Percutaneous coronary intervention versus coronary bypass graft surgery for patients with medically refractory myocardial ischemia and risk factors for adverse outcomes with bypass: The VA AWESOME multicenter registry: Comparison with the randomized clinical trial

Douglass A. Morrison, Gulshan Sethi, Jerome Sacks, William Henderson, Frederick Grover, Steven Sedlis, Rick Esposito, K Ramanathan, Darryl Weiman, J. David Talley, Jorge Saucedo, Tamim Antakli, Venki Paramesh, Stuart Pett, Sarah Vernon, Vladimir Birjiniuk, Frederick Welt, Mitchell Krucoff, Walter Wolfe, John C. LuckeSundeep Mediratta, David Booth, Charles Barbiere, Dan Lewis

Research output: Contribution to journalArticle

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Abstract

OBJECTIVES: This study was designed to compare the three-year survival after percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG) in physician-directed and patient-choice registries with the Angina With Extremely Serious Operative Mortality Evaluation (AWESOME) randomized trial results. BACKGROUND: The AWESOME multicenter randomized trial and registry compared the long-term survival after PCI and CABG for the treatment of patients with medically refractory myocardial ischemia and at least one additional risk factor for adverse outcome with CABG. The randomized trial demonstrated comparable three-year survival. METHODS: Over a five-year period (1995 to 2000), 2,431 patients with medically refractory myocardial ischemia and at least one of five risk factors (prior heart surgery, myocardial infarction within seven days, left ventricular ejection fraction <0.35, age >70 years, intra-aortic balloon required to stabilize) were identified. By physician consensus, 1,650 patients formed a physician-directed registry assigned to CABG (692), PCI (651) or further medical therapy (307), and 781 were angiographically eligible for random allocation; 454 of these patients constitute the randomized trial, and the remaining 327 constitute a patient choice registry. Survival for CABG and PCI was compared using Kaplan-Meier curves and log-rank tests. RESULTS: The CABG and PCI 36-month survival rates for randomized patients were 79% and 80%, respectively. The CABG and PCI 36-month survival rates were both 76% for the physician-directed subgroup; comparable survival rates for the patient-choice subgroup were 80% and 89%, respectively. None of the global log-rank tests for survival demonstrated significant differences. CONCLUSIONS: Both registries support the randomized trial conclusion: PCI is an alternative to CABG for some medically refractory high-risk patients.

Original languageEnglish (US)
Pages (from-to)266-273
Number of pages8
JournalJournal of the American College of Cardiology
Volume39
Issue number2
DOIs
StatePublished - Jan 16 2002
Externally publishedYes

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Percutaneous Coronary Intervention
Myocardial Ischemia
Registries
Coronary Artery Bypass
Randomized Controlled Trials
Transplants
Mortality
Survival
Physicians
Survival Rate
Random Allocation
Stroke Volume
Thoracic Surgery
Multicenter Studies
Myocardial Infarction
Therapeutics

All Science Journal Classification (ASJC) codes

  • Cardiology and Cardiovascular Medicine

Cite this

Percutaneous coronary intervention versus coronary bypass graft surgery for patients with medically refractory myocardial ischemia and risk factors for adverse outcomes with bypass : The VA AWESOME multicenter registry: Comparison with the randomized clinical trial. / Morrison, Douglass A.; Sethi, Gulshan; Sacks, Jerome; Henderson, William; Grover, Frederick; Sedlis, Steven; Esposito, Rick; Ramanathan, K; Weiman, Darryl; Talley, J. David; Saucedo, Jorge; Antakli, Tamim; Paramesh, Venki; Pett, Stuart; Vernon, Sarah; Birjiniuk, Vladimir; Welt, Frederick; Krucoff, Mitchell; Wolfe, Walter; Lucke, John C.; Mediratta, Sundeep; Booth, David; Barbiere, Charles; Lewis, Dan.

In: Journal of the American College of Cardiology, Vol. 39, No. 2, 16.01.2002, p. 266-273.

Research output: Contribution to journalArticle

Morrison, DA, Sethi, G, Sacks, J, Henderson, W, Grover, F, Sedlis, S, Esposito, R, Ramanathan, K, Weiman, D, Talley, JD, Saucedo, J, Antakli, T, Paramesh, V, Pett, S, Vernon, S, Birjiniuk, V, Welt, F, Krucoff, M, Wolfe, W, Lucke, JC, Mediratta, S, Booth, D, Barbiere, C & Lewis, D 2002, 'Percutaneous coronary intervention versus coronary bypass graft surgery for patients with medically refractory myocardial ischemia and risk factors for adverse outcomes with bypass: The VA AWESOME multicenter registry: Comparison with the randomized clinical trial', Journal of the American College of Cardiology, vol. 39, no. 2, pp. 266-273. https://doi.org/10.1016/S0735-1097(01)01720-X
Morrison, Douglass A. ; Sethi, Gulshan ; Sacks, Jerome ; Henderson, William ; Grover, Frederick ; Sedlis, Steven ; Esposito, Rick ; Ramanathan, K ; Weiman, Darryl ; Talley, J. David ; Saucedo, Jorge ; Antakli, Tamim ; Paramesh, Venki ; Pett, Stuart ; Vernon, Sarah ; Birjiniuk, Vladimir ; Welt, Frederick ; Krucoff, Mitchell ; Wolfe, Walter ; Lucke, John C. ; Mediratta, Sundeep ; Booth, David ; Barbiere, Charles ; Lewis, Dan. / Percutaneous coronary intervention versus coronary bypass graft surgery for patients with medically refractory myocardial ischemia and risk factors for adverse outcomes with bypass : The VA AWESOME multicenter registry: Comparison with the randomized clinical trial. In: Journal of the American College of Cardiology. 2002 ; Vol. 39, No. 2. pp. 266-273.
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abstract = "OBJECTIVES: This study was designed to compare the three-year survival after percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG) in physician-directed and patient-choice registries with the Angina With Extremely Serious Operative Mortality Evaluation (AWESOME) randomized trial results. BACKGROUND: The AWESOME multicenter randomized trial and registry compared the long-term survival after PCI and CABG for the treatment of patients with medically refractory myocardial ischemia and at least one additional risk factor for adverse outcome with CABG. The randomized trial demonstrated comparable three-year survival. METHODS: Over a five-year period (1995 to 2000), 2,431 patients with medically refractory myocardial ischemia and at least one of five risk factors (prior heart surgery, myocardial infarction within seven days, left ventricular ejection fraction <0.35, age >70 years, intra-aortic balloon required to stabilize) were identified. By physician consensus, 1,650 patients formed a physician-directed registry assigned to CABG (692), PCI (651) or further medical therapy (307), and 781 were angiographically eligible for random allocation; 454 of these patients constitute the randomized trial, and the remaining 327 constitute a patient choice registry. Survival for CABG and PCI was compared using Kaplan-Meier curves and log-rank tests. RESULTS: The CABG and PCI 36-month survival rates for randomized patients were 79{\%} and 80{\%}, respectively. The CABG and PCI 36-month survival rates were both 76{\%} for the physician-directed subgroup; comparable survival rates for the patient-choice subgroup were 80{\%} and 89{\%}, respectively. None of the global log-rank tests for survival demonstrated significant differences. CONCLUSIONS: Both registries support the randomized trial conclusion: PCI is an alternative to CABG for some medically refractory high-risk patients.",
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T1 - Percutaneous coronary intervention versus coronary bypass graft surgery for patients with medically refractory myocardial ischemia and risk factors for adverse outcomes with bypass

T2 - The VA AWESOME multicenter registry: Comparison with the randomized clinical trial

AU - Morrison, Douglass A.

AU - Sethi, Gulshan

AU - Sacks, Jerome

AU - Henderson, William

AU - Grover, Frederick

AU - Sedlis, Steven

AU - Esposito, Rick

AU - Ramanathan, K

AU - Weiman, Darryl

AU - Talley, J. David

AU - Saucedo, Jorge

AU - Antakli, Tamim

AU - Paramesh, Venki

AU - Pett, Stuart

AU - Vernon, Sarah

AU - Birjiniuk, Vladimir

AU - Welt, Frederick

AU - Krucoff, Mitchell

AU - Wolfe, Walter

AU - Lucke, John C.

AU - Mediratta, Sundeep

AU - Booth, David

AU - Barbiere, Charles

AU - Lewis, Dan

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N2 - OBJECTIVES: This study was designed to compare the three-year survival after percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG) in physician-directed and patient-choice registries with the Angina With Extremely Serious Operative Mortality Evaluation (AWESOME) randomized trial results. BACKGROUND: The AWESOME multicenter randomized trial and registry compared the long-term survival after PCI and CABG for the treatment of patients with medically refractory myocardial ischemia and at least one additional risk factor for adverse outcome with CABG. The randomized trial demonstrated comparable three-year survival. METHODS: Over a five-year period (1995 to 2000), 2,431 patients with medically refractory myocardial ischemia and at least one of five risk factors (prior heart surgery, myocardial infarction within seven days, left ventricular ejection fraction <0.35, age >70 years, intra-aortic balloon required to stabilize) were identified. By physician consensus, 1,650 patients formed a physician-directed registry assigned to CABG (692), PCI (651) or further medical therapy (307), and 781 were angiographically eligible for random allocation; 454 of these patients constitute the randomized trial, and the remaining 327 constitute a patient choice registry. Survival for CABG and PCI was compared using Kaplan-Meier curves and log-rank tests. RESULTS: The CABG and PCI 36-month survival rates for randomized patients were 79% and 80%, respectively. The CABG and PCI 36-month survival rates were both 76% for the physician-directed subgroup; comparable survival rates for the patient-choice subgroup were 80% and 89%, respectively. None of the global log-rank tests for survival demonstrated significant differences. CONCLUSIONS: Both registries support the randomized trial conclusion: PCI is an alternative to CABG for some medically refractory high-risk patients.

AB - OBJECTIVES: This study was designed to compare the three-year survival after percutaneous coronary intervention (PCI) or coronary artery bypass graft surgery (CABG) in physician-directed and patient-choice registries with the Angina With Extremely Serious Operative Mortality Evaluation (AWESOME) randomized trial results. BACKGROUND: The AWESOME multicenter randomized trial and registry compared the long-term survival after PCI and CABG for the treatment of patients with medically refractory myocardial ischemia and at least one additional risk factor for adverse outcome with CABG. The randomized trial demonstrated comparable three-year survival. METHODS: Over a five-year period (1995 to 2000), 2,431 patients with medically refractory myocardial ischemia and at least one of five risk factors (prior heart surgery, myocardial infarction within seven days, left ventricular ejection fraction <0.35, age >70 years, intra-aortic balloon required to stabilize) were identified. By physician consensus, 1,650 patients formed a physician-directed registry assigned to CABG (692), PCI (651) or further medical therapy (307), and 781 were angiographically eligible for random allocation; 454 of these patients constitute the randomized trial, and the remaining 327 constitute a patient choice registry. Survival for CABG and PCI was compared using Kaplan-Meier curves and log-rank tests. RESULTS: The CABG and PCI 36-month survival rates for randomized patients were 79% and 80%, respectively. The CABG and PCI 36-month survival rates were both 76% for the physician-directed subgroup; comparable survival rates for the patient-choice subgroup were 80% and 89%, respectively. None of the global log-rank tests for survival demonstrated significant differences. CONCLUSIONS: Both registries support the randomized trial conclusion: PCI is an alternative to CABG for some medically refractory high-risk patients.

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