CLINICAL STUDY
Percutaneous coronary intervention versus coronary artery bypass graft surgery for patients with medically refractory myocardial ischemia and risk factors for adverse outcomes with bypass: a multicenter, randomized trial
Douglass A. Morrison, MD, FACC,
Gulshan Sethi, MD, FACC,
Jerome Sacks, PhD,
William Henderson, PhD,
Frederick Grover, MD, FACC,
Steven Sedlis, MD, FACC,
Rick Esposito, MD,
Kodangudi Ramanathan, MD, FACC,
Darryl Weiman, MD,
Jorge Saucedo, MD,
Tamim Antakli, MD,
Venki Paramesh, MD,
Stuart Pett, MD,
Sarah Vernon, MD, FACC,
Vladimir Birjiniuk, MD,
Frederick Welt, MD,
Mitchell Krucoff, MD, FACC,
Walter Wolfe, MD, FACC,
John C. Lucke, MD,
Sundeep Mediratta, MD,
David Booth, MD, FACC,
Charles Barbiere, CCRN,
Daniel Lewis, MD, FACC for the Investigators of the Department of Veterans Affairs Cooperative Study 385 the Angina With Extremely Serious Operative Mortality Evaluation (AWESOME)
Manuscript received December 18, 2000;
revised manuscript received March 27, 2001,
accepted April 6, 2001.
Reprint requests and correspondence: Dr. Douglass A. Morrison, Department of Medicine and Radiology, University of Arizona SAVAHCS, 3601 South Sixth Avenue, Tucson, Arizona 85723
BACKGROUND
Percutaneous coronary intervention (PCI) and coronary artery bypass graft surgery (CABG) are being applied to high-risk populations, but previous randomized trials comparing revascularization methods have excluded a number of important high-risk groups.
OBJECTIVES
This five-year, multicenter, randomized clinical trial was designed to compare long-term survival among patients with medically refractory myocardial ischemia and a high risk of adverse outcomes assigned to either a CABG or a PCI strategy, which could include stents.
METHODS
Patients from 16 Veterans Affairs Medical Centers were screened to identify myocardial ischemia refractory to medical management and the presence of one or more risk factors for adverse outcome with CABG, including prior open-heart surgery, age >70 years, left ventricular ejection fraction <0.35, myocardial infarction within seven days or intraaortic balloon pump required. Clinically eligible patients (n = 2,431) underwent coronary angiography; 781 were angiographically acceptable; 454 (58% of eligible) patients consented to random assignment between CABG and PCI.
RESULTS
A total of 232 patients was randomized to CABG and 222 to PCI. The 30-day survivals for CABG and PCI were 95% and 97%, respectively. Survival rates for CABG and PCI were 90% versus 94% at six months and 79% versus 80% at 36 months (log-rank test, p = 0.46).
CONCLUSIONS
Percutaneous coronary intervention is an alternative to CABG for patients with medically refractory myocardial ischemia and a high risk of adverse outcomes with CABG.
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Abbreviations and Acronyms
| | AWESOME | = Angina With Extremely Serious Operative Mortality Evaluation | | BARI | = Bypass Angioplasty Revascularization Investigation | | CAD | = coronary artery disease | | CABG | = coronary artery bypass graft surgery | | EAST | = Emory Angioplasty Surgery Trial | | IABP | = intra-aortic balloon pump | | LVEF | = left ventricular ejection fraction | | MI | = myocardial infarction | | PCI | = percutaneous coronary invervention | | VA | = United States Department of Veterans Affairs |
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