American College of Cardiology (ACC): Cardiovascular Conference at Snowmass

SNOWMASS, COLO. – The Food and Drug Administration has approved the first-ever U.S. randomized clinical trial of transcatheter aortic valve replacement versus open surgical replacement in low–surgical risk patients with symptomatic severe aortic stenosis.

The PARTNER III trial will enroll roughly 1,200 patients age 65 or older, all with a Society of Thoracic Surgeons risk score of less than 4%, at 50 sites beginning this spring, Dr. Vinod H. Thourani said at the Annual Cardiovascular Conference at Snowmass.

This is a noninferiority trial with a primary endpoint comprising a 1-year composite of death, stroke, or rehospitalization. The study is sponsored by Edwards Lifesciences, and patients randomized to transcatheter aortic valve replacement (TAVR) will receive the company’s low-profile Sapien 3 valve.

Coprincipal investigators are Dr. Michael J. Mack of the Baylor Health Care System in Plano, Tex., and Dr. Martin B. Leon of Columbia University, New York. Dr. Thourani is a member of the PARTNER III executive committee.

This is a study that could upend clinical practice, he observed.

“Are we going to have within the next 5 years 80%-90% of all patients who present with severe symptomatic aortic stenosis treated with transcatheter valves? We’re really at a major crossroads here, I believe,” said Dr. Thourani, professor of surgery and medicine and codirector of the structural heart and valve center at Emory University in Atlanta.

He ran down the numbers: Today, roughly 80% of all surgical aortic valve replacements (SAVR) in the United States are performed in low–surgical risk patients. These low-risk patients comprise roughly 65% of the total operable population with severe aortic stenosis. If PARTNER III and other data show that TAVR provides results comparable to SAVR in this group, Dr. Thourani predicted that it’s likely most low–surgical risk patients will opt for the less invasive approach. The appeal is no surgical incision, less pain, a shorter or no ICU stay, and faster return to normal activity.

Right now, U.S. and European guidelines state that TAVR is the preferred or alternative strategy to SAVR only in the relatively small group comprised of inoperable or high–surgical risk patients. In clinical practice, TAVR has already supplanted SAVR in the 10% of operable patients with high surgical risk. And TAVR is poised to do so in the roughly 25% of patients who fall into the intermediate–surgical risk category, according to the cardiothoracic surgeon.

He predicted that the 1-year outcomes of TAVR in more than 1,000 intermediate-risk participants in the PARTNER II trial will create a stir when presented this year, as a late-breaker at the annual meeting of the American College of Cardiology in Chicago. Although he stressed that he doesn’t know the results, the 30-day outcomes presented at last year’s Transcatheter Cardiovascular Therapeutics conference are extremely promising: a 1.1% all-cause mortality rate in patients with an average Society of Thoracic Surgeons risk score of 5.3%, for a stunning observed-to-expected ratio of just 0.21. Plus, a 1.0% rate of disabling stroke in this large multicenter randomized experience.

“That becomes really compelling data for us to think we’re ready now to go to the next step,” Dr. Thourani said. “My belief is at the rate we’re going, we’ll see most intermediate-risk patients going to TAVR.”

To date there has been only one randomized trial of TAVR versus SAVR in low–surgical risk patients: the Nordic Aortic Valve Intervention Trial (NOTION), which included 280 randomized patients with an average Society of Thoracic Surgeons risk score of 3%.

In the 2-year results presented by Dr. Lars Søndergaard of the University of Copenhagen at TCT 2015, all-cause mortality was 2.1% with TAVR and 3.7% with SAVR at 30 days, 4.9% with TAVR and 7.5% with SAVR at 12 months, and 8.0% versus 9.8% at 24 months. The 30-day rates of major bleeding, cardiogenic shock, atrial fibrillation, and acute kidney injury were all substantially lower in the TAVR group. All very impressive. However, Dr. Thourani found the TAVR patients’ pacemaker-requirement rate troubling. At 30 days post TAVR, 34% of patients had a pacemaker, compared with 1.6% of the SAVR group. By 24 months, 41% of the TAVR group had received a pacemaker, compared with just 4% of the SAVR group.

“What’s the acceptable pacemaker rate for someone utilizing TAVR – 5%, 10%, 40%? That’s something we as a community have to look at,” the surgeon observed. He noted that his purchase price for a TAVR valve is roughly $32,500, whereas a SAVR valve costs him $4,500. And at Emory, putting in a pacemaker costs an added $10,000-$15,000 for the device.

“If I’m putting a pacemaker in 40% of my TAVR patients at a cost of $40,000-$45,000 per patient for the valve and pacemaker, that becomes an issue,” Dr. Thourani said.

Other concerns surrounding TAVR, in addition to reimbursement, include the uncertain long-term impact of residual minimal paravalvular leak, which is common.

“We’re not done talking about paravalvular leak rates. As cardiologists you’re not okay with me giving your patient a minimal paravalvular leak post-SAVR. Are we going to change the bar a little bit for TAVR?” he mused.

Another issue is thrombosis of TAVR valve leaflets, Dr. Thourani continued. In a large patient series reported last year, this event occurred in 0.6% of patients, with an average of 181 days from TAVR to confirmatory abnormal imaging (Circ Cardiovasc Interv. 2015 Apr;8[4]. pii: e001779). Two clinical trials are gearing up to examine various anticoagulant strategies to address the problem.

Despite the various concerns, however, Dr. Thourani is extremely optimistic about TAVR’s future. It’s a booming field, with 396 U.S. TAVR centers as of 2015. The indications appear to be on the verge of expansion. Technical progress continues, with half a dozen TAVR valves in development in addition to the two now FDA approved.

“We have just scratched the surface of what we’re going to do in the management of severe aortic stenosis,” the surgeon promised.

The latest results of minimalist TAVR provide another reason for optimism regarding TAVR’s future.

Emory University surgeons and interventional cardiologists have been pacesetters in the minimalist TAVR approach. The key elements of minimalist TAVR are that the procedure is performed in the cardiac catheterization laboratory via transfemoral access, under conscious sedation, with transthoracic echocardiographic guidance, no Swan-Ganz catheter, and no ICU stay for most patients.

Dr. Thourani presented as-yet unpublished data on a recent series of 111 high–surgical risk patients who underwent minimalist TAVR with implantation of a Sapien 3 valve at Emory. Although their Society of Thoracic Surgeons risk score was 8%, there was zero 30-day mortality in this group. One patient had a major stroke, two had major vascular complications, and the 30-day readmission rate was just 3.8%.

“Can we get to these results universally? We think we can. This is the bar we need to start thinking about,” Dr. Thourani said.

Dr. Thourani reported serving as a consultant to Edwards Lifesciences and St. Jude Medical and receiving research grants from Abbott, Boston Scientific, Medtronic, and Sorin.

bjancin@frontlinemedcom.com

SNOWMASS, COLO. – The Food and Drug Administration has approved the first-ever U.S. randomized clinical trial of transcatheter aortic valve replacement versus open surgical replacement in low–surgical risk patients with symptomatic severe aortic stenosis.

The PARTNER III trial will enroll roughly 1,200 patients age 65 or older, all with a Society of Thoracic Surgeons risk score of less than 4%, at 50 sites beginning this spring, Dr. Vinod H. Thourani said at the Annual Cardiovascular Conference at Snowmass.

This is a noninferiority trial with a primary endpoint comprising a 1-year composite of death, stroke, or rehospitalization. The study is sponsored by Edwards Lifesciences, and patients randomized to transcatheter aortic valve replacement (TAVR) will receive the company’s low-profile Sapien 3 valve.

Coprincipal investigators are Dr. Michael J. Mack of the Baylor Health Care System in Plano, Tex., and Dr. Martin B. Leon of Columbia University, New York. Dr. Thourani is a member of the PARTNER III executive committee.

This is a study that could upend clinical practice, he observed.

“Are we going to have within the next 5 years 80%-90% of all patients who present with severe symptomatic aortic stenosis treated with transcatheter valves? We’re really at a major crossroads here, I believe,” said Dr. Thourani, professor of surgery and medicine and codirector of the structural heart and valve center at Emory University in Atlanta.

He ran down the numbers: Today, roughly 80% of all surgical aortic valve replacements (SAVR) in the United States are performed in low–surgical risk patients. These low-risk patients comprise roughly 65% of the total operable population with severe aortic stenosis. If PARTNER III and other data show that TAVR provides results comparable to SAVR in this group, Dr. Thourani predicted that it’s likely most low–surgical risk patients will opt for the less invasive approach. The appeal is no surgical incision, less pain, a shorter or no ICU stay, and faster return to normal activity.

Right now, U.S. and European guidelines state that TAVR is the preferred or alternative strategy to SAVR only in the relatively small group comprised of inoperable or high–surgical risk patients. In clinical practice, TAVR has already supplanted SAVR in the 10% of operable patients with high surgical risk. And TAVR is poised to do so in the roughly 25% of patients who fall into the intermediate–surgical risk category, according to the cardiothoracic surgeon.

He predicted that the 1-year outcomes of TAVR in more than 1,000 intermediate-risk participants in the PARTNER II trial will create a stir when presented this year, as a late-breaker at the annual meeting of the American College of Cardiology in Chicago. Although he stressed that he doesn’t know the results, the 30-day outcomes presented at last year’s Transcatheter Cardiovascular Therapeutics conference are extremely promising: a 1.1% all-cause mortality rate in patients with an average Society of Thoracic Surgeons risk score of 5.3%, for a stunning observed-to-expected ratio of just 0.21. Plus, a 1.0% rate of disabling stroke in this large multicenter randomized experience.

“That becomes really compelling data for us to think we’re ready now to go to the next step,” Dr. Thourani said. “My belief is at the rate we’re going, we’ll see most intermediate-risk patients going to TAVR.”

To date there has been only one randomized trial of TAVR versus SAVR in low–surgical risk patients: the Nordic Aortic Valve Intervention Trial (NOTION), which included 280 randomized patients with an average Society of Thoracic Surgeons risk score of 3%.

In the 2-year results presented by Dr. Lars Søndergaard of the University of Copenhagen at TCT 2015, all-cause mortality was 2.1% with TAVR and 3.7% with SAVR at 30 days, 4.9% with TAVR and 7.5% with SAVR at 12 months, and 8.0% versus 9.8% at 24 months. The 30-day rates of major bleeding, cardiogenic shock, atrial fibrillation, and acute kidney injury were all substantially lower in the TAVR group. All very impressive. However, Dr. Thourani found the TAVR patients’ pacemaker-requirement rate troubling. At 30 days post TAVR, 34% of patients had a pacemaker, compared with 1.6% of the SAVR group. By 24 months, 41% of the TAVR group had received a pacemaker, compared with just 4% of the SAVR group.

“What’s the acceptable pacemaker rate for someone utilizing TAVR – 5%, 10%, 40%? That’s something we as a community have to look at,” the surgeon observed. He noted that his purchase price for a TAVR valve is roughly $32,500, whereas a SAVR valve costs him $4,500. And at Emory, putting in a pacemaker costs an added $10,000-$15,000 for the device.

“If I’m putting a pacemaker in 40% of my TAVR patients at a cost of $40,000-$45,000 per patient for the valve and pacemaker, that becomes an issue,” Dr. Thourani said.

Other concerns surrounding TAVR, in addition to reimbursement, include the uncertain long-term impact of residual minimal paravalvular leak, which is common.

“We’re not done talking about paravalvular leak rates. As cardiologists you’re not okay with me giving your patient a minimal paravalvular leak post-SAVR. Are we going to change the bar a little bit for TAVR?” he mused.

Another issue is thrombosis of TAVR valve leaflets, Dr. Thourani continued. In a large patient series reported last year, this event occurred in 0.6% of patients, with an average of 181 days from TAVR to confirmatory abnormal imaging (Circ Cardiovasc Interv. 2015 Apr;8[4]. pii: e001779). Two clinical trials are gearing up to examine various anticoagulant strategies to address the problem.

Despite the various concerns, however, Dr. Thourani is extremely optimistic about TAVR’s future. It’s a booming field, with 396 U.S. TAVR centers as of 2015. The indications appear to be on the verge of expansion. Technical progress continues, with half a dozen TAVR valves in development in addition to the two now FDA approved.

“We have just scratched the surface of what we’re going to do in the management of severe aortic stenosis,” the surgeon promised.

The latest results of minimalist TAVR provide another reason for optimism regarding TAVR’s future.

Emory University surgeons and interventional cardiologists have been pacesetters in the minimalist TAVR approach. The key elements of minimalist TAVR are that the procedure is performed in the cardiac catheterization laboratory via transfemoral access, under conscious sedation, with transthoracic echocardiographic guidance, no Swan-Ganz catheter, and no ICU stay for most patients.

Dr. Thourani presented as-yet unpublished data on a recent series of 111 high–surgical risk patients who underwent minimalist TAVR with implantation of a Sapien 3 valve at Emory. Although their Society of Thoracic Surgeons risk score was 8%, there was zero 30-day mortality in this group. One patient had a major stroke, two had major vascular complications, and the 30-day readmission rate was just 3.8%.

“Can we get to these results universally? We think we can. This is the bar we need to start thinking about,” Dr. Thourani said.

Dr. Thourani reported serving as a consultant to Edwards Lifesciences and St. Jude Medical and receiving research grants from Abbott, Boston Scientific, Medtronic, and Sorin.

bjancin@frontlinemedcom.com

SNOWMASS, COLO. – The Food and Drug Administration has approved the first-ever U.S. randomized clinical trial of transcatheter aortic valve replacement versus open surgical replacement in low–surgical risk patients with symptomatic severe aortic stenosis.

The PARTNER III trial will enroll roughly 1,200 patients age 65 or older, all with a Society of Thoracic Surgeons risk score of less than 4%, at 50 sites beginning this spring, Dr. Vinod H. Thourani said at the Annual Cardiovascular Conference at Snowmass.

This is a noninferiority trial with a primary endpoint comprising a 1-year composite of death, stroke, or rehospitalization. The study is sponsored by Edwards Lifesciences, and patients randomized to transcatheter aortic valve replacement (TAVR) will receive the company’s low-profile Sapien 3 valve.

Coprincipal investigators are Dr. Michael J. Mack of the Baylor Health Care System in Plano, Tex., and Dr. Martin B. Leon of Columbia University, New York. Dr. Thourani is a member of the PARTNER III executive committee.

This is a study that could upend clinical practice, he observed.

“Are we going to have within the next 5 years 80%-90% of all patients who present with severe symptomatic aortic stenosis treated with transcatheter valves? We’re really at a major crossroads here, I believe,” said Dr. Thourani, professor of surgery and medicine and codirector of the structural heart and valve center at Emory University in Atlanta.

He ran down the numbers: Today, roughly 80% of all surgical aortic valve replacements (SAVR) in the United States are performed in low–surgical risk patients. These low-risk patients comprise roughly 65% of the total operable population with severe aortic stenosis. If PARTNER III and other data show that TAVR provides results comparable to SAVR in this group, Dr. Thourani predicted that it’s likely most low–surgical risk patients will opt for the less invasive approach. The appeal is no surgical incision, less pain, a shorter or no ICU stay, and faster return to normal activity.

Right now, U.S. and European guidelines state that TAVR is the preferred or alternative strategy to SAVR only in the relatively small group comprised of inoperable or high–surgical risk patients. In clinical practice, TAVR has already supplanted SAVR in the 10% of operable patients with high surgical risk. And TAVR is poised to do so in the roughly 25% of patients who fall into the intermediate–surgical risk category, according to the cardiothoracic surgeon.

He predicted that the 1-year outcomes of TAVR in more than 1,000 intermediate-risk participants in the PARTNER II trial will create a stir when presented this year, as a late-breaker at the annual meeting of the American College of Cardiology in Chicago. Although he stressed that he doesn’t know the results, the 30-day outcomes presented at last year’s Transcatheter Cardiovascular Therapeutics conference are extremely promising: a 1.1% all-cause mortality rate in patients with an average Society of Thoracic Surgeons risk score of 5.3%, for a stunning observed-to-expected ratio of just 0.21. Plus, a 1.0% rate of disabling stroke in this large multicenter randomized experience.

“That becomes really compelling data for us to think we’re ready now to go to the next step,” Dr. Thourani said. “My belief is at the rate we’re going, we’ll see most intermediate-risk patients going to TAVR.”

To date there has been only one randomized trial of TAVR versus SAVR in low–surgical risk patients: the Nordic Aortic Valve Intervention Trial (NOTION), which included 280 randomized patients with an average Society of Thoracic Surgeons risk score of 3%.

In the 2-year results presented by Dr. Lars Søndergaard of the University of Copenhagen at TCT 2015, all-cause mortality was 2.1% with TAVR and 3.7% with SAVR at 30 days, 4.9% with TAVR and 7.5% with SAVR at 12 months, and 8.0% versus 9.8% at 24 months. The 30-day rates of major bleeding, cardiogenic shock, atrial fibrillation, and acute kidney injury were all substantially lower in the TAVR group. All very impressive. However, Dr. Thourani found the TAVR patients’ pacemaker-requirement rate troubling. At 30 days post TAVR, 34% of patients had a pacemaker, compared with 1.6% of the SAVR group. By 24 months, 41% of the TAVR group had received a pacemaker, compared with just 4% of the SAVR group.

“What’s the acceptable pacemaker rate for someone utilizing TAVR – 5%, 10%, 40%? That’s something we as a community have to look at,” the surgeon observed. He noted that his purchase price for a TAVR valve is roughly $32,500, whereas a SAVR valve costs him $4,500. And at Emory, putting in a pacemaker costs an added $10,000-$15,000 for the device.

“If I’m putting a pacemaker in 40% of my TAVR patients at a cost of $40,000-$45,000 per patient for the valve and pacemaker, that becomes an issue,” Dr. Thourani said.

Other concerns surrounding TAVR, in addition to reimbursement, include the uncertain long-term impact of residual minimal paravalvular leak, which is common.

“We’re not done talking about paravalvular leak rates. As cardiologists you’re not okay with me giving your patient a minimal paravalvular leak post-SAVR. Are we going to change the bar a little bit for TAVR?” he mused.

Another issue is thrombosis of TAVR valve leaflets, Dr. Thourani continued. In a large patient series reported last year, this event occurred in 0.6% of patients, with an average of 181 days from TAVR to confirmatory abnormal imaging (Circ Cardiovasc Interv. 2015 Apr;8[4]. pii: e001779). Two clinical trials are gearing up to examine various anticoagulant strategies to address the problem.

Despite the various concerns, however, Dr. Thourani is extremely optimistic about TAVR’s future. It’s a booming field, with 396 U.S. TAVR centers as of 2015. The indications appear to be on the verge of expansion. Technical progress continues, with half a dozen TAVR valves in development in addition to the two now FDA approved.

“We have just scratched the surface of what we’re going to do in the management of severe aortic stenosis,” the surgeon promised.

The latest results of minimalist TAVR provide another reason for optimism regarding TAVR’s future.

Emory University surgeons and interventional cardiologists have been pacesetters in the minimalist TAVR approach. The key elements of minimalist TAVR are that the procedure is performed in the cardiac catheterization laboratory via transfemoral access, under conscious sedation, with transthoracic echocardiographic guidance, no Swan-Ganz catheter, and no ICU stay for most patients.

Dr. Thourani presented as-yet unpublished data on a recent series of 111 high–surgical risk patients who underwent minimalist TAVR with implantation of a Sapien 3 valve at Emory. Although their Society of Thoracic Surgeons risk score was 8%, there was zero 30-day mortality in this group. One patient had a major stroke, two had major vascular complications, and the 30-day readmission rate was just 3.8%.

“Can we get to these results universally? We think we can. This is the bar we need to start thinking about,” Dr. Thourani said.

Dr. Thourani reported serving as a consultant to Edwards Lifesciences and St. Jude Medical and receiving research grants from Abbott, Boston Scientific, Medtronic, and Sorin.

bjancin@frontlinemedcom.com

SNOWMASS, COLO. – Current American Heart Association consensus recommendations for noninvasive testing of women with suspected ischemic heart disease utilize a novel and simplified approach to pretest risk stratification.

The writing committee’s thinking was that a new risk assessment method specific to symptomatic women was needed. Conventional risk scores, such as the Framingham and American College of Cardiology/AHA atherosclerotic cardiovascular disease risk calculator, are weighted for risk evaluation in the general population of asymptomatic men and women, committee cochair Dr. Jennifer H. Mieres explained at the Annual Cardiovascular Conference at Snowmass.

Bruce Jancin/Frontline Medical News

The pretest risk assessment strategy for ischemic heart disease (IHD) described in the AHA consensus statement (Circulation. 2014 Jul 22;130[4]:350-79) is applicable only in women who present with chest pain symptoms or an ischemic equivalent such as excessive shortness of breath not attributable to underlying pulmonary disease. It’s designed to avoid overuse of costly noninvasive and invasive diagnostic testing, which has become common in concert with increasing physician awareness that the pattern of symptom presentation is broader in women than men with IHD.

Given the epidemiologic evidence that coronary heart disease tends to occur a decade later in women than men, the female-specific risk assessment method utilizes age as its starting point. In general, women who present with symptoms suggestive of IHD in their 50s are classified as low risk. Those in their 60s are deemed intermediate risk. And symptomatic women in their 70s are categorized as high risk. A patient gets bumped up one risk category if she has multiple cardiac risk factors or functional disability, according to Dr. Mieres, professor of cardiology and population health at Hofstra University in Hempstead, N.Y.

Functional disability is defined as inability to perform activities of daily living or as a limited exercise capacity estimated at less than 5 metabolic equivalents (METs) using the Duke Activities Status Index (DASI), a validated brief 12-item questionnaire suitable for patients to complete in the waiting room.

A symptomatic woman’s baseline fitness level is important for a couple of reasons. If she can’t perform basic activities of daily living or do more than 5 METs of exercise then the exercise treadmill test is not the initial diagnostic test of choice because she won’t be able to achieve maximum stress.

Plus, the landmark Women’s Ischemia Syndrome Evaluation (WISE) study showed that a symptomatic woman’s baseline fitness level is a powerful predictor of her prognosis: Participants who had an estimated exercise capacity of 4.7 METs or less based upon their DASI score had a 3.7-fold greater risk of death or nonfatal MI during follow-up did than those with a DASI score of 10 METs or more. Those with a DASI score of 4.8-7.4 METs were 2.1-fold more likely to experience death or MI, and women with an estimated exercise capacity of 7.5-9.9 METs based upon DASI were at 1.9-fold increased risk of death or MI, compared with those having a DASI score of at least 10 METs (J Am Coll Cardiol. 2006 Feb 7;47[3 Suppl]:S36-43).

In addition, the women’s IHD risk evaluation utilizes several high-risk equivalents which automatically move a symptomatic woman into the high-risk category regardless of her age. These are peripheral artery disease, longstanding poorly controlled diabetes, and a history of cerebrovascular accident, Dr. Mieres continued.

She stressed that most low-risk symptomatic women are not candidates for diagnostic testing. The exercise treadmill test is the first-line diagnostic test for women at intermediate risk for IHD who are functionally capable and have a normal resting ECG.

Stress imaging studies are reserved for intermediate- and high-risk women with resting ST-segment abnormalities, inability to exercise adequately, or an indeterminate exercise treadmill test.

Stress echocardiography gets a class I recommendation in these situations. So does stress myocardial perfusion imaging with SPECT or PET except in premenopausal women, where concerns about radiation exposure dictate that stress echo or stress cardiac magnetic resonance imaging is preferable.

Otherwise, stress cardiac magnetic resonance gets a class IIb – “may be reasonable” – recommendation as an initial imaging test in these situations.

Coronary artery calcium measurement via CT angiography gets a class IIb recommendation in intermediate-risk symptomatic women. This imaging method is unique in that it not only provides accurate information about the obstructive burden of CAD, but it measures the nonobstructive burden as well. That’s particularly important in women because they have a greater burden of nonobstructive CAD, defined as 1%-49% stenosis, than do men. Women with stress test abnormalities and nonobstructive CAD are no longer defined as having a false-positive test, as was traditionally the case; instead, their test is categorized as abnormal because the WISE study has shown they are at elevated IHD risk, Dr. Mieres said.

She reported having no financial conflicts regarding her presentation.

SNOWMASS, COLO. – Current American Heart Association consensus recommendations for noninvasive testing of women with suspected ischemic heart disease utilize a novel and simplified approach to pretest risk stratification.

The writing committee’s thinking was that a new risk assessment method specific to symptomatic women was needed. Conventional risk scores, such as the Framingham and American College of Cardiology/AHA atherosclerotic cardiovascular disease risk calculator, are weighted for risk evaluation in the general population of asymptomatic men and women, committee cochair Dr. Jennifer H. Mieres explained at the Annual Cardiovascular Conference at Snowmass.

Bruce Jancin/Frontline Medical News

The pretest risk assessment strategy for ischemic heart disease (IHD) described in the AHA consensus statement (Circulation. 2014 Jul 22;130[4]:350-79) is applicable only in women who present with chest pain symptoms or an ischemic equivalent such as excessive shortness of breath not attributable to underlying pulmonary disease. It’s designed to avoid overuse of costly noninvasive and invasive diagnostic testing, which has become common in concert with increasing physician awareness that the pattern of symptom presentation is broader in women than men with IHD.

Given the epidemiologic evidence that coronary heart disease tends to occur a decade later in women than men, the female-specific risk assessment method utilizes age as its starting point. In general, women who present with symptoms suggestive of IHD in their 50s are classified as low risk. Those in their 60s are deemed intermediate risk. And symptomatic women in their 70s are categorized as high risk. A patient gets bumped up one risk category if she has multiple cardiac risk factors or functional disability, according to Dr. Mieres, professor of cardiology and population health at Hofstra University in Hempstead, N.Y.

Functional disability is defined as inability to perform activities of daily living or as a limited exercise capacity estimated at less than 5 metabolic equivalents (METs) using the Duke Activities Status Index (DASI), a validated brief 12-item questionnaire suitable for patients to complete in the waiting room.

A symptomatic woman’s baseline fitness level is important for a couple of reasons. If she can’t perform basic activities of daily living or do more than 5 METs of exercise then the exercise treadmill test is not the initial diagnostic test of choice because she won’t be able to achieve maximum stress.

Plus, the landmark Women’s Ischemia Syndrome Evaluation (WISE) study showed that a symptomatic woman’s baseline fitness level is a powerful predictor of her prognosis: Participants who had an estimated exercise capacity of 4.7 METs or less based upon their DASI score had a 3.7-fold greater risk of death or nonfatal MI during follow-up did than those with a DASI score of 10 METs or more. Those with a DASI score of 4.8-7.4 METs were 2.1-fold more likely to experience death or MI, and women with an estimated exercise capacity of 7.5-9.9 METs based upon DASI were at 1.9-fold increased risk of death or MI, compared with those having a DASI score of at least 10 METs (J Am Coll Cardiol. 2006 Feb 7;47[3 Suppl]:S36-43).

In addition, the women’s IHD risk evaluation utilizes several high-risk equivalents which automatically move a symptomatic woman into the high-risk category regardless of her age. These are peripheral artery disease, longstanding poorly controlled diabetes, and a history of cerebrovascular accident, Dr. Mieres continued.

She stressed that most low-risk symptomatic women are not candidates for diagnostic testing. The exercise treadmill test is the first-line diagnostic test for women at intermediate risk for IHD who are functionally capable and have a normal resting ECG.

Stress imaging studies are reserved for intermediate- and high-risk women with resting ST-segment abnormalities, inability to exercise adequately, or an indeterminate exercise treadmill test.

Stress echocardiography gets a class I recommendation in these situations. So does stress myocardial perfusion imaging with SPECT or PET except in premenopausal women, where concerns about radiation exposure dictate that stress echo or stress cardiac magnetic resonance imaging is preferable.

Otherwise, stress cardiac magnetic resonance gets a class IIb – “may be reasonable” – recommendation as an initial imaging test in these situations.

Coronary artery calcium measurement via CT angiography gets a class IIb recommendation in intermediate-risk symptomatic women. This imaging method is unique in that it not only provides accurate information about the obstructive burden of CAD, but it measures the nonobstructive burden as well. That’s particularly important in women because they have a greater burden of nonobstructive CAD, defined as 1%-49% stenosis, than do men. Women with stress test abnormalities and nonobstructive CAD are no longer defined as having a false-positive test, as was traditionally the case; instead, their test is categorized as abnormal because the WISE study has shown they are at elevated IHD risk, Dr. Mieres said.

She reported having no financial conflicts regarding her presentation.

SNOWMASS, COLO. – Current American Heart Association consensus recommendations for noninvasive testing of women with suspected ischemic heart disease utilize a novel and simplified approach to pretest risk stratification.

The writing committee’s thinking was that a new risk assessment method specific to symptomatic women was needed. Conventional risk scores, such as the Framingham and American College of Cardiology/AHA atherosclerotic cardiovascular disease risk calculator, are weighted for risk evaluation in the general population of asymptomatic men and women, committee cochair Dr. Jennifer H. Mieres explained at the Annual Cardiovascular Conference at Snowmass.

Bruce Jancin/Frontline Medical News

The pretest risk assessment strategy for ischemic heart disease (IHD) described in the AHA consensus statement (Circulation. 2014 Jul 22;130[4]:350-79) is applicable only in women who present with chest pain symptoms or an ischemic equivalent such as excessive shortness of breath not attributable to underlying pulmonary disease. It’s designed to avoid overuse of costly noninvasive and invasive diagnostic testing, which has become common in concert with increasing physician awareness that the pattern of symptom presentation is broader in women than men with IHD.

Given the epidemiologic evidence that coronary heart disease tends to occur a decade later in women than men, the female-specific risk assessment method utilizes age as its starting point. In general, women who present with symptoms suggestive of IHD in their 50s are classified as low risk. Those in their 60s are deemed intermediate risk. And symptomatic women in their 70s are categorized as high risk. A patient gets bumped up one risk category if she has multiple cardiac risk factors or functional disability, according to Dr. Mieres, professor of cardiology and population health at Hofstra University in Hempstead, N.Y.

Functional disability is defined as inability to perform activities of daily living or as a limited exercise capacity estimated at less than 5 metabolic equivalents (METs) using the Duke Activities Status Index (DASI), a validated brief 12-item questionnaire suitable for patients to complete in the waiting room.

A symptomatic woman’s baseline fitness level is important for a couple of reasons. If she can’t perform basic activities of daily living or do more than 5 METs of exercise then the exercise treadmill test is not the initial diagnostic test of choice because she won’t be able to achieve maximum stress.

Plus, the landmark Women’s Ischemia Syndrome Evaluation (WISE) study showed that a symptomatic woman’s baseline fitness level is a powerful predictor of her prognosis: Participants who had an estimated exercise capacity of 4.7 METs or less based upon their DASI score had a 3.7-fold greater risk of death or nonfatal MI during follow-up did than those with a DASI score of 10 METs or more. Those with a DASI score of 4.8-7.4 METs were 2.1-fold more likely to experience death or MI, and women with an estimated exercise capacity of 7.5-9.9 METs based upon DASI were at 1.9-fold increased risk of death or MI, compared with those having a DASI score of at least 10 METs (J Am Coll Cardiol. 2006 Feb 7;47[3 Suppl]:S36-43).

In addition, the women’s IHD risk evaluation utilizes several high-risk equivalents which automatically move a symptomatic woman into the high-risk category regardless of her age. These are peripheral artery disease, longstanding poorly controlled diabetes, and a history of cerebrovascular accident, Dr. Mieres continued.

She stressed that most low-risk symptomatic women are not candidates for diagnostic testing. The exercise treadmill test is the first-line diagnostic test for women at intermediate risk for IHD who are functionally capable and have a normal resting ECG.

Stress imaging studies are reserved for intermediate- and high-risk women with resting ST-segment abnormalities, inability to exercise adequately, or an indeterminate exercise treadmill test.

Stress echocardiography gets a class I recommendation in these situations. So does stress myocardial perfusion imaging with SPECT or PET except in premenopausal women, where concerns about radiation exposure dictate that stress echo or stress cardiac magnetic resonance imaging is preferable.

Otherwise, stress cardiac magnetic resonance gets a class IIb – “may be reasonable” – recommendation as an initial imaging test in these situations.

Coronary artery calcium measurement via CT angiography gets a class IIb recommendation in intermediate-risk symptomatic women. This imaging method is unique in that it not only provides accurate information about the obstructive burden of CAD, but it measures the nonobstructive burden as well. That’s particularly important in women because they have a greater burden of nonobstructive CAD, defined as 1%-49% stenosis, than do men. Women with stress test abnormalities and nonobstructive CAD are no longer defined as having a false-positive test, as was traditionally the case; instead, their test is categorized as abnormal because the WISE study has shown they are at elevated IHD risk, Dr. Mieres said.

She reported having no financial conflicts regarding her presentation.

SNOWMASS, COLO. – Current American Heart Association consensus recommendations for noninvasive testing of women with suspected ischemic heart disease utilize a novel and simplified approach to pretest risk stratification.

The writing committee’s thinking was that a new risk assessment method specific to symptomatic women was needed. Conventional risk scores, such as the Framingham and American College of Cardiology/AHA atherosclerotic cardiovascular disease risk calculator, are weighted for risk evaluation in the general population of asymptomatic men and women, committee cochair Dr. Jennifer H. Mieres explained at the Annual Cardiovascular Conference at Snowmass.

Bruce Jancin/Frontline Medical News

The pretest risk assessment strategy for ischemic heart disease (IHD) described in the AHA consensus statement (Circulation. 2014 Jul 22;130[4]:350-79) is applicable only in women who present with chest pain symptoms or an ischemic equivalent such as excessive shortness of breath not attributable to underlying pulmonary disease. It’s designed to avoid overuse of costly noninvasive and invasive diagnostic testing, which has become common in concert with increasing physician awareness that the pattern of symptom presentation is broader in women than men with IHD.

Given the epidemiologic evidence that coronary heart disease tends to occur a decade later in women than men, the female-specific risk assessment method utilizes age as its starting point. In general, women who present with symptoms suggestive of IHD in their 50s are classified as low risk. Those in their 60s are deemed intermediate risk. And symptomatic women in their 70s are categorized as high risk. A patient gets bumped up one risk category if she has multiple cardiac risk factors or functional disability, according to Dr. Mieres, professor of cardiology and population health at Hofstra University in Hempstead, N.Y.

Functional disability is defined as inability to perform activities of daily living or as a limited exercise capacity estimated at less than 5 metabolic equivalents (METs) using the Duke Activities Status Index (DASI), a validated brief 12-item questionnaire suitable for patients to complete in the waiting room.

A symptomatic woman’s baseline fitness level is important for a couple of reasons. If she can’t perform basic activities of daily living or do more than 5 METs of exercise then the exercise treadmill test is not the initial diagnostic test of choice because she won’t be able to achieve maximum stress.

Plus, the landmark Women’s Ischemia Syndrome Evaluation (WISE) study showed that a symptomatic woman’s baseline fitness level is a powerful predictor of her prognosis: Participants who had an estimated exercise capacity of 4.7 METs or less based upon their DASI score had a 3.7-fold greater risk of death or nonfatal MI during follow-up did than those with a DASI score of 10 METs or more. Those with a DASI score of 4.8-7.4 METs were 2.1-fold more likely to experience death or MI, and women with an estimated exercise capacity of 7.5-9.9 METs based upon DASI were at 1.9-fold increased risk of death or MI, compared with those having a DASI score of at least 10 METs (J Am Coll Cardiol. 2006 Feb 7;47[3 Suppl]:S36-43).

In addition, the women’s IHD risk evaluation utilizes several high-risk equivalents which automatically move a symptomatic woman into the high-risk category regardless of her age. These are peripheral artery disease, longstanding poorly controlled diabetes, and a history of cerebrovascular accident, Dr. Mieres continued.

She stressed that most low-risk symptomatic women are not candidates for diagnostic testing. The exercise treadmill test is the first-line diagnostic test for women at intermediate risk for IHD who are functionally capable and have a normal resting ECG.

Stress imaging studies are reserved for intermediate- and high-risk women with resting ST-segment abnormalities, inability to exercise adequately, or an indeterminate exercise treadmill test.

Stress echocardiography gets a class I recommendation in these situations. So does stress myocardial perfusion imaging with SPECT or PET except in premenopausal women, where concerns about radiation exposure dictate that stress echo or stress cardiac magnetic resonance imaging is preferable.

Otherwise, stress cardiac magnetic resonance gets a class IIb – “may be reasonable” – recommendation as an initial imaging test in these situations.

Coronary artery calcium measurement via CT angiography gets a class IIb recommendation in intermediate-risk symptomatic women. This imaging method is unique in that it not only provides accurate information about the obstructive burden of CAD, but it measures the nonobstructive burden as well. That’s particularly important in women because they have a greater burden of nonobstructive CAD, defined as 1%-49% stenosis, than do men. Women with stress test abnormalities and nonobstructive CAD are no longer defined as having a false-positive test, as was traditionally the case; instead, their test is categorized as abnormal because the WISE study has shown they are at elevated IHD risk, Dr. Mieres said.

She reported having no financial conflicts regarding her presentation.

bjancin@frontlinemedcom.com

SNOWMASS, COLO. – Current American Heart Association consensus recommendations for noninvasive testing of women with suspected ischemic heart disease utilize a novel and simplified approach to pretest risk stratification.

The writing committee’s thinking was that a new risk assessment method specific to symptomatic women was needed. Conventional risk scores, such as the Framingham and American College of Cardiology/AHA atherosclerotic cardiovascular disease risk calculator, are weighted for risk evaluation in the general population of asymptomatic men and women, committee cochair Dr. Jennifer H. Mieres explained at the Annual Cardiovascular Conference at Snowmass.

Bruce Jancin/Frontline Medical News

The pretest risk assessment strategy for ischemic heart disease (IHD) described in the AHA consensus statement (Circulation. 2014 Jul 22;130[4]:350-79) is applicable only in women who present with chest pain symptoms or an ischemic equivalent such as excessive shortness of breath not attributable to underlying pulmonary disease. It’s designed to avoid overuse of costly noninvasive and invasive diagnostic testing, which has become common in concert with increasing physician awareness that the pattern of symptom presentation is broader in women than men with IHD.

Given the epidemiologic evidence that coronary heart disease tends to occur a decade later in women than men, the female-specific risk assessment method utilizes age as its starting point. In general, women who present with symptoms suggestive of IHD in their 50s are classified as low risk. Those in their 60s are deemed intermediate risk. And symptomatic women in their 70s are categorized as high risk. A patient gets bumped up one risk category if she has multiple cardiac risk factors or functional disability, according to Dr. Mieres, professor of cardiology and population health at Hofstra University in Hempstead, N.Y.

Functional disability is defined as inability to perform activities of daily living or as a limited exercise capacity estimated at less than 5 metabolic equivalents (METs) using the Duke Activities Status Index (DASI), a validated brief 12-item questionnaire suitable for patients to complete in the waiting room.

A symptomatic woman’s baseline fitness level is important for a couple of reasons. If she can’t perform basic activities of daily living or do more than 5 METs of exercise then the exercise treadmill test is not the initial diagnostic test of choice because she won’t be able to achieve maximum stress.

Plus, the landmark Women’s Ischemia Syndrome Evaluation (WISE) study showed that a symptomatic woman’s baseline fitness level is a powerful predictor of her prognosis: Participants who had an estimated exercise capacity of 4.7 METs or less based upon their DASI score had a 3.7-fold greater risk of death or nonfatal MI during follow-up did than those with a DASI score of 10 METs or more. Those with a DASI score of 4.8-7.4 METs were 2.1-fold more likely to experience death or MI, and women with an estimated exercise capacity of 7.5-9.9 METs based upon DASI were at 1.9-fold increased risk of death or MI, compared with those having a DASI score of at least 10 METs (J Am Coll Cardiol. 2006 Feb 7;47[3 Suppl]:S36-43).

In addition, the women’s IHD risk evaluation utilizes several high-risk equivalents which automatically move a symptomatic woman into the high-risk category regardless of her age. These are peripheral artery disease, longstanding poorly controlled diabetes, and a history of cerebrovascular accident, Dr. Mieres continued.

She stressed that most low-risk symptomatic women are not candidates for diagnostic testing. The exercise treadmill test is the first-line diagnostic test for women at intermediate risk for IHD who are functionally capable and have a normal resting ECG.

Stress imaging studies are reserved for intermediate- and high-risk women with resting ST-segment abnormalities, inability to exercise adequately, or an indeterminate exercise treadmill test.

Stress echocardiography gets a class I recommendation in these situations. So does stress myocardial perfusion imaging with SPECT or PET except in premenopausal women, where concerns about radiation exposure dictate that stress echo or stress cardiac magnetic resonance imaging is preferable.

Otherwise, stress cardiac magnetic resonance gets a class IIb – “may be reasonable” – recommendation as an initial imaging test in these situations.

Coronary artery calcium measurement via CT angiography gets a class IIb recommendation in intermediate-risk symptomatic women. This imaging method is unique in that it not only provides accurate information about the obstructive burden of CAD, but it measures the nonobstructive burden as well. That’s particularly important in women because they have a greater burden of nonobstructive CAD, defined as 1%-49% stenosis, than do men. Women with stress test abnormalities and nonobstructive CAD are no longer defined as having a false-positive test, as was traditionally the case; instead, their test is categorized as abnormal because the WISE study has shown they are at elevated IHD risk, Dr. Mieres said.

She reported having no financial conflicts regarding her presentation.

bjancin@frontlinemedcom.com

SNOWMASS, COLO. – Current American Heart Association consensus recommendations for noninvasive testing of women with suspected ischemic heart disease utilize a novel and simplified approach to pretest risk stratification.

The writing committee’s thinking was that a new risk assessment method specific to symptomatic women was needed. Conventional risk scores, such as the Framingham and American College of Cardiology/AHA atherosclerotic cardiovascular disease risk calculator, are weighted for risk evaluation in the general population of asymptomatic men and women, committee cochair Dr. Jennifer H. Mieres explained at the Annual Cardiovascular Conference at Snowmass.

Bruce Jancin/Frontline Medical News

The pretest risk assessment strategy for ischemic heart disease (IHD) described in the AHA consensus statement (Circulation. 2014 Jul 22;130[4]:350-79) is applicable only in women who present with chest pain symptoms or an ischemic equivalent such as excessive shortness of breath not attributable to underlying pulmonary disease. It’s designed to avoid overuse of costly noninvasive and invasive diagnostic testing, which has become common in concert with increasing physician awareness that the pattern of symptom presentation is broader in women than men with IHD.

Given the epidemiologic evidence that coronary heart disease tends to occur a decade later in women than men, the female-specific risk assessment method utilizes age as its starting point. In general, women who present with symptoms suggestive of IHD in their 50s are classified as low risk. Those in their 60s are deemed intermediate risk. And symptomatic women in their 70s are categorized as high risk. A patient gets bumped up one risk category if she has multiple cardiac risk factors or functional disability, according to Dr. Mieres, professor of cardiology and population health at Hofstra University in Hempstead, N.Y.

Functional disability is defined as inability to perform activities of daily living or as a limited exercise capacity estimated at less than 5 metabolic equivalents (METs) using the Duke Activities Status Index (DASI), a validated brief 12-item questionnaire suitable for patients to complete in the waiting room.

A symptomatic woman’s baseline fitness level is important for a couple of reasons. If she can’t perform basic activities of daily living or do more than 5 METs of exercise then the exercise treadmill test is not the initial diagnostic test of choice because she won’t be able to achieve maximum stress.

Plus, the landmark Women’s Ischemia Syndrome Evaluation (WISE) study showed that a symptomatic woman’s baseline fitness level is a powerful predictor of her prognosis: Participants who had an estimated exercise capacity of 4.7 METs or less based upon their DASI score had a 3.7-fold greater risk of death or nonfatal MI during follow-up did than those with a DASI score of 10 METs or more. Those with a DASI score of 4.8-7.4 METs were 2.1-fold more likely to experience death or MI, and women with an estimated exercise capacity of 7.5-9.9 METs based upon DASI were at 1.9-fold increased risk of death or MI, compared with those having a DASI score of at least 10 METs (J Am Coll Cardiol. 2006 Feb 7;47[3 Suppl]:S36-43).

In addition, the women’s IHD risk evaluation utilizes several high-risk equivalents which automatically move a symptomatic woman into the high-risk category regardless of her age. These are peripheral artery disease, longstanding poorly controlled diabetes, and a history of cerebrovascular accident, Dr. Mieres continued.

She stressed that most low-risk symptomatic women are not candidates for diagnostic testing. The exercise treadmill test is the first-line diagnostic test for women at intermediate risk for IHD who are functionally capable and have a normal resting ECG.

Stress imaging studies are reserved for intermediate- and high-risk women with resting ST-segment abnormalities, inability to exercise adequately, or an indeterminate exercise treadmill test.

Stress echocardiography gets a class I recommendation in these situations. So does stress myocardial perfusion imaging with SPECT or PET except in premenopausal women, where concerns about radiation exposure dictate that stress echo or stress cardiac magnetic resonance imaging is preferable.

Otherwise, stress cardiac magnetic resonance gets a class IIb – “may be reasonable” – recommendation as an initial imaging test in these situations.

Coronary artery calcium measurement via CT angiography gets a class IIb recommendation in intermediate-risk symptomatic women. This imaging method is unique in that it not only provides accurate information about the obstructive burden of CAD, but it measures the nonobstructive burden as well. That’s particularly important in women because they have a greater burden of nonobstructive CAD, defined as 1%-49% stenosis, than do men. Women with stress test abnormalities and nonobstructive CAD are no longer defined as having a false-positive test, as was traditionally the case; instead, their test is categorized as abnormal because the WISE study has shown they are at elevated IHD risk, Dr. Mieres said.

She reported having no financial conflicts regarding her presentation.

bjancin@frontlinemedcom.com

SNOWMASS, COLO. – Forthcoming guideline updates addressing the duration of dual-antiplatelet therapy will recommend shorter minimum durations following elective coronary stent placement for patients with stable ischemic heart disease in order to provide physicians with more room to exercise clinical judgment and individualize therapy.

“The American College of Cardiology and the American Heart Association have gone through a several month process of revising all recommendations with respect to antiplatelet therapy across six different guidelines. That should be published in the next few months. I suspect it will be similar to what the Europeans have been espousing,” Dr. Patrick T. O’Gara, ACC immediate past president, said at the Annual Cardiovascular Conference at Snowmass.

jancin

“If you look at the European Society of Cardiology guidelines, it’s as little as 30 days of DAPT [dual-antiplatelet therapy] following placement of a bare metal stent in a stable ischemic heart disease patient, 3 months for current generation drug-eluting stents, extending that out a little longer for the bioabsorbable stent platforms,” said Dr. O’Gara, professor of medicine at Harvard Medical School and director of clinical cardiology at Brigham and Women’s Hospital, Boston.

The impetus for the updated guidelines on DAPT duration, according to the cardiologist, was a growing appreciation of the trade-offs involved in this potent therapy, which reduces the risk of major adverse cardiovascular events at the price of a significant increase in major bleeding.

The new ACC/AHA recommendation calling for as little as 3 months of DAPT following placement of current generation drug-eluting stents in patients with stable ischemic heart disease (IHD) follows from the observation that the risks of late and very late stent thrombosis are extremely low with these devices, whereas the risk of bleeding remains higher, he continued.

The new, shorter recommended minimum DAPT durations are consistent with the underlying histopathology of stable IHD with intermittent claudication. Plaque rupture is unlikely to occur at that stage of atherosclerotic heart disease, in contrast to the inherent instability of the vulnerable plaque with a thin fibrous cap that’s present in an acute coronary syndrome (ACS). Patients with ACS have increased risks of recurrent ischemia or MI, stent thrombosis, bleeding, and death, compared with those with stable IHD.

“It’s just their biology,” Dr. O’Gara explained. “Think of ACS as a prothrombotic state which has a tail of activity over the next 6-12 months.”

That’s why a minimum of 12 months of DAPT featuring aspirin at 81 mg/day following stent placement in patients who present with ACS will continue to be recommended in the update. The same applies to patients who undergo coronary artery bypass grafting after presenting with ACS, although Dr. O’Gara said many surgeons appear to be unaware of this recommendation.

“You’re obligated to complete 12 months of DAPT in that situation. One of the common mistakes made in clinical practice is for surgeons to simply send those patients home on aspirin without a P2Y12 inhibitor,” according to Dr. O’Gara.

The positive outcomes seen with DAPT lasting for longer than 12 months after stent implantation in patients with ACS in the large DAPT trial and the more recent PEGASUS-TIMI 54 trial have put considerable pressure on guideline-writing committees to give a strong endorsement of extended DAPT. But the steep price paid in terms of major bleeding with this prolonged DAPT strategy, he said, gives one pause.

PEGASUS-TIMI 54 randomized more than 21,000 patients with a history of MI nearly 2 years earlier plus one additional high-risk factor such as diabetes to an average of 33 months of double-blind treatment with ticagrelor (Brilinta) at 60 or 90 mg/day or placebo on top of low-dose aspirin (N Engl J Med. 2015 May 7;372[19]:1791-800).

“For every 1,000 patients treated with prolonged DAPT, there were four fewer major ischemic events but three additional major bleeding events per year. Is this a clear winner? For all the enthusiasm there’s been about PEGASUS, those numbers look relatively small. It gets back to the point that individual judgment trumps everything,” Dr. O’Gara said.

He noted that this theme of a close overall risk/benefit balance for prolonged DAPT received further support at last year’s annual meeting of the European Society of Cardiology, where Dr. Jay A. Udell of the University of Toronto presented a meta-analysis of six randomized trials of prolonged DAPT versus aspirin alone in more than 33,000 high-risk patients with a history of MI. The results, which were recently published, showed a 22% reduction in the relative risk of major adverse cardiovascular events with extended DAPT, but a 73% increase in the risk of major bleeding (Eur Heart J. 2016 Jan 21;37[4]:390-9).

The DAPT trial investigators have developed a risk score in an effort to aid clinicians in deciding whether to extend DAPT for more than 12 months after stent placement for ACS in a given individual. The score, which utilizes eight clinical variables, was unveiled at last November’s AHA scientific sessions. For patients with a DAPT score of 2 or more, the number needed to treat for 18 additional months after the initial 12 months of DAPT in order to prevent one major adverse cardiovascular event was 34, with the number needed to harm in the form of major bleeding being 272. For patients with a DAPT score of less than 2, the number needed to treat was 153, and the number needed to harm was 64.

However, Dr. O’Gara said he doesn’t consider the DAPT score ready for use in daily clinical practice for a couple of reasons: It hasn’t yet been validated externally, and it hasn’t yet been published in a peer-reviewed journal.

“I suspect it’s going through a lot of editorial revisions in terms of its statistical underpinnings,” the cardiologist said.

He reported having no financial conflicts of interest regarding his presentation.

SNOWMASS, COLO. – Forthcoming guideline updates addressing the duration of dual-antiplatelet therapy will recommend shorter minimum durations following elective coronary stent placement for patients with stable ischemic heart disease in order to provide physicians with more room to exercise clinical judgment and individualize therapy.

“The American College of Cardiology and the American Heart Association have gone through a several month process of revising all recommendations with respect to antiplatelet therapy across six different guidelines. That should be published in the next few months. I suspect it will be similar to what the Europeans have been espousing,” Dr. Patrick T. O’Gara, ACC immediate past president, said at the Annual Cardiovascular Conference at Snowmass.

jancin

“If you look at the European Society of Cardiology guidelines, it’s as little as 30 days of DAPT [dual-antiplatelet therapy] following placement of a bare metal stent in a stable ischemic heart disease patient, 3 months for current generation drug-eluting stents, extending that out a little longer for the bioabsorbable stent platforms,” said Dr. O’Gara, professor of medicine at Harvard Medical School and director of clinical cardiology at Brigham and Women’s Hospital, Boston.

The impetus for the updated guidelines on DAPT duration, according to the cardiologist, was a growing appreciation of the trade-offs involved in this potent therapy, which reduces the risk of major adverse cardiovascular events at the price of a significant increase in major bleeding.

The new ACC/AHA recommendation calling for as little as 3 months of DAPT following placement of current generation drug-eluting stents in patients with stable ischemic heart disease (IHD) follows from the observation that the risks of late and very late stent thrombosis are extremely low with these devices, whereas the risk of bleeding remains higher, he continued.

The new, shorter recommended minimum DAPT durations are consistent with the underlying histopathology of stable IHD with intermittent claudication. Plaque rupture is unlikely to occur at that stage of atherosclerotic heart disease, in contrast to the inherent instability of the vulnerable plaque with a thin fibrous cap that’s present in an acute coronary syndrome (ACS). Patients with ACS have increased risks of recurrent ischemia or MI, stent thrombosis, bleeding, and death, compared with those with stable IHD.

“It’s just their biology,” Dr. O’Gara explained. “Think of ACS as a prothrombotic state which has a tail of activity over the next 6-12 months.”

That’s why a minimum of 12 months of DAPT featuring aspirin at 81 mg/day following stent placement in patients who present with ACS will continue to be recommended in the update. The same applies to patients who undergo coronary artery bypass grafting after presenting with ACS, although Dr. O’Gara said many surgeons appear to be unaware of this recommendation.

“You’re obligated to complete 12 months of DAPT in that situation. One of the common mistakes made in clinical practice is for surgeons to simply send those patients home on aspirin without a P2Y12 inhibitor,” according to Dr. O’Gara.

The positive outcomes seen with DAPT lasting for longer than 12 months after stent implantation in patients with ACS in the large DAPT trial and the more recent PEGASUS-TIMI 54 trial have put considerable pressure on guideline-writing committees to give a strong endorsement of extended DAPT. But the steep price paid in terms of major bleeding with this prolonged DAPT strategy, he said, gives one pause.

PEGASUS-TIMI 54 randomized more than 21,000 patients with a history of MI nearly 2 years earlier plus one additional high-risk factor such as diabetes to an average of 33 months of double-blind treatment with ticagrelor (Brilinta) at 60 or 90 mg/day or placebo on top of low-dose aspirin (N Engl J Med. 2015 May 7;372[19]:1791-800).

“For every 1,000 patients treated with prolonged DAPT, there were four fewer major ischemic events but three additional major bleeding events per year. Is this a clear winner? For all the enthusiasm there’s been about PEGASUS, those numbers look relatively small. It gets back to the point that individual judgment trumps everything,” Dr. O’Gara said.

He noted that this theme of a close overall risk/benefit balance for prolonged DAPT received further support at last year’s annual meeting of the European Society of Cardiology, where Dr. Jay A. Udell of the University of Toronto presented a meta-analysis of six randomized trials of prolonged DAPT versus aspirin alone in more than 33,000 high-risk patients with a history of MI. The results, which were recently published, showed a 22% reduction in the relative risk of major adverse cardiovascular events with extended DAPT, but a 73% increase in the risk of major bleeding (Eur Heart J. 2016 Jan 21;37[4]:390-9).

The DAPT trial investigators have developed a risk score in an effort to aid clinicians in deciding whether to extend DAPT for more than 12 months after stent placement for ACS in a given individual. The score, which utilizes eight clinical variables, was unveiled at last November’s AHA scientific sessions. For patients with a DAPT score of 2 or more, the number needed to treat for 18 additional months after the initial 12 months of DAPT in order to prevent one major adverse cardiovascular event was 34, with the number needed to harm in the form of major bleeding being 272. For patients with a DAPT score of less than 2, the number needed to treat was 153, and the number needed to harm was 64.

However, Dr. O’Gara said he doesn’t consider the DAPT score ready for use in daily clinical practice for a couple of reasons: It hasn’t yet been validated externally, and it hasn’t yet been published in a peer-reviewed journal.

“I suspect it’s going through a lot of editorial revisions in terms of its statistical underpinnings,” the cardiologist said.

He reported having no financial conflicts of interest regarding his presentation.

SNOWMASS, COLO. – Forthcoming guideline updates addressing the duration of dual-antiplatelet therapy will recommend shorter minimum durations following elective coronary stent placement for patients with stable ischemic heart disease in order to provide physicians with more room to exercise clinical judgment and individualize therapy.

“The American College of Cardiology and the American Heart Association have gone through a several month process of revising all recommendations with respect to antiplatelet therapy across six different guidelines. That should be published in the next few months. I suspect it will be similar to what the Europeans have been espousing,” Dr. Patrick T. O’Gara, ACC immediate past president, said at the Annual Cardiovascular Conference at Snowmass.

jancin

“If you look at the European Society of Cardiology guidelines, it’s as little as 30 days of DAPT [dual-antiplatelet therapy] following placement of a bare metal stent in a stable ischemic heart disease patient, 3 months for current generation drug-eluting stents, extending that out a little longer for the bioabsorbable stent platforms,” said Dr. O’Gara, professor of medicine at Harvard Medical School and director of clinical cardiology at Brigham and Women’s Hospital, Boston.

The impetus for the updated guidelines on DAPT duration, according to the cardiologist, was a growing appreciation of the trade-offs involved in this potent therapy, which reduces the risk of major adverse cardiovascular events at the price of a significant increase in major bleeding.

The new ACC/AHA recommendation calling for as little as 3 months of DAPT following placement of current generation drug-eluting stents in patients with stable ischemic heart disease (IHD) follows from the observation that the risks of late and very late stent thrombosis are extremely low with these devices, whereas the risk of bleeding remains higher, he continued.

The new, shorter recommended minimum DAPT durations are consistent with the underlying histopathology of stable IHD with intermittent claudication. Plaque rupture is unlikely to occur at that stage of atherosclerotic heart disease, in contrast to the inherent instability of the vulnerable plaque with a thin fibrous cap that’s present in an acute coronary syndrome (ACS). Patients with ACS have increased risks of recurrent ischemia or MI, stent thrombosis, bleeding, and death, compared with those with stable IHD.

“It’s just their biology,” Dr. O’Gara explained. “Think of ACS as a prothrombotic state which has a tail of activity over the next 6-12 months.”

That’s why a minimum of 12 months of DAPT featuring aspirin at 81 mg/day following stent placement in patients who present with ACS will continue to be recommended in the update. The same applies to patients who undergo coronary artery bypass grafting after presenting with ACS, although Dr. O’Gara said many surgeons appear to be unaware of this recommendation.

“You’re obligated to complete 12 months of DAPT in that situation. One of the common mistakes made in clinical practice is for surgeons to simply send those patients home on aspirin without a P2Y12 inhibitor,” according to Dr. O’Gara.

The positive outcomes seen with DAPT lasting for longer than 12 months after stent implantation in patients with ACS in the large DAPT trial and the more recent PEGASUS-TIMI 54 trial have put considerable pressure on guideline-writing committees to give a strong endorsement of extended DAPT. But the steep price paid in terms of major bleeding with this prolonged DAPT strategy, he said, gives one pause.

PEGASUS-TIMI 54 randomized more than 21,000 patients with a history of MI nearly 2 years earlier plus one additional high-risk factor such as diabetes to an average of 33 months of double-blind treatment with ticagrelor (Brilinta) at 60 or 90 mg/day or placebo on top of low-dose aspirin (N Engl J Med. 2015 May 7;372[19]:1791-800).

“For every 1,000 patients treated with prolonged DAPT, there were four fewer major ischemic events but three additional major bleeding events per year. Is this a clear winner? For all the enthusiasm there’s been about PEGASUS, those numbers look relatively small. It gets back to the point that individual judgment trumps everything,” Dr. O’Gara said.

He noted that this theme of a close overall risk/benefit balance for prolonged DAPT received further support at last year’s annual meeting of the European Society of Cardiology, where Dr. Jay A. Udell of the University of Toronto presented a meta-analysis of six randomized trials of prolonged DAPT versus aspirin alone in more than 33,000 high-risk patients with a history of MI. The results, which were recently published, showed a 22% reduction in the relative risk of major adverse cardiovascular events with extended DAPT, but a 73% increase in the risk of major bleeding (Eur Heart J. 2016 Jan 21;37[4]:390-9).

The DAPT trial investigators have developed a risk score in an effort to aid clinicians in deciding whether to extend DAPT for more than 12 months after stent placement for ACS in a given individual. The score, which utilizes eight clinical variables, was unveiled at last November’s AHA scientific sessions. For patients with a DAPT score of 2 or more, the number needed to treat for 18 additional months after the initial 12 months of DAPT in order to prevent one major adverse cardiovascular event was 34, with the number needed to harm in the form of major bleeding being 272. For patients with a DAPT score of less than 2, the number needed to treat was 153, and the number needed to harm was 64.

However, Dr. O’Gara said he doesn’t consider the DAPT score ready for use in daily clinical practice for a couple of reasons: It hasn’t yet been validated externally, and it hasn’t yet been published in a peer-reviewed journal.

“I suspect it’s going through a lot of editorial revisions in terms of its statistical underpinnings,” the cardiologist said.

He reported having no financial conflicts of interest regarding his presentation.

SNOWMASS, COLO. – Forthcoming guideline updates addressing the duration of dual-antiplatelet therapy will recommend shorter minimum durations following elective coronary stent placement for patients with stable ischemic heart disease in order to provide physicians with more room to exercise clinical judgment and individualize therapy.

“The American College of Cardiology and the American Heart Association have gone through a several month process of revising all recommendations with respect to antiplatelet therapy across six different guidelines. That should be published in the next few months. I suspect it will be similar to what the Europeans have been espousing,” Dr. Patrick T. O’Gara, ACC immediate past president, said at the Annual Cardiovascular Conference at Snowmass.

jancin

“If you look at the European Society of Cardiology guidelines, it’s as little as 30 days of DAPT [dual-antiplatelet therapy] following placement of a bare metal stent in a stable ischemic heart disease patient, 3 months for current generation drug-eluting stents, extending that out a little longer for the bioabsorbable stent platforms,” said Dr. O’Gara, professor of medicine at Harvard Medical School and director of clinical cardiology at Brigham and Women’s Hospital, Boston.

The impetus for the updated guidelines on DAPT duration, according to the cardiologist, was a growing appreciation of the trade-offs involved in this potent therapy, which reduces the risk of major adverse cardiovascular events at the price of a significant increase in major bleeding.

The new ACC/AHA recommendation calling for as little as 3 months of DAPT following placement of current generation drug-eluting stents in patients with stable ischemic heart disease (IHD) follows from the observation that the risks of late and very late stent thrombosis are extremely low with these devices, whereas the risk of bleeding remains higher, he continued.

The new, shorter recommended minimum DAPT durations are consistent with the underlying histopathology of stable IHD with intermittent claudication. Plaque rupture is unlikely to occur at that stage of atherosclerotic heart disease, in contrast to the inherent instability of the vulnerable plaque with a thin fibrous cap that’s present in an acute coronary syndrome (ACS). Patients with ACS have increased risks of recurrent ischemia or MI, stent thrombosis, bleeding, and death, compared with those with stable IHD.

“It’s just their biology,” Dr. O’Gara explained. “Think of ACS as a prothrombotic state which has a tail of activity over the next 6-12 months.”

That’s why a minimum of 12 months of DAPT featuring aspirin at 81 mg/day following stent placement in patients who present with ACS will continue to be recommended in the update. The same applies to patients who undergo coronary artery bypass grafting after presenting with ACS, although Dr. O’Gara said many surgeons appear to be unaware of this recommendation.

“You’re obligated to complete 12 months of DAPT in that situation. One of the common mistakes made in clinical practice is for surgeons to simply send those patients home on aspirin without a P2Y12 inhibitor,” according to Dr. O’Gara.

The positive outcomes seen with DAPT lasting for longer than 12 months after stent implantation in patients with ACS in the large DAPT trial and the more recent PEGASUS-TIMI 54 trial have put considerable pressure on guideline-writing committees to give a strong endorsement of extended DAPT. But the steep price paid in terms of major bleeding with this prolonged DAPT strategy, he said, gives one pause.

PEGASUS-TIMI 54 randomized more than 21,000 patients with a history of MI nearly 2 years earlier plus one additional high-risk factor such as diabetes to an average of 33 months of double-blind treatment with ticagrelor (Brilinta) at 60 or 90 mg/day or placebo on top of low-dose aspirin (N Engl J Med. 2015 May 7;372[19]:1791-800).

“For every 1,000 patients treated with prolonged DAPT, there were four fewer major ischemic events but three additional major bleeding events per year. Is this a clear winner? For all the enthusiasm there’s been about PEGASUS, those numbers look relatively small. It gets back to the point that individual judgment trumps everything,” Dr. O’Gara said.

He noted that this theme of a close overall risk/benefit balance for prolonged DAPT received further support at last year’s annual meeting of the European Society of Cardiology, where Dr. Jay A. Udell of the University of Toronto presented a meta-analysis of six randomized trials of prolonged DAPT versus aspirin alone in more than 33,000 high-risk patients with a history of MI. The results, which were recently published, showed a 22% reduction in the relative risk of major adverse cardiovascular events with extended DAPT, but a 73% increase in the risk of major bleeding (Eur Heart J. 2016 Jan 21;37[4]:390-9).

The DAPT trial investigators have developed a risk score in an effort to aid clinicians in deciding whether to extend DAPT for more than 12 months after stent placement for ACS in a given individual. The score, which utilizes eight clinical variables, was unveiled at last November’s AHA scientific sessions. For patients with a DAPT score of 2 or more, the number needed to treat for 18 additional months after the initial 12 months of DAPT in order to prevent one major adverse cardiovascular event was 34, with the number needed to harm in the form of major bleeding being 272. For patients with a DAPT score of less than 2, the number needed to treat was 153, and the number needed to harm was 64.

However, Dr. O’Gara said he doesn’t consider the DAPT score ready for use in daily clinical practice for a couple of reasons: It hasn’t yet been validated externally, and it hasn’t yet been published in a peer-reviewed journal.

“I suspect it’s going through a lot of editorial revisions in terms of its statistical underpinnings,” the cardiologist said.

He reported having no financial conflicts of interest regarding his presentation.

bjancin@frontlinemedcom.com

SNOWMASS, COLO. – Forthcoming guideline updates addressing the duration of dual-antiplatelet therapy will recommend shorter minimum durations following elective coronary stent placement for patients with stable ischemic heart disease in order to provide physicians with more room to exercise clinical judgment and individualize therapy.

“The American College of Cardiology and the American Heart Association have gone through a several month process of revising all recommendations with respect to antiplatelet therapy across six different guidelines. That should be published in the next few months. I suspect it will be similar to what the Europeans have been espousing,” Dr. Patrick T. O’Gara, ACC immediate past president, said at the Annual Cardiovascular Conference at Snowmass.

jancin

“If you look at the European Society of Cardiology guidelines, it’s as little as 30 days of DAPT [dual-antiplatelet therapy] following placement of a bare metal stent in a stable ischemic heart disease patient, 3 months for current generation drug-eluting stents, extending that out a little longer for the bioabsorbable stent platforms,” said Dr. O’Gara, professor of medicine at Harvard Medical School and director of clinical cardiology at Brigham and Women’s Hospital, Boston.

The impetus for the updated guidelines on DAPT duration, according to the cardiologist, was a growing appreciation of the trade-offs involved in this potent therapy, which reduces the risk of major adverse cardiovascular events at the price of a significant increase in major bleeding.

The new ACC/AHA recommendation calling for as little as 3 months of DAPT following placement of current generation drug-eluting stents in patients with stable ischemic heart disease (IHD) follows from the observation that the risks of late and very late stent thrombosis are extremely low with these devices, whereas the risk of bleeding remains higher, he continued.

The new, shorter recommended minimum DAPT durations are consistent with the underlying histopathology of stable IHD with intermittent claudication. Plaque rupture is unlikely to occur at that stage of atherosclerotic heart disease, in contrast to the inherent instability of the vulnerable plaque with a thin fibrous cap that’s present in an acute coronary syndrome (ACS). Patients with ACS have increased risks of recurrent ischemia or MI, stent thrombosis, bleeding, and death, compared with those with stable IHD.

“It’s just their biology,” Dr. O’Gara explained. “Think of ACS as a prothrombotic state which has a tail of activity over the next 6-12 months.”

That’s why a minimum of 12 months of DAPT featuring aspirin at 81 mg/day following stent placement in patients who present with ACS will continue to be recommended in the update. The same applies to patients who undergo coronary artery bypass grafting after presenting with ACS, although Dr. O’Gara said many surgeons appear to be unaware of this recommendation.

“You’re obligated to complete 12 months of DAPT in that situation. One of the common mistakes made in clinical practice is for surgeons to simply send those patients home on aspirin without a P2Y12 inhibitor,” according to Dr. O’Gara.

The positive outcomes seen with DAPT lasting for longer than 12 months after stent implantation in patients with ACS in the large DAPT trial and the more recent PEGASUS-TIMI 54 trial have put considerable pressure on guideline-writing committees to give a strong endorsement of extended DAPT. But the steep price paid in terms of major bleeding with this prolonged DAPT strategy, he said, gives one pause.

PEGASUS-TIMI 54 randomized more than 21,000 patients with a history of MI nearly 2 years earlier plus one additional high-risk factor such as diabetes to an average of 33 months of double-blind treatment with ticagrelor (Brilinta) at 60 or 90 mg/day or placebo on top of low-dose aspirin (N Engl J Med. 2015 May 7;372[19]:1791-800).

“For every 1,000 patients treated with prolonged DAPT, there were four fewer major ischemic events but three additional major bleeding events per year. Is this a clear winner? For all the enthusiasm there’s been about PEGASUS, those numbers look relatively small. It gets back to the point that individual judgment trumps everything,” Dr. O’Gara said.

He noted that this theme of a close overall risk/benefit balance for prolonged DAPT received further support at last year’s annual meeting of the European Society of Cardiology, where Dr. Jay A. Udell of the University of Toronto presented a meta-analysis of six randomized trials of prolonged DAPT versus aspirin alone in more than 33,000 high-risk patients with a history of MI. The results, which were recently published, showed a 22% reduction in the relative risk of major adverse cardiovascular events with extended DAPT, but a 73% increase in the risk of major bleeding (Eur Heart J. 2016 Jan 21;37[4]:390-9).

The DAPT trial investigators have developed a risk score in an effort to aid clinicians in deciding whether to extend DAPT for more than 12 months after stent placement for ACS in a given individual. The score, which utilizes eight clinical variables, was unveiled at last November’s AHA scientific sessions. For patients with a DAPT score of 2 or more, the number needed to treat for 18 additional months after the initial 12 months of DAPT in order to prevent one major adverse cardiovascular event was 34, with the number needed to harm in the form of major bleeding being 272. For patients with a DAPT score of less than 2, the number needed to treat was 153, and the number needed to harm was 64.

However, Dr. O’Gara said he doesn’t consider the DAPT score ready for use in daily clinical practice for a couple of reasons: It hasn’t yet been validated externally, and it hasn’t yet been published in a peer-reviewed journal.

“I suspect it’s going through a lot of editorial revisions in terms of its statistical underpinnings,” the cardiologist said.

He reported having no financial conflicts of interest regarding his presentation.

bjancin@frontlinemedcom.com

SNOWMASS, COLO. – Forthcoming guideline updates addressing the duration of dual-antiplatelet therapy will recommend shorter minimum durations following elective coronary stent placement for patients with stable ischemic heart disease in order to provide physicians with more room to exercise clinical judgment and individualize therapy.

“The American College of Cardiology and the American Heart Association have gone through a several month process of revising all recommendations with respect to antiplatelet therapy across six different guidelines. That should be published in the next few months. I suspect it will be similar to what the Europeans have been espousing,” Dr. Patrick T. O’Gara, ACC immediate past president, said at the Annual Cardiovascular Conference at Snowmass.

jancin

“If you look at the European Society of Cardiology guidelines, it’s as little as 30 days of DAPT [dual-antiplatelet therapy] following placement of a bare metal stent in a stable ischemic heart disease patient, 3 months for current generation drug-eluting stents, extending that out a little longer for the bioabsorbable stent platforms,” said Dr. O’Gara, professor of medicine at Harvard Medical School and director of clinical cardiology at Brigham and Women’s Hospital, Boston.

The impetus for the updated guidelines on DAPT duration, according to the cardiologist, was a growing appreciation of the trade-offs involved in this potent therapy, which reduces the risk of major adverse cardiovascular events at the price of a significant increase in major bleeding.

The new ACC/AHA recommendation calling for as little as 3 months of DAPT following placement of current generation drug-eluting stents in patients with stable ischemic heart disease (IHD) follows from the observation that the risks of late and very late stent thrombosis are extremely low with these devices, whereas the risk of bleeding remains higher, he continued.

The new, shorter recommended minimum DAPT durations are consistent with the underlying histopathology of stable IHD with intermittent claudication. Plaque rupture is unlikely to occur at that stage of atherosclerotic heart disease, in contrast to the inherent instability of the vulnerable plaque with a thin fibrous cap that’s present in an acute coronary syndrome (ACS). Patients with ACS have increased risks of recurrent ischemia or MI, stent thrombosis, bleeding, and death, compared with those with stable IHD.

“It’s just their biology,” Dr. O’Gara explained. “Think of ACS as a prothrombotic state which has a tail of activity over the next 6-12 months.”

That’s why a minimum of 12 months of DAPT featuring aspirin at 81 mg/day following stent placement in patients who present with ACS will continue to be recommended in the update. The same applies to patients who undergo coronary artery bypass grafting after presenting with ACS, although Dr. O’Gara said many surgeons appear to be unaware of this recommendation.

“You’re obligated to complete 12 months of DAPT in that situation. One of the common mistakes made in clinical practice is for surgeons to simply send those patients home on aspirin without a P2Y12 inhibitor,” according to Dr. O’Gara.

The positive outcomes seen with DAPT lasting for longer than 12 months after stent implantation in patients with ACS in the large DAPT trial and the more recent PEGASUS-TIMI 54 trial have put considerable pressure on guideline-writing committees to give a strong endorsement of extended DAPT. But the steep price paid in terms of major bleeding with this prolonged DAPT strategy, he said, gives one pause.

PEGASUS-TIMI 54 randomized more than 21,000 patients with a history of MI nearly 2 years earlier plus one additional high-risk factor such as diabetes to an average of 33 months of double-blind treatment with ticagrelor (Brilinta) at 60 or 90 mg/day or placebo on top of low-dose aspirin (N Engl J Med. 2015 May 7;372[19]:1791-800).

“For every 1,000 patients treated with prolonged DAPT, there were four fewer major ischemic events but three additional major bleeding events per year. Is this a clear winner? For all the enthusiasm there’s been about PEGASUS, those numbers look relatively small. It gets back to the point that individual judgment trumps everything,” Dr. O’Gara said.

He noted that this theme of a close overall risk/benefit balance for prolonged DAPT received further support at last year’s annual meeting of the European Society of Cardiology, where Dr. Jay A. Udell of the University of Toronto presented a meta-analysis of six randomized trials of prolonged DAPT versus aspirin alone in more than 33,000 high-risk patients with a history of MI. The results, which were recently published, showed a 22% reduction in the relative risk of major adverse cardiovascular events with extended DAPT, but a 73% increase in the risk of major bleeding (Eur Heart J. 2016 Jan 21;37[4]:390-9).

The DAPT trial investigators have developed a risk score in an effort to aid clinicians in deciding whether to extend DAPT for more than 12 months after stent placement for ACS in a given individual. The score, which utilizes eight clinical variables, was unveiled at last November’s AHA scientific sessions. For patients with a DAPT score of 2 or more, the number needed to treat for 18 additional months after the initial 12 months of DAPT in order to prevent one major adverse cardiovascular event was 34, with the number needed to harm in the form of major bleeding being 272. For patients with a DAPT score of less than 2, the number needed to treat was 153, and the number needed to harm was 64.

However, Dr. O’Gara said he doesn’t consider the DAPT score ready for use in daily clinical practice for a couple of reasons: It hasn’t yet been validated externally, and it hasn’t yet been published in a peer-reviewed journal.

“I suspect it’s going through a lot of editorial revisions in terms of its statistical underpinnings,” the cardiologist said.

He reported having no financial conflicts of interest regarding his presentation.

bjancin@frontlinemedcom.com