pfizer. Dr. Deitelzweig reported serving as a consultant to Pfizer and receiving research grants from Bristol-Myers Squibb and Portola.
SOURCE: Deitelzweig SB. ACC 2018.
ORLANDO – Apixaban outperformed both rivaroxaban and dabigatran in a retrospective, observational study of real-world prescribing of direct oral anticoagulants in nearly 163,000 U.S. patients with nonvalvular atrial fibrillation, Steven B. Deitelzweig, MD, reported at the annual meeting of the American College of Cardiology.
This ongoing study, known as ARISTOPHANES (Anticoagulants for Reduction in Stroke: Observational Pooled Analysis on Health Outcomes and Experience of Patients), is the largest real-world analysis of direct oral anticoagulants (DOACs) to date. Unlike most of the previous observational studies of DOACs, which used a single insurance claims database, ARISTOPHANES pools data from Medicare and four large U.S. commercial insurance claims databases that collectively cover more than 180 million Americans.
This was a study of real-world prescribing. Unlike in randomized trials, where everyone is on a standard-dose DOAC, lower-dose therapy was common. It was prescribed for 21% of patients on apixaban, 15% on dabigatran, and 24% on rivaroxaban.
ARISTOPHANES results
The biggest difference in outcome was between patients on apixaban and those on dabigatran. The incidence of stroke/systemic embolism in 27,096 patients on apixaban (Eliquis) was 1.01% in 360 days, for a statistically significant 31% reduction in risk relative to the 1.42% incidence rate in 27,096 extensively matched patients on dabigatran (Pradaxa). The 360-day incidence of major bleeding was 2.7% in the apixaban group and 3.3% in those on dabigatran, for a 23% relative risk reduction. In the apixaban/rivaroxaban comparison, which included 62,619 patients in each group, the incidence of stroke/systemic embolism was 1.21% with apixaban and 1.42% with rivaroxaban, for a 27% relative risk reduction. Major bleeding occurred in 3.1% of the apixaban group and 5.3% of those on rivaroxaban, for a 46% reduction in risk favoring apixaban.
In a comparison of 27,538 patients on dabigatran and an equal number of rivaroxaban, the 360-day cumulative incidence of stroke/systemic embolism was 1.40% with dabigatran versus 1.23% with rivaroxaban, while the major bleeding rate was 3.28% in the dabigatran group and 4.76% with rivaroxaban.
Dr. Deitelzweig was quick to acknowledge the major limitation of ARISTOPHANES.
“Only associations can be drawn from a nonrandomized, retrospective, observational study, not conclusions regarding causality, even though the cohorts were matched using propensity scoring,” he emphasized.
The critique
Session cochair Jeanne E. Poole, MD, professor of medicine and director of the clinical cardiac electrophysiology program at the University of Washington, Seattle, commented, “The problem, of course, with using these large databases is that you may not be able to find out important information, such as whether rivaroxaban was being taken appropriately with meals, which is frequently not the case. If it wasn’t, that decreases absorption and efficacy by 40%. That’s a limitation.”
Audience member James A. Reiffel, MD, rose to add that, in his view, another significant limitation of all real-world, observational analyses using claims data is that it’s not possible to know why physicians selected a given drug for a given patient. He used as an example a patient with atrial fibrillation and gastroesophageal reflux disease (GERD).
“People with GERD may be less likely to get dabigatran, and if they’re less likely to get dabigatran with GERD, maybe they’re less likely to get a GI bleed. I don’t know,” said Dr. Reiffel, professor of clinical medicine and director of the electrocardiography laboratory at Columbia University Medical Center, New York.
“We have to take all the real-world analyses with a little grain of salt,” he added.
Dr. Deitelzweig replied, “This study is not meant to be the be-all and end-all.”
That being said, he noted that although randomized trials have shown that DOACs are at least as effective and safe as warfarin for stroke prevention in atrial fibrillation, there have been no randomized, head-to-head clinical trials comparing them, nor are any such studies likely to be done for the foreseeable future. Yet physicians and their patients are hungry for comparative effectiveness data, even if it doesn’t rise to the status of level I evidence.
ARISTOPHANES is sponsored by Bristol-Myers Squibb and Pfizer. Dr. Deitelzweig reported serving as a consultant to Pfizer and receiving research grants from Bristol-Myers Squibb and Portola.
SOURCE: Deitelzweig SB. ACC 2018.
ORLANDO – Apixaban outperformed both rivaroxaban and dabigatran in a retrospective, observational study of real-world prescribing of direct oral anticoagulants in nearly 163,000 U.S. patients with nonvalvular atrial fibrillation, Steven B. Deitelzweig, MD, reported at the annual meeting of the American College of Cardiology.
This ongoing study, known as ARISTOPHANES (Anticoagulants for Reduction in Stroke: Observational Pooled Analysis on Health Outcomes and Experience of Patients), is the largest real-world analysis of direct oral anticoagulants (DOACs) to date. Unlike most of the previous observational studies of DOACs, which used a single insurance claims database, ARISTOPHANES pools data from Medicare and four large U.S. commercial insurance claims databases that collectively cover more than 180 million Americans.
This was a study of real-world prescribing. Unlike in randomized trials, where everyone is on a standard-dose DOAC, lower-dose therapy was common. It was prescribed for 21% of patients on apixaban, 15% on dabigatran, and 24% on rivaroxaban.
ARISTOPHANES results
The biggest difference in outcome was between patients on apixaban and those on dabigatran. The incidence of stroke/systemic embolism in 27,096 patients on apixaban (Eliquis) was 1.01% in 360 days, for a statistically significant 31% reduction in risk relative to the 1.42% incidence rate in 27,096 extensively matched patients on dabigatran (Pradaxa). The 360-day incidence of major bleeding was 2.7% in the apixaban group and 3.3% in those on dabigatran, for a 23% relative risk reduction. In the apixaban/rivaroxaban comparison, which included 62,619 patients in each group, the incidence of stroke/systemic embolism was 1.21% with apixaban and 1.42% with rivaroxaban, for a 27% relative risk reduction. Major bleeding occurred in 3.1% of the apixaban group and 5.3% of those on rivaroxaban, for a 46% reduction in risk favoring apixaban.
In a comparison of 27,538 patients on dabigatran and an equal number of rivaroxaban, the 360-day cumulative incidence of stroke/systemic embolism was 1.40% with dabigatran versus 1.23% with rivaroxaban, while the major bleeding rate was 3.28% in the dabigatran group and 4.76% with rivaroxaban.
Dr. Deitelzweig was quick to acknowledge the major limitation of ARISTOPHANES.
“Only associations can be drawn from a nonrandomized, retrospective, observational study, not conclusions regarding causality, even though the cohorts were matched using propensity scoring,” he emphasized.
The critique
Session cochair Jeanne E. Poole, MD, professor of medicine and director of the clinical cardiac electrophysiology program at the University of Washington, Seattle, commented, “The problem, of course, with using these large databases is that you may not be able to find out important information, such as whether rivaroxaban was being taken appropriately with meals, which is frequently not the case. If it wasn’t, that decreases absorption and efficacy by 40%. That’s a limitation.”
Audience member James A. Reiffel, MD, rose to add that, in his view, another significant limitation of all real-world, observational analyses using claims data is that it’s not possible to know why physicians selected a given drug for a given patient. He used as an example a patient with atrial fibrillation and gastroesophageal reflux disease (GERD).
“People with GERD may be less likely to get dabigatran, and if they’re less likely to get dabigatran with GERD, maybe they’re less likely to get a GI bleed. I don’t know,” said Dr. Reiffel, professor of clinical medicine and director of the electrocardiography laboratory at Columbia University Medical Center, New York.
“We have to take all the real-world analyses with a little grain of salt,” he added.
Dr. Deitelzweig replied, “This study is not meant to be the be-all and end-all.”
That being said, he noted that although randomized trials have shown that DOACs are at least as effective and safe as warfarin for stroke prevention in atrial fibrillation, there have been no randomized, head-to-head clinical trials comparing them, nor are any such studies likely to be done for the foreseeable future. Yet physicians and their patients are hungry for comparative effectiveness data, even if it doesn’t rise to the status of level I evidence.
ARISTOPHANES is sponsored by Bristol-Myers Squibb and Pfizer. Dr. Deitelzweig reported serving as a consultant to Pfizer and receiving research grants from Bristol-Myers Squibb and Portola.
SOURCE: Deitelzweig SB. ACC 2018.
REPORTING FROM ACC 2018
Key clinical point:
Major finding: The risk of stroke/systemic embolism in apixaban-treated patients was 31% lower than in those on dabigatran and 27% lower than with rivaroxaban.
Study details: This retrospective, observational study based upon claims data included 162,707 propensity score-matched patients with atrial fibrillation on a direct oral anticoagulant for stroke prevention.
Disclosures: The ongoing ARISTOPHANES study is sponsored by Bristol-Myers Squibb and Pfizer. The presenter reported serving as a consultant to Pfizer and receiving research grants from Bristol-Myers Squibb and Portola.
Source: Deitelzweig SB. ACC 2018.
Transcatheter valves underperform for native aortic regurgitation
WASHINGTON – Transcatheter heart valves (THV) developed for the treatment of symptomatic aortic stenosis have been used off label for the treatment of native aortic valve regurgitation (NAVR), but registry data suggest that outcomes have been disappointing, according to a presentation at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
“Although significant improvement was seen with newer-generation THV devices, TAVR [transcatheter aortic valve replacement] for NAVR is a challenging approach associated with limited procedural efficacy,” reported Danny Dvir, MD, a prosthetic heart valve specialist and assistant professor of cardiology at the University of Washington, Seattle.
Results improved substantially with second-generation devices. For example, Dr. Dvir reported that the rate of device success climbed from 47% to 82% while correct positioning climbed from 67% to 91%. The proportion of patients without moderate or severe aortic regurgitation after placement of the THV climbed from 69% to 96%.
These improvements were reflected in clinical outcomes at 30 days. When second-generation devices were compared with first-generation devices, there was a reduction in all cause mortality (8% vs. 17%) and cardiac mortality (7% vs. 12%). There were also reductions from first- to second-generation devices in noncardiac mortality (1% vs. 5%), valve-related dysfunction (10% vs. 29%), and proportion of patients in New York Heart Association class III or IV (13% vs. 18%).
The improvement in outcomes from first- to second-generation devices is encouraging, but Dr. Dvir indicated that the main message is that TAVR for NAVR is producing success rates that “are suboptimal” and “not comparable to those being achieved when the indication is aortic stenosis.” The reasons cannot be derived from these data, but he suggested that optimal sizing of the device for NAVR might be different than it is for aortic stenosis.
“I wonder if we should have better devices designed specifically for aortic regurgitation,” Dr. Dvir said.
Despite the improved results with second-generation THV, receipt of a first-generation device was not a significant predictor of mortality at 1 year. Rather, in an analysis of predictors, mortality was significantly increased in those with moderate or worse aortic regurgitation, Society of Thoracic Surgeons risk score of 8% or greater, and acute kidney injury of grade 2 or higher. There was also a trend for increased mortality in those with pulmonary hypertension.
Most of the devices (76%) were placed with a transfemoral approach. No difference in mortality was observed when a transfemoral approach was compared with a nontransfemoral approach.
According to the registry data, a 10%-20% oversizing of the THV was associated with a reduced risk of malpositioning, relative to devices with less than 10% oversizing or greater than 20% oversizing, reinforcing Dr. Dvir’s hypothesis that sizing is a variable affecting outcome in NAVR.
Although Dr. Dvir contended that these data raise issues about the suitability of current THV designs for use in the treatment of NAVR, not all experts were convinced by these data. Jeffrey Popma, MD, director of the interventional cardiology clinical service at Beth Israel Deaconess Hospital, Boston, questioned whether more experience is placing these devices for NAVR might lead to greater success.
“There are two variables to consider,” Dr. Popma said. “One is the valve and one is how much we’ve evolved our procedure over the past couple of years.” He indicated that these data do not preclude advances that would improve results in NAVR even without developing new valves specific for this indication.
Dr. Dvir reported financial relationships with Edwards Lifesciences, Medtronic, Abbott, and Jena.
SOURCE: Dvir D. CRT 2018.
WASHINGTON – Transcatheter heart valves (THV) developed for the treatment of symptomatic aortic stenosis have been used off label for the treatment of native aortic valve regurgitation (NAVR), but registry data suggest that outcomes have been disappointing, according to a presentation at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
“Although significant improvement was seen with newer-generation THV devices, TAVR [transcatheter aortic valve replacement] for NAVR is a challenging approach associated with limited procedural efficacy,” reported Danny Dvir, MD, a prosthetic heart valve specialist and assistant professor of cardiology at the University of Washington, Seattle.
Results improved substantially with second-generation devices. For example, Dr. Dvir reported that the rate of device success climbed from 47% to 82% while correct positioning climbed from 67% to 91%. The proportion of patients without moderate or severe aortic regurgitation after placement of the THV climbed from 69% to 96%.
These improvements were reflected in clinical outcomes at 30 days. When second-generation devices were compared with first-generation devices, there was a reduction in all cause mortality (8% vs. 17%) and cardiac mortality (7% vs. 12%). There were also reductions from first- to second-generation devices in noncardiac mortality (1% vs. 5%), valve-related dysfunction (10% vs. 29%), and proportion of patients in New York Heart Association class III or IV (13% vs. 18%).
The improvement in outcomes from first- to second-generation devices is encouraging, but Dr. Dvir indicated that the main message is that TAVR for NAVR is producing success rates that “are suboptimal” and “not comparable to those being achieved when the indication is aortic stenosis.” The reasons cannot be derived from these data, but he suggested that optimal sizing of the device for NAVR might be different than it is for aortic stenosis.
“I wonder if we should have better devices designed specifically for aortic regurgitation,” Dr. Dvir said.
Despite the improved results with second-generation THV, receipt of a first-generation device was not a significant predictor of mortality at 1 year. Rather, in an analysis of predictors, mortality was significantly increased in those with moderate or worse aortic regurgitation, Society of Thoracic Surgeons risk score of 8% or greater, and acute kidney injury of grade 2 or higher. There was also a trend for increased mortality in those with pulmonary hypertension.
Most of the devices (76%) were placed with a transfemoral approach. No difference in mortality was observed when a transfemoral approach was compared with a nontransfemoral approach.
According to the registry data, a 10%-20% oversizing of the THV was associated with a reduced risk of malpositioning, relative to devices with less than 10% oversizing or greater than 20% oversizing, reinforcing Dr. Dvir’s hypothesis that sizing is a variable affecting outcome in NAVR.
Although Dr. Dvir contended that these data raise issues about the suitability of current THV designs for use in the treatment of NAVR, not all experts were convinced by these data. Jeffrey Popma, MD, director of the interventional cardiology clinical service at Beth Israel Deaconess Hospital, Boston, questioned whether more experience is placing these devices for NAVR might lead to greater success.
“There are two variables to consider,” Dr. Popma said. “One is the valve and one is how much we’ve evolved our procedure over the past couple of years.” He indicated that these data do not preclude advances that would improve results in NAVR even without developing new valves specific for this indication.
Dr. Dvir reported financial relationships with Edwards Lifesciences, Medtronic, Abbott, and Jena.
SOURCE: Dvir D. CRT 2018.
WASHINGTON – Transcatheter heart valves (THV) developed for the treatment of symptomatic aortic stenosis have been used off label for the treatment of native aortic valve regurgitation (NAVR), but registry data suggest that outcomes have been disappointing, according to a presentation at CRT 2018 sponsored by the Cardiovascular Research Institute at Washington Hospital Center.
“Although significant improvement was seen with newer-generation THV devices, TAVR [transcatheter aortic valve replacement] for NAVR is a challenging approach associated with limited procedural efficacy,” reported Danny Dvir, MD, a prosthetic heart valve specialist and assistant professor of cardiology at the University of Washington, Seattle.
Results improved substantially with second-generation devices. For example, Dr. Dvir reported that the rate of device success climbed from 47% to 82% while correct positioning climbed from 67% to 91%. The proportion of patients without moderate or severe aortic regurgitation after placement of the THV climbed from 69% to 96%.
These improvements were reflected in clinical outcomes at 30 days. When second-generation devices were compared with first-generation devices, there was a reduction in all cause mortality (8% vs. 17%) and cardiac mortality (7% vs. 12%). There were also reductions from first- to second-generation devices in noncardiac mortality (1% vs. 5%), valve-related dysfunction (10% vs. 29%), and proportion of patients in New York Heart Association class III or IV (13% vs. 18%).
The improvement in outcomes from first- to second-generation devices is encouraging, but Dr. Dvir indicated that the main message is that TAVR for NAVR is producing success rates that “are suboptimal” and “not comparable to those being achieved when the indication is aortic stenosis.” The reasons cannot be derived from these data, but he suggested that optimal sizing of the device for NAVR might be different than it is for aortic stenosis.
“I wonder if we should have better devices designed specifically for aortic regurgitation,” Dr. Dvir said.
Despite the improved results with second-generation THV, receipt of a first-generation device was not a significant predictor of mortality at 1 year. Rather, in an analysis of predictors, mortality was significantly increased in those with moderate or worse aortic regurgitation, Society of Thoracic Surgeons risk score of 8% or greater, and acute kidney injury of grade 2 or higher. There was also a trend for increased mortality in those with pulmonary hypertension.
Most of the devices (76%) were placed with a transfemoral approach. No difference in mortality was observed when a transfemoral approach was compared with a nontransfemoral approach.
According to the registry data, a 10%-20% oversizing of the THV was associated with a reduced risk of malpositioning, relative to devices with less than 10% oversizing or greater than 20% oversizing, reinforcing Dr. Dvir’s hypothesis that sizing is a variable affecting outcome in NAVR.
Although Dr. Dvir contended that these data raise issues about the suitability of current THV designs for use in the treatment of NAVR, not all experts were convinced by these data. Jeffrey Popma, MD, director of the interventional cardiology clinical service at Beth Israel Deaconess Hospital, Boston, questioned whether more experience is placing these devices for NAVR might lead to greater success.
“There are two variables to consider,” Dr. Popma said. “One is the valve and one is how much we’ve evolved our procedure over the past couple of years.” He indicated that these data do not preclude advances that would improve results in NAVR even without developing new valves specific for this indication.
Dr. Dvir reported financial relationships with Edwards Lifesciences, Medtronic, Abbott, and Jena.
SOURCE: Dvir D. CRT 2018.
AT THE 2018 CRT MEETING
Key clinical point:
Major finding: With newer-generation THV, rates of incorrect positioning (9%), persistent regurgitation (4%), and 30-day mortality (8%) remain unacceptably high.
Data source: A registry data analysis.
Disclosures: Dr. Dvir reported financial relationships with Edwards Lifesciences, Medtronic, Abbott, and Jena.
Source: Dvir D. CRT 2018.
Cardiovascular risk in type 2 diabetes: Patients are often clueless
ORLANDO – What most people with type 2 diabetes don’t know about their cardiovascular risk could get them killed.
A national online survey revealed a surprising lack of awareness among patients with type 2 diabetes and their loved ones regarding the well-established significantly increased risk of cardiovascular mortality associated with the disease.
The same low rate of awareness was present in the general population, as represented by the 1,004 controls who didn’t have type 2 diabetes or know anyone who did, Jonathan Pak, PharmD, reported at the annual meeting of the American College of Cardiology.
“We thought patient awareness would be higher, but some who I think understand this space better are surprised it’s even this high,” Dr. Pak said in an interview.
Putting aside the widespread lack of awareness of cardiovascular disease as the leading cause of death in patients with type 2 diabetes, 52% of the patients with type 2 diabetes and a similar proportion of their loved ones were unaware that type 2 diabetes is associated with any increased risk of cardiovascular disease and other macrovascular events, noted Dr. Pak, director of metabolism at Boehringer Ingelheim in Ridgefield, Conn.
There was a strong whiff of denial in the patients’ attitudes. For example, only 24% of the group with type 2 diabetes rated themselves as “likely” to have an amputation in the future, yet they rated 42% of others with type 2 disease as likely to undergo amputation. The same attitude pertained to the prospect of having an acute MI: It’s the others who are at increased risk, not me.
Encouragingly though, more than 80% of the type 2 diabetes patients who hadn’t realized they were at increased cardiovascular risk indicated that if they truly are at increased risk, they would take preventive measures to reduce that risk, including dietary modification and a conversation with their healthcare provider. In addition, 80% said their motivation in doing so would be to improve their quality of life, and 73% cited a desire to live longer and spend more time with their family, Dr. Pak observed.
“The findings from this survey highlight a huge opportunity to educate and inform, and for patients and their loved ones to act on,” he said.
The For Your Sweetheart survey was supported by Boehringer Ingelheim, Eli Lilly, and the Company Diabetes Alliance.
SOURCE: Pak J. ACC 18.
ORLANDO – What most people with type 2 diabetes don’t know about their cardiovascular risk could get them killed.
A national online survey revealed a surprising lack of awareness among patients with type 2 diabetes and their loved ones regarding the well-established significantly increased risk of cardiovascular mortality associated with the disease.
The same low rate of awareness was present in the general population, as represented by the 1,004 controls who didn’t have type 2 diabetes or know anyone who did, Jonathan Pak, PharmD, reported at the annual meeting of the American College of Cardiology.
“We thought patient awareness would be higher, but some who I think understand this space better are surprised it’s even this high,” Dr. Pak said in an interview.
Putting aside the widespread lack of awareness of cardiovascular disease as the leading cause of death in patients with type 2 diabetes, 52% of the patients with type 2 diabetes and a similar proportion of their loved ones were unaware that type 2 diabetes is associated with any increased risk of cardiovascular disease and other macrovascular events, noted Dr. Pak, director of metabolism at Boehringer Ingelheim in Ridgefield, Conn.
There was a strong whiff of denial in the patients’ attitudes. For example, only 24% of the group with type 2 diabetes rated themselves as “likely” to have an amputation in the future, yet they rated 42% of others with type 2 disease as likely to undergo amputation. The same attitude pertained to the prospect of having an acute MI: It’s the others who are at increased risk, not me.
Encouragingly though, more than 80% of the type 2 diabetes patients who hadn’t realized they were at increased cardiovascular risk indicated that if they truly are at increased risk, they would take preventive measures to reduce that risk, including dietary modification and a conversation with their healthcare provider. In addition, 80% said their motivation in doing so would be to improve their quality of life, and 73% cited a desire to live longer and spend more time with their family, Dr. Pak observed.
“The findings from this survey highlight a huge opportunity to educate and inform, and for patients and their loved ones to act on,” he said.
The For Your Sweetheart survey was supported by Boehringer Ingelheim, Eli Lilly, and the Company Diabetes Alliance.
SOURCE: Pak J. ACC 18.
ORLANDO – What most people with type 2 diabetes don’t know about their cardiovascular risk could get them killed.
A national online survey revealed a surprising lack of awareness among patients with type 2 diabetes and their loved ones regarding the well-established significantly increased risk of cardiovascular mortality associated with the disease.
The same low rate of awareness was present in the general population, as represented by the 1,004 controls who didn’t have type 2 diabetes or know anyone who did, Jonathan Pak, PharmD, reported at the annual meeting of the American College of Cardiology.
“We thought patient awareness would be higher, but some who I think understand this space better are surprised it’s even this high,” Dr. Pak said in an interview.
Putting aside the widespread lack of awareness of cardiovascular disease as the leading cause of death in patients with type 2 diabetes, 52% of the patients with type 2 diabetes and a similar proportion of their loved ones were unaware that type 2 diabetes is associated with any increased risk of cardiovascular disease and other macrovascular events, noted Dr. Pak, director of metabolism at Boehringer Ingelheim in Ridgefield, Conn.
There was a strong whiff of denial in the patients’ attitudes. For example, only 24% of the group with type 2 diabetes rated themselves as “likely” to have an amputation in the future, yet they rated 42% of others with type 2 disease as likely to undergo amputation. The same attitude pertained to the prospect of having an acute MI: It’s the others who are at increased risk, not me.
Encouragingly though, more than 80% of the type 2 diabetes patients who hadn’t realized they were at increased cardiovascular risk indicated that if they truly are at increased risk, they would take preventive measures to reduce that risk, including dietary modification and a conversation with their healthcare provider. In addition, 80% said their motivation in doing so would be to improve their quality of life, and 73% cited a desire to live longer and spend more time with their family, Dr. Pak observed.
“The findings from this survey highlight a huge opportunity to educate and inform, and for patients and their loved ones to act on,” he said.
The For Your Sweetheart survey was supported by Boehringer Ingelheim, Eli Lilly, and the Company Diabetes Alliance.
SOURCE: Pak J. ACC 18.
REPORTING FROM ACC 2018
Key clinical point: What most people with type 2 diabetes don’t know about their cardiovascular risk could get them killed.
Major finding: More than half of patients with type 2 diabetes who participated in an online survey were unaware that their disease places them at increased cardiovascular risk.
Study details: This online, cross-sectional survey included 1,869 respondents.
Disclosures: The For Your Sweetheart survey was supported by Boehringer Ingelheim and Eli Lilly. The presenter is a Boehringer Ingelheim employee.
Source: Pak J. ACC 18.
Permanent His-bundle pacing superior to RV pacing
ORLANDO – Pacing at the bundle of His was associated with significantly reduced morbidity and mortality, compared with right ventricular pacing, over time in a large observational registry of patients needing a permanent pacemaker for bradycardia, Mohamed Abdelrahman, MD, reported at the annual meeting of the American College of Cardiology.
The superiority of His-bundle pacing (HBP) was concentrated in patients who required ventricular pacing more than 20% of the time. This finding is consistent with previous reports that even a modest utilization of ventricular pacing is sufficient to boost the risk of left ventricular dysfunction secondary to electrical and mechanical dyssynchrony, added Dr. Abdelrahman of the Geisinger Heart Institute in Danville, Pa.
The primary study endpoint was a composite of all-cause mortality, heart-failure hospitalization, and biventricular pacing upgrade. During a mean 2 years of follow-up, this endpoint was reached in 25% of the HBP group, compared with 32% of the RVP group, for a significant 29% relative risk reduction. In patients with a ventricular pacing burden greater than 20%, the primary endpoint occurred in 25% of the HBP group and 36% of patients with RVP, for a 35% relative risk reduction. However, in patients who required ventricular pacing less than 20% of the time, there was no significant difference in the primary outcome between the two groups.
Heart failure hospitalization occurred in 12.4% of the HBP group and 17.6% of the RVP patients, for a 37% relative risk reduction. In patients with ventricular pacing more than 20% of the time, the rates were 12.4% and 20.1%, for a 46% relative risk reduction in favor of HBP.
Among patients with a ventricular pacing burden of more than 20%, all-cause mortality occurred in 18% of the HBP group, compared with 23.7% of RVP-treated patients.
One patient in the HBP group required an upgrade to biventricular pacing, as did six patients in the RVP group. Lead revision was necessary in 14 patients in the HBP group, versus 2 in the RVP group. Pericardial effusion within the first month of pacemaker implantation occurred in three patients in the RVP group and did not occur in the HBP group.
Discussant Kristen K. Patton, MD, called the Geisinger work “a really wonderful study,” adding, “It’s incredibly difficult to overstate how excited we are in electrophysiology about His-bundle pacing and what a wonderfully elegant solution this is to the problem of pacing-induced dyssynchrony.
“Is there anything that gives you pause, any patients in whom the increased risk of revisions makes you think, ‘I shouldn’t do this in everyone?’ Because I can tell you, it’s hard not to want to do this in everyone,” said Dr. Patton, professor of medicine at the University of Washington, Seattle.
Dr. Abdelrahman replied that Geisinger electrophysiologists now utilize HBP in all patients who require a permanent pacemaker for bradycardia.
Session chair Martin B. Leon, MD, of Columbia University, New York, had a question: “This is such an important area. Why didn’t you do a randomized trial from the start?”
Dr. Abdelrahman’s senior coinvestigator, Pugazhendhi Vijayaraman, MD, explained: “His-bundle pacing has been around for the last 20 years. It’s had its ups and downs. In the last few years there’s been a groundswell of implanters doing His-bundle pacing. The number of implanters here and around the world is rapidly expanding. So we are ready for a randomized trial, and we’ve applied for funding from the National Institutes of Health. Industry support for this has not been forthcoming because His-bundle pacing does not seem to add to the value of a company’s portfolio, but more to better patient outcomes.”
He emphasized that, of the 14 patients in the HBP group who underwent lead revision, only 2 had absolute lead failure and loss of capture, underscoring the safety of this pacing strategy.
Dr. Abdelrahman reported having no financial conflicts of interest regarding the study.
SOURCE: Abdelrahman M. ACC 18.
ORLANDO – Pacing at the bundle of His was associated with significantly reduced morbidity and mortality, compared with right ventricular pacing, over time in a large observational registry of patients needing a permanent pacemaker for bradycardia, Mohamed Abdelrahman, MD, reported at the annual meeting of the American College of Cardiology.
The superiority of His-bundle pacing (HBP) was concentrated in patients who required ventricular pacing more than 20% of the time. This finding is consistent with previous reports that even a modest utilization of ventricular pacing is sufficient to boost the risk of left ventricular dysfunction secondary to electrical and mechanical dyssynchrony, added Dr. Abdelrahman of the Geisinger Heart Institute in Danville, Pa.
The primary study endpoint was a composite of all-cause mortality, heart-failure hospitalization, and biventricular pacing upgrade. During a mean 2 years of follow-up, this endpoint was reached in 25% of the HBP group, compared with 32% of the RVP group, for a significant 29% relative risk reduction. In patients with a ventricular pacing burden greater than 20%, the primary endpoint occurred in 25% of the HBP group and 36% of patients with RVP, for a 35% relative risk reduction. However, in patients who required ventricular pacing less than 20% of the time, there was no significant difference in the primary outcome between the two groups.
Heart failure hospitalization occurred in 12.4% of the HBP group and 17.6% of the RVP patients, for a 37% relative risk reduction. In patients with ventricular pacing more than 20% of the time, the rates were 12.4% and 20.1%, for a 46% relative risk reduction in favor of HBP.
Among patients with a ventricular pacing burden of more than 20%, all-cause mortality occurred in 18% of the HBP group, compared with 23.7% of RVP-treated patients.
One patient in the HBP group required an upgrade to biventricular pacing, as did six patients in the RVP group. Lead revision was necessary in 14 patients in the HBP group, versus 2 in the RVP group. Pericardial effusion within the first month of pacemaker implantation occurred in three patients in the RVP group and did not occur in the HBP group.
Discussant Kristen K. Patton, MD, called the Geisinger work “a really wonderful study,” adding, “It’s incredibly difficult to overstate how excited we are in electrophysiology about His-bundle pacing and what a wonderfully elegant solution this is to the problem of pacing-induced dyssynchrony.
“Is there anything that gives you pause, any patients in whom the increased risk of revisions makes you think, ‘I shouldn’t do this in everyone?’ Because I can tell you, it’s hard not to want to do this in everyone,” said Dr. Patton, professor of medicine at the University of Washington, Seattle.
Dr. Abdelrahman replied that Geisinger electrophysiologists now utilize HBP in all patients who require a permanent pacemaker for bradycardia.
Session chair Martin B. Leon, MD, of Columbia University, New York, had a question: “This is such an important area. Why didn’t you do a randomized trial from the start?”
Dr. Abdelrahman’s senior coinvestigator, Pugazhendhi Vijayaraman, MD, explained: “His-bundle pacing has been around for the last 20 years. It’s had its ups and downs. In the last few years there’s been a groundswell of implanters doing His-bundle pacing. The number of implanters here and around the world is rapidly expanding. So we are ready for a randomized trial, and we’ve applied for funding from the National Institutes of Health. Industry support for this has not been forthcoming because His-bundle pacing does not seem to add to the value of a company’s portfolio, but more to better patient outcomes.”
He emphasized that, of the 14 patients in the HBP group who underwent lead revision, only 2 had absolute lead failure and loss of capture, underscoring the safety of this pacing strategy.
Dr. Abdelrahman reported having no financial conflicts of interest regarding the study.
SOURCE: Abdelrahman M. ACC 18.
ORLANDO – Pacing at the bundle of His was associated with significantly reduced morbidity and mortality, compared with right ventricular pacing, over time in a large observational registry of patients needing a permanent pacemaker for bradycardia, Mohamed Abdelrahman, MD, reported at the annual meeting of the American College of Cardiology.
The superiority of His-bundle pacing (HBP) was concentrated in patients who required ventricular pacing more than 20% of the time. This finding is consistent with previous reports that even a modest utilization of ventricular pacing is sufficient to boost the risk of left ventricular dysfunction secondary to electrical and mechanical dyssynchrony, added Dr. Abdelrahman of the Geisinger Heart Institute in Danville, Pa.
The primary study endpoint was a composite of all-cause mortality, heart-failure hospitalization, and biventricular pacing upgrade. During a mean 2 years of follow-up, this endpoint was reached in 25% of the HBP group, compared with 32% of the RVP group, for a significant 29% relative risk reduction. In patients with a ventricular pacing burden greater than 20%, the primary endpoint occurred in 25% of the HBP group and 36% of patients with RVP, for a 35% relative risk reduction. However, in patients who required ventricular pacing less than 20% of the time, there was no significant difference in the primary outcome between the two groups.
Heart failure hospitalization occurred in 12.4% of the HBP group and 17.6% of the RVP patients, for a 37% relative risk reduction. In patients with ventricular pacing more than 20% of the time, the rates were 12.4% and 20.1%, for a 46% relative risk reduction in favor of HBP.
Among patients with a ventricular pacing burden of more than 20%, all-cause mortality occurred in 18% of the HBP group, compared with 23.7% of RVP-treated patients.
One patient in the HBP group required an upgrade to biventricular pacing, as did six patients in the RVP group. Lead revision was necessary in 14 patients in the HBP group, versus 2 in the RVP group. Pericardial effusion within the first month of pacemaker implantation occurred in three patients in the RVP group and did not occur in the HBP group.
Discussant Kristen K. Patton, MD, called the Geisinger work “a really wonderful study,” adding, “It’s incredibly difficult to overstate how excited we are in electrophysiology about His-bundle pacing and what a wonderfully elegant solution this is to the problem of pacing-induced dyssynchrony.
“Is there anything that gives you pause, any patients in whom the increased risk of revisions makes you think, ‘I shouldn’t do this in everyone?’ Because I can tell you, it’s hard not to want to do this in everyone,” said Dr. Patton, professor of medicine at the University of Washington, Seattle.
Dr. Abdelrahman replied that Geisinger electrophysiologists now utilize HBP in all patients who require a permanent pacemaker for bradycardia.
Session chair Martin B. Leon, MD, of Columbia University, New York, had a question: “This is such an important area. Why didn’t you do a randomized trial from the start?”
Dr. Abdelrahman’s senior coinvestigator, Pugazhendhi Vijayaraman, MD, explained: “His-bundle pacing has been around for the last 20 years. It’s had its ups and downs. In the last few years there’s been a groundswell of implanters doing His-bundle pacing. The number of implanters here and around the world is rapidly expanding. So we are ready for a randomized trial, and we’ve applied for funding from the National Institutes of Health. Industry support for this has not been forthcoming because His-bundle pacing does not seem to add to the value of a company’s portfolio, but more to better patient outcomes.”
He emphasized that, of the 14 patients in the HBP group who underwent lead revision, only 2 had absolute lead failure and loss of capture, underscoring the safety of this pacing strategy.
Dr. Abdelrahman reported having no financial conflicts of interest regarding the study.
SOURCE: Abdelrahman M. ACC 18.
REPORTING FROM ACC 18
Key clinical point:
Major finding: The combined rate of all-cause mortality, heart-failure hospitalization, and biventricular pacing upgrade during a mean 2 years of follow-up was 25% in patients with His-bundle pacing, compared with 32% with right ventricular pacing.
Study details: This observational registry included 765 consecutive patients who required an initial permanent pacemaker implantation. All those treated at one medical center underwent an attempt at His-bundle pacing, while all those at a closely allied sister medical center received right ventricular pacing.
Disclosures: The study presenter reported having no financial conflicts of interest.
Source: Abdelrahman M. ACC 18.
Statins, ACE inhibitors linked to fetal cardiac anomalies
ORLANDO – Women exposed to statin treatment during the first trimester of pregnancy had a doubled rate of delivering neonates with a cardiac anomaly, and a nearly 400% increased rate of delivering a baby with a ventricular septal defect, compared with infants born to unexposed women in a case-control review of nearly 400,000 U.S. births during 2003-2014.
A similar, parallel analysis of the same cohort also showed that exposure to an ACE inhibitor at any time during pregnancy linked with roughly tripled rates of premature delivery, low birth weight, and neonatal cardiac anomaly, compared with unexposed women, Ming-Sum Lee, MD, and her associates reported in two posters presented at the annual meeting of the American College of Cardiology.
For the statin analysis the researchers reviewed data collected from 379,238 singleton pregnancies delivered during January 2003-December 2014 to women who received their health care from Kaiser Permanente of Southern California. The cohort included 280 women who filled at least one prescription for a statin during their first trimester of pregnancy. Half the women received simvastatin, and 37% received lovastatin. The researchers used propensity score matching to identify 1,160 women with no statin exposure who closely matched 279 of the women with statin exposure.
The review showed a 2.1% incidence of fetal cardiac anomalies in the infants born to the unexposed women and a 5.0% rate among the exposed women; the hazard ratio was 2.5, which was statistically significant. More detailed analysis showed that the increased incidence of cardiac anomalies was primarily caused by ventricular septal defects, which occurred at a 4.3% rate among the infants born to exposed mothers, a rate 370% higher than among the unexposed pregnancies. No other types of cardiac anomaly examined showed a significant increase among the exposed infants.
Assessment of links with ACE-inhibitor use focused on 404 women who had exposure to the drug class at any time during pregnancy. The most commonly used drug was lisinopril, by 98% of the women. The researchers compared these links against all the other women with exposure to an ACE inhibitor who delivered in the database without propensity score matching or in general any adjustment for clinical features or comorbidities. The analysis showed premature birth (less than 37 weeks’ gestational age) occurred at a 24% rate among the ACE inhibitor–exposed infants and 8% of the unexposed; low birth weight (less than 2,500 g) occurred in 15% of the exposed infants and in 5% of those not exposed, and any type of cardiac anomaly occurred in 4.5% of the exposed neonates and in 1.4% of the unexposed.
Dr. Lee and her associates reported the results of one adjusted analysis that factored maternal comorbidities into the calculation of the relative risk for delivering a neonate with any cardiac anomaly. After adjustment, the incremental risk linked with ACE inhibitor exposure any time during gestation was a statistically significant 80% increase.
Dr. Lee had no disclosures.
SOURCES: Hekimian A et al. ACC 18, Poster 1124-366. Chintamaneni S et al. ACC 18, Poster 1124-365.
ORLANDO – Women exposed to statin treatment during the first trimester of pregnancy had a doubled rate of delivering neonates with a cardiac anomaly, and a nearly 400% increased rate of delivering a baby with a ventricular septal defect, compared with infants born to unexposed women in a case-control review of nearly 400,000 U.S. births during 2003-2014.
A similar, parallel analysis of the same cohort also showed that exposure to an ACE inhibitor at any time during pregnancy linked with roughly tripled rates of premature delivery, low birth weight, and neonatal cardiac anomaly, compared with unexposed women, Ming-Sum Lee, MD, and her associates reported in two posters presented at the annual meeting of the American College of Cardiology.
For the statin analysis the researchers reviewed data collected from 379,238 singleton pregnancies delivered during January 2003-December 2014 to women who received their health care from Kaiser Permanente of Southern California. The cohort included 280 women who filled at least one prescription for a statin during their first trimester of pregnancy. Half the women received simvastatin, and 37% received lovastatin. The researchers used propensity score matching to identify 1,160 women with no statin exposure who closely matched 279 of the women with statin exposure.
The review showed a 2.1% incidence of fetal cardiac anomalies in the infants born to the unexposed women and a 5.0% rate among the exposed women; the hazard ratio was 2.5, which was statistically significant. More detailed analysis showed that the increased incidence of cardiac anomalies was primarily caused by ventricular septal defects, which occurred at a 4.3% rate among the infants born to exposed mothers, a rate 370% higher than among the unexposed pregnancies. No other types of cardiac anomaly examined showed a significant increase among the exposed infants.
Assessment of links with ACE-inhibitor use focused on 404 women who had exposure to the drug class at any time during pregnancy. The most commonly used drug was lisinopril, by 98% of the women. The researchers compared these links against all the other women with exposure to an ACE inhibitor who delivered in the database without propensity score matching or in general any adjustment for clinical features or comorbidities. The analysis showed premature birth (less than 37 weeks’ gestational age) occurred at a 24% rate among the ACE inhibitor–exposed infants and 8% of the unexposed; low birth weight (less than 2,500 g) occurred in 15% of the exposed infants and in 5% of those not exposed, and any type of cardiac anomaly occurred in 4.5% of the exposed neonates and in 1.4% of the unexposed.
Dr. Lee and her associates reported the results of one adjusted analysis that factored maternal comorbidities into the calculation of the relative risk for delivering a neonate with any cardiac anomaly. After adjustment, the incremental risk linked with ACE inhibitor exposure any time during gestation was a statistically significant 80% increase.
Dr. Lee had no disclosures.
SOURCES: Hekimian A et al. ACC 18, Poster 1124-366. Chintamaneni S et al. ACC 18, Poster 1124-365.
ORLANDO – Women exposed to statin treatment during the first trimester of pregnancy had a doubled rate of delivering neonates with a cardiac anomaly, and a nearly 400% increased rate of delivering a baby with a ventricular septal defect, compared with infants born to unexposed women in a case-control review of nearly 400,000 U.S. births during 2003-2014.
A similar, parallel analysis of the same cohort also showed that exposure to an ACE inhibitor at any time during pregnancy linked with roughly tripled rates of premature delivery, low birth weight, and neonatal cardiac anomaly, compared with unexposed women, Ming-Sum Lee, MD, and her associates reported in two posters presented at the annual meeting of the American College of Cardiology.
For the statin analysis the researchers reviewed data collected from 379,238 singleton pregnancies delivered during January 2003-December 2014 to women who received their health care from Kaiser Permanente of Southern California. The cohort included 280 women who filled at least one prescription for a statin during their first trimester of pregnancy. Half the women received simvastatin, and 37% received lovastatin. The researchers used propensity score matching to identify 1,160 women with no statin exposure who closely matched 279 of the women with statin exposure.
The review showed a 2.1% incidence of fetal cardiac anomalies in the infants born to the unexposed women and a 5.0% rate among the exposed women; the hazard ratio was 2.5, which was statistically significant. More detailed analysis showed that the increased incidence of cardiac anomalies was primarily caused by ventricular septal defects, which occurred at a 4.3% rate among the infants born to exposed mothers, a rate 370% higher than among the unexposed pregnancies. No other types of cardiac anomaly examined showed a significant increase among the exposed infants.
Assessment of links with ACE-inhibitor use focused on 404 women who had exposure to the drug class at any time during pregnancy. The most commonly used drug was lisinopril, by 98% of the women. The researchers compared these links against all the other women with exposure to an ACE inhibitor who delivered in the database without propensity score matching or in general any adjustment for clinical features or comorbidities. The analysis showed premature birth (less than 37 weeks’ gestational age) occurred at a 24% rate among the ACE inhibitor–exposed infants and 8% of the unexposed; low birth weight (less than 2,500 g) occurred in 15% of the exposed infants and in 5% of those not exposed, and any type of cardiac anomaly occurred in 4.5% of the exposed neonates and in 1.4% of the unexposed.
Dr. Lee and her associates reported the results of one adjusted analysis that factored maternal comorbidities into the calculation of the relative risk for delivering a neonate with any cardiac anomaly. After adjustment, the incremental risk linked with ACE inhibitor exposure any time during gestation was a statistically significant 80% increase.
Dr. Lee had no disclosures.
SOURCES: Hekimian A et al. ACC 18, Poster 1124-366. Chintamaneni S et al. ACC 18, Poster 1124-365.
REPORTING FROM ACC 18
Key clinical point: Fetal exposures to statins or ACE inhibitors link to cardiac anomalies.
Major finding: Ventricular septal defects occurred 370% more often among infants born after first-trimester statin exposure.
Study details: A retrospective review of 379,238 singleton pregnancies delivered at Kaiser Permanente of Southern California during 2003-2014.
Disclosures: Dr. Lee had no disclosures.
Sources: Hekimian A et al. ACC 18, Poster 1124-366. Chintamaneni S et al. ACC 18, Poster 1124-365.
A refined strategy for confirming diagnosis in suspected NSTEMI
ORLANDO – A novel diagnostic strategy of performing CT angiography or cardiovascular MRI first in patients with suspected non-ST-elevation MI safely improved appropriate selection for invasive coronary angiography in the Dutch randomized CARMENTA trial.
The strategy of using noninvasive imaging first significantly cut down on the high proportion of diagnostic invasive angiography procedures that end up showing no significant obstructive coronary artery disease in the current era of high-sensitivity cardiac troponin assays, Martijn W. Smulders, MD, reported at the annual meeting of the American College of Cardiology.
CARMENTA (Cardiovascular Magnetic Resonance Imaging and Computed Tomography Angiography) was a single-center, prospective, randomized trial including 207 patients with suspected NSTEMI on the basis of acute chest pain, an elevated high-sensitivity cardiac troponin level, and an inconclusive ECG. They were randomized to one of three diagnostic strategies: a routine invasive strategy in which they were sent straight to the cardiac catheterization lab for invasive coronary angiography, or either CTA- or CMR-first as gatekeeper strategies in which referral for invasive angiography was reserved for only those patients whose noninvasive imaging demonstrated myocardial ischemia, infarction, or obstructive CAD with at least a 70% stenosis.
The impetus for the trial was the investigators’ concern that widespread embrace of high-sensitivity cardiac troponin assays has resulted in a serious clinical problem: Although these assays offer very high sensitivity for rapid detection of acute MI, their positive predictive value is only 56%, compared with 76% for the older troponin assays.
“That means almost one out of two patients with acute chest pain and an elevated high-sensitivity troponin level does not have a type 1 MI. We see a twofold higher incidence of elevated troponin levels with these assays, so there has been a significant increase in referrals for invasive angiography – and up to one-third of these patients with suspected NSTEMI don’t have an obstructive stenosis. We need a strategy to improve patient selection,” explained Dr. Smulders of Maastricht (the Netherlands) University.
The CARMENTA strategy worked. The primary outcome – the proportion of patients with suspected NSTEMI who underwent invasive coronary angiography during their initial hospitalization – was 65% in the CTA-first group and 77% in the CMR group, compared with 100% in the routine invasive-strategy control group. Moreover, fully 38% of patients in the control group turned out not to have obstructive CAD, compared with 15% who were sent for invasive angiography only after CTA and 31% who first had CMR.
Procedure-related complications, a secondary outcome, occurred in 12% of the CMR-first group, 13% of the CTA-first group, and 16% of patients in the routine invasive strategy control group. Major adverse cardiac events during 1 year of follow-up, which was the other secondary outcome, occurred in 9% of the CMR group, 6% of the CTA group, and 9% of the control group.
A limitation of the CARMENTA trial was that, even though it was scheduled to enroll 288 patients to achieve strong statistical power, the study’s data safety monitoring committee recommended on the basis of an interim analysis that the trial be halted early. The reasoning was that the experience of the first 200 enrollees made it clear that the noninvasive-imaging-first strategy would achieve the goal of reducing the volume of referrals to invasive angiography for suspected NSTEMI.
Session cochair Stefan D. Anker, MD, was irked by the trial’s early termination, which weakened the strength of the conclusions, especially with regard to the safety of the novel strategy.
“I agree that this imaging-first strategy reduces procedures, but the use of the word ‘safely’ is premature,” said Dr. Anker, professor of homeostasis and cachexia at Charite Medical School in Berlin.
“I totally agree with you,” Dr. Smulders replied. “We need a bigger trial to confirm our results – preferably a multicenter trial.”
“How can you do a bigger trial when your data safety monitoring board didn’t allow you to complete even this trial? They killed your trial. That’s the way I see it,” Dr. Anker said.
The CARMENTA trial was funded by the Dutch Heart Foundation. Dr. Smulders reported having no financial conflicts of interest.
SOURCE: Smulders M. ACC 18.
ORLANDO – A novel diagnostic strategy of performing CT angiography or cardiovascular MRI first in patients with suspected non-ST-elevation MI safely improved appropriate selection for invasive coronary angiography in the Dutch randomized CARMENTA trial.
The strategy of using noninvasive imaging first significantly cut down on the high proportion of diagnostic invasive angiography procedures that end up showing no significant obstructive coronary artery disease in the current era of high-sensitivity cardiac troponin assays, Martijn W. Smulders, MD, reported at the annual meeting of the American College of Cardiology.
CARMENTA (Cardiovascular Magnetic Resonance Imaging and Computed Tomography Angiography) was a single-center, prospective, randomized trial including 207 patients with suspected NSTEMI on the basis of acute chest pain, an elevated high-sensitivity cardiac troponin level, and an inconclusive ECG. They were randomized to one of three diagnostic strategies: a routine invasive strategy in which they were sent straight to the cardiac catheterization lab for invasive coronary angiography, or either CTA- or CMR-first as gatekeeper strategies in which referral for invasive angiography was reserved for only those patients whose noninvasive imaging demonstrated myocardial ischemia, infarction, or obstructive CAD with at least a 70% stenosis.
The impetus for the trial was the investigators’ concern that widespread embrace of high-sensitivity cardiac troponin assays has resulted in a serious clinical problem: Although these assays offer very high sensitivity for rapid detection of acute MI, their positive predictive value is only 56%, compared with 76% for the older troponin assays.
“That means almost one out of two patients with acute chest pain and an elevated high-sensitivity troponin level does not have a type 1 MI. We see a twofold higher incidence of elevated troponin levels with these assays, so there has been a significant increase in referrals for invasive angiography – and up to one-third of these patients with suspected NSTEMI don’t have an obstructive stenosis. We need a strategy to improve patient selection,” explained Dr. Smulders of Maastricht (the Netherlands) University.
The CARMENTA strategy worked. The primary outcome – the proportion of patients with suspected NSTEMI who underwent invasive coronary angiography during their initial hospitalization – was 65% in the CTA-first group and 77% in the CMR group, compared with 100% in the routine invasive-strategy control group. Moreover, fully 38% of patients in the control group turned out not to have obstructive CAD, compared with 15% who were sent for invasive angiography only after CTA and 31% who first had CMR.
Procedure-related complications, a secondary outcome, occurred in 12% of the CMR-first group, 13% of the CTA-first group, and 16% of patients in the routine invasive strategy control group. Major adverse cardiac events during 1 year of follow-up, which was the other secondary outcome, occurred in 9% of the CMR group, 6% of the CTA group, and 9% of the control group.
A limitation of the CARMENTA trial was that, even though it was scheduled to enroll 288 patients to achieve strong statistical power, the study’s data safety monitoring committee recommended on the basis of an interim analysis that the trial be halted early. The reasoning was that the experience of the first 200 enrollees made it clear that the noninvasive-imaging-first strategy would achieve the goal of reducing the volume of referrals to invasive angiography for suspected NSTEMI.
Session cochair Stefan D. Anker, MD, was irked by the trial’s early termination, which weakened the strength of the conclusions, especially with regard to the safety of the novel strategy.
“I agree that this imaging-first strategy reduces procedures, but the use of the word ‘safely’ is premature,” said Dr. Anker, professor of homeostasis and cachexia at Charite Medical School in Berlin.
“I totally agree with you,” Dr. Smulders replied. “We need a bigger trial to confirm our results – preferably a multicenter trial.”
“How can you do a bigger trial when your data safety monitoring board didn’t allow you to complete even this trial? They killed your trial. That’s the way I see it,” Dr. Anker said.
The CARMENTA trial was funded by the Dutch Heart Foundation. Dr. Smulders reported having no financial conflicts of interest.
SOURCE: Smulders M. ACC 18.
ORLANDO – A novel diagnostic strategy of performing CT angiography or cardiovascular MRI first in patients with suspected non-ST-elevation MI safely improved appropriate selection for invasive coronary angiography in the Dutch randomized CARMENTA trial.
The strategy of using noninvasive imaging first significantly cut down on the high proportion of diagnostic invasive angiography procedures that end up showing no significant obstructive coronary artery disease in the current era of high-sensitivity cardiac troponin assays, Martijn W. Smulders, MD, reported at the annual meeting of the American College of Cardiology.
CARMENTA (Cardiovascular Magnetic Resonance Imaging and Computed Tomography Angiography) was a single-center, prospective, randomized trial including 207 patients with suspected NSTEMI on the basis of acute chest pain, an elevated high-sensitivity cardiac troponin level, and an inconclusive ECG. They were randomized to one of three diagnostic strategies: a routine invasive strategy in which they were sent straight to the cardiac catheterization lab for invasive coronary angiography, or either CTA- or CMR-first as gatekeeper strategies in which referral for invasive angiography was reserved for only those patients whose noninvasive imaging demonstrated myocardial ischemia, infarction, or obstructive CAD with at least a 70% stenosis.
The impetus for the trial was the investigators’ concern that widespread embrace of high-sensitivity cardiac troponin assays has resulted in a serious clinical problem: Although these assays offer very high sensitivity for rapid detection of acute MI, their positive predictive value is only 56%, compared with 76% for the older troponin assays.
“That means almost one out of two patients with acute chest pain and an elevated high-sensitivity troponin level does not have a type 1 MI. We see a twofold higher incidence of elevated troponin levels with these assays, so there has been a significant increase in referrals for invasive angiography – and up to one-third of these patients with suspected NSTEMI don’t have an obstructive stenosis. We need a strategy to improve patient selection,” explained Dr. Smulders of Maastricht (the Netherlands) University.
The CARMENTA strategy worked. The primary outcome – the proportion of patients with suspected NSTEMI who underwent invasive coronary angiography during their initial hospitalization – was 65% in the CTA-first group and 77% in the CMR group, compared with 100% in the routine invasive-strategy control group. Moreover, fully 38% of patients in the control group turned out not to have obstructive CAD, compared with 15% who were sent for invasive angiography only after CTA and 31% who first had CMR.
Procedure-related complications, a secondary outcome, occurred in 12% of the CMR-first group, 13% of the CTA-first group, and 16% of patients in the routine invasive strategy control group. Major adverse cardiac events during 1 year of follow-up, which was the other secondary outcome, occurred in 9% of the CMR group, 6% of the CTA group, and 9% of the control group.
A limitation of the CARMENTA trial was that, even though it was scheduled to enroll 288 patients to achieve strong statistical power, the study’s data safety monitoring committee recommended on the basis of an interim analysis that the trial be halted early. The reasoning was that the experience of the first 200 enrollees made it clear that the noninvasive-imaging-first strategy would achieve the goal of reducing the volume of referrals to invasive angiography for suspected NSTEMI.
Session cochair Stefan D. Anker, MD, was irked by the trial’s early termination, which weakened the strength of the conclusions, especially with regard to the safety of the novel strategy.
“I agree that this imaging-first strategy reduces procedures, but the use of the word ‘safely’ is premature,” said Dr. Anker, professor of homeostasis and cachexia at Charite Medical School in Berlin.
“I totally agree with you,” Dr. Smulders replied. “We need a bigger trial to confirm our results – preferably a multicenter trial.”
“How can you do a bigger trial when your data safety monitoring board didn’t allow you to complete even this trial? They killed your trial. That’s the way I see it,” Dr. Anker said.
The CARMENTA trial was funded by the Dutch Heart Foundation. Dr. Smulders reported having no financial conflicts of interest.
SOURCE: Smulders M. ACC 18.
REPORTING FROM ACC 18
Key clinical point: Dutch cardiologists have come up with a novel way to reduce the high rate of negative diagnostic coronary angiography in patients with suspected NSTEMI.
Major finding: Reserving invasive coronary angiography for only those patients with suspected NSTEMI who first showed positive findings on noninvasive CT angiography reduced invasive angiography volume by 35%.
Study details: This single-center, randomized, prospective, three-arm clinical trial included 207 patients with suspected NSTEMI.
Disclosures: The CARMENTA trial was funded by the Dutch Heart Foundation. The presenter reported having no financial conflicts of interest.
Source: Smulders M. ACC 18.
VIDEO: PFO closure device 100% effective against future strokes
ORLANDO – Closing a patent foramen ovale reduced the incidence of stroke and other adverse events in patients at increased risk the DEFENSE-PRO trial.
“The potential association between patent foramen ovale [PFO] and cryptogenic stroke has been a controversial issue for decades,” Jae Kwan Song, MD, of Asan Medical Center in Seoul, South Korea, said in an interview at the annual meeting of the American College of Cardiology.
In this study, 60 patients with high-risk PFOs (at least 2 mm) were randomized to receive anticoagulant or antiplatelet medications alone, and 60 were randomized to medication plus implantation of the Amplatzer PFO closure device.
The device implantation was successful for all patients in the device group. The primary endpoint was a combination of stroke, vascular death, and major bleeding within 2 years of follow-up after the procedure.
After an average follow-up of 2.8 years, none of the patients in the device group and six (10%) of patients in the medication-only group experienced a primary endpoint event. The events in the medication-only group included five cases of ischemic stroke, two cases of TIMI-defined major bleeding, one cerebral hemorrhage, and one transient ischemic attack.
Nonfatal procedural complications included two cases of atrial fibrillation, one case of pericardial effusion, and one pseudoaneurysm.
The average age of the patients was 54 years in the medication-only group and 49 years in the device group, and roughly one-third of the patients in each group were male. The baseline clinical characteristics, including the presence of hypertension, diabetes, smoking, and high cholesterol, were similar between the groups.
“We should consider two things before clinical decision of device closure,” Dr. Song said. First, exclude other causes of cryptogenic stroke; and second, conduct a comprehensive evaluation of the PFO to determine which patients are at highest risk and would be most likely to benefit from the procedure, he said.
To better determine which patients would benefit from the device implantation, Dr. Song and his colleagues used imaging to review data on the size and features of the PFO; patients with evidence of an atrial septal aneurysm or hypermobility (defined as a septal excursion 10 mm or larger) were deemed at especially high risk.
Dr. Song said that the next steps for research on management of PFOs include determining which medications are most effective in patients treated with medication alone, as well as clarifying the process of patient selection for device use based on PFO morphology.
The study was terminated early because of several factors, including low patient recruitment and the decision not to deny patients the closure treatment because of its demonstrated effectiveness, Dr. Song noted.
The study was supported by the Cardiovascular Research Foundation in Seoul, South Korea. Dr. Song had no financial conflicts to disclose. The findings were published simultaneously in the Journal of the American College of Cardiology (doi: 10.1016/j.jacc.2018.02.046).
SOURCE: Song J. ACC 2018.
ORLANDO – Closing a patent foramen ovale reduced the incidence of stroke and other adverse events in patients at increased risk the DEFENSE-PRO trial.
“The potential association between patent foramen ovale [PFO] and cryptogenic stroke has been a controversial issue for decades,” Jae Kwan Song, MD, of Asan Medical Center in Seoul, South Korea, said in an interview at the annual meeting of the American College of Cardiology.
In this study, 60 patients with high-risk PFOs (at least 2 mm) were randomized to receive anticoagulant or antiplatelet medications alone, and 60 were randomized to medication plus implantation of the Amplatzer PFO closure device.
The device implantation was successful for all patients in the device group. The primary endpoint was a combination of stroke, vascular death, and major bleeding within 2 years of follow-up after the procedure.
After an average follow-up of 2.8 years, none of the patients in the device group and six (10%) of patients in the medication-only group experienced a primary endpoint event. The events in the medication-only group included five cases of ischemic stroke, two cases of TIMI-defined major bleeding, one cerebral hemorrhage, and one transient ischemic attack.
Nonfatal procedural complications included two cases of atrial fibrillation, one case of pericardial effusion, and one pseudoaneurysm.
The average age of the patients was 54 years in the medication-only group and 49 years in the device group, and roughly one-third of the patients in each group were male. The baseline clinical characteristics, including the presence of hypertension, diabetes, smoking, and high cholesterol, were similar between the groups.
“We should consider two things before clinical decision of device closure,” Dr. Song said. First, exclude other causes of cryptogenic stroke; and second, conduct a comprehensive evaluation of the PFO to determine which patients are at highest risk and would be most likely to benefit from the procedure, he said.
To better determine which patients would benefit from the device implantation, Dr. Song and his colleagues used imaging to review data on the size and features of the PFO; patients with evidence of an atrial septal aneurysm or hypermobility (defined as a septal excursion 10 mm or larger) were deemed at especially high risk.
Dr. Song said that the next steps for research on management of PFOs include determining which medications are most effective in patients treated with medication alone, as well as clarifying the process of patient selection for device use based on PFO morphology.
The study was terminated early because of several factors, including low patient recruitment and the decision not to deny patients the closure treatment because of its demonstrated effectiveness, Dr. Song noted.
The study was supported by the Cardiovascular Research Foundation in Seoul, South Korea. Dr. Song had no financial conflicts to disclose. The findings were published simultaneously in the Journal of the American College of Cardiology (doi: 10.1016/j.jacc.2018.02.046).
SOURCE: Song J. ACC 2018.
ORLANDO – Closing a patent foramen ovale reduced the incidence of stroke and other adverse events in patients at increased risk the DEFENSE-PRO trial.
“The potential association between patent foramen ovale [PFO] and cryptogenic stroke has been a controversial issue for decades,” Jae Kwan Song, MD, of Asan Medical Center in Seoul, South Korea, said in an interview at the annual meeting of the American College of Cardiology.
In this study, 60 patients with high-risk PFOs (at least 2 mm) were randomized to receive anticoagulant or antiplatelet medications alone, and 60 were randomized to medication plus implantation of the Amplatzer PFO closure device.
The device implantation was successful for all patients in the device group. The primary endpoint was a combination of stroke, vascular death, and major bleeding within 2 years of follow-up after the procedure.
After an average follow-up of 2.8 years, none of the patients in the device group and six (10%) of patients in the medication-only group experienced a primary endpoint event. The events in the medication-only group included five cases of ischemic stroke, two cases of TIMI-defined major bleeding, one cerebral hemorrhage, and one transient ischemic attack.
Nonfatal procedural complications included two cases of atrial fibrillation, one case of pericardial effusion, and one pseudoaneurysm.
The average age of the patients was 54 years in the medication-only group and 49 years in the device group, and roughly one-third of the patients in each group were male. The baseline clinical characteristics, including the presence of hypertension, diabetes, smoking, and high cholesterol, were similar between the groups.
“We should consider two things before clinical decision of device closure,” Dr. Song said. First, exclude other causes of cryptogenic stroke; and second, conduct a comprehensive evaluation of the PFO to determine which patients are at highest risk and would be most likely to benefit from the procedure, he said.
To better determine which patients would benefit from the device implantation, Dr. Song and his colleagues used imaging to review data on the size and features of the PFO; patients with evidence of an atrial septal aneurysm or hypermobility (defined as a septal excursion 10 mm or larger) were deemed at especially high risk.
Dr. Song said that the next steps for research on management of PFOs include determining which medications are most effective in patients treated with medication alone, as well as clarifying the process of patient selection for device use based on PFO morphology.
The study was terminated early because of several factors, including low patient recruitment and the decision not to deny patients the closure treatment because of its demonstrated effectiveness, Dr. Song noted.
The study was supported by the Cardiovascular Research Foundation in Seoul, South Korea. Dr. Song had no financial conflicts to disclose. The findings were published simultaneously in the Journal of the American College of Cardiology (doi: 10.1016/j.jacc.2018.02.046).
SOURCE: Song J. ACC 2018.
REPORTING FROM ACC 18
Key clinical point: Closure of patent foramen ovale resulted in no adverse events or recurrent strokes during 2 years’ follow-up.
Major finding: No adverse event or strokes occurred in the device-plus-medication group, compared with six events in the medication-only group.
Study details: The data come from DEFENSE-PFO, a randomized trial of 120 adults with a history of cryptogenic stroke and high-risk PFO.
Disclosures: DEFENSE-PFO was supported by the Cardiovascular Research Foundation in Seoul, South Korea. Dr. Song had no financial conflicts to disclose.
Source: Song J. ACC 2018.
