Acquired Cardiovascular Disease

The first-ever AATS Mitral Conclave was held on May 5^th and 6^th. The world’s leading experts in mitral valve disease convened to discuss management guidelines, imaging, pathology, minimally invasive procedures, percutaneous approaches, surgical techniques, devices, and long-term results.

"With 39 faculty and 250 presentations, including selected abstracts and videos, our goal was to have a comprehensive meeting focused on mitral valve disease that would allow attendees to gain exposure to all of the common approaches used in the top centers throughout the world," said Program Director David H. Adams, MD. "We continue to see tremendous progress in our understanding of mitral disease intervention, and a great interest among surgeons in learning and advancing mitral valve repair strategies," said Dr. Adams, chairman of the department of cardiothoracic surgery at the Mount Sinai Medical Center, New York.

More than 1,000 individuals – including about 800 physicians – from 66 countries participated. Industry support was provided by Edwards Lifesciences LLC (Premier Platinum), Metronic, Inc. (Platinum), Abbott Vascular (Gold), Sorin Heart Valves (Gold), and St. Jude Medical Inc. (Bronze).

"I figured we might get 250 physicians, and would have considered that a success. This is fantastic," said AATS President Irving L. Kron, MD.

Presentations included lectures, expert video sessions, and "Presentations on Demand," accessible on video screens positioned in the exhibit hall. In a plenary address, Robert O. Bonow, MD, said that current valvular heart disease guidelines are based largely on expert opinion rather than evidence from clinical trials. Referring to the 2008 revised joint guidelines from the American College of Cardiology/American Heart Association and the 2007 European Society of Cardiology guidelines, he said, "Unfortunately, the evidence base underpinning them is limited by an inadequate number of randomized clinical trials. We really need to provide more evidence-based information to devise true guidelines and performance measures."

The question of whether mitral valve repair should be considered in all patients with severe mitral valve regurgitation is still being debated.

"It’s at least likely that certain patient subsets would benefit, but current data are insufficient to determine which ones," said Dr. Bonow, of Northwestern University. As an example of ambiguity, U.S. guidelines recommend that patients considered eligible for repair be referred to an "experienced center," but don’t provide criteria for determining that status. Moreover, individual surgeon volume and experience clearly predict successful mitral repair outcomes, even within one institution.

Dr. Bonow is optimistic that useful data will come from two ongoing trials sponsored by the National Heart, Lung, and Blood Institute via the Cardiothoracic Surgical Trials Network.

Dr. Adams presented the Mitral Conclave Career Achievement Award to the legendary Alain F. Carpentier, MD, whose 1983 landmark paper, "Cardiac Valve Surgery – the ‘French Correction,’ " is credited with heralding the modern era of mitral valve reconstructive surgery. Professor Carpentier delivered the Conclave Honored Lecture.

A series of "mini debates" addressed controversies surrounding the use of annuloplasty rings (flexible versus remodeling versus no ring at all), minimally invasive surgery (for all patients versus for some), and the correct approach for specific clinical scenarios of tricuspid valve disease.

The next Aortic Symposium will be held April 26-27, 2012, and the next Mitral Conclave will take place May 2-3, 2013, both in New York. Proceedings from the 2011 Mitral Conclave will be published in an upcoming supplement to The Journal of Thoracic and Cardiovascular Surgery.n

The first-ever AATS Mitral Conclave was held on May 5^th and 6^th. The world’s leading experts in mitral valve disease convened to discuss management guidelines, imaging, pathology, minimally invasive procedures, percutaneous approaches, surgical techniques, devices, and long-term results.

"With 39 faculty and 250 presentations, including selected abstracts and videos, our goal was to have a comprehensive meeting focused on mitral valve disease that would allow attendees to gain exposure to all of the common approaches used in the top centers throughout the world," said Program Director David H. Adams, MD. "We continue to see tremendous progress in our understanding of mitral disease intervention, and a great interest among surgeons in learning and advancing mitral valve repair strategies," said Dr. Adams, chairman of the department of cardiothoracic surgery at the Mount Sinai Medical Center, New York.

More than 1,000 individuals – including about 800 physicians – from 66 countries participated. Industry support was provided by Edwards Lifesciences LLC (Premier Platinum), Metronic, Inc. (Platinum), Abbott Vascular (Gold), Sorin Heart Valves (Gold), and St. Jude Medical Inc. (Bronze).

"I figured we might get 250 physicians, and would have considered that a success. This is fantastic," said AATS President Irving L. Kron, MD.

Presentations included lectures, expert video sessions, and "Presentations on Demand," accessible on video screens positioned in the exhibit hall. In a plenary address, Robert O. Bonow, MD, said that current valvular heart disease guidelines are based largely on expert opinion rather than evidence from clinical trials. Referring to the 2008 revised joint guidelines from the American College of Cardiology/American Heart Association and the 2007 European Society of Cardiology guidelines, he said, "Unfortunately, the evidence base underpinning them is limited by an inadequate number of randomized clinical trials. We really need to provide more evidence-based information to devise true guidelines and performance measures."

The question of whether mitral valve repair should be considered in all patients with severe mitral valve regurgitation is still being debated.

"It’s at least likely that certain patient subsets would benefit, but current data are insufficient to determine which ones," said Dr. Bonow, of Northwestern University. As an example of ambiguity, U.S. guidelines recommend that patients considered eligible for repair be referred to an "experienced center," but don’t provide criteria for determining that status. Moreover, individual surgeon volume and experience clearly predict successful mitral repair outcomes, even within one institution.

Dr. Bonow is optimistic that useful data will come from two ongoing trials sponsored by the National Heart, Lung, and Blood Institute via the Cardiothoracic Surgical Trials Network.

Dr. Adams presented the Mitral Conclave Career Achievement Award to the legendary Alain F. Carpentier, MD, whose 1983 landmark paper, "Cardiac Valve Surgery – the ‘French Correction,’ " is credited with heralding the modern era of mitral valve reconstructive surgery. Professor Carpentier delivered the Conclave Honored Lecture.

A series of "mini debates" addressed controversies surrounding the use of annuloplasty rings (flexible versus remodeling versus no ring at all), minimally invasive surgery (for all patients versus for some), and the correct approach for specific clinical scenarios of tricuspid valve disease.

The next Aortic Symposium will be held April 26-27, 2012, and the next Mitral Conclave will take place May 2-3, 2013, both in New York. Proceedings from the 2011 Mitral Conclave will be published in an upcoming supplement to The Journal of Thoracic and Cardiovascular Surgery.n

The first-ever AATS Mitral Conclave was held on May 5^th and 6^th. The world’s leading experts in mitral valve disease convened to discuss management guidelines, imaging, pathology, minimally invasive procedures, percutaneous approaches, surgical techniques, devices, and long-term results.

"With 39 faculty and 250 presentations, including selected abstracts and videos, our goal was to have a comprehensive meeting focused on mitral valve disease that would allow attendees to gain exposure to all of the common approaches used in the top centers throughout the world," said Program Director David H. Adams, MD. "We continue to see tremendous progress in our understanding of mitral disease intervention, and a great interest among surgeons in learning and advancing mitral valve repair strategies," said Dr. Adams, chairman of the department of cardiothoracic surgery at the Mount Sinai Medical Center, New York.

More than 1,000 individuals – including about 800 physicians – from 66 countries participated. Industry support was provided by Edwards Lifesciences LLC (Premier Platinum), Metronic, Inc. (Platinum), Abbott Vascular (Gold), Sorin Heart Valves (Gold), and St. Jude Medical Inc. (Bronze).

"I figured we might get 250 physicians, and would have considered that a success. This is fantastic," said AATS President Irving L. Kron, MD.

Presentations included lectures, expert video sessions, and "Presentations on Demand," accessible on video screens positioned in the exhibit hall. In a plenary address, Robert O. Bonow, MD, said that current valvular heart disease guidelines are based largely on expert opinion rather than evidence from clinical trials. Referring to the 2008 revised joint guidelines from the American College of Cardiology/American Heart Association and the 2007 European Society of Cardiology guidelines, he said, "Unfortunately, the evidence base underpinning them is limited by an inadequate number of randomized clinical trials. We really need to provide more evidence-based information to devise true guidelines and performance measures."

The question of whether mitral valve repair should be considered in all patients with severe mitral valve regurgitation is still being debated.

"It’s at least likely that certain patient subsets would benefit, but current data are insufficient to determine which ones," said Dr. Bonow, of Northwestern University. As an example of ambiguity, U.S. guidelines recommend that patients considered eligible for repair be referred to an "experienced center," but don’t provide criteria for determining that status. Moreover, individual surgeon volume and experience clearly predict successful mitral repair outcomes, even within one institution.

Dr. Bonow is optimistic that useful data will come from two ongoing trials sponsored by the National Heart, Lung, and Blood Institute via the Cardiothoracic Surgical Trials Network.

Dr. Adams presented the Mitral Conclave Career Achievement Award to the legendary Alain F. Carpentier, MD, whose 1983 landmark paper, "Cardiac Valve Surgery – the ‘French Correction,’ " is credited with heralding the modern era of mitral valve reconstructive surgery. Professor Carpentier delivered the Conclave Honored Lecture.

A series of "mini debates" addressed controversies surrounding the use of annuloplasty rings (flexible versus remodeling versus no ring at all), minimally invasive surgery (for all patients versus for some), and the correct approach for specific clinical scenarios of tricuspid valve disease.

The next Aortic Symposium will be held April 26-27, 2012, and the next Mitral Conclave will take place May 2-3, 2013, both in New York. Proceedings from the 2011 Mitral Conclave will be published in an upcoming supplement to The Journal of Thoracic and Cardiovascular Surgery.n

NEW ORLEANS – An association has been reported between elevated proteo­glycan biopsy results and severe mitral valve prolapse.

Dr. Paolo Romanelli and his associates compared eight patients with echocar­diography-proven severe mitral valve prolapse (MVP) and six controls with no cardiac symptoms. They took two 4-mm punch biopsies from normal-ap­pearing forearm skin of each participant to test for proteoglycan mucin levels.

Dr. Romanelli’s study, presented at the annual meeting of the American Acade­my of Dermatology demonstrated that quantitative proteoglycan analysis was greater among patients with MVP (0.6 mg/g), compared with controls (0.4 mg/g). In addition, semiquantitative as­sessment of proteoglycan deposition by hematoxylin-eosin staining and colloidal iron staining showed a mean 3.4 in MVP patients, compared with 1.0 in controls, noted Dr. Romanelli of the University of Miami. All participants were younger than 55 years. All of the MVP patients were comorbid with conditions that in­cluded atrial fibrillation, palpitations, and mild chest discomfort.

The study findings need to be validat­ed, Dr. Romanelli said. Nevertheless, he said he foresees a time when a skin biop­sy will predict the subset of patients at greatest risk for arrhythmias and sudden death from MVP.

I have checked the following facts in my story: (Please initial each.)

Dr. Romanelli said that he had no rel­evant disclosures. 

NEW ORLEANS – An association has been reported between elevated proteo­glycan biopsy results and severe mitral valve prolapse.

Dr. Paolo Romanelli and his associates compared eight patients with echocar­diography-proven severe mitral valve prolapse (MVP) and six controls with no cardiac symptoms. They took two 4-mm punch biopsies from normal-ap­pearing forearm skin of each participant to test for proteoglycan mucin levels.

Dr. Romanelli’s study, presented at the annual meeting of the American Acade­my of Dermatology demonstrated that quantitative proteoglycan analysis was greater among patients with MVP (0.6 mg/g), compared with controls (0.4 mg/g). In addition, semiquantitative as­sessment of proteoglycan deposition by hematoxylin-eosin staining and colloidal iron staining showed a mean 3.4 in MVP patients, compared with 1.0 in controls, noted Dr. Romanelli of the University of Miami. All participants were younger than 55 years. All of the MVP patients were comorbid with conditions that in­cluded atrial fibrillation, palpitations, and mild chest discomfort.

The study findings need to be validat­ed, Dr. Romanelli said. Nevertheless, he said he foresees a time when a skin biop­sy will predict the subset of patients at greatest risk for arrhythmias and sudden death from MVP.

I have checked the following facts in my story: (Please initial each.)

Dr. Romanelli said that he had no rel­evant disclosures. 

NEW ORLEANS – An association has been reported between elevated proteo­glycan biopsy results and severe mitral valve prolapse.

Dr. Paolo Romanelli and his associates compared eight patients with echocar­diography-proven severe mitral valve prolapse (MVP) and six controls with no cardiac symptoms. They took two 4-mm punch biopsies from normal-ap­pearing forearm skin of each participant to test for proteoglycan mucin levels.

Dr. Romanelli’s study, presented at the annual meeting of the American Acade­my of Dermatology demonstrated that quantitative proteoglycan analysis was greater among patients with MVP (0.6 mg/g), compared with controls (0.4 mg/g). In addition, semiquantitative as­sessment of proteoglycan deposition by hematoxylin-eosin staining and colloidal iron staining showed a mean 3.4 in MVP patients, compared with 1.0 in controls, noted Dr. Romanelli of the University of Miami. All participants were younger than 55 years. All of the MVP patients were comorbid with conditions that in­cluded atrial fibrillation, palpitations, and mild chest discomfort.

The study findings need to be validat­ed, Dr. Romanelli said. Nevertheless, he said he foresees a time when a skin biop­sy will predict the subset of patients at greatest risk for arrhythmias and sudden death from MVP.

I have checked the following facts in my story: (Please initial each.)

Dr. Romanelli said that he had no rel­evant disclosures. 

NEW ORLEANS  Select patients with unprotected left main coronary artery stenosis can be effectively treated with percutaneous coronary intervention with sirolimus-eluting stents rather than coronary artery bypass grafting, South Korean investigators reported at a late-breaking clinical trials session of the annual meeting of the American College of Cardiology.

PCI with sirolimus-eluting stents appears to be an alternative to coronary artery bypass grafting based on a noninferior incidence of major cardiac and cerebrovascular events in a median 2-year follow-up of 600 patients with unprotected left main coronary artery stenosis randomized to undergo either CABG or PCI with a sirolimus-eluting stent [Cordis, Johnson & Johnson], said Dr. Seung-Jung Park, the principal investigator of PRECOMBAT (Premier of Randomized Comparison of Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease). 

Major adverse cardiac or cerebrovascular events (MACCE) included all-cause death, myocardial infarction, stroke, ischemia-driven target-vessel revascularization, and cerebrovascular events, said Dr. Park of Asan Medical Center, Seoul, South Korea. 

The rate of MACCE at 2 years was comparable at 12.2% for PCI-treated patients and 8.1% for CABG-treated patients. The composite of death, myocardial infarction and stroke  which the investigators considered a marker of safety  was 4.4% in the PCI group and 4.7% in the CABG group. The major difference was the rate of ischemia-driven target-vessel revascularization ? 9% with PCI and 4.2% with CABG. Further, in subgroup analyses, PCI was associated with a higher risk of MACCE in patients with unprotected left main coronary artery stenosis plus three-vessel disease.

Concomitant with the presentation, the results were published online in the New England Journal of Medicine (N. Engl. J. Med. 2011, April 4 [doi: 10.1056/NEJMoa1100452]). 

PRECOMBAT baseline patient characteristics were similar. Mean age was 62 years, 76.5% were men, mean ejection fraction was 60% and high operative risk was noted for 6% of the PCI group and 8% of the CABG group. Median follow-up was 24 months.

The primary end point was a composite comparison of MACCE at 1 year and 2 years. The primary analysis was a noninferiority comparison. 

MACCE occurred in 26 patients assigned to PCI and in 20 patients assigned to CABG, for cumulative event rates of 8.7% and 6.7%, respectively. The 2.0% absolute risk difference supported noninferiority of PCI to CABG (P = .01). When patient analysis was based on the actual treatment received, however, the 1-year cumulative MACCE rates were 9.2% for PCI and 5.9%, for CABG (P = .04 for noninferiority).

The all-cause death rate in year 1 was 2% for PCI and 2.7% for CABG and in year 2 was 2.4% and 3.4%, respectively (P = .45). Cardiac deaths occurred in 1.0% and 2.7%, respectively, at 2 years.

Strokes and myocardial infarction were also infrequent and the rate of these events did not differ between the treatment arms. Symptomatic graft occlusion and stent thrombosis were observed in 0.3% of the PCI group and in 1.4% of the CABG group. There were no differences by subgroup.

Describing the procedural characteristics, Dr. Park noted that in the PCI group the mean number of stents per patient was 2.7 and in the CABG group the mean number of grafts was 2.7. The procedures were completed in 205 PCI patients and in 211 CABG patients, for comparable revascularization rates of 68% and 70%, respectively.

"Our major finding, that event rates after PCI and CABG did not differ signifi?cantly in this clinical setting, are in agreement with the results of the SYN?TAX substudy involving patients with left main coronary artery stenosis," he said.

In SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery), CABG showed more benefit than did PCI for the overall study population (N. Engl. J. Med. 2009;360:961-72). 

Among patients with left main coronary artery disease in SYNTAX, however, the 12-month rate of MACCE was similar at 13.7% in the CABG group and 15.8% in the PCI group (P = .44). The rate of repeat revascularization among patients with left main coronary artery disease was 11.8% in the PCI group and 6.5% in the CABG group (P = .02), but the CABG group had 2.7% rate of stroke as compared to a 0.3% rate in the PCI subgroup; (P = .01). 

In SYNTAX, nearly 37% of patients with left main coronary artery disease also had three-vessel disease. The subgroup with concomitant two- or three-vessel disease had higher MACCE rates than did the subgroups of patients with left main coronary artery disease alone or in combination with one-vessel disease.

Event rates at 1 year in SYNTAX were higher than those in PRECOMBAT, and the PRECOMBAT patient population had less complex disease, lower SYNTAX scores, and less comorbidity, Dr. Park said.

Dr. Park reported receiving consulting fees and honoraria from Johnson & Johnson and Cordis. 

NEW ORLEANS  Select patients with unprotected left main coronary artery stenosis can be effectively treated with percutaneous coronary intervention with sirolimus-eluting stents rather than coronary artery bypass grafting, South Korean investigators reported at a late-breaking clinical trials session of the annual meeting of the American College of Cardiology.

PCI with sirolimus-eluting stents appears to be an alternative to coronary artery bypass grafting based on a noninferior incidence of major cardiac and cerebrovascular events in a median 2-year follow-up of 600 patients with unprotected left main coronary artery stenosis randomized to undergo either CABG or PCI with a sirolimus-eluting stent [Cordis, Johnson & Johnson], said Dr. Seung-Jung Park, the principal investigator of PRECOMBAT (Premier of Randomized Comparison of Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease). 

Major adverse cardiac or cerebrovascular events (MACCE) included all-cause death, myocardial infarction, stroke, ischemia-driven target-vessel revascularization, and cerebrovascular events, said Dr. Park of Asan Medical Center, Seoul, South Korea. 

The rate of MACCE at 2 years was comparable at 12.2% for PCI-treated patients and 8.1% for CABG-treated patients. The composite of death, myocardial infarction and stroke  which the investigators considered a marker of safety  was 4.4% in the PCI group and 4.7% in the CABG group. The major difference was the rate of ischemia-driven target-vessel revascularization ? 9% with PCI and 4.2% with CABG. Further, in subgroup analyses, PCI was associated with a higher risk of MACCE in patients with unprotected left main coronary artery stenosis plus three-vessel disease.

Concomitant with the presentation, the results were published online in the New England Journal of Medicine (N. Engl. J. Med. 2011, April 4 [doi: 10.1056/NEJMoa1100452]). 

PRECOMBAT baseline patient characteristics were similar. Mean age was 62 years, 76.5% were men, mean ejection fraction was 60% and high operative risk was noted for 6% of the PCI group and 8% of the CABG group. Median follow-up was 24 months.

The primary end point was a composite comparison of MACCE at 1 year and 2 years. The primary analysis was a noninferiority comparison. 

MACCE occurred in 26 patients assigned to PCI and in 20 patients assigned to CABG, for cumulative event rates of 8.7% and 6.7%, respectively. The 2.0% absolute risk difference supported noninferiority of PCI to CABG (P = .01). When patient analysis was based on the actual treatment received, however, the 1-year cumulative MACCE rates were 9.2% for PCI and 5.9%, for CABG (P = .04 for noninferiority).

The all-cause death rate in year 1 was 2% for PCI and 2.7% for CABG and in year 2 was 2.4% and 3.4%, respectively (P = .45). Cardiac deaths occurred in 1.0% and 2.7%, respectively, at 2 years.

Strokes and myocardial infarction were also infrequent and the rate of these events did not differ between the treatment arms. Symptomatic graft occlusion and stent thrombosis were observed in 0.3% of the PCI group and in 1.4% of the CABG group. There were no differences by subgroup.

Describing the procedural characteristics, Dr. Park noted that in the PCI group the mean number of stents per patient was 2.7 and in the CABG group the mean number of grafts was 2.7. The procedures were completed in 205 PCI patients and in 211 CABG patients, for comparable revascularization rates of 68% and 70%, respectively.

"Our major finding, that event rates after PCI and CABG did not differ signifi?cantly in this clinical setting, are in agreement with the results of the SYN?TAX substudy involving patients with left main coronary artery stenosis," he said.

In SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery), CABG showed more benefit than did PCI for the overall study population (N. Engl. J. Med. 2009;360:961-72). 

Among patients with left main coronary artery disease in SYNTAX, however, the 12-month rate of MACCE was similar at 13.7% in the CABG group and 15.8% in the PCI group (P = .44). The rate of repeat revascularization among patients with left main coronary artery disease was 11.8% in the PCI group and 6.5% in the CABG group (P = .02), but the CABG group had 2.7% rate of stroke as compared to a 0.3% rate in the PCI subgroup; (P = .01). 

In SYNTAX, nearly 37% of patients with left main coronary artery disease also had three-vessel disease. The subgroup with concomitant two- or three-vessel disease had higher MACCE rates than did the subgroups of patients with left main coronary artery disease alone or in combination with one-vessel disease.

Event rates at 1 year in SYNTAX were higher than those in PRECOMBAT, and the PRECOMBAT patient population had less complex disease, lower SYNTAX scores, and less comorbidity, Dr. Park said.

Dr. Park reported receiving consulting fees and honoraria from Johnson & Johnson and Cordis. 

NEW ORLEANS  Select patients with unprotected left main coronary artery stenosis can be effectively treated with percutaneous coronary intervention with sirolimus-eluting stents rather than coronary artery bypass grafting, South Korean investigators reported at a late-breaking clinical trials session of the annual meeting of the American College of Cardiology.

PCI with sirolimus-eluting stents appears to be an alternative to coronary artery bypass grafting based on a noninferior incidence of major cardiac and cerebrovascular events in a median 2-year follow-up of 600 patients with unprotected left main coronary artery stenosis randomized to undergo either CABG or PCI with a sirolimus-eluting stent [Cordis, Johnson & Johnson], said Dr. Seung-Jung Park, the principal investigator of PRECOMBAT (Premier of Randomized Comparison of Bypass Surgery Versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease). 

Major adverse cardiac or cerebrovascular events (MACCE) included all-cause death, myocardial infarction, stroke, ischemia-driven target-vessel revascularization, and cerebrovascular events, said Dr. Park of Asan Medical Center, Seoul, South Korea. 

The rate of MACCE at 2 years was comparable at 12.2% for PCI-treated patients and 8.1% for CABG-treated patients. The composite of death, myocardial infarction and stroke  which the investigators considered a marker of safety  was 4.4% in the PCI group and 4.7% in the CABG group. The major difference was the rate of ischemia-driven target-vessel revascularization ? 9% with PCI and 4.2% with CABG. Further, in subgroup analyses, PCI was associated with a higher risk of MACCE in patients with unprotected left main coronary artery stenosis plus three-vessel disease.

Concomitant with the presentation, the results were published online in the New England Journal of Medicine (N. Engl. J. Med. 2011, April 4 [doi: 10.1056/NEJMoa1100452]). 

PRECOMBAT baseline patient characteristics were similar. Mean age was 62 years, 76.5% were men, mean ejection fraction was 60% and high operative risk was noted for 6% of the PCI group and 8% of the CABG group. Median follow-up was 24 months.

The primary end point was a composite comparison of MACCE at 1 year and 2 years. The primary analysis was a noninferiority comparison. 

MACCE occurred in 26 patients assigned to PCI and in 20 patients assigned to CABG, for cumulative event rates of 8.7% and 6.7%, respectively. The 2.0% absolute risk difference supported noninferiority of PCI to CABG (P = .01). When patient analysis was based on the actual treatment received, however, the 1-year cumulative MACCE rates were 9.2% for PCI and 5.9%, for CABG (P = .04 for noninferiority).

The all-cause death rate in year 1 was 2% for PCI and 2.7% for CABG and in year 2 was 2.4% and 3.4%, respectively (P = .45). Cardiac deaths occurred in 1.0% and 2.7%, respectively, at 2 years.

Strokes and myocardial infarction were also infrequent and the rate of these events did not differ between the treatment arms. Symptomatic graft occlusion and stent thrombosis were observed in 0.3% of the PCI group and in 1.4% of the CABG group. There were no differences by subgroup.

Describing the procedural characteristics, Dr. Park noted that in the PCI group the mean number of stents per patient was 2.7 and in the CABG group the mean number of grafts was 2.7. The procedures were completed in 205 PCI patients and in 211 CABG patients, for comparable revascularization rates of 68% and 70%, respectively.

"Our major finding, that event rates after PCI and CABG did not differ signifi?cantly in this clinical setting, are in agreement with the results of the SYN?TAX substudy involving patients with left main coronary artery stenosis," he said.

In SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery), CABG showed more benefit than did PCI for the overall study population (N. Engl. J. Med. 2009;360:961-72). 

Among patients with left main coronary artery disease in SYNTAX, however, the 12-month rate of MACCE was similar at 13.7% in the CABG group and 15.8% in the PCI group (P = .44). The rate of repeat revascularization among patients with left main coronary artery disease was 11.8% in the PCI group and 6.5% in the CABG group (P = .02), but the CABG group had 2.7% rate of stroke as compared to a 0.3% rate in the PCI subgroup; (P = .01). 

In SYNTAX, nearly 37% of patients with left main coronary artery disease also had three-vessel disease. The subgroup with concomitant two- or three-vessel disease had higher MACCE rates than did the subgroups of patients with left main coronary artery disease alone or in combination with one-vessel disease.

Event rates at 1 year in SYNTAX were higher than those in PRECOMBAT, and the PRECOMBAT patient population had less complex disease, lower SYNTAX scores, and less comorbidity, Dr. Park said.

Dr. Park reported receiving consulting fees and honoraria from Johnson & Johnson and Cordis. 

In patients with three-vessel or left main coronary artery disease, coronary artery bypass graft surgery provides greater relief from angina at 6 months and at 12 months after revascularization than does per?cutaneous coronary intervention with paclitaxel-eluting stents, according to a report in the New England Journal of Medicine.

EMBARGOED UNTIL 5 PM WED. 3/16

This benefit with CABG was consistent across a broad range of patient characteristics, said Dr. David J. Cohen of Saint Lukes Mid America Heart Institute, University of Missouri Kansas City, and his associates in the Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) trial. SYNTAX was funded by Boston Scientific, maker of the paclitaxel-eluting stent.

SYNTAX was an international randomized trial in which 1,800 patients with three-vessel or left main coronary artery disease underwent either CABG or percutaneous coronary intervention (PCI) with placement of paclitaxel-eluting stents in 2005-2007.

The rate of the composite primary efficacy end point of death, myocardial infarction, stroke, or repeat revascularization was found to be lower with CABG at 1 year.

The current analysis was a quality-of-life substudy of SYNTAX aimed at determining whether the two approaches differed with regard to relief from angina and quality of life. It included 903 patients who had been randomly assigned to PCI with stents and 897 who had been assigned to CABG.

At baseline, approximately 12% of the subjects reported having daily angina and 20% reported no angina; the remaining subjects reported occasional angina.

Both PCI and CABG led to significant improvements in disease-specific and general health status over the course of 12 months, according to the investigators.

The primary quality-of-life end point was the score on the Seattle Angina Questionnaire angina frequency subscale. The improvement in this score was slightly but significantly greater with CABG than with PCI at 6 and 12 months.

?There were marked benefits with PCI as compared with CABG in general health-related quality of life as assessed by the SF-36 [Medical Outcomes Study 36-Item Short Form Health Survey] as well as EQ-SD [European Quality of Life

********* TEXT BREAK *********5-Dimensions instrument] at 1 month, but these differences had largely disappeared by 6 months, Dr. Cohen and his col?leagues reported (N. Engl. J. Med. 2011;364:1016-26).

<[stk 2]>Subgroup analysis showed that CABGs superiority in reducing the frequency of angina persisted across a broad range of patients. <[etk]>

<[stk 2]>Subjects who had reported daily or weekly angina at baseline showed significantly better relief after CABG than after PCI, although they reported that the extent of the benefit was small (76.3% vs. 71.6%, respectively, P = .05). <[etk]>

<[stk 3]>However, the majority of the study subjects had reported less frequent or no angina at baseline, and there was no significant difference in relief from angina between the two approaches in this large subgroup. <[etk]>

The researchers noted that these findings ?reflect only the first year of follow-up after revascularization; whether similar effects are observed over the long term is currently un?known.?

I have checked the following facts in my story:

MM     Drug names and dosages MSL

NA     Lab test values and their units NA

MM     Nos. are correct and add up, and percentages based on those nos. are correct MSL

MM    Citation MSL

MM     Investigators? names and affiliations MSL

MM     All other proper names (e.g., clinical trials; geographic, company, and test names) MSL

MM     Investigators? conflicts of interest and sponsor of study MSL

Best contact number = 301-325-5890; email = [email protected]

Dr. Cohen and his associates reported that they had ties to numerous industry sources, including Boston Scientific. 

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In patients with three-vessel or left main coronary artery disease, coronary artery bypass graft surgery provides greater relief from angina at 6 months and at 12 months after revascularization than does per?cutaneous coronary intervention with paclitaxel-eluting stents, according to a report in the New England Journal of Medicine.

EMBARGOED UNTIL 5 PM WED. 3/16

This benefit with CABG was consistent across a broad range of patient characteristics, said Dr. David J. Cohen of Saint Lukes Mid America Heart Institute, University of Missouri Kansas City, and his associates in the Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) trial. SYNTAX was funded by Boston Scientific, maker of the paclitaxel-eluting stent.

SYNTAX was an international randomized trial in which 1,800 patients with three-vessel or left main coronary artery disease underwent either CABG or percutaneous coronary intervention (PCI) with placement of paclitaxel-eluting stents in 2005-2007.

The rate of the composite primary efficacy end point of death, myocardial infarction, stroke, or repeat revascularization was found to be lower with CABG at 1 year.

The current analysis was a quality-of-life substudy of SYNTAX aimed at determining whether the two approaches differed with regard to relief from angina and quality of life. It included 903 patients who had been randomly assigned to PCI with stents and 897 who had been assigned to CABG.

At baseline, approximately 12% of the subjects reported having daily angina and 20% reported no angina; the remaining subjects reported occasional angina.

Both PCI and CABG led to significant improvements in disease-specific and general health status over the course of 12 months, according to the investigators.

The primary quality-of-life end point was the score on the Seattle Angina Questionnaire angina frequency subscale. The improvement in this score was slightly but significantly greater with CABG than with PCI at 6 and 12 months.

?There were marked benefits with PCI as compared with CABG in general health-related quality of life as assessed by the SF-36 [Medical Outcomes Study 36-Item Short Form Health Survey] as well as EQ-SD [European Quality of Life

********* TEXT BREAK *********5-Dimensions instrument] at 1 month, but these differences had largely disappeared by 6 months, Dr. Cohen and his col?leagues reported (N. Engl. J. Med. 2011;364:1016-26).

<[stk 2]>Subgroup analysis showed that CABGs superiority in reducing the frequency of angina persisted across a broad range of patients. <[etk]>

<[stk 2]>Subjects who had reported daily or weekly angina at baseline showed significantly better relief after CABG than after PCI, although they reported that the extent of the benefit was small (76.3% vs. 71.6%, respectively, P = .05). <[etk]>

<[stk 3]>However, the majority of the study subjects had reported less frequent or no angina at baseline, and there was no significant difference in relief from angina between the two approaches in this large subgroup. <[etk]>

The researchers noted that these findings ?reflect only the first year of follow-up after revascularization; whether similar effects are observed over the long term is currently un?known.?

I have checked the following facts in my story:

MM     Drug names and dosages MSL

NA     Lab test values and their units NA

MM     Nos. are correct and add up, and percentages based on those nos. are correct MSL

MM    Citation MSL

MM     Investigators? names and affiliations MSL

MM     All other proper names (e.g., clinical trials; geographic, company, and test names) MSL

MM     Investigators? conflicts of interest and sponsor of study MSL

Best contact number = 301-325-5890; email = [email protected]

Dr. Cohen and his associates reported that they had ties to numerous industry sources, including Boston Scientific. 

********* UNDERSET  1  LINES *********

In patients with three-vessel or left main coronary artery disease, coronary artery bypass graft surgery provides greater relief from angina at 6 months and at 12 months after revascularization than does per?cutaneous coronary intervention with paclitaxel-eluting stents, according to a report in the New England Journal of Medicine.

EMBARGOED UNTIL 5 PM WED. 3/16

This benefit with CABG was consistent across a broad range of patient characteristics, said Dr. David J. Cohen of Saint Lukes Mid America Heart Institute, University of Missouri Kansas City, and his associates in the Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) trial. SYNTAX was funded by Boston Scientific, maker of the paclitaxel-eluting stent.

SYNTAX was an international randomized trial in which 1,800 patients with three-vessel or left main coronary artery disease underwent either CABG or percutaneous coronary intervention (PCI) with placement of paclitaxel-eluting stents in 2005-2007.

The rate of the composite primary efficacy end point of death, myocardial infarction, stroke, or repeat revascularization was found to be lower with CABG at 1 year.

The current analysis was a quality-of-life substudy of SYNTAX aimed at determining whether the two approaches differed with regard to relief from angina and quality of life. It included 903 patients who had been randomly assigned to PCI with stents and 897 who had been assigned to CABG.

At baseline, approximately 12% of the subjects reported having daily angina and 20% reported no angina; the remaining subjects reported occasional angina.

Both PCI and CABG led to significant improvements in disease-specific and general health status over the course of 12 months, according to the investigators.

The primary quality-of-life end point was the score on the Seattle Angina Questionnaire angina frequency subscale. The improvement in this score was slightly but significantly greater with CABG than with PCI at 6 and 12 months.

?There were marked benefits with PCI as compared with CABG in general health-related quality of life as assessed by the SF-36 [Medical Outcomes Study 36-Item Short Form Health Survey] as well as EQ-SD [European Quality of Life

********* TEXT BREAK *********5-Dimensions instrument] at 1 month, but these differences had largely disappeared by 6 months, Dr. Cohen and his col?leagues reported (N. Engl. J. Med. 2011;364:1016-26).

<[stk 2]>Subgroup analysis showed that CABGs superiority in reducing the frequency of angina persisted across a broad range of patients. <[etk]>

<[stk 2]>Subjects who had reported daily or weekly angina at baseline showed significantly better relief after CABG than after PCI, although they reported that the extent of the benefit was small (76.3% vs. 71.6%, respectively, P = .05). <[etk]>

<[stk 3]>However, the majority of the study subjects had reported less frequent or no angina at baseline, and there was no significant difference in relief from angina between the two approaches in this large subgroup. <[etk]>

The researchers noted that these findings ?reflect only the first year of follow-up after revascularization; whether similar effects are observed over the long term is currently un?known.?

I have checked the following facts in my story:

MM     Drug names and dosages MSL

NA     Lab test values and their units NA

MM     Nos. are correct and add up, and percentages based on those nos. are correct MSL

MM    Citation MSL

MM     Investigators? names and affiliations MSL

MM     All other proper names (e.g., clinical trials; geographic, company, and test names) MSL

MM     Investigators? conflicts of interest and sponsor of study MSL

Best contact number = 301-325-5890; email = [email protected]

Dr. Cohen and his associates reported that they had ties to numerous industry sources, including Boston Scientific. 

********* UNDERSET  1  LINES *********

The American College of Cardiolo­gy Foundation and the American Heart Association have published updated guidelines for managing pa­tients with unstable angina/non–ST el­evation myocardial infarction, taking into consideration the use of a newer agent, prasugrel, as an alternative to clopidogrel, and recommending diag­nostic angiography sooner for patients at high risk, among other changes.

The guidelines, published March 28in the Journal of the American College of Cardiology  (Am. J. Cardiol. 2011 March 28 [doi:10.1016/j.jacc.2011.02.009]) and based on the most recent clinical trial ev­idence available, update recommenda­tions from 2007, and include several changes clinicians should be aware of, the guidelines’ lead author, Dr. R. Scott Wright of the Mayo Clinic in Rochester, Minn., said in an e-mail interview. These are, in order of importance:

• The timing of invasive therapy in medium- and high-risk patients.
• The role of triple- vs. dual-antiplatelet therapy in patients at medium and high risk.
• The role of invasive therapy in pa­tients with chronic kidney disease.
• The importance of participating in quality improvement processes.
• The role of prasugrel in non–ST ele­vation acute coronary syndrome.

Clinicians face tough decisions about when to perform an invasive strategy such as diagnostic coronary angiography – whether within hours of presentation or days, Dr. Wright and his colleagues wrote in their analysis.

Immediate catheterization with revas­cularization of unstable coronary lesions may prevent ischemic events that would otherwise occur during medical therapy – but pretreatment with antithrombotics “may diminish thrombus burden and ‘passivate’ unstable plaques,” improving the safety of the procedure and reducing the risk of ischemic complications.

<[stk 2]>The new guidelines, based on findings from three randomized controlled trials evaluating the timing of angiography, recommend an early invasive strategy (12-24 hours after presentation) over a delayed invasive strategy (more than 24 hours after presentation) for initially stabilized high-risk patients with UA/NSTEMI. <[etk]>

“For patients not at high risk, a delayed invasive approach is also reasonable,” Dr. Wright and his colleagues wrote.

Several changes to earlier recommen­dations for antiplatelet therapy are con­tained in the new guidelines, including altered loading doses for clopidogrel to counter the potential for the drug to be less effective in some patient groups, and the addition of prasugrel, which was approved by the Food and Drug Ad­ministration after the last guidelines were published.

Prasugrel, in a randomized controlled trial comparing it with clopidogrel, was shown to be superior in reducing clinical events but at the expense of an increased risk of bleeding, the guideline writers noted.

In March 2010 the FDA issued a warn­ing that in some patient groups clopido­grel is less effective than it should be because of a genetic variant that inhibits the body’s conversion of the prodrug to the drug.

However, Dr. Wright and his col­leagues stopped short of endorsing pra­sugrel as a first choice over clopidogrel because of the higher bleeding risk and other considerations. People aged 75 years or older, those with a history of transient ischemic attack or stroke or with active pathological bleeding, and people weighing less than 60 kg saw no benefit and/or net harm from prasugrel, they noted.

Dr. Wright and his colleagues also changed recommendations involving glycoprotein IIB/IIIa inhibitors, noting that recent studies “more strongly sup­port a strategy of selective rather than provisional use of GP IIb/IIIa inhibitor
therapy as part of triple-antiplatelet ther­apy,” due to concerns about the poten­tial bleeding risks. Therefore, according to the new guidelines, for UA/NSTEMI patients who are at low risk of ischemic events or at high risk of bleeding and who are already receiving aspirin and clopidogrel, upstream GP IIb/IIIa in­hibitors are not recommended.

People with kidney disease should re­ceive adequate preparatory hydration before catheterization, say the new guidelines, which also tweak earlier recommendations about the contrast agents used in angiography.

Finally, the guidelines recommend that clinicians and hospitals “participate in a standardized quality-of-care data registry designed to track and measure outcomes, complications, and adherence to evidence-based processes of care and quality improvement for UA/NSTEMI.” No such recommendation had been included in the 2007 guidelines.

I have checked the following facts in my story: (Please initial each.)

<[stk 1]>Dr. Wright declared no conflicts of in­terest. Several of Dr. Wright’s coau­thors, including Dr. Jeffrey L. Anderson, the writing committee’s vice chair, dis­closed consultant relationships with pharmaceutical firms Sanofi-Aventis, Bristol Myers-Squibb, Lilly, and Daiichi. Members with conflicts were not per­mitted to vote on recommended drug therapies.

The American College of Cardiolo­gy Foundation and the American Heart Association have published updated guidelines for managing pa­tients with unstable angina/non–ST el­evation myocardial infarction, taking into consideration the use of a newer agent, prasugrel, as an alternative to clopidogrel, and recommending diag­nostic angiography sooner for patients at high risk, among other changes.

The guidelines, published March 28in the Journal of the American College of Cardiology  (Am. J. Cardiol. 2011 March 28 [doi:10.1016/j.jacc.2011.02.009]) and based on the most recent clinical trial ev­idence available, update recommenda­tions from 2007, and include several changes clinicians should be aware of, the guidelines’ lead author, Dr. R. Scott Wright of the Mayo Clinic in Rochester, Minn., said in an e-mail interview. These are, in order of importance:

• The timing of invasive therapy in medium- and high-risk patients.
• The role of triple- vs. dual-antiplatelet therapy in patients at medium and high risk.
• The role of invasive therapy in pa­tients with chronic kidney disease.
• The importance of participating in quality improvement processes.
• The role of prasugrel in non–ST ele­vation acute coronary syndrome.

Clinicians face tough decisions about when to perform an invasive strategy such as diagnostic coronary angiography – whether within hours of presentation or days, Dr. Wright and his colleagues wrote in their analysis.

Immediate catheterization with revas­cularization of unstable coronary lesions may prevent ischemic events that would otherwise occur during medical therapy – but pretreatment with antithrombotics “may diminish thrombus burden and ‘passivate’ unstable plaques,” improving the safety of the procedure and reducing the risk of ischemic complications.

<[stk 2]>The new guidelines, based on findings from three randomized controlled trials evaluating the timing of angiography, recommend an early invasive strategy (12-24 hours after presentation) over a delayed invasive strategy (more than 24 hours after presentation) for initially stabilized high-risk patients with UA/NSTEMI. <[etk]>

“For patients not at high risk, a delayed invasive approach is also reasonable,” Dr. Wright and his colleagues wrote.

Several changes to earlier recommen­dations for antiplatelet therapy are con­tained in the new guidelines, including altered loading doses for clopidogrel to counter the potential for the drug to be less effective in some patient groups, and the addition of prasugrel, which was approved by the Food and Drug Ad­ministration after the last guidelines were published.

Prasugrel, in a randomized controlled trial comparing it with clopidogrel, was shown to be superior in reducing clinical events but at the expense of an increased risk of bleeding, the guideline writers noted.

In March 2010 the FDA issued a warn­ing that in some patient groups clopido­grel is less effective than it should be because of a genetic variant that inhibits the body’s conversion of the prodrug to the drug.

However, Dr. Wright and his col­leagues stopped short of endorsing pra­sugrel as a first choice over clopidogrel because of the higher bleeding risk and other considerations. People aged 75 years or older, those with a history of transient ischemic attack or stroke or with active pathological bleeding, and people weighing less than 60 kg saw no benefit and/or net harm from prasugrel, they noted.

Dr. Wright and his colleagues also changed recommendations involving glycoprotein IIB/IIIa inhibitors, noting that recent studies “more strongly sup­port a strategy of selective rather than provisional use of GP IIb/IIIa inhibitor
therapy as part of triple-antiplatelet ther­apy,” due to concerns about the poten­tial bleeding risks. Therefore, according to the new guidelines, for UA/NSTEMI patients who are at low risk of ischemic events or at high risk of bleeding and who are already receiving aspirin and clopidogrel, upstream GP IIb/IIIa in­hibitors are not recommended.

People with kidney disease should re­ceive adequate preparatory hydration before catheterization, say the new guidelines, which also tweak earlier recommendations about the contrast agents used in angiography.

Finally, the guidelines recommend that clinicians and hospitals “participate in a standardized quality-of-care data registry designed to track and measure outcomes, complications, and adherence to evidence-based processes of care and quality improvement for UA/NSTEMI.” No such recommendation had been included in the 2007 guidelines.

I have checked the following facts in my story: (Please initial each.)

<[stk 1]>Dr. Wright declared no conflicts of in­terest. Several of Dr. Wright’s coau­thors, including Dr. Jeffrey L. Anderson, the writing committee’s vice chair, dis­closed consultant relationships with pharmaceutical firms Sanofi-Aventis, Bristol Myers-Squibb, Lilly, and Daiichi. Members with conflicts were not per­mitted to vote on recommended drug therapies.

The American College of Cardiolo­gy Foundation and the American Heart Association have published updated guidelines for managing pa­tients with unstable angina/non–ST el­evation myocardial infarction, taking into consideration the use of a newer agent, prasugrel, as an alternative to clopidogrel, and recommending diag­nostic angiography sooner for patients at high risk, among other changes.

The guidelines, published March 28in the Journal of the American College of Cardiology  (Am. J. Cardiol. 2011 March 28 [doi:10.1016/j.jacc.2011.02.009]) and based on the most recent clinical trial ev­idence available, update recommenda­tions from 2007, and include several changes clinicians should be aware of, the guidelines’ lead author, Dr. R. Scott Wright of the Mayo Clinic in Rochester, Minn., said in an e-mail interview. These are, in order of importance:

• The timing of invasive therapy in medium- and high-risk patients.
• The role of triple- vs. dual-antiplatelet therapy in patients at medium and high risk.
• The role of invasive therapy in pa­tients with chronic kidney disease.
• The importance of participating in quality improvement processes.
• The role of prasugrel in non–ST ele­vation acute coronary syndrome.

Clinicians face tough decisions about when to perform an invasive strategy such as diagnostic coronary angiography – whether within hours of presentation or days, Dr. Wright and his colleagues wrote in their analysis.

Immediate catheterization with revas­cularization of unstable coronary lesions may prevent ischemic events that would otherwise occur during medical therapy – but pretreatment with antithrombotics “may diminish thrombus burden and ‘passivate’ unstable plaques,” improving the safety of the procedure and reducing the risk of ischemic complications.

<[stk 2]>The new guidelines, based on findings from three randomized controlled trials evaluating the timing of angiography, recommend an early invasive strategy (12-24 hours after presentation) over a delayed invasive strategy (more than 24 hours after presentation) for initially stabilized high-risk patients with UA/NSTEMI. <[etk]>

“For patients not at high risk, a delayed invasive approach is also reasonable,” Dr. Wright and his colleagues wrote.

Several changes to earlier recommen­dations for antiplatelet therapy are con­tained in the new guidelines, including altered loading doses for clopidogrel to counter the potential for the drug to be less effective in some patient groups, and the addition of prasugrel, which was approved by the Food and Drug Ad­ministration after the last guidelines were published.

Prasugrel, in a randomized controlled trial comparing it with clopidogrel, was shown to be superior in reducing clinical events but at the expense of an increased risk of bleeding, the guideline writers noted.

In March 2010 the FDA issued a warn­ing that in some patient groups clopido­grel is less effective than it should be because of a genetic variant that inhibits the body’s conversion of the prodrug to the drug.

However, Dr. Wright and his col­leagues stopped short of endorsing pra­sugrel as a first choice over clopidogrel because of the higher bleeding risk and other considerations. People aged 75 years or older, those with a history of transient ischemic attack or stroke or with active pathological bleeding, and people weighing less than 60 kg saw no benefit and/or net harm from prasugrel, they noted.

Dr. Wright and his colleagues also changed recommendations involving glycoprotein IIB/IIIa inhibitors, noting that recent studies “more strongly sup­port a strategy of selective rather than provisional use of GP IIb/IIIa inhibitor
therapy as part of triple-antiplatelet ther­apy,” due to concerns about the poten­tial bleeding risks. Therefore, according to the new guidelines, for UA/NSTEMI patients who are at low risk of ischemic events or at high risk of bleeding and who are already receiving aspirin and clopidogrel, upstream GP IIb/IIIa in­hibitors are not recommended.

People with kidney disease should re­ceive adequate preparatory hydration before catheterization, say the new guidelines, which also tweak earlier recommendations about the contrast agents used in angiography.

Finally, the guidelines recommend that clinicians and hospitals “participate in a standardized quality-of-care data registry designed to track and measure outcomes, complications, and adherence to evidence-based processes of care and quality improvement for UA/NSTEMI.” No such recommendation had been included in the 2007 guidelines.

I have checked the following facts in my story: (Please initial each.)

<[stk 1]>Dr. Wright declared no conflicts of in­terest. Several of Dr. Wright’s coau­thors, including Dr. Jeffrey L. Anderson, the writing committee’s vice chair, dis­closed consultant relationships with pharmaceutical firms Sanofi-Aventis, Bristol Myers-Squibb, Lilly, and Daiichi. Members with conflicts were not per­mitted to vote on recommended drug therapies.

NEW ORLEANS Transcatheter aortic valve replacement was associated with the same survival rates at 1 year as was found in conventional surgery for older, high-risk patients who suffered from severe, symptomatic aortic stenosis, according to the results of the PARTNER trial.

All-cause mortality at 30 days favored the use of transcatheter aortic valve replacement (TAVR) at 3.4%, compared with 6.5% for open surgery, and was similar at 1 year (24% vs, 27%, respectively). 

The difference at 1 year reached the trial's prespecified noninferiority margin with a P value of .001.

"We already learned from the previous cohort that TAVR is the standard of care for patients who can't tolerate surgery. So this [finding] opens up a new set of patients who may very well benefit as much with TAVR as with the gold standard surgery," coprincipal investigator Dr. Craig B. Smith said at the annual meeting of the American College of Cardiology.

However, The stroke rate with TAVR as seen in the in­dustry-sponsored PARTNER (Placement of Aortic Transcatheter Valve) trial, turned out to be twice the rate for these patients as that observed with conventional surgical repair.

Stroke plus transient ischemic attack (TIA) rates were significantly more frequent with TAVR than surgery at both 30 days (5.5% vs. 2.4%) and 1 year (8.3% vs. 4.3%). 

When only major strokes were compared, the difference was not significant between TAVR and convential surgery at 30 days (3.8% vs. 2.1%) or 1 year (5.1% vs. 2.4%), said Dr. Smith, chief of cardiothoracic surgery at New York Presby­terian Hospital/Columbia Uni­versity Medical Center in New York City. 

Notably, patients who un?derwent conventional surgery were significantly more likely than TAVR patients to experience major bleeding at 30 days (19.5% vs. 9.3%) and 1 year (26% vs. 15%), as well as new atrial fibrillation at both 30 days (16% vs. 8.6%) and 1 year (17% vs. 12%).

An examination of echocardiographic findings indicated a small hemodynamic benefit ocurred with TAVR vs. surgery at 1 year, but there was significantly increased paravalvular aortic re­gurgitation at 30 days, 6 months, and 1 year.

"TAVR and AVR [aortic valve replacement] are both acceptable therapies in these high-risk patients; differing periprocedural hazards should influence case-based decision making," Dr. Smith said.

Dr. David Moliterno, chair of the intervention program (i2 Summit) at the meeting, told reporters that they were witnessing histo­ry in the making.

"This will prob­ably be seen as one of the biggest steps in cardiovascular medicine, as far as intervention is concerned, potentially in our lifetime," said Dr. Moliterno, chief of cardiovascular medicine at the University of Kentucky, Lex­ington. 

"If we look back to balloon angio­plasty, the advent of stents and drug-eluting stents, this will be seen as the next major turning point."

Last year, the PARTNER trial investigators reported a 20% survival benefit at 1 year in a separate cohort of 358 inoperable patients with severe aortic stenosis who underwent transfemoral TAVR vs. standard therapy, including balloon aortic valvuloplasty (N. Engl. J. Med. 2010;363:1597-607). TAVR was as­sociated with significantly more major vascular complications (16% vs. 1%) and a higher incidence of major strokes (5% vs. 1%).

The current portion of PARTNER randomly assigned 699 patients at 26 centers to surgery or TAVR. These pa­tients were treated using the transfemoral approach in 492 cases and the transapical approach in 207. 

Severe stenosis was defined as an aortic valve area of less than 0.8 cm2 and mean aortic valve gradient of more than 40 mm Hg or a peak aortic jet velocity of more than 4.0 m/second. 

The patients in the trial had a New York Heart Association heart failure class II or greater, and they also had a predicted risk of operative mortality of at least 15% as determined by the site surgeon and cardiologist, coupled with a Society of Thoracic Surgery (STS) score of at least 10.

The mean age of the patients in the study was 83 years, and 94% of them were NYHA class III or IV. In all, 42 patients were not treated as assigned, Dr. Smith said.

All-cause mortality at 1 year was sim­ilar for the transfemoral TAVR subgroup, at 22.2% and 26.4% for surgery, as well as for the transapical TAVR subgroup (29% vs. 28%, respectively).

A preliminary subgroup analysis sug­gested that there may be a possible benefit found with TAVR in women and in patients without prior coronary artery bypass surgery, but Dr. Smith said that those results should be inter­preted cautiously.

Overall, the TAVR mortality of 3.4% at 30 days was the lowest reported in any series, despite the use of an early-gener­ation device and limited previous oper­ator experience, he said, noting that nine of the participating centers had never performed TAVR before the trial.

Symptom improvement, including NYHA class and 6-minute walk distance, favored TAVR at 30 days and was similar to conventional surgery at 1 year, Dr. Moliterno said.

Coinvestigator Dr. Murat Tuzcu, vice chair of the department of cardiovascu?lar medicine at the Cleveland Clinic, stressed that the results were accomplished only through unprecedented teamwork among cardiologists, sur­geons, and imaging experts, who con­sulted on each case in the trial.

"I want to emphasize that if we fail to pay equal attention to what we have done in this trial after the device is ap­proved, I don't think we will be able to replicate the same results," he said.

Several speakers at the press conference noted the balancing act that all clinicians will face regarding public demand for the new procedure. 

Dr. Michael Crawford, chief of clini­cal cardiology at the University of California, San Francisco, observed that centers will face substantial up-front costs in the adoption of TAVR, including hybrid surgical/interventional suites, and that this will restrict initial uptake to high-volume centers of excellence.

The 3.4% mortality rate represents an “amazing effort, particularly in the use of the larger, first-generation device, said invited discussant Dr. Martyn Thomas, clinical director of cardiothoracic services at St. Thomas Hospital, London. 

The delivery catheters used in PARTNER are sized at 22 and 24 French, which corresponds to an outside diam­eter of 7-8 mm. 

The size of catheters has been decreased down to 16-Fr in Europe, where more than 5,000 TAVR procedures have been done and where both the Edwards Lifesciences Corp.'s Sapien valve that was used in PARTNER and the Medtronic Inc.'s CoreValve are already approved for commercial use. 

Recruitment began in February for the PARTNER II trial that is evaluating the smaller Edwards Sapien XT device and the later generation NovaFlex delivery system among inoperable patients with symptomatic severe aortic stenosis. The trial is expected to enroll 600 patients, and is targeted for primary com­pletion in December 2011.

When asked whether the advent of newer, thinner devices will mean adop­tion in patients with lower risk, Dr. Smith replied that the adoption of TAVR will "march steadily down the risk cate­gories."

Edwards Lifesciences sponsored the trial. Dr. Smith and his coauthors reported no conflicts of interest.

NEW ORLEANS Transcatheter aortic valve replacement was associated with the same survival rates at 1 year as was found in conventional surgery for older, high-risk patients who suffered from severe, symptomatic aortic stenosis, according to the results of the PARTNER trial.

All-cause mortality at 30 days favored the use of transcatheter aortic valve replacement (TAVR) at 3.4%, compared with 6.5% for open surgery, and was similar at 1 year (24% vs, 27%, respectively). 

The difference at 1 year reached the trial's prespecified noninferiority margin with a P value of .001.

"We already learned from the previous cohort that TAVR is the standard of care for patients who can't tolerate surgery. So this [finding] opens up a new set of patients who may very well benefit as much with TAVR as with the gold standard surgery," coprincipal investigator Dr. Craig B. Smith said at the annual meeting of the American College of Cardiology.

However, The stroke rate with TAVR as seen in the in­dustry-sponsored PARTNER (Placement of Aortic Transcatheter Valve) trial, turned out to be twice the rate for these patients as that observed with conventional surgical repair.

Stroke plus transient ischemic attack (TIA) rates were significantly more frequent with TAVR than surgery at both 30 days (5.5% vs. 2.4%) and 1 year (8.3% vs. 4.3%). 

When only major strokes were compared, the difference was not significant between TAVR and convential surgery at 30 days (3.8% vs. 2.1%) or 1 year (5.1% vs. 2.4%), said Dr. Smith, chief of cardiothoracic surgery at New York Presby­terian Hospital/Columbia Uni­versity Medical Center in New York City. 

Notably, patients who un?derwent conventional surgery were significantly more likely than TAVR patients to experience major bleeding at 30 days (19.5% vs. 9.3%) and 1 year (26% vs. 15%), as well as new atrial fibrillation at both 30 days (16% vs. 8.6%) and 1 year (17% vs. 12%).

An examination of echocardiographic findings indicated a small hemodynamic benefit ocurred with TAVR vs. surgery at 1 year, but there was significantly increased paravalvular aortic re­gurgitation at 30 days, 6 months, and 1 year.

"TAVR and AVR [aortic valve replacement] are both acceptable therapies in these high-risk patients; differing periprocedural hazards should influence case-based decision making," Dr. Smith said.

Dr. David Moliterno, chair of the intervention program (i2 Summit) at the meeting, told reporters that they were witnessing histo­ry in the making.

"This will prob­ably be seen as one of the biggest steps in cardiovascular medicine, as far as intervention is concerned, potentially in our lifetime," said Dr. Moliterno, chief of cardiovascular medicine at the University of Kentucky, Lex­ington. 

"If we look back to balloon angio­plasty, the advent of stents and drug-eluting stents, this will be seen as the next major turning point."

Last year, the PARTNER trial investigators reported a 20% survival benefit at 1 year in a separate cohort of 358 inoperable patients with severe aortic stenosis who underwent transfemoral TAVR vs. standard therapy, including balloon aortic valvuloplasty (N. Engl. J. Med. 2010;363:1597-607). TAVR was as­sociated with significantly more major vascular complications (16% vs. 1%) and a higher incidence of major strokes (5% vs. 1%).

The current portion of PARTNER randomly assigned 699 patients at 26 centers to surgery or TAVR. These pa­tients were treated using the transfemoral approach in 492 cases and the transapical approach in 207. 

Severe stenosis was defined as an aortic valve area of less than 0.8 cm2 and mean aortic valve gradient of more than 40 mm Hg or a peak aortic jet velocity of more than 4.0 m/second. 

The patients in the trial had a New York Heart Association heart failure class II or greater, and they also had a predicted risk of operative mortality of at least 15% as determined by the site surgeon and cardiologist, coupled with a Society of Thoracic Surgery (STS) score of at least 10.

The mean age of the patients in the study was 83 years, and 94% of them were NYHA class III or IV. In all, 42 patients were not treated as assigned, Dr. Smith said.

All-cause mortality at 1 year was sim­ilar for the transfemoral TAVR subgroup, at 22.2% and 26.4% for surgery, as well as for the transapical TAVR subgroup (29% vs. 28%, respectively).

A preliminary subgroup analysis sug­gested that there may be a possible benefit found with TAVR in women and in patients without prior coronary artery bypass surgery, but Dr. Smith said that those results should be inter­preted cautiously.

Overall, the TAVR mortality of 3.4% at 30 days was the lowest reported in any series, despite the use of an early-gener­ation device and limited previous oper­ator experience, he said, noting that nine of the participating centers had never performed TAVR before the trial.

Symptom improvement, including NYHA class and 6-minute walk distance, favored TAVR at 30 days and was similar to conventional surgery at 1 year, Dr. Moliterno said.

Coinvestigator Dr. Murat Tuzcu, vice chair of the department of cardiovascu?lar medicine at the Cleveland Clinic, stressed that the results were accomplished only through unprecedented teamwork among cardiologists, sur­geons, and imaging experts, who con­sulted on each case in the trial.

"I want to emphasize that if we fail to pay equal attention to what we have done in this trial after the device is ap­proved, I don't think we will be able to replicate the same results," he said.

Several speakers at the press conference noted the balancing act that all clinicians will face regarding public demand for the new procedure. 

Dr. Michael Crawford, chief of clini­cal cardiology at the University of California, San Francisco, observed that centers will face substantial up-front costs in the adoption of TAVR, including hybrid surgical/interventional suites, and that this will restrict initial uptake to high-volume centers of excellence.

The 3.4% mortality rate represents an “amazing effort, particularly in the use of the larger, first-generation device, said invited discussant Dr. Martyn Thomas, clinical director of cardiothoracic services at St. Thomas Hospital, London. 

The delivery catheters used in PARTNER are sized at 22 and 24 French, which corresponds to an outside diam­eter of 7-8 mm. 

The size of catheters has been decreased down to 16-Fr in Europe, where more than 5,000 TAVR procedures have been done and where both the Edwards Lifesciences Corp.'s Sapien valve that was used in PARTNER and the Medtronic Inc.'s CoreValve are already approved for commercial use. 

Recruitment began in February for the PARTNER II trial that is evaluating the smaller Edwards Sapien XT device and the later generation NovaFlex delivery system among inoperable patients with symptomatic severe aortic stenosis. The trial is expected to enroll 600 patients, and is targeted for primary com­pletion in December 2011.

When asked whether the advent of newer, thinner devices will mean adop­tion in patients with lower risk, Dr. Smith replied that the adoption of TAVR will "march steadily down the risk cate­gories."

Edwards Lifesciences sponsored the trial. Dr. Smith and his coauthors reported no conflicts of interest.

NEW ORLEANS Transcatheter aortic valve replacement was associated with the same survival rates at 1 year as was found in conventional surgery for older, high-risk patients who suffered from severe, symptomatic aortic stenosis, according to the results of the PARTNER trial.

All-cause mortality at 30 days favored the use of transcatheter aortic valve replacement (TAVR) at 3.4%, compared with 6.5% for open surgery, and was similar at 1 year (24% vs, 27%, respectively). 

The difference at 1 year reached the trial's prespecified noninferiority margin with a P value of .001.

"We already learned from the previous cohort that TAVR is the standard of care for patients who can't tolerate surgery. So this [finding] opens up a new set of patients who may very well benefit as much with TAVR as with the gold standard surgery," coprincipal investigator Dr. Craig B. Smith said at the annual meeting of the American College of Cardiology.

However, The stroke rate with TAVR as seen in the in­dustry-sponsored PARTNER (Placement of Aortic Transcatheter Valve) trial, turned out to be twice the rate for these patients as that observed with conventional surgical repair.

Stroke plus transient ischemic attack (TIA) rates were significantly more frequent with TAVR than surgery at both 30 days (5.5% vs. 2.4%) and 1 year (8.3% vs. 4.3%). 

When only major strokes were compared, the difference was not significant between TAVR and convential surgery at 30 days (3.8% vs. 2.1%) or 1 year (5.1% vs. 2.4%), said Dr. Smith, chief of cardiothoracic surgery at New York Presby­terian Hospital/Columbia Uni­versity Medical Center in New York City. 

Notably, patients who un?derwent conventional surgery were significantly more likely than TAVR patients to experience major bleeding at 30 days (19.5% vs. 9.3%) and 1 year (26% vs. 15%), as well as new atrial fibrillation at both 30 days (16% vs. 8.6%) and 1 year (17% vs. 12%).

An examination of echocardiographic findings indicated a small hemodynamic benefit ocurred with TAVR vs. surgery at 1 year, but there was significantly increased paravalvular aortic re­gurgitation at 30 days, 6 months, and 1 year.

"TAVR and AVR [aortic valve replacement] are both acceptable therapies in these high-risk patients; differing periprocedural hazards should influence case-based decision making," Dr. Smith said.

Dr. David Moliterno, chair of the intervention program (i2 Summit) at the meeting, told reporters that they were witnessing histo­ry in the making.

"This will prob­ably be seen as one of the biggest steps in cardiovascular medicine, as far as intervention is concerned, potentially in our lifetime," said Dr. Moliterno, chief of cardiovascular medicine at the University of Kentucky, Lex­ington. 

"If we look back to balloon angio­plasty, the advent of stents and drug-eluting stents, this will be seen as the next major turning point."

Last year, the PARTNER trial investigators reported a 20% survival benefit at 1 year in a separate cohort of 358 inoperable patients with severe aortic stenosis who underwent transfemoral TAVR vs. standard therapy, including balloon aortic valvuloplasty (N. Engl. J. Med. 2010;363:1597-607). TAVR was as­sociated with significantly more major vascular complications (16% vs. 1%) and a higher incidence of major strokes (5% vs. 1%).

The current portion of PARTNER randomly assigned 699 patients at 26 centers to surgery or TAVR. These pa­tients were treated using the transfemoral approach in 492 cases and the transapical approach in 207. 

Severe stenosis was defined as an aortic valve area of less than 0.8 cm2 and mean aortic valve gradient of more than 40 mm Hg or a peak aortic jet velocity of more than 4.0 m/second. 

The patients in the trial had a New York Heart Association heart failure class II or greater, and they also had a predicted risk of operative mortality of at least 15% as determined by the site surgeon and cardiologist, coupled with a Society of Thoracic Surgery (STS) score of at least 10.

The mean age of the patients in the study was 83 years, and 94% of them were NYHA class III or IV. In all, 42 patients were not treated as assigned, Dr. Smith said.

All-cause mortality at 1 year was sim­ilar for the transfemoral TAVR subgroup, at 22.2% and 26.4% for surgery, as well as for the transapical TAVR subgroup (29% vs. 28%, respectively).

A preliminary subgroup analysis sug­gested that there may be a possible benefit found with TAVR in women and in patients without prior coronary artery bypass surgery, but Dr. Smith said that those results should be inter­preted cautiously.

Overall, the TAVR mortality of 3.4% at 30 days was the lowest reported in any series, despite the use of an early-gener­ation device and limited previous oper­ator experience, he said, noting that nine of the participating centers had never performed TAVR before the trial.

Symptom improvement, including NYHA class and 6-minute walk distance, favored TAVR at 30 days and was similar to conventional surgery at 1 year, Dr. Moliterno said.

Coinvestigator Dr. Murat Tuzcu, vice chair of the department of cardiovascu?lar medicine at the Cleveland Clinic, stressed that the results were accomplished only through unprecedented teamwork among cardiologists, sur­geons, and imaging experts, who con­sulted on each case in the trial.

"I want to emphasize that if we fail to pay equal attention to what we have done in this trial after the device is ap­proved, I don't think we will be able to replicate the same results," he said.

Several speakers at the press conference noted the balancing act that all clinicians will face regarding public demand for the new procedure. 

Dr. Michael Crawford, chief of clini­cal cardiology at the University of California, San Francisco, observed that centers will face substantial up-front costs in the adoption of TAVR, including hybrid surgical/interventional suites, and that this will restrict initial uptake to high-volume centers of excellence.

The 3.4% mortality rate represents an “amazing effort, particularly in the use of the larger, first-generation device, said invited discussant Dr. Martyn Thomas, clinical director of cardiothoracic services at St. Thomas Hospital, London. 

The delivery catheters used in PARTNER are sized at 22 and 24 French, which corresponds to an outside diam­eter of 7-8 mm. 

The size of catheters has been decreased down to 16-Fr in Europe, where more than 5,000 TAVR procedures have been done and where both the Edwards Lifesciences Corp.'s Sapien valve that was used in PARTNER and the Medtronic Inc.'s CoreValve are already approved for commercial use. 

Recruitment began in February for the PARTNER II trial that is evaluating the smaller Edwards Sapien XT device and the later generation NovaFlex delivery system among inoperable patients with symptomatic severe aortic stenosis. The trial is expected to enroll 600 patients, and is targeted for primary com­pletion in December 2011.

When asked whether the advent of newer, thinner devices will mean adop­tion in patients with lower risk, Dr. Smith replied that the adoption of TAVR will "march steadily down the risk cate­gories."

Edwards Lifesciences sponsored the trial. Dr. Smith and his coauthors reported no conflicts of interest.

SAN DIEGO - The Society of Thoracic Surgeons Predicted Risk of Mortality score is a well-validated predictor of mortality during the first 30 days after cardiac surgery. The PROM score's role in predicting longer-term survival, however, has not been investigated, according to Dr. John D. Puskas at the annual meeting of the Society of Thoracic Surgeons.

To fill this void, Dr. Puskas and his colleagues from Emory University, Atlanta, undertook a study to statistically validate PROM at 1, 3, 5, and 10 years after cardiac surgery. He presented the study's results at the meeting.

The investigators found that the STS PROM algorithm accurately predicted mortality both at 30 days and during 12 years of follow-up with almost equally strong discriminatory power. "This may have profound implications for informed consent as well as for longitudinal comparative effectiveness studies," Dr. Puskas said in an interview.

"The STS Predicted Risk of Mortality models are probably underutilized and underappreciated in their power to predict short and long-term outcomes for our patients. The STS provides this service free of charge, and it is available online 24/7. I am hopeful that this newfound ability to predict longer-term survival after cardiac surgery will find utility in comparative effectiveness research and ultimately in shaping health policy," he added.

Dr. Puskas and his colleagues evaluated the survival rates for 24,222 patients who underwent cardiac surgery at a single academic center during 1996-2009. Long-term all-cause mortality was determined by referencing the national Social Security Death Master File. Logistic and Cox survival regression analyses were used to evaluate the long-term predictive utility of PROM.

The AUROC (area under the receiver operator characteristic) curve measured the discrimination of PROM at 1, 3, 5, and 10 years. Kaplan-Meier curves were stratified by quartiles of PROM risk to compare long-term survival. All analyses were performed for both the whole sample and 30-day survivors.
The investigators found an overall 30-day mortality rate of 2.78%.

Among all patients and 30-day survivors, AUROC values for PROM at 1, 3, 5, and 10 years were remarkably similar to the 30-day end point for which PROM is calibrated.

Moreover, PROM was highly predictive of Kaplan-Meier survival, even when this analysis was restricted to patients surviving beyond 30 days, he added.

Among 30-day survivors, each percent increase in PROM score was significantly associated with a 9.6% increase in instantaneous hazard of death (P less than .001).

Dr. Puskas and his colleagues reported no relevant disclosures with regard to their study.

SAN DIEGO - The Society of Thoracic Surgeons Predicted Risk of Mortality score is a well-validated predictor of mortality during the first 30 days after cardiac surgery. The PROM score's role in predicting longer-term survival, however, has not been investigated, according to Dr. John D. Puskas at the annual meeting of the Society of Thoracic Surgeons.

To fill this void, Dr. Puskas and his colleagues from Emory University, Atlanta, undertook a study to statistically validate PROM at 1, 3, 5, and 10 years after cardiac surgery. He presented the study's results at the meeting.

The investigators found that the STS PROM algorithm accurately predicted mortality both at 30 days and during 12 years of follow-up with almost equally strong discriminatory power. "This may have profound implications for informed consent as well as for longitudinal comparative effectiveness studies," Dr. Puskas said in an interview.

"The STS Predicted Risk of Mortality models are probably underutilized and underappreciated in their power to predict short and long-term outcomes for our patients. The STS provides this service free of charge, and it is available online 24/7. I am hopeful that this newfound ability to predict longer-term survival after cardiac surgery will find utility in comparative effectiveness research and ultimately in shaping health policy," he added.

Dr. Puskas and his colleagues evaluated the survival rates for 24,222 patients who underwent cardiac surgery at a single academic center during 1996-2009. Long-term all-cause mortality was determined by referencing the national Social Security Death Master File. Logistic and Cox survival regression analyses were used to evaluate the long-term predictive utility of PROM.

The AUROC (area under the receiver operator characteristic) curve measured the discrimination of PROM at 1, 3, 5, and 10 years. Kaplan-Meier curves were stratified by quartiles of PROM risk to compare long-term survival. All analyses were performed for both the whole sample and 30-day survivors.
The investigators found an overall 30-day mortality rate of 2.78%.

Among all patients and 30-day survivors, AUROC values for PROM at 1, 3, 5, and 10 years were remarkably similar to the 30-day end point for which PROM is calibrated.

Moreover, PROM was highly predictive of Kaplan-Meier survival, even when this analysis was restricted to patients surviving beyond 30 days, he added.

Among 30-day survivors, each percent increase in PROM score was significantly associated with a 9.6% increase in instantaneous hazard of death (P less than .001).

Dr. Puskas and his colleagues reported no relevant disclosures with regard to their study.

SAN DIEGO - The Society of Thoracic Surgeons Predicted Risk of Mortality score is a well-validated predictor of mortality during the first 30 days after cardiac surgery. The PROM score's role in predicting longer-term survival, however, has not been investigated, according to Dr. John D. Puskas at the annual meeting of the Society of Thoracic Surgeons.

To fill this void, Dr. Puskas and his colleagues from Emory University, Atlanta, undertook a study to statistically validate PROM at 1, 3, 5, and 10 years after cardiac surgery. He presented the study's results at the meeting.

The investigators found that the STS PROM algorithm accurately predicted mortality both at 30 days and during 12 years of follow-up with almost equally strong discriminatory power. "This may have profound implications for informed consent as well as for longitudinal comparative effectiveness studies," Dr. Puskas said in an interview.

"The STS Predicted Risk of Mortality models are probably underutilized and underappreciated in their power to predict short and long-term outcomes for our patients. The STS provides this service free of charge, and it is available online 24/7. I am hopeful that this newfound ability to predict longer-term survival after cardiac surgery will find utility in comparative effectiveness research and ultimately in shaping health policy," he added.

Dr. Puskas and his colleagues evaluated the survival rates for 24,222 patients who underwent cardiac surgery at a single academic center during 1996-2009. Long-term all-cause mortality was determined by referencing the national Social Security Death Master File. Logistic and Cox survival regression analyses were used to evaluate the long-term predictive utility of PROM.

The AUROC (area under the receiver operator characteristic) curve measured the discrimination of PROM at 1, 3, 5, and 10 years. Kaplan-Meier curves were stratified by quartiles of PROM risk to compare long-term survival. All analyses were performed for both the whole sample and 30-day survivors.
The investigators found an overall 30-day mortality rate of 2.78%.

Among all patients and 30-day survivors, AUROC values for PROM at 1, 3, 5, and 10 years were remarkably similar to the 30-day end point for which PROM is calibrated.

Moreover, PROM was highly predictive of Kaplan-Meier survival, even when this analysis was restricted to patients surviving beyond 30 days, he added.

Among 30-day survivors, each percent increase in PROM score was significantly associated with a 9.6% increase in instantaneous hazard of death (P less than .001).

Dr. Puskas and his colleagues reported no relevant disclosures with regard to their study.

SAN DIEGO - The Society of Thoracic Surgeons Predicted Risk of Mortality score is a well-validated predictor of mortality during the first 30 days after cardiac surgery. The PROM score's role in predicting longer-term survival, however, has not been investigated, according to Dr. John D. Puskas at the annual meeting of the Society of Thoracic Surgeons.

To fill this void, Dr. Puskas and his colleagues from Emory University, Atlanta, undertook a study to statistically validate PROM at 1, 3, 5, and 10 years after cardiac surgery. He presented the study's results at the meeting.

The investigators found that the STS PROM algorithm accurately predicted mortality both at 30 days and during 12 years of follow-up with almost equally strong discriminatory power. "This may have profound implications for informed consent as well as for longitudinal comparative effectiveness studies," Dr. Puskas said in an interview.

"The STS Predicted Risk of Mortality models are probably underutilized and underappreciated in their power to predict short and long-term outcomes for our patients. The STS provides this service free of charge, and it is available online 24/7. I am hopeful that this newfound ability to predict longer-term survival after cardiac surgery will find utility in comparative effectiveness research and ultimately in shaping health policy," he added.

Dr. Puskas and his colleagues evaluated the survival rates for 24,222 patients who underwent cardiac surgery at a single academic center during 1996-2009. Long-term all-cause mortality was determined by referencing the national Social Security Death Master File. Logistic and Cox survival regression analyses were used to evaluate the long-term predictive utility of PROM.

The AUROC (area under the receiver operator characteristic) curve measured the discrimination of PROM at 1, 3, 5, and 10 years. Kaplan-Meier curves were stratified by quartiles of PROM risk to compare long-term survival. All analyses were performed for both the whole sample and 30-day survivors.
The investigators found an overall 30-day mortality rate of 2.78%.

Among all patients and 30-day survivors, AUROC values for PROM at 1, 3, 5, and 10 years were remarkably similar to the 30-day end point for which PROM is calibrated.

Moreover, PROM was highly predictive of Kaplan-Meier survival, even when this analysis was restricted to patients surviving beyond 30 days, he added.

Among 30-day survivors, each percent increase in PROM score was significantly associated with a 9.6% increase in instantaneous hazard of death (P less than .001).

Dr. Puskas and his colleagues reported no relevant disclosures with regard to their study.

SAN DIEGO - The Society of Thoracic Surgeons Predicted Risk of Mortality score is a well-validated predictor of mortality during the first 30 days after cardiac surgery. The PROM score's role in predicting longer-term survival, however, has not been investigated, according to Dr. John D. Puskas at the annual meeting of the Society of Thoracic Surgeons.

To fill this void, Dr. Puskas and his colleagues from Emory University, Atlanta, undertook a study to statistically validate PROM at 1, 3, 5, and 10 years after cardiac surgery. He presented the study's results at the meeting.

The investigators found that the STS PROM algorithm accurately predicted mortality both at 30 days and during 12 years of follow-up with almost equally strong discriminatory power. "This may have profound implications for informed consent as well as for longitudinal comparative effectiveness studies," Dr. Puskas said in an interview.

"The STS Predicted Risk of Mortality models are probably underutilized and underappreciated in their power to predict short and long-term outcomes for our patients. The STS provides this service free of charge, and it is available online 24/7. I am hopeful that this newfound ability to predict longer-term survival after cardiac surgery will find utility in comparative effectiveness research and ultimately in shaping health policy," he added.

Dr. Puskas and his colleagues evaluated the survival rates for 24,222 patients who underwent cardiac surgery at a single academic center during 1996-2009. Long-term all-cause mortality was determined by referencing the national Social Security Death Master File. Logistic and Cox survival regression analyses were used to evaluate the long-term predictive utility of PROM.

The AUROC (area under the receiver operator characteristic) curve measured the discrimination of PROM at 1, 3, 5, and 10 years. Kaplan-Meier curves were stratified by quartiles of PROM risk to compare long-term survival. All analyses were performed for both the whole sample and 30-day survivors.
The investigators found an overall 30-day mortality rate of 2.78%.

Among all patients and 30-day survivors, AUROC values for PROM at 1, 3, 5, and 10 years were remarkably similar to the 30-day end point for which PROM is calibrated.

Moreover, PROM was highly predictive of Kaplan-Meier survival, even when this analysis was restricted to patients surviving beyond 30 days, he added.

Among 30-day survivors, each percent increase in PROM score was significantly associated with a 9.6% increase in instantaneous hazard of death (P less than .001).

Dr. Puskas and his colleagues reported no relevant disclosures with regard to their study.

SAN DIEGO - The Society of Thoracic Surgeons Predicted Risk of Mortality score is a well-validated predictor of mortality during the first 30 days after cardiac surgery. The PROM score's role in predicting longer-term survival, however, has not been investigated, according to Dr. John D. Puskas at the annual meeting of the Society of Thoracic Surgeons.

To fill this void, Dr. Puskas and his colleagues from Emory University, Atlanta, undertook a study to statistically validate PROM at 1, 3, 5, and 10 years after cardiac surgery. He presented the study's results at the meeting.

The investigators found that the STS PROM algorithm accurately predicted mortality both at 30 days and during 12 years of follow-up with almost equally strong discriminatory power. "This may have profound implications for informed consent as well as for longitudinal comparative effectiveness studies," Dr. Puskas said in an interview.

"The STS Predicted Risk of Mortality models are probably underutilized and underappreciated in their power to predict short and long-term outcomes for our patients. The STS provides this service free of charge, and it is available online 24/7. I am hopeful that this newfound ability to predict longer-term survival after cardiac surgery will find utility in comparative effectiveness research and ultimately in shaping health policy," he added.

Dr. Puskas and his colleagues evaluated the survival rates for 24,222 patients who underwent cardiac surgery at a single academic center during 1996-2009. Long-term all-cause mortality was determined by referencing the national Social Security Death Master File. Logistic and Cox survival regression analyses were used to evaluate the long-term predictive utility of PROM.

The AUROC (area under the receiver operator characteristic) curve measured the discrimination of PROM at 1, 3, 5, and 10 years. Kaplan-Meier curves were stratified by quartiles of PROM risk to compare long-term survival. All analyses were performed for both the whole sample and 30-day survivors.
The investigators found an overall 30-day mortality rate of 2.78%.

Among all patients and 30-day survivors, AUROC values for PROM at 1, 3, 5, and 10 years were remarkably similar to the 30-day end point for which PROM is calibrated.

Moreover, PROM was highly predictive of Kaplan-Meier survival, even when this analysis was restricted to patients surviving beyond 30 days, he added.

Among 30-day survivors, each percent increase in PROM score was significantly associated with a 9.6% increase in instantaneous hazard of death (P less than .001).

Dr. Puskas and his colleagues reported no relevant disclosures with regard to their study.

SAN DIEGO - The Society of Thoracic Surgeons Predicted Risk of Mortality score is a well-validated predictor of mortality during the first 30 days after cardiac surgery. The PROM score's role in predicting longer-term survival, however, has not been investigated, according to Dr. John D. Puskas at the annual meeting of the Society of Thoracic Surgeons.

To fill this void, Dr. Puskas and his colleagues from Emory University, Atlanta, undertook a study to statistically validate PROM at 1, 3, 5, and 10 years after cardiac surgery. He presented the study's results at the meeting.

The investigators found that the STS PROM algorithm accurately predicted mortality both at 30 days and during 12 years of follow-up with almost equally strong discriminatory power. "This may have profound implications for informed consent as well as for longitudinal comparative effectiveness studies," Dr. Puskas said in an interview.

"The STS Predicted Risk of Mortality models are probably underutilized and underappreciated in their power to predict short and long-term outcomes for our patients. The STS provides this service free of charge, and it is available online 24/7. I am hopeful that this newfound ability to predict longer-term survival after cardiac surgery will find utility in comparative effectiveness research and ultimately in shaping health policy," he added.

Dr. Puskas and his colleagues evaluated the survival rates for 24,222 patients who underwent cardiac surgery at a single academic center during 1996-2009. Long-term all-cause mortality was determined by referencing the national Social Security Death Master File. Logistic and Cox survival regression analyses were used to evaluate the long-term predictive utility of PROM.

The AUROC (area under the receiver operator characteristic) curve measured the discrimination of PROM at 1, 3, 5, and 10 years. Kaplan-Meier curves were stratified by quartiles of PROM risk to compare long-term survival. All analyses were performed for both the whole sample and 30-day survivors.
The investigators found an overall 30-day mortality rate of 2.78%.

Among all patients and 30-day survivors, AUROC values for PROM at 1, 3, 5, and 10 years were remarkably similar to the 30-day end point for which PROM is calibrated.

Moreover, PROM was highly predictive of Kaplan-Meier survival, even when this analysis was restricted to patients surviving beyond 30 days, he added.

Among 30-day survivors, each percent increase in PROM score was significantly associated with a 9.6% increase in instantaneous hazard of death (P less than .001).

Dr. Puskas and his colleagues reported no relevant disclosures with regard to their study.

SAN DIEGO - The Society of Thoracic Surgeons Predicted Risk of Mortality score is a well-validated predictor of mortality during the first 30 days after cardiac surgery. The PROM score's role in predicting longer-term survival, however, has not been investigated, according to Dr. John D. Puskas at the annual meeting of the Society of Thoracic Surgeons.

To fill this void, Dr. Puskas and his colleagues from Emory University, Atlanta, undertook a study to statistically validate PROM at 1, 3, 5, and 10 years after cardiac surgery. He presented the study's results at the meeting.

The investigators found that the STS PROM algorithm accurately predicted mortality both at 30 days and during 12 years of follow-up with almost equally strong discriminatory power. "This may have profound implications for informed consent as well as for longitudinal comparative effectiveness studies," Dr. Puskas said in an interview.

"The STS Predicted Risk of Mortality models are probably underutilized and underappreciated in their power to predict short and long-term outcomes for our patients. The STS provides this service free of charge, and it is available online 24/7. I am hopeful that this newfound ability to predict longer-term survival after cardiac surgery will find utility in comparative effectiveness research and ultimately in shaping health policy," he added.

Dr. Puskas and his colleagues evaluated the survival rates for 24,222 patients who underwent cardiac surgery at a single academic center during 1996-2009. Long-term all-cause mortality was determined by referencing the national Social Security Death Master File. Logistic and Cox survival regression analyses were used to evaluate the long-term predictive utility of PROM.

The AUROC (area under the receiver operator characteristic) curve measured the discrimination of PROM at 1, 3, 5, and 10 years. Kaplan-Meier curves were stratified by quartiles of PROM risk to compare long-term survival. All analyses were performed for both the whole sample and 30-day survivors.
The investigators found an overall 30-day mortality rate of 2.78%.

Among all patients and 30-day survivors, AUROC values for PROM at 1, 3, 5, and 10 years were remarkably similar to the 30-day end point for which PROM is calibrated.

Moreover, PROM was highly predictive of Kaplan-Meier survival, even when this analysis was restricted to patients surviving beyond 30 days, he added.

Among 30-day survivors, each percent increase in PROM score was significantly associated with a 9.6% increase in instantaneous hazard of death (P less than .001).

Dr. Puskas and his colleagues reported no relevant disclosures with regard to their study.

SAN DIEGO - The Society of Thoracic Surgeons Predicted Risk of Mortality score is a well-validated predictor of mortality during the first 30 days after cardiac surgery. The PROM score's role in predicting longer-term survival, however, has not been investigated, according to Dr. John D. Puskas at the annual meeting of the Society of Thoracic Surgeons.

To fill this void, Dr. Puskas and his colleagues from Emory University, Atlanta, undertook a study to statistically validate PROM at 1, 3, 5, and 10 years after cardiac surgery. He presented the study's results at the meeting.

The investigators found that the STS PROM algorithm accurately predicted mortality both at 30 days and during 12 years of follow-up with almost equally strong discriminatory power. "This may have profound implications for informed consent as well as for longitudinal comparative effectiveness studies," Dr. Puskas said in an interview.

"The STS Predicted Risk of Mortality models are probably underutilized and underappreciated in their power to predict short and long-term outcomes for our patients. The STS provides this service free of charge, and it is available online 24/7. I am hopeful that this newfound ability to predict longer-term survival after cardiac surgery will find utility in comparative effectiveness research and ultimately in shaping health policy," he added.

Dr. Puskas and his colleagues evaluated the survival rates for 24,222 patients who underwent cardiac surgery at a single academic center during 1996-2009. Long-term all-cause mortality was determined by referencing the national Social Security Death Master File. Logistic and Cox survival regression analyses were used to evaluate the long-term predictive utility of PROM.

The AUROC (area under the receiver operator characteristic) curve measured the discrimination of PROM at 1, 3, 5, and 10 years. Kaplan-Meier curves were stratified by quartiles of PROM risk to compare long-term survival. All analyses were performed for both the whole sample and 30-day survivors.
The investigators found an overall 30-day mortality rate of 2.78%.

Among all patients and 30-day survivors, AUROC values for PROM at 1, 3, 5, and 10 years were remarkably similar to the 30-day end point for which PROM is calibrated.

Moreover, PROM was highly predictive of Kaplan-Meier survival, even when this analysis was restricted to patients surviving beyond 30 days, he added.

Among 30-day survivors, each percent increase in PROM score was significantly associated with a 9.6% increase in instantaneous hazard of death (P less than .001).

Dr. Puskas and his colleagues reported no relevant disclosures with regard to their study.

SAN DIEGO - Although the right internal thoracic artery is biologically identical to the left internal thoracic artery, it is rarely used in coronary artery bypass grafting.

In a study comparing the use of different graft sources for coronary artery bypass grafting (CABG), Dr. James Tatoulis and his colleagues found that the right internal thoracic artery (RITA) showed equivalent results to using the left internal thoracic artery (LITA).

Dr. Tatoulis of the Royal Melbourne Hospital and his colleagues evaluated consecutive RITA graft angiograms performed from 1986 to 2008. Patency was examined over time by coronary territory and by whether the RITA was in situ or free, and was compared with other coronary conduits, according to the study presented at the annual meeting of the Society of Thoracic Surgeons.

A total of 5,766 patients had a RITA graft, usually as part of bilateral internal thoracic artery CABG. The operative mortality was 1.1%, and the rate of deep sternal infection was 1.5%. Of the nearly 7,800 coronary conduits studied, 991 RITA conduits were examined at a mean of 100 months postoperatively.

The overall 10-year RITA patency was 90%. RITA graft patency to the left anterior descending artery (n = 149) was 95% at 10 years and 90% at 15 years. Ten-year RITA patency to the circumflex marginal artery was 91% (n = 436), 85% (n = 199) to the right coronary artery (RCA), and 86% (n = 207) to the posterior descending artery (PDA). Ten-year patencies of RITA and LITA to the left anterior descending artery were identical.

In situ RITA (n=451) and free RITA (n=540) had similar 10-year patencies, 89% vs. 91% respectively.

RITA patency was found to be significantly better than radial artery and saphenous vein grafts for the circumflex marginal artery, the RCA, and the PDA. The 10-year survival of patients with RITA and LITA for triple-vessel coronary disease were identical at 89%.

Dr. Tatoulis and his colleagues stated that late patencies of RITA are excellent, equivalent to the LITA for identical territories, and always better than radial artery and saphenous vein grafts.

“Unfortunately, less than 10% of all coronary artery surgery worldwide is performed with two internal thoracic arteries," Dr. Tatoulis said in an interview.
He added that the use of this technique could improve patient outcomes and could offer an even better revascularization alternative to stents, particularly for triple-vessel coronary disease.

Dr. Tatoulis and his colleagues reported that they had no relevant disclosures.

SAN DIEGO - Although the right internal thoracic artery is biologically identical to the left internal thoracic artery, it is rarely used in coronary artery bypass grafting.

In a study comparing the use of different graft sources for coronary artery bypass grafting (CABG), Dr. James Tatoulis and his colleagues found that the right internal thoracic artery (RITA) showed equivalent results to using the left internal thoracic artery (LITA).

Dr. Tatoulis of the Royal Melbourne Hospital and his colleagues evaluated consecutive RITA graft angiograms performed from 1986 to 2008. Patency was examined over time by coronary territory and by whether the RITA was in situ or free, and was compared with other coronary conduits, according to the study presented at the annual meeting of the Society of Thoracic Surgeons.

A total of 5,766 patients had a RITA graft, usually as part of bilateral internal thoracic artery CABG. The operative mortality was 1.1%, and the rate of deep sternal infection was 1.5%. Of the nearly 7,800 coronary conduits studied, 991 RITA conduits were examined at a mean of 100 months postoperatively.

The overall 10-year RITA patency was 90%. RITA graft patency to the left anterior descending artery (n = 149) was 95% at 10 years and 90% at 15 years. Ten-year RITA patency to the circumflex marginal artery was 91% (n = 436), 85% (n = 199) to the right coronary artery (RCA), and 86% (n = 207) to the posterior descending artery (PDA). Ten-year patencies of RITA and LITA to the left anterior descending artery were identical.

In situ RITA (n=451) and free RITA (n=540) had similar 10-year patencies, 89% vs. 91% respectively.

RITA patency was found to be significantly better than radial artery and saphenous vein grafts for the circumflex marginal artery, the RCA, and the PDA. The 10-year survival of patients with RITA and LITA for triple-vessel coronary disease were identical at 89%.

Dr. Tatoulis and his colleagues stated that late patencies of RITA are excellent, equivalent to the LITA for identical territories, and always better than radial artery and saphenous vein grafts.

“Unfortunately, less than 10% of all coronary artery surgery worldwide is performed with two internal thoracic arteries," Dr. Tatoulis said in an interview.
He added that the use of this technique could improve patient outcomes and could offer an even better revascularization alternative to stents, particularly for triple-vessel coronary disease.

Dr. Tatoulis and his colleagues reported that they had no relevant disclosures.

SAN DIEGO - Although the right internal thoracic artery is biologically identical to the left internal thoracic artery, it is rarely used in coronary artery bypass grafting.

In a study comparing the use of different graft sources for coronary artery bypass grafting (CABG), Dr. James Tatoulis and his colleagues found that the right internal thoracic artery (RITA) showed equivalent results to using the left internal thoracic artery (LITA).

Dr. Tatoulis of the Royal Melbourne Hospital and his colleagues evaluated consecutive RITA graft angiograms performed from 1986 to 2008. Patency was examined over time by coronary territory and by whether the RITA was in situ or free, and was compared with other coronary conduits, according to the study presented at the annual meeting of the Society of Thoracic Surgeons.

A total of 5,766 patients had a RITA graft, usually as part of bilateral internal thoracic artery CABG. The operative mortality was 1.1%, and the rate of deep sternal infection was 1.5%. Of the nearly 7,800 coronary conduits studied, 991 RITA conduits were examined at a mean of 100 months postoperatively.

The overall 10-year RITA patency was 90%. RITA graft patency to the left anterior descending artery (n = 149) was 95% at 10 years and 90% at 15 years. Ten-year RITA patency to the circumflex marginal artery was 91% (n = 436), 85% (n = 199) to the right coronary artery (RCA), and 86% (n = 207) to the posterior descending artery (PDA). Ten-year patencies of RITA and LITA to the left anterior descending artery were identical.

In situ RITA (n=451) and free RITA (n=540) had similar 10-year patencies, 89% vs. 91% respectively.

RITA patency was found to be significantly better than radial artery and saphenous vein grafts for the circumflex marginal artery, the RCA, and the PDA. The 10-year survival of patients with RITA and LITA for triple-vessel coronary disease were identical at 89%.

Dr. Tatoulis and his colleagues stated that late patencies of RITA are excellent, equivalent to the LITA for identical territories, and always better than radial artery and saphenous vein grafts.

“Unfortunately, less than 10% of all coronary artery surgery worldwide is performed with two internal thoracic arteries," Dr. Tatoulis said in an interview.
He added that the use of this technique could improve patient outcomes and could offer an even better revascularization alternative to stents, particularly for triple-vessel coronary disease.

Dr. Tatoulis and his colleagues reported that they had no relevant disclosures.