Acute Coronary Syndromes

SAN DIEGO – In the long run, patients with left main coronary artery disease fare better if they undergo coronary artery bypass grafting (CABG) instead of percutaneous coronary intervention (PCI) with drug-eluting stents, suggest 10-year results of the MAIN-COMPARE trial. Findings were reported at the Transcatheter Cardiovascular Therapeutics annual meeting.

Susan London/MDedge News

Although CABG is the standard choice for revascularization in this patient population, PCI has been making inroads thanks to advances in stents, antithrombotic drugs, periprocedural management, and operator expertise, noted senior author Seung-Jung Park, MD, PhD, chairman of the Heart Institute at Asan Medical Center in Seoul and professor of medicine at University of Ulsan, South Korea. “Indeed, many studies showed that PCI using drug-eluting stents might be a good alternative for selected patients with left main coronary artery disease.”

Two large, randomized, controlled trials, EXCEL and NOBLE, have compared these treatment strategies and helped clarify outcomes at intermediate follow-up periods of 3-5 years. But long-term data, increasingly important as survival improves, are lacking.

Dr. Park reported the 10-year update of a prospective, observational cohort study that analyzed data from more than 2,000 patients with unprotected left main coronary artery disease in the MAIN-COMPARE registry, which captures revascularization procedures performed at 12 Korean cardiac centers.

In the entire cohort, about a fifth of the patients died, and roughly a fourth experienced a composite adverse outcome of death and cardiovascular events regardless of whether they received PCI or CABG, but the former yielded a rate of target vessel revascularization that was more than three times higher, according to results reported at the meeting and simultaneously published (J Am Coll Cardiol. 2018 Sep 14. doi: 10.1016/j.jacc.2018.09.012). Among the subset of patients treated in the more recent drug-eluting stent era, those who underwent PCI were more likely to die and to experience the composite outcome starting at the 5-year mark.

“Drug-eluting stents were associated with higher risks of death and serious composite outcomes compared to CABG after 5 years. The treatment benefit of CABG has diverged over time during continued follow-up,” Dr. Park noted. “The rate of target-vessel failure was consistently higher in the PCI group.”

“We used mainly first-generation drug-eluting stents,” he acknowledged. “However, many studies have demonstrated there is not too much difference between the first- and second-generation stents.”
 

Data worth the wait

In the same session, investigators reported the 10-year update of the European and U.S. randomized SYNTAX Extended Survival trial, called SYNTAXES. SYNTAX enrolled patients with three-vessel or left main coronary disease. That trial found no significant difference in survival between PCI with drug-eluting stents and CABG overall. In stratified analysis, mortality was higher with PCI among patients with three-vessel disease, but not among patients with left main disease.

Taken together, these trials help clarify the long-term comparative efficacy of PCI and begin to inform patient selection, according to press conference panelist Morton J. Kern, MD, a professor at the University of California, Irvine Medical Center.

Susan London/MDedge News

Study details

The MAIN-COMPARE analyses were based on 2,240 patients with unprotected left main coronary artery disease (stenosis of more than 50% and no coronary artery bypass grafts to the left anterior descending or the left circumflex artery) treated during 2000-2006.

A total of 1,102 patients underwent PCI with stenting: 318 in the era of bare-metal stents and 784 in the era of drug-eluting stents, predominantly sirolimus-eluting stents. A total of 1,138 patients underwent CABG. The minimum follow-up was 10 years in all patients, with a median of 12 years.

In the entire study cohort, PCI and CABG yielded similar rates of death (21.1% vs. 23.2%) and the composite of death, Q-wave myocardial infarction, or stroke (23.8% vs. 26.3%), but the PCI patients had a significantly higher rate of target vessel revascularization (21.1% vs. 5.8%), according to data reported at the meeting, which was sponsored by the New York–based Cardiovascular Research Foundation.

In analyses using a propensity score weighting technique, results for the entire cohort were much the same. But on stratification, PCI with drug-eluting stents versus CABG yielded higher risks of death (hazard ratio, 1.35; P = .05) and the composite adverse outcome (HR, 1.46; P = .009) from 5 years onward, as well as a sharply higher risk of target vessel revascularization for the full duration of follow-up (HR, 5.82; P less than .001).

Dr. Park disclosed that he had no conflicts of interest. The study was supported by the Korean Society of Interventional Cardiology and the CardioVascular Research Foundation of South Korea.

SOURCE: Park SJ et al. J Am Coll Cardiol. 2018 Sep 14. doi: 10.1016/j.jacc.2018.09.012).

SAN DIEGO – In the long run, patients with left main coronary artery disease fare better if they undergo coronary artery bypass grafting (CABG) instead of percutaneous coronary intervention (PCI) with drug-eluting stents, suggest 10-year results of the MAIN-COMPARE trial. Findings were reported at the Transcatheter Cardiovascular Therapeutics annual meeting.

Susan London/MDedge News

Although CABG is the standard choice for revascularization in this patient population, PCI has been making inroads thanks to advances in stents, antithrombotic drugs, periprocedural management, and operator expertise, noted senior author Seung-Jung Park, MD, PhD, chairman of the Heart Institute at Asan Medical Center in Seoul and professor of medicine at University of Ulsan, South Korea. “Indeed, many studies showed that PCI using drug-eluting stents might be a good alternative for selected patients with left main coronary artery disease.”

Two large, randomized, controlled trials, EXCEL and NOBLE, have compared these treatment strategies and helped clarify outcomes at intermediate follow-up periods of 3-5 years. But long-term data, increasingly important as survival improves, are lacking.

Dr. Park reported the 10-year update of a prospective, observational cohort study that analyzed data from more than 2,000 patients with unprotected left main coronary artery disease in the MAIN-COMPARE registry, which captures revascularization procedures performed at 12 Korean cardiac centers.

In the entire cohort, about a fifth of the patients died, and roughly a fourth experienced a composite adverse outcome of death and cardiovascular events regardless of whether they received PCI or CABG, but the former yielded a rate of target vessel revascularization that was more than three times higher, according to results reported at the meeting and simultaneously published (J Am Coll Cardiol. 2018 Sep 14. doi: 10.1016/j.jacc.2018.09.012). Among the subset of patients treated in the more recent drug-eluting stent era, those who underwent PCI were more likely to die and to experience the composite outcome starting at the 5-year mark.

“Drug-eluting stents were associated with higher risks of death and serious composite outcomes compared to CABG after 5 years. The treatment benefit of CABG has diverged over time during continued follow-up,” Dr. Park noted. “The rate of target-vessel failure was consistently higher in the PCI group.”

“We used mainly first-generation drug-eluting stents,” he acknowledged. “However, many studies have demonstrated there is not too much difference between the first- and second-generation stents.”
 

Data worth the wait

In the same session, investigators reported the 10-year update of the European and U.S. randomized SYNTAX Extended Survival trial, called SYNTAXES. SYNTAX enrolled patients with three-vessel or left main coronary disease. That trial found no significant difference in survival between PCI with drug-eluting stents and CABG overall. In stratified analysis, mortality was higher with PCI among patients with three-vessel disease, but not among patients with left main disease.

Taken together, these trials help clarify the long-term comparative efficacy of PCI and begin to inform patient selection, according to press conference panelist Morton J. Kern, MD, a professor at the University of California, Irvine Medical Center.

Susan London/MDedge News

Study details

The MAIN-COMPARE analyses were based on 2,240 patients with unprotected left main coronary artery disease (stenosis of more than 50% and no coronary artery bypass grafts to the left anterior descending or the left circumflex artery) treated during 2000-2006.

A total of 1,102 patients underwent PCI with stenting: 318 in the era of bare-metal stents and 784 in the era of drug-eluting stents, predominantly sirolimus-eluting stents. A total of 1,138 patients underwent CABG. The minimum follow-up was 10 years in all patients, with a median of 12 years.

In the entire study cohort, PCI and CABG yielded similar rates of death (21.1% vs. 23.2%) and the composite of death, Q-wave myocardial infarction, or stroke (23.8% vs. 26.3%), but the PCI patients had a significantly higher rate of target vessel revascularization (21.1% vs. 5.8%), according to data reported at the meeting, which was sponsored by the New York–based Cardiovascular Research Foundation.

In analyses using a propensity score weighting technique, results for the entire cohort were much the same. But on stratification, PCI with drug-eluting stents versus CABG yielded higher risks of death (hazard ratio, 1.35; P = .05) and the composite adverse outcome (HR, 1.46; P = .009) from 5 years onward, as well as a sharply higher risk of target vessel revascularization for the full duration of follow-up (HR, 5.82; P less than .001).

Dr. Park disclosed that he had no conflicts of interest. The study was supported by the Korean Society of Interventional Cardiology and the CardioVascular Research Foundation of South Korea.

SOURCE: Park SJ et al. J Am Coll Cardiol. 2018 Sep 14. doi: 10.1016/j.jacc.2018.09.012).

SAN DIEGO – In the long run, patients with left main coronary artery disease fare better if they undergo coronary artery bypass grafting (CABG) instead of percutaneous coronary intervention (PCI) with drug-eluting stents, suggest 10-year results of the MAIN-COMPARE trial. Findings were reported at the Transcatheter Cardiovascular Therapeutics annual meeting.

Susan London/MDedge News

Although CABG is the standard choice for revascularization in this patient population, PCI has been making inroads thanks to advances in stents, antithrombotic drugs, periprocedural management, and operator expertise, noted senior author Seung-Jung Park, MD, PhD, chairman of the Heart Institute at Asan Medical Center in Seoul and professor of medicine at University of Ulsan, South Korea. “Indeed, many studies showed that PCI using drug-eluting stents might be a good alternative for selected patients with left main coronary artery disease.”

Two large, randomized, controlled trials, EXCEL and NOBLE, have compared these treatment strategies and helped clarify outcomes at intermediate follow-up periods of 3-5 years. But long-term data, increasingly important as survival improves, are lacking.

Dr. Park reported the 10-year update of a prospective, observational cohort study that analyzed data from more than 2,000 patients with unprotected left main coronary artery disease in the MAIN-COMPARE registry, which captures revascularization procedures performed at 12 Korean cardiac centers.

In the entire cohort, about a fifth of the patients died, and roughly a fourth experienced a composite adverse outcome of death and cardiovascular events regardless of whether they received PCI or CABG, but the former yielded a rate of target vessel revascularization that was more than three times higher, according to results reported at the meeting and simultaneously published (J Am Coll Cardiol. 2018 Sep 14. doi: 10.1016/j.jacc.2018.09.012). Among the subset of patients treated in the more recent drug-eluting stent era, those who underwent PCI were more likely to die and to experience the composite outcome starting at the 5-year mark.

“Drug-eluting stents were associated with higher risks of death and serious composite outcomes compared to CABG after 5 years. The treatment benefit of CABG has diverged over time during continued follow-up,” Dr. Park noted. “The rate of target-vessel failure was consistently higher in the PCI group.”

“We used mainly first-generation drug-eluting stents,” he acknowledged. “However, many studies have demonstrated there is not too much difference between the first- and second-generation stents.”
 

Data worth the wait

In the same session, investigators reported the 10-year update of the European and U.S. randomized SYNTAX Extended Survival trial, called SYNTAXES. SYNTAX enrolled patients with three-vessel or left main coronary disease. That trial found no significant difference in survival between PCI with drug-eluting stents and CABG overall. In stratified analysis, mortality was higher with PCI among patients with three-vessel disease, but not among patients with left main disease.

Taken together, these trials help clarify the long-term comparative efficacy of PCI and begin to inform patient selection, according to press conference panelist Morton J. Kern, MD, a professor at the University of California, Irvine Medical Center.

Susan London/MDedge News

Study details

The MAIN-COMPARE analyses were based on 2,240 patients with unprotected left main coronary artery disease (stenosis of more than 50% and no coronary artery bypass grafts to the left anterior descending or the left circumflex artery) treated during 2000-2006.

A total of 1,102 patients underwent PCI with stenting: 318 in the era of bare-metal stents and 784 in the era of drug-eluting stents, predominantly sirolimus-eluting stents. A total of 1,138 patients underwent CABG. The minimum follow-up was 10 years in all patients, with a median of 12 years.

In the entire study cohort, PCI and CABG yielded similar rates of death (21.1% vs. 23.2%) and the composite of death, Q-wave myocardial infarction, or stroke (23.8% vs. 26.3%), but the PCI patients had a significantly higher rate of target vessel revascularization (21.1% vs. 5.8%), according to data reported at the meeting, which was sponsored by the New York–based Cardiovascular Research Foundation.

In analyses using a propensity score weighting technique, results for the entire cohort were much the same. But on stratification, PCI with drug-eluting stents versus CABG yielded higher risks of death (hazard ratio, 1.35; P = .05) and the composite adverse outcome (HR, 1.46; P = .009) from 5 years onward, as well as a sharply higher risk of target vessel revascularization for the full duration of follow-up (HR, 5.82; P less than .001).

Dr. Park disclosed that he had no conflicts of interest. The study was supported by the Korean Society of Interventional Cardiology and the CardioVascular Research Foundation of South Korea.

SOURCE: Park SJ et al. J Am Coll Cardiol. 2018 Sep 14. doi: 10.1016/j.jacc.2018.09.012).

SAN DIEGO – The rule-in cutoff level for high-sensitivity cardiac troponin measures in the diagnosis of acute MI have been established by the European Society of Cardiology, but the value might not be applicable to a U.S. population.

In a video interview at the annual scientific assembly of the American College of Emergency Physicians, Richard M. Nowak, MD, of the department of emergency medicine at Henry Ford Hospital, Detroit, explains why the rule-in cutoff is not likely to apply to American patients and may be associated with a higher risk of false positives.

Since high-sensitivity troponin measures will soon be coming to every ED, each institution may have to arrive at their own rule-in cutoff value in order to diagnose acute MI with an acceptable number of false positives, he said. Dr. Nowak explains how to begin addressing that process.

SAN DIEGO – The rule-in cutoff level for high-sensitivity cardiac troponin measures in the diagnosis of acute MI have been established by the European Society of Cardiology, but the value might not be applicable to a U.S. population.

In a video interview at the annual scientific assembly of the American College of Emergency Physicians, Richard M. Nowak, MD, of the department of emergency medicine at Henry Ford Hospital, Detroit, explains why the rule-in cutoff is not likely to apply to American patients and may be associated with a higher risk of false positives.

Since high-sensitivity troponin measures will soon be coming to every ED, each institution may have to arrive at their own rule-in cutoff value in order to diagnose acute MI with an acceptable number of false positives, he said. Dr. Nowak explains how to begin addressing that process.

SAN DIEGO – The rule-in cutoff level for high-sensitivity cardiac troponin measures in the diagnosis of acute MI have been established by the European Society of Cardiology, but the value might not be applicable to a U.S. population.

In a video interview at the annual scientific assembly of the American College of Emergency Physicians, Richard M. Nowak, MD, of the department of emergency medicine at Henry Ford Hospital, Detroit, explains why the rule-in cutoff is not likely to apply to American patients and may be associated with a higher risk of false positives.

Since high-sensitivity troponin measures will soon be coming to every ED, each institution may have to arrive at their own rule-in cutoff value in order to diagnose acute MI with an acceptable number of false positives, he said. Dr. Nowak explains how to begin addressing that process.

SAN DIEGO – A simplified version of the SYNTAX score for coronary artery disease complexity strongly correlated with the unmodified SYNTAX score and could make it easier for cardiologists to employ it in everyday practice. The modified version can be easily memorized and has simplified values that a clinician can calculate and use to determine an appropriate treatment without breaking their work flow to consult a computerized system.

Jim Kling/MDedge News

“It’s primarily simplifying the values for the location of the lesions that has allowed it to be more memorizable. That does make it a slightly blunter tool, but only slightly,” said Sonya Burgess, MBCHB, during a presentation at the Transcatheter Cardiovascular Therapeutics annual meeting. Dr. Burgess is an interventional cardiologist at the University of New South Wales, Sydney.

In common practice, SYNTAX scores often go uncalculated because of their complexity, despite guidelines that recommend it. “My guess might be that 1 in every 10 [cardiologists] do it, and that’s not right for our patients,” said Dr. Burgess.

Others at the session agreed that SYNTAX is underutilized, but not all agreed with Dr. Burgess’ solution. Notable among the attendees was Patrick Serruys, MD, of Erasmus University, Rotterdam, the Netherlands, who originally published the SYNTAX system. He doesn’t like the idea of simplifying SYNTAX, based in part on previous experience. “About 10 years ago, Boston Scientific found the score too difficult and they wanted to simplify it, but the score completely lost its prognostic value. I was very emotional about that and I said, ‘no, we have to keep all of the components until we understand [the risk factors] much better,’ ” said Dr. Serruys.

But Dr. Burgess argued that the simplified system, which she and her coinvestigators created, makes concessions to the realities of an interventional cardiology suite. To obtain a standard SYNTAX score, “they have to stop doing something or rebook something, or there’s a lesion there that they just want to treat. [With the simplified score], at least before they go on to treat that lesion, they don’t have to take their gowns and gloves off. You can even have a card hanging on the bar [to refer to].” Dr. Burgess did not provide details of the system.

Courtesy Cardiovascular Research Foundation

Dr. Serruys agreed with the source of the problem. “Dr. Burgess is right, it is somewhat demanding,” he allowed, but he also called on clinicians to consider the needs of the patient, even going so far as picturing the patient as a family member. “People complain that doing the SYNTAX is on average 7 minutes, with a standard deviation of 7, so you could work 15 minutes just looking at film. But when you think that the future of your father or brother is depending on the surgeon and the cardiologist looking carefully, I find the argument absolutely obnoxious,” said Dr. Serruys at the meeting sponsored by the Cardiovascular Research Foundation.

Rather than simplification, he stresses teamwork. With at least three people looking at the angiogram, the results are consistent and useful. “You look at the film with the trainees, and that’s how they learn. Never do a SYNTAX score alone,” said Dr. Serruys.

To assess the simplified SYNTAX score, the researchers conducted a retrospective assessment of both the SYNTAX score and the simplified SYNTAX score in 617 patients who had multivessel disease. They performed both assessments in subgroups of patients with 169 patients with ST-segment elevation MI, 78 patients with chronic total occlusion, and 113 patients with left main coronary artery (LMCA) stenosis. They used a 100-patient derivation cohort to determine cutoffs for patients who would not be suitable for percutaneous coronary intervention. They also looked at the accuracy of the simplified version compared with standard SYNTAX in 517 patients from five tertiary centers.

The Spearman’s rho value was 0.93 overall and at least 0.91 for all subgroups (P less than .001 for all). In patients with LMCA stenosis, the simplified version had a sensitivity of 100%, specificity of 85%, negative predictive of 100%, and an area under the curve of 1.0 (P less than .001). For patients with multivessel disease and no LMCA stenosis, the values were 98%, 82%, 99%, and 0.971, respectively (P less than .001).

Dr. Burgess and Dr. Serruys reported no financial conflicts of interest.

SAN DIEGO – A simplified version of the SYNTAX score for coronary artery disease complexity strongly correlated with the unmodified SYNTAX score and could make it easier for cardiologists to employ it in everyday practice. The modified version can be easily memorized and has simplified values that a clinician can calculate and use to determine an appropriate treatment without breaking their work flow to consult a computerized system.

Jim Kling/MDedge News

“It’s primarily simplifying the values for the location of the lesions that has allowed it to be more memorizable. That does make it a slightly blunter tool, but only slightly,” said Sonya Burgess, MBCHB, during a presentation at the Transcatheter Cardiovascular Therapeutics annual meeting. Dr. Burgess is an interventional cardiologist at the University of New South Wales, Sydney.

In common practice, SYNTAX scores often go uncalculated because of their complexity, despite guidelines that recommend it. “My guess might be that 1 in every 10 [cardiologists] do it, and that’s not right for our patients,” said Dr. Burgess.

Others at the session agreed that SYNTAX is underutilized, but not all agreed with Dr. Burgess’ solution. Notable among the attendees was Patrick Serruys, MD, of Erasmus University, Rotterdam, the Netherlands, who originally published the SYNTAX system. He doesn’t like the idea of simplifying SYNTAX, based in part on previous experience. “About 10 years ago, Boston Scientific found the score too difficult and they wanted to simplify it, but the score completely lost its prognostic value. I was very emotional about that and I said, ‘no, we have to keep all of the components until we understand [the risk factors] much better,’ ” said Dr. Serruys.

But Dr. Burgess argued that the simplified system, which she and her coinvestigators created, makes concessions to the realities of an interventional cardiology suite. To obtain a standard SYNTAX score, “they have to stop doing something or rebook something, or there’s a lesion there that they just want to treat. [With the simplified score], at least before they go on to treat that lesion, they don’t have to take their gowns and gloves off. You can even have a card hanging on the bar [to refer to].” Dr. Burgess did not provide details of the system.

Courtesy Cardiovascular Research Foundation

Dr. Serruys agreed with the source of the problem. “Dr. Burgess is right, it is somewhat demanding,” he allowed, but he also called on clinicians to consider the needs of the patient, even going so far as picturing the patient as a family member. “People complain that doing the SYNTAX is on average 7 minutes, with a standard deviation of 7, so you could work 15 minutes just looking at film. But when you think that the future of your father or brother is depending on the surgeon and the cardiologist looking carefully, I find the argument absolutely obnoxious,” said Dr. Serruys at the meeting sponsored by the Cardiovascular Research Foundation.

Rather than simplification, he stresses teamwork. With at least three people looking at the angiogram, the results are consistent and useful. “You look at the film with the trainees, and that’s how they learn. Never do a SYNTAX score alone,” said Dr. Serruys.

To assess the simplified SYNTAX score, the researchers conducted a retrospective assessment of both the SYNTAX score and the simplified SYNTAX score in 617 patients who had multivessel disease. They performed both assessments in subgroups of patients with 169 patients with ST-segment elevation MI, 78 patients with chronic total occlusion, and 113 patients with left main coronary artery (LMCA) stenosis. They used a 100-patient derivation cohort to determine cutoffs for patients who would not be suitable for percutaneous coronary intervention. They also looked at the accuracy of the simplified version compared with standard SYNTAX in 517 patients from five tertiary centers.

The Spearman’s rho value was 0.93 overall and at least 0.91 for all subgroups (P less than .001 for all). In patients with LMCA stenosis, the simplified version had a sensitivity of 100%, specificity of 85%, negative predictive of 100%, and an area under the curve of 1.0 (P less than .001). For patients with multivessel disease and no LMCA stenosis, the values were 98%, 82%, 99%, and 0.971, respectively (P less than .001).

Dr. Burgess and Dr. Serruys reported no financial conflicts of interest.

SAN DIEGO – A simplified version of the SYNTAX score for coronary artery disease complexity strongly correlated with the unmodified SYNTAX score and could make it easier for cardiologists to employ it in everyday practice. The modified version can be easily memorized and has simplified values that a clinician can calculate and use to determine an appropriate treatment without breaking their work flow to consult a computerized system.

Jim Kling/MDedge News

“It’s primarily simplifying the values for the location of the lesions that has allowed it to be more memorizable. That does make it a slightly blunter tool, but only slightly,” said Sonya Burgess, MBCHB, during a presentation at the Transcatheter Cardiovascular Therapeutics annual meeting. Dr. Burgess is an interventional cardiologist at the University of New South Wales, Sydney.

In common practice, SYNTAX scores often go uncalculated because of their complexity, despite guidelines that recommend it. “My guess might be that 1 in every 10 [cardiologists] do it, and that’s not right for our patients,” said Dr. Burgess.

Others at the session agreed that SYNTAX is underutilized, but not all agreed with Dr. Burgess’ solution. Notable among the attendees was Patrick Serruys, MD, of Erasmus University, Rotterdam, the Netherlands, who originally published the SYNTAX system. He doesn’t like the idea of simplifying SYNTAX, based in part on previous experience. “About 10 years ago, Boston Scientific found the score too difficult and they wanted to simplify it, but the score completely lost its prognostic value. I was very emotional about that and I said, ‘no, we have to keep all of the components until we understand [the risk factors] much better,’ ” said Dr. Serruys.

But Dr. Burgess argued that the simplified system, which she and her coinvestigators created, makes concessions to the realities of an interventional cardiology suite. To obtain a standard SYNTAX score, “they have to stop doing something or rebook something, or there’s a lesion there that they just want to treat. [With the simplified score], at least before they go on to treat that lesion, they don’t have to take their gowns and gloves off. You can even have a card hanging on the bar [to refer to].” Dr. Burgess did not provide details of the system.

Courtesy Cardiovascular Research Foundation

Dr. Serruys agreed with the source of the problem. “Dr. Burgess is right, it is somewhat demanding,” he allowed, but he also called on clinicians to consider the needs of the patient, even going so far as picturing the patient as a family member. “People complain that doing the SYNTAX is on average 7 minutes, with a standard deviation of 7, so you could work 15 minutes just looking at film. But when you think that the future of your father or brother is depending on the surgeon and the cardiologist looking carefully, I find the argument absolutely obnoxious,” said Dr. Serruys at the meeting sponsored by the Cardiovascular Research Foundation.

Rather than simplification, he stresses teamwork. With at least three people looking at the angiogram, the results are consistent and useful. “You look at the film with the trainees, and that’s how they learn. Never do a SYNTAX score alone,” said Dr. Serruys.

To assess the simplified SYNTAX score, the researchers conducted a retrospective assessment of both the SYNTAX score and the simplified SYNTAX score in 617 patients who had multivessel disease. They performed both assessments in subgroups of patients with 169 patients with ST-segment elevation MI, 78 patients with chronic total occlusion, and 113 patients with left main coronary artery (LMCA) stenosis. They used a 100-patient derivation cohort to determine cutoffs for patients who would not be suitable for percutaneous coronary intervention. They also looked at the accuracy of the simplified version compared with standard SYNTAX in 517 patients from five tertiary centers.

The Spearman’s rho value was 0.93 overall and at least 0.91 for all subgroups (P less than .001 for all). In patients with LMCA stenosis, the simplified version had a sensitivity of 100%, specificity of 85%, negative predictive of 100%, and an area under the curve of 1.0 (P less than .001). For patients with multivessel disease and no LMCA stenosis, the values were 98%, 82%, 99%, and 0.971, respectively (P less than .001).

Dr. Burgess and Dr. Serruys reported no financial conflicts of interest.

Fluctuations in body weight, systolic blood pressure, total cholesterol, and fasting blood glucose in healthy people were associated with an increased risk of myocardial infarction, stroke, and death from any cause, and the effects are additive, based on data from a 5.5-year population-based study in Korea.

Fuse/ThinkStock

SOURCE: Lee S-H et al. Circulation. 2018 Oct.

Fluctuations in body weight, systolic blood pressure, total cholesterol, and fasting blood glucose in healthy people were associated with an increased risk of myocardial infarction, stroke, and death from any cause, and the effects are additive, based on data from a 5.5-year population-based study in Korea.

Fuse/ThinkStock

SOURCE: Lee S-H et al. Circulation. 2018 Oct.

Fluctuations in body weight, systolic blood pressure, total cholesterol, and fasting blood glucose in healthy people were associated with an increased risk of myocardial infarction, stroke, and death from any cause, and the effects are additive, based on data from a 5.5-year population-based study in Korea.

Fuse/ThinkStock

SOURCE: Lee S-H et al. Circulation. 2018 Oct.

A 4 g/day dose of the triglyceride-reducing drug Vascepa (Amarin), compared to placebo, was associated with a 25% lower risk of a heart attack, a stroke, an intervention for arterial thrombosis, or chest pain requiring a hospitalization in a study of 8,179 people who had high triglycerides and previous cardiovascular disorders or diabetes and another risk factor for heart disease.

In the ASCEND study, presented at the annual congress of the European Society of Cardiology, 1 g/day of omega-3 fatty acids showed no net cardiovascular benefits in people with diabetes and no known cardiovascular disease.

The results of the Amarin study, announced in a press release, are slated for presentation at the American Heart Association scientific sessions in November.

A 4 g/day dose of the triglyceride-reducing drug Vascepa (Amarin), compared to placebo, was associated with a 25% lower risk of a heart attack, a stroke, an intervention for arterial thrombosis, or chest pain requiring a hospitalization in a study of 8,179 people who had high triglycerides and previous cardiovascular disorders or diabetes and another risk factor for heart disease.

In the ASCEND study, presented at the annual congress of the European Society of Cardiology, 1 g/day of omega-3 fatty acids showed no net cardiovascular benefits in people with diabetes and no known cardiovascular disease.

The results of the Amarin study, announced in a press release, are slated for presentation at the American Heart Association scientific sessions in November.

A 4 g/day dose of the triglyceride-reducing drug Vascepa (Amarin), compared to placebo, was associated with a 25% lower risk of a heart attack, a stroke, an intervention for arterial thrombosis, or chest pain requiring a hospitalization in a study of 8,179 people who had high triglycerides and previous cardiovascular disorders or diabetes and another risk factor for heart disease.

In the ASCEND study, presented at the annual congress of the European Society of Cardiology, 1 g/day of omega-3 fatty acids showed no net cardiovascular benefits in people with diabetes and no known cardiovascular disease.

The results of the Amarin study, announced in a press release, are slated for presentation at the American Heart Association scientific sessions in November.

AstraZeneca announced top-line results of its phase III DECLARE-TIMI 58 cardiovascular outcomes trial for dapagliflozin (Farxiga). The 5-year international trial evaluated the cardiovascular outcomes of dapagliflozin compared with placebo in more than 17,000 adults with type 2 diabetes at high cardiovascular risk or established disease.

DECLARE met its primary safety endpoint of noninferiority for major adverse cardiovascular events for dabigatran the company said. Specifically, it achieved a statistically significant reduction in the composite endpoint of hospitalization for heart failure or cardiovascular death.

Dapagliflozin, approved in 2014, is a sodium-glucose  cotransporter  2  (SGLT2)  inhibitor  indicated as  an  adjunct  to  diet  and  exercise  to  improve  glycemic  control  in  adults  with type 2 diabetes.

Full results of DECLARE will be presented on November 10 at the American Heart Association annual meeting, according to the AstraZeneca release.

AstraZeneca announced top-line results of its phase III DECLARE-TIMI 58 cardiovascular outcomes trial for dapagliflozin (Farxiga). The 5-year international trial evaluated the cardiovascular outcomes of dapagliflozin compared with placebo in more than 17,000 adults with type 2 diabetes at high cardiovascular risk or established disease.

DECLARE met its primary safety endpoint of noninferiority for major adverse cardiovascular events for dabigatran the company said. Specifically, it achieved a statistically significant reduction in the composite endpoint of hospitalization for heart failure or cardiovascular death.

Dapagliflozin, approved in 2014, is a sodium-glucose  cotransporter  2  (SGLT2)  inhibitor  indicated as  an  adjunct  to  diet  and  exercise  to  improve  glycemic  control  in  adults  with type 2 diabetes.

Full results of DECLARE will be presented on November 10 at the American Heart Association annual meeting, according to the AstraZeneca release.

AstraZeneca announced top-line results of its phase III DECLARE-TIMI 58 cardiovascular outcomes trial for dapagliflozin (Farxiga). The 5-year international trial evaluated the cardiovascular outcomes of dapagliflozin compared with placebo in more than 17,000 adults with type 2 diabetes at high cardiovascular risk or established disease.

DECLARE met its primary safety endpoint of noninferiority for major adverse cardiovascular events for dabigatran the company said. Specifically, it achieved a statistically significant reduction in the composite endpoint of hospitalization for heart failure or cardiovascular death.

Dapagliflozin, approved in 2014, is a sodium-glucose  cotransporter  2  (SGLT2)  inhibitor  indicated as  an  adjunct  to  diet  and  exercise  to  improve  glycemic  control  in  adults  with type 2 diabetes.

Full results of DECLARE will be presented on November 10 at the American Heart Association annual meeting, according to the AstraZeneca release.

MUNICH – The largest-ever study of spontaneous coronary artery dissection shows that, while most affected patients do well with conservative management, two independent risk factors identify subgroups at high risk for in-hospital and 30-day major adverse events.

Bruce Jancin/MDedge News

Women whose spontaneous coronary artery dissection (SCAD) occurred during the peripartum period were at 2.8-fold increased risk of in-hospital major adverse events in a multivariate analysis, while those with a background connective tissue disorder were at 8.7-fold increased risk for major adverse cardiovascular events within 30 days of hospitalization in the Canadian SCAD (CanSCAD) study, Jacqueline Saw, MD, reported at the annual congress of the European Society of Cardiology.

CanSCAD is an ongoing, rigorous, prospective, multicenter, observational study of 750 patients with SCAD documented on angiography and confirmed in a core lab. To put the study in perspective, the worldwide medical literature published over the last decade contains fewer than 1,300 other cases of this seriously underdiagnosed, poorly understood disorder, noted Dr. Saw, CanSCAD principal investigator and a cardiologist at the University of British Columbia, Vancouver. Because much remains unclear about SCAD, a condition mistakenly considered to be rare in the past, the Canadian study was undertaken to shed light on predisposing and precipitating factors, optimal management, and clinical outcomes. Although Dr. Saw could present only the in-hospital and 30-day outcomes, follow-up will continue at 6, 12, 24, and 36 months.

SCAD is a nontraumatic, noniatrogenic, nonatherosclerotic separation of the coronary artery wall by intramural hematoma, creating a false lumen which compresses the true arterial lumen. This compromises blood flow with resultant myocardial ischemia or infarction. Intimal tear may or may not be present.

CanSCAD underscored that this is predominantly a disease affecting relatively young women: 89% of SCAD participants were female, 55% of whom were postmenopausal. The mean age at presentation was 52 years, and only 9% of subjects were older than age 65. Seventy percent of subjects presented with non–ST-elevation MI, the other 30% with STEMI. The predominant symptom was chest pain in 92% of patients. The average length of hospital stay was 4 days.

In terms of precipitating factors, half of patients cited high or severe emotional stress, with 41% of subjects scoring 20 or higher on the Perceived Stress Scale. About 30% of patients cited unusually intense physical stress, such as lifting more than 50 pounds, as a precipitating factor.

Of note, one-third of patients had no cardiovascular risk factors.

The in-hospital major adverse event rate – a composite of all-cause mortality, stroke, recurrent MI, cardiogenic shock, heart failure, cardiac arrest, repeat or unplanned revascularization, and heart transplantation – was 8.8%. Mortality through 1 month was reassuringly low, at 0.1%. Nonetheless, 4.9% of patients experienced recurrent symptoms necessitating emergency room visits within 30 days post discharge, and 2.5% required hospitalization because of their chest pain.

Patients who presented with SCAD during the peripartum period were more severely affected. Although they accounted for only 4.5% of subjects, their in-hospital major adverse event rate was 20.6%, compared with 8.2% in the others. They had a 17.6% prevalence of a left ventricular ejection fraction below 35%, as did only 3.1% of patients without peripartum SCAD. They were more than twice as likely to have elevated cardiac troponin levels. Moreover, peripartum SCAD was independently associated with a 2.9-fold increased risk of major adverse cardiovascular events at 30 days, a composite of all-cause mortality, stroke, recurrent MI, heart failure, or revascularization.

The other independent predictor of 30-day major adverse cardiovascular events in a multivariate logistic regression analysis was having a connective tissue disorder, present in 3.6% of participants.

Management was conservative, with no percutaneous coronary intervention used in 84% of patients. Outcomes were worse in the subgroup who underwent PCI, but Dr. Saw cautioned against making much of that.

“Keep in mind that the patients who undergo PCI are typically the higher-risk cohort with ongoing ischemia and chest pain, so there will be some bias there,” according to the cardiologist.

Bruce Jancin/MDedge News

Session chair Patrick W. Serruys, MD, of Erasmus University, Rotterdam, the Netherlands, commented, “It seems like there is a critical period of 30 days, more or less, and beyond that time the situation can be considered as settled and a wait-and-see attitude is fine. It looked like patients with peripartum dissection or connective tissue disease should potentially be kept in hospital for at least 15 days, and maybe 30 days, because I see your cumulative adverse event curve plateauing around 15 days.”

“Are you doing that in your practice?” asked Dr. Serruys.

“It’s true that conservatively managed patients should remain in hospital for typically about 4 days. For patients with a high-risk presentation we do advocate staying in hospital for longer periods,” Dr. Saw replied. “It would be great to keep them for 15 days, although typically if their chest pain has settled by 10 days they can be discharged home.”

Audience members were eager to hear her recommendations regarding dual-antiplatelet therapy. She explained that in her practice patients are generally discharged on aspirin and clopidogrel and typically continue the clopidogrel for at least a month.

“When we follow them in the office at 1 month, if their chest pain has settled, we would discontinue DAPT,” Dr. Saw said.
 

The ongoing CanSCAD study is sponsored by the Canadian Institutes of Health Research, the Stroke Foundation of Canada, the National Institutes of Health, Abbott Vascular, Boston Scientific, AstraZeneca, and Servier. Dr. Saw reported serving as a consultant to Abbott Vascular and Boston Scientific.

[email protected]

MUNICH – The largest-ever study of spontaneous coronary artery dissection shows that, while most affected patients do well with conservative management, two independent risk factors identify subgroups at high risk for in-hospital and 30-day major adverse events.

Bruce Jancin/MDedge News

Women whose spontaneous coronary artery dissection (SCAD) occurred during the peripartum period were at 2.8-fold increased risk of in-hospital major adverse events in a multivariate analysis, while those with a background connective tissue disorder were at 8.7-fold increased risk for major adverse cardiovascular events within 30 days of hospitalization in the Canadian SCAD (CanSCAD) study, Jacqueline Saw, MD, reported at the annual congress of the European Society of Cardiology.

CanSCAD is an ongoing, rigorous, prospective, multicenter, observational study of 750 patients with SCAD documented on angiography and confirmed in a core lab. To put the study in perspective, the worldwide medical literature published over the last decade contains fewer than 1,300 other cases of this seriously underdiagnosed, poorly understood disorder, noted Dr. Saw, CanSCAD principal investigator and a cardiologist at the University of British Columbia, Vancouver. Because much remains unclear about SCAD, a condition mistakenly considered to be rare in the past, the Canadian study was undertaken to shed light on predisposing and precipitating factors, optimal management, and clinical outcomes. Although Dr. Saw could present only the in-hospital and 30-day outcomes, follow-up will continue at 6, 12, 24, and 36 months.

SCAD is a nontraumatic, noniatrogenic, nonatherosclerotic separation of the coronary artery wall by intramural hematoma, creating a false lumen which compresses the true arterial lumen. This compromises blood flow with resultant myocardial ischemia or infarction. Intimal tear may or may not be present.

CanSCAD underscored that this is predominantly a disease affecting relatively young women: 89% of SCAD participants were female, 55% of whom were postmenopausal. The mean age at presentation was 52 years, and only 9% of subjects were older than age 65. Seventy percent of subjects presented with non–ST-elevation MI, the other 30% with STEMI. The predominant symptom was chest pain in 92% of patients. The average length of hospital stay was 4 days.

In terms of precipitating factors, half of patients cited high or severe emotional stress, with 41% of subjects scoring 20 or higher on the Perceived Stress Scale. About 30% of patients cited unusually intense physical stress, such as lifting more than 50 pounds, as a precipitating factor.

Of note, one-third of patients had no cardiovascular risk factors.

The in-hospital major adverse event rate – a composite of all-cause mortality, stroke, recurrent MI, cardiogenic shock, heart failure, cardiac arrest, repeat or unplanned revascularization, and heart transplantation – was 8.8%. Mortality through 1 month was reassuringly low, at 0.1%. Nonetheless, 4.9% of patients experienced recurrent symptoms necessitating emergency room visits within 30 days post discharge, and 2.5% required hospitalization because of their chest pain.

Patients who presented with SCAD during the peripartum period were more severely affected. Although they accounted for only 4.5% of subjects, their in-hospital major adverse event rate was 20.6%, compared with 8.2% in the others. They had a 17.6% prevalence of a left ventricular ejection fraction below 35%, as did only 3.1% of patients without peripartum SCAD. They were more than twice as likely to have elevated cardiac troponin levels. Moreover, peripartum SCAD was independently associated with a 2.9-fold increased risk of major adverse cardiovascular events at 30 days, a composite of all-cause mortality, stroke, recurrent MI, heart failure, or revascularization.

The other independent predictor of 30-day major adverse cardiovascular events in a multivariate logistic regression analysis was having a connective tissue disorder, present in 3.6% of participants.

Management was conservative, with no percutaneous coronary intervention used in 84% of patients. Outcomes were worse in the subgroup who underwent PCI, but Dr. Saw cautioned against making much of that.

“Keep in mind that the patients who undergo PCI are typically the higher-risk cohort with ongoing ischemia and chest pain, so there will be some bias there,” according to the cardiologist.

Bruce Jancin/MDedge News

Session chair Patrick W. Serruys, MD, of Erasmus University, Rotterdam, the Netherlands, commented, “It seems like there is a critical period of 30 days, more or less, and beyond that time the situation can be considered as settled and a wait-and-see attitude is fine. It looked like patients with peripartum dissection or connective tissue disease should potentially be kept in hospital for at least 15 days, and maybe 30 days, because I see your cumulative adverse event curve plateauing around 15 days.”

“Are you doing that in your practice?” asked Dr. Serruys.

“It’s true that conservatively managed patients should remain in hospital for typically about 4 days. For patients with a high-risk presentation we do advocate staying in hospital for longer periods,” Dr. Saw replied. “It would be great to keep them for 15 days, although typically if their chest pain has settled by 10 days they can be discharged home.”

Audience members were eager to hear her recommendations regarding dual-antiplatelet therapy. She explained that in her practice patients are generally discharged on aspirin and clopidogrel and typically continue the clopidogrel for at least a month.

“When we follow them in the office at 1 month, if their chest pain has settled, we would discontinue DAPT,” Dr. Saw said.
 

The ongoing CanSCAD study is sponsored by the Canadian Institutes of Health Research, the Stroke Foundation of Canada, the National Institutes of Health, Abbott Vascular, Boston Scientific, AstraZeneca, and Servier. Dr. Saw reported serving as a consultant to Abbott Vascular and Boston Scientific.

[email protected]

MUNICH – The largest-ever study of spontaneous coronary artery dissection shows that, while most affected patients do well with conservative management, two independent risk factors identify subgroups at high risk for in-hospital and 30-day major adverse events.

Bruce Jancin/MDedge News

Women whose spontaneous coronary artery dissection (SCAD) occurred during the peripartum period were at 2.8-fold increased risk of in-hospital major adverse events in a multivariate analysis, while those with a background connective tissue disorder were at 8.7-fold increased risk for major adverse cardiovascular events within 30 days of hospitalization in the Canadian SCAD (CanSCAD) study, Jacqueline Saw, MD, reported at the annual congress of the European Society of Cardiology.

CanSCAD is an ongoing, rigorous, prospective, multicenter, observational study of 750 patients with SCAD documented on angiography and confirmed in a core lab. To put the study in perspective, the worldwide medical literature published over the last decade contains fewer than 1,300 other cases of this seriously underdiagnosed, poorly understood disorder, noted Dr. Saw, CanSCAD principal investigator and a cardiologist at the University of British Columbia, Vancouver. Because much remains unclear about SCAD, a condition mistakenly considered to be rare in the past, the Canadian study was undertaken to shed light on predisposing and precipitating factors, optimal management, and clinical outcomes. Although Dr. Saw could present only the in-hospital and 30-day outcomes, follow-up will continue at 6, 12, 24, and 36 months.

SCAD is a nontraumatic, noniatrogenic, nonatherosclerotic separation of the coronary artery wall by intramural hematoma, creating a false lumen which compresses the true arterial lumen. This compromises blood flow with resultant myocardial ischemia or infarction. Intimal tear may or may not be present.

CanSCAD underscored that this is predominantly a disease affecting relatively young women: 89% of SCAD participants were female, 55% of whom were postmenopausal. The mean age at presentation was 52 years, and only 9% of subjects were older than age 65. Seventy percent of subjects presented with non–ST-elevation MI, the other 30% with STEMI. The predominant symptom was chest pain in 92% of patients. The average length of hospital stay was 4 days.

In terms of precipitating factors, half of patients cited high or severe emotional stress, with 41% of subjects scoring 20 or higher on the Perceived Stress Scale. About 30% of patients cited unusually intense physical stress, such as lifting more than 50 pounds, as a precipitating factor.

Of note, one-third of patients had no cardiovascular risk factors.

The in-hospital major adverse event rate – a composite of all-cause mortality, stroke, recurrent MI, cardiogenic shock, heart failure, cardiac arrest, repeat or unplanned revascularization, and heart transplantation – was 8.8%. Mortality through 1 month was reassuringly low, at 0.1%. Nonetheless, 4.9% of patients experienced recurrent symptoms necessitating emergency room visits within 30 days post discharge, and 2.5% required hospitalization because of their chest pain.

Patients who presented with SCAD during the peripartum period were more severely affected. Although they accounted for only 4.5% of subjects, their in-hospital major adverse event rate was 20.6%, compared with 8.2% in the others. They had a 17.6% prevalence of a left ventricular ejection fraction below 35%, as did only 3.1% of patients without peripartum SCAD. They were more than twice as likely to have elevated cardiac troponin levels. Moreover, peripartum SCAD was independently associated with a 2.9-fold increased risk of major adverse cardiovascular events at 30 days, a composite of all-cause mortality, stroke, recurrent MI, heart failure, or revascularization.

The other independent predictor of 30-day major adverse cardiovascular events in a multivariate logistic regression analysis was having a connective tissue disorder, present in 3.6% of participants.

Management was conservative, with no percutaneous coronary intervention used in 84% of patients. Outcomes were worse in the subgroup who underwent PCI, but Dr. Saw cautioned against making much of that.

“Keep in mind that the patients who undergo PCI are typically the higher-risk cohort with ongoing ischemia and chest pain, so there will be some bias there,” according to the cardiologist.

Bruce Jancin/MDedge News

Session chair Patrick W. Serruys, MD, of Erasmus University, Rotterdam, the Netherlands, commented, “It seems like there is a critical period of 30 days, more or less, and beyond that time the situation can be considered as settled and a wait-and-see attitude is fine. It looked like patients with peripartum dissection or connective tissue disease should potentially be kept in hospital for at least 15 days, and maybe 30 days, because I see your cumulative adverse event curve plateauing around 15 days.”

“Are you doing that in your practice?” asked Dr. Serruys.

“It’s true that conservatively managed patients should remain in hospital for typically about 4 days. For patients with a high-risk presentation we do advocate staying in hospital for longer periods,” Dr. Saw replied. “It would be great to keep them for 15 days, although typically if their chest pain has settled by 10 days they can be discharged home.”

Audience members were eager to hear her recommendations regarding dual-antiplatelet therapy. She explained that in her practice patients are generally discharged on aspirin and clopidogrel and typically continue the clopidogrel for at least a month.

“When we follow them in the office at 1 month, if their chest pain has settled, we would discontinue DAPT,” Dr. Saw said.
 

The ongoing CanSCAD study is sponsored by the Canadian Institutes of Health Research, the Stroke Foundation of Canada, the National Institutes of Health, Abbott Vascular, Boston Scientific, AstraZeneca, and Servier. Dr. Saw reported serving as a consultant to Abbott Vascular and Boston Scientific.

[email protected]

Canakinumab, an interleukin-1–beta blocker, reduced the risk of a gout attack by 52% when administered every 3 months, according to a secondary exploratory analysis of data from the multicenter, randomized, double-blind, placebo-controlled CANTOS trial (NCT01327846). The results of this analysis were published Sept. 17 in the Annals of Internal Medicine (doi: 10.7326/M18-1167).

We covered this story before it was published in the journal. Find our conference coverage at the links below.

Canakinumab, an interleukin-1–beta blocker, reduced the risk of a gout attack by 52% when administered every 3 months, according to a secondary exploratory analysis of data from the multicenter, randomized, double-blind, placebo-controlled CANTOS trial (NCT01327846). The results of this analysis were published Sept. 17 in the Annals of Internal Medicine (doi: 10.7326/M18-1167).

We covered this story before it was published in the journal. Find our conference coverage at the links below.

Canakinumab, an interleukin-1–beta blocker, reduced the risk of a gout attack by 52% when administered every 3 months, according to a secondary exploratory analysis of data from the multicenter, randomized, double-blind, placebo-controlled CANTOS trial (NCT01327846). The results of this analysis were published Sept. 17 in the Annals of Internal Medicine (doi: 10.7326/M18-1167).

We covered this story before it was published in the journal. Find our conference coverage at the links below.

The Food and Drug administration has approved the PK Papyrus Covered Coronary Stent System to treat acute coronary artery perforations, according to an announcement from the agency.

These small tears in the arterial wall are rare but life-threatening complications of certain procedures, such as percutaneous coronary interventions. The device uses a balloon catheter like that used with PCI and, when successful, it can spare patients more invasive procedures, such as open heart surgery.

The approval is based on survey data from 80 patients treated with this device. In 76 of the patients (95%), the device was successfully delivered to the site of the acute coronary arterial perforation, and it successfully healed the tear in 73 patients (91%). Two patients died during the procedure, and five whose perforations were sealed successfully died in the hospital after the procedure, as did one whose perforation was not sealed.

The agency noted that this is the first device approved for the indication in 17 years. More information can be found in the full FDA announcement.

[email protected]

The Food and Drug administration has approved the PK Papyrus Covered Coronary Stent System to treat acute coronary artery perforations, according to an announcement from the agency.

These small tears in the arterial wall are rare but life-threatening complications of certain procedures, such as percutaneous coronary interventions. The device uses a balloon catheter like that used with PCI and, when successful, it can spare patients more invasive procedures, such as open heart surgery.

The approval is based on survey data from 80 patients treated with this device. In 76 of the patients (95%), the device was successfully delivered to the site of the acute coronary arterial perforation, and it successfully healed the tear in 73 patients (91%). Two patients died during the procedure, and five whose perforations were sealed successfully died in the hospital after the procedure, as did one whose perforation was not sealed.

The agency noted that this is the first device approved for the indication in 17 years. More information can be found in the full FDA announcement.

[email protected]

The Food and Drug administration has approved the PK Papyrus Covered Coronary Stent System to treat acute coronary artery perforations, according to an announcement from the agency.

These small tears in the arterial wall are rare but life-threatening complications of certain procedures, such as percutaneous coronary interventions. The device uses a balloon catheter like that used with PCI and, when successful, it can spare patients more invasive procedures, such as open heart surgery.

The approval is based on survey data from 80 patients treated with this device. In 76 of the patients (95%), the device was successfully delivered to the site of the acute coronary arterial perforation, and it successfully healed the tear in 73 patients (91%). Two patients died during the procedure, and five whose perforations were sealed successfully died in the hospital after the procedure, as did one whose perforation was not sealed.

The agency noted that this is the first device approved for the indication in 17 years. More information can be found in the full FDA announcement.

[email protected]

PARIS – Treatment with a drug-eluting balloon rather than bare-metal stent provided superior outcomes in patients at high bleeding risk with large-vessel coronary lesions, according to the results of the randomized DEBUT study.

Bruce Jancin/MDedge News

“PCI with a drug-eluting balloon, with the possibility of bailout stenting if needed, is a safe and efficient novel option in patients with high bleeding risk,” Tuomas T. Rissanen, MD, PhD, said in presenting the results of the trial at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions.

“The major advantage of the drug-eluting balloon–only strategy is that DAPT [dual-antiplatelet therapy] duration is short – usually 1 month – and positive remodeling of the treated vessel may occur because there is no metallic material present,” added Dr. Rissanen, head of the Heart Center at the University of Eastern Finland in Joensuu.

DEBUT (Drug-Eluting Balloon in Stable and Unstable Angina in a Randomized Controlled Noninferiority Trial) was a five-center, single-blind Finnish study in which patients at elevated bleeding risk – most often because they required oral anticoagulation and were over age 80 – were randomized to a paclitaxel-coated drug-eluting balloon (DEB) applied for a minimum of 30 seconds or a bare-metal stent (BMS). They were placed on DAPT for 1 month if they had stable coronary artery disease and 6 months after an acute coronary syndrome.

Participants had to have a target vessel diameter amenable for PCI with a DEB: that is, 2.5-4.0 mm. Patients with in-stent restenosis, an unprotected left main lesion, ST-elevation MI, chronic total occlusion, a dissection sufficient to reduce flow, greater than 30% recoil after predilation, or a bifurcation lesion requiring side branch stenting were excluded.

The impetus for the DEBUT trial was a recognition that, while the use of DEBs is recommended for treatment of in-stent restenosis by European Society of Cardiology guidelines, until DEBUT there were no high-quality randomized trial data regarding the use of such devices in de novo coronary lesions, the cardiologist noted.

The study results were unequivocal. Indeed, DEBUT, planned for 530 patients, was halted after enrollment of only 208 because an interim analysis showed clear superiority for the DEB strategy.

To wit, the primary endpoint – a composite of cardiovascular death, nonfatal MI, or target lesion revascularization at 9 months post PCI – occurred in 1.9% of the DEB group, compared with 12.4% of BMS recipients. This absolute 10.5% difference in risk translated to an 85% relative risk reduction.

Target lesion revascularization, a major secondary outcome, occurred in none of the DEB group and 4.8% of the BMS group. Bleeding Academic Research Consortium (BARC) type 2 bleeding rates were similar at 11%-12% in the two groups.

Four percent of the DEB group required bailout stenting.

“Importantly, at 9 months, there were two definite stent thrombosis cases in the BMS group and no vessel closures in the DEB group,” Dr. Rissanen observed.

Discussant Antonio Colombo, MD, said, “I think a strategy with a drug-eluting balloon makes sense.”

Even though the 2-year results of the LEADERS FREE trial have shown that the BioFreedom polymer-free drug-coated stent proved safer and more effective than a BMS in high–bleeding risk patients with 1 month of DAPT (J Am Coll Cardiol. 2017 Jan 17;69[2]:162-71), not all PCI centers have access to the BioFreedom stent.

“Why do you need to place a stent in everyone? If you have a good result with the DEB, there is no reason to. Maybe you should use fractional flow reserve [FFR] to give reassurance that the result is really good, but I am in favor of this strategy. I think if you find a small dissection, and the residual lumen is large, it’s okay. It will usually heal. I think a dissection is problematic when the residual lumen is not large,” said Dr. Colombo, chief of invasive cardiology at San Raffaele Hospital in Milan.

There is a practical problem with the DEB-only strategy, however: “Many operators are uncomfortable in not using a stent in a large vessel, even when they have a good result,” he noted.

His fellow discussant Marc Bosiers, MD, said interventional cardiologists need to get over that hangup, which isn’t evidence based.

“We have the same experience in the periphery: We leave arteries as is after DEB therapy with only small Type A, B, and even C dissections, and we have fantastic results. We have total vessel remodeling. In many cases we see the patients back after 6 months or a year and do follow-up angiography, and you’ll be surprised at what you see with DEB alone,” according to Dr. Bosiers, head of the department of vascular surgery at St. Blasius Hospital in Dendermonde, Belgium.

Dr. Rissanen said that, for their next research project, he and his coinvestigators plan to mount a multicenter randomized trial of DEB versus a drug-eluting stent rather than a BMS in high–bleeding risk patients with de novo coronary lesions. And they’re considering ditching the 1 month of DAPT in the DEB patients.

“What is this 1-month DAPT for DEB based on, anyway? I don’t think we need it at all. We could use single-antiplatelet therapy or only the loading dose of the second agent,” he asserted.

But, as one of the discussants responded, that may well be true, and perhaps in the future a course of post-DEB therapy with a single antiplatelet agent or a direct-acting oral anticoagulant will be the routine strategy, but before clinical practice is revised such novel proposals will need to be well-grounded in proof of safety and efficacy. Dr. Rissanen reported having no financial conflicts regarding the DEBUT study, conducted free of commercial support.

[email protected]

PARIS – Treatment with a drug-eluting balloon rather than bare-metal stent provided superior outcomes in patients at high bleeding risk with large-vessel coronary lesions, according to the results of the randomized DEBUT study.

Bruce Jancin/MDedge News

“PCI with a drug-eluting balloon, with the possibility of bailout stenting if needed, is a safe and efficient novel option in patients with high bleeding risk,” Tuomas T. Rissanen, MD, PhD, said in presenting the results of the trial at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions.

“The major advantage of the drug-eluting balloon–only strategy is that DAPT [dual-antiplatelet therapy] duration is short – usually 1 month – and positive remodeling of the treated vessel may occur because there is no metallic material present,” added Dr. Rissanen, head of the Heart Center at the University of Eastern Finland in Joensuu.

DEBUT (Drug-Eluting Balloon in Stable and Unstable Angina in a Randomized Controlled Noninferiority Trial) was a five-center, single-blind Finnish study in which patients at elevated bleeding risk – most often because they required oral anticoagulation and were over age 80 – were randomized to a paclitaxel-coated drug-eluting balloon (DEB) applied for a minimum of 30 seconds or a bare-metal stent (BMS). They were placed on DAPT for 1 month if they had stable coronary artery disease and 6 months after an acute coronary syndrome.

Participants had to have a target vessel diameter amenable for PCI with a DEB: that is, 2.5-4.0 mm. Patients with in-stent restenosis, an unprotected left main lesion, ST-elevation MI, chronic total occlusion, a dissection sufficient to reduce flow, greater than 30% recoil after predilation, or a bifurcation lesion requiring side branch stenting were excluded.

The impetus for the DEBUT trial was a recognition that, while the use of DEBs is recommended for treatment of in-stent restenosis by European Society of Cardiology guidelines, until DEBUT there were no high-quality randomized trial data regarding the use of such devices in de novo coronary lesions, the cardiologist noted.

The study results were unequivocal. Indeed, DEBUT, planned for 530 patients, was halted after enrollment of only 208 because an interim analysis showed clear superiority for the DEB strategy.

To wit, the primary endpoint – a composite of cardiovascular death, nonfatal MI, or target lesion revascularization at 9 months post PCI – occurred in 1.9% of the DEB group, compared with 12.4% of BMS recipients. This absolute 10.5% difference in risk translated to an 85% relative risk reduction.

Target lesion revascularization, a major secondary outcome, occurred in none of the DEB group and 4.8% of the BMS group. Bleeding Academic Research Consortium (BARC) type 2 bleeding rates were similar at 11%-12% in the two groups.

Four percent of the DEB group required bailout stenting.

“Importantly, at 9 months, there were two definite stent thrombosis cases in the BMS group and no vessel closures in the DEB group,” Dr. Rissanen observed.

Discussant Antonio Colombo, MD, said, “I think a strategy with a drug-eluting balloon makes sense.”

Even though the 2-year results of the LEADERS FREE trial have shown that the BioFreedom polymer-free drug-coated stent proved safer and more effective than a BMS in high–bleeding risk patients with 1 month of DAPT (J Am Coll Cardiol. 2017 Jan 17;69[2]:162-71), not all PCI centers have access to the BioFreedom stent.

“Why do you need to place a stent in everyone? If you have a good result with the DEB, there is no reason to. Maybe you should use fractional flow reserve [FFR] to give reassurance that the result is really good, but I am in favor of this strategy. I think if you find a small dissection, and the residual lumen is large, it’s okay. It will usually heal. I think a dissection is problematic when the residual lumen is not large,” said Dr. Colombo, chief of invasive cardiology at San Raffaele Hospital in Milan.

There is a practical problem with the DEB-only strategy, however: “Many operators are uncomfortable in not using a stent in a large vessel, even when they have a good result,” he noted.

His fellow discussant Marc Bosiers, MD, said interventional cardiologists need to get over that hangup, which isn’t evidence based.

“We have the same experience in the periphery: We leave arteries as is after DEB therapy with only small Type A, B, and even C dissections, and we have fantastic results. We have total vessel remodeling. In many cases we see the patients back after 6 months or a year and do follow-up angiography, and you’ll be surprised at what you see with DEB alone,” according to Dr. Bosiers, head of the department of vascular surgery at St. Blasius Hospital in Dendermonde, Belgium.

Dr. Rissanen said that, for their next research project, he and his coinvestigators plan to mount a multicenter randomized trial of DEB versus a drug-eluting stent rather than a BMS in high–bleeding risk patients with de novo coronary lesions. And they’re considering ditching the 1 month of DAPT in the DEB patients.

“What is this 1-month DAPT for DEB based on, anyway? I don’t think we need it at all. We could use single-antiplatelet therapy or only the loading dose of the second agent,” he asserted.

But, as one of the discussants responded, that may well be true, and perhaps in the future a course of post-DEB therapy with a single antiplatelet agent or a direct-acting oral anticoagulant will be the routine strategy, but before clinical practice is revised such novel proposals will need to be well-grounded in proof of safety and efficacy. Dr. Rissanen reported having no financial conflicts regarding the DEBUT study, conducted free of commercial support.

[email protected]

PARIS – Treatment with a drug-eluting balloon rather than bare-metal stent provided superior outcomes in patients at high bleeding risk with large-vessel coronary lesions, according to the results of the randomized DEBUT study.

Bruce Jancin/MDedge News

“PCI with a drug-eluting balloon, with the possibility of bailout stenting if needed, is a safe and efficient novel option in patients with high bleeding risk,” Tuomas T. Rissanen, MD, PhD, said in presenting the results of the trial at the annual meeting of the European Association of Percutaneous Cardiovascular Interventions.

“The major advantage of the drug-eluting balloon–only strategy is that DAPT [dual-antiplatelet therapy] duration is short – usually 1 month – and positive remodeling of the treated vessel may occur because there is no metallic material present,” added Dr. Rissanen, head of the Heart Center at the University of Eastern Finland in Joensuu.

DEBUT (Drug-Eluting Balloon in Stable and Unstable Angina in a Randomized Controlled Noninferiority Trial) was a five-center, single-blind Finnish study in which patients at elevated bleeding risk – most often because they required oral anticoagulation and were over age 80 – were randomized to a paclitaxel-coated drug-eluting balloon (DEB) applied for a minimum of 30 seconds or a bare-metal stent (BMS). They were placed on DAPT for 1 month if they had stable coronary artery disease and 6 months after an acute coronary syndrome.

Participants had to have a target vessel diameter amenable for PCI with a DEB: that is, 2.5-4.0 mm. Patients with in-stent restenosis, an unprotected left main lesion, ST-elevation MI, chronic total occlusion, a dissection sufficient to reduce flow, greater than 30% recoil after predilation, or a bifurcation lesion requiring side branch stenting were excluded.

The impetus for the DEBUT trial was a recognition that, while the use of DEBs is recommended for treatment of in-stent restenosis by European Society of Cardiology guidelines, until DEBUT there were no high-quality randomized trial data regarding the use of such devices in de novo coronary lesions, the cardiologist noted.

The study results were unequivocal. Indeed, DEBUT, planned for 530 patients, was halted after enrollment of only 208 because an interim analysis showed clear superiority for the DEB strategy.

To wit, the primary endpoint – a composite of cardiovascular death, nonfatal MI, or target lesion revascularization at 9 months post PCI – occurred in 1.9% of the DEB group, compared with 12.4% of BMS recipients. This absolute 10.5% difference in risk translated to an 85% relative risk reduction.

Target lesion revascularization, a major secondary outcome, occurred in none of the DEB group and 4.8% of the BMS group. Bleeding Academic Research Consortium (BARC) type 2 bleeding rates were similar at 11%-12% in the two groups.

Four percent of the DEB group required bailout stenting.

“Importantly, at 9 months, there were two definite stent thrombosis cases in the BMS group and no vessel closures in the DEB group,” Dr. Rissanen observed.

Discussant Antonio Colombo, MD, said, “I think a strategy with a drug-eluting balloon makes sense.”

Even though the 2-year results of the LEADERS FREE trial have shown that the BioFreedom polymer-free drug-coated stent proved safer and more effective than a BMS in high–bleeding risk patients with 1 month of DAPT (J Am Coll Cardiol. 2017 Jan 17;69[2]:162-71), not all PCI centers have access to the BioFreedom stent.

“Why do you need to place a stent in everyone? If you have a good result with the DEB, there is no reason to. Maybe you should use fractional flow reserve [FFR] to give reassurance that the result is really good, but I am in favor of this strategy. I think if you find a small dissection, and the residual lumen is large, it’s okay. It will usually heal. I think a dissection is problematic when the residual lumen is not large,” said Dr. Colombo, chief of invasive cardiology at San Raffaele Hospital in Milan.

There is a practical problem with the DEB-only strategy, however: “Many operators are uncomfortable in not using a stent in a large vessel, even when they have a good result,” he noted.

His fellow discussant Marc Bosiers, MD, said interventional cardiologists need to get over that hangup, which isn’t evidence based.

“We have the same experience in the periphery: We leave arteries as is after DEB therapy with only small Type A, B, and even C dissections, and we have fantastic results. We have total vessel remodeling. In many cases we see the patients back after 6 months or a year and do follow-up angiography, and you’ll be surprised at what you see with DEB alone,” according to Dr. Bosiers, head of the department of vascular surgery at St. Blasius Hospital in Dendermonde, Belgium.

Dr. Rissanen said that, for their next research project, he and his coinvestigators plan to mount a multicenter randomized trial of DEB versus a drug-eluting stent rather than a BMS in high–bleeding risk patients with de novo coronary lesions. And they’re considering ditching the 1 month of DAPT in the DEB patients.

“What is this 1-month DAPT for DEB based on, anyway? I don’t think we need it at all. We could use single-antiplatelet therapy or only the loading dose of the second agent,” he asserted.

But, as one of the discussants responded, that may well be true, and perhaps in the future a course of post-DEB therapy with a single antiplatelet agent or a direct-acting oral anticoagulant will be the routine strategy, but before clinical practice is revised such novel proposals will need to be well-grounded in proof of safety and efficacy. Dr. Rissanen reported having no financial conflicts regarding the DEBUT study, conducted free of commercial support.

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