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CLINICAL STUDY

Percutaneous coronary intervention versus coronary bypass graft surgery for diabetic patients with unstable angina and risk factors for adverse outcomes with bypass

outcome of diabetic patients in the AWESOME randomized trial and registry

Steven P. Sedlis, MD, FACC^*,*, Douglass A. Morrison, MD, FACC, Jeffrey D. Lorin, MD, FACC^*, Rick Esposito, MD^*, Gulshan Sethi, MD, FACC, Jerome Sacks, PhD, William Henderson, PhD, Frederick Grover, MD, FACC, K. B. 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^||||, Edward Murphy, MD, FACC^¶¶, Herbert Ward, MD, FACC^***, LaWayne Miller, MD, Stefan Kiesz, MD, FACC, Charles Barbiere, CCRN, Dan Lewis, MD, FACC Investigators of the Department of Veterans Affairs Cooperative Study #385, the Angina With Extremely Serious Operative Mortality Evaluation (AWESOME)

^* New York VA Medical Center, New York, New York, USA
Tucson VA Medical Center, Tucson, Arizona, USA
CSPCC Hines VA Hospital, Hines, Illinois, USA
Denver VA Medical Center, Denver, Colorado, USA
^|| Memphis VA Medical Center, Memphis, Tennessee, USA
^¶ Little Rock VA Medical Center, Little Rock, Arkansas, USA
^** Albuquerque VA Medical Center, Albuquerque, New Mexico, USA
West Roxbury VA Medical Center, West Roxbury, Massachusetts, USA
Durham VA Medical Center, Durham, North Carolina, USA
Asheville VA Medical Center, Asheville, North Carolina, USA
^|||| Lexington VA Medical Center, Lexington, Kentucky, USA
^¶¶ Portland VA Medical Center, Portland, Oregon, USA
^*** Minneapolis VA Medical Center, Minneapolis, Minnesota, USA
San Antonio VA Medical Center, San Antonio, Texas, USA
Kansas City VA Medical Center, Kansas City, Kansas, USA

Manuscript received February 27, 2002; revised manuscript received April 30, 2002, accepted May 31, 2002.

^* Reprint requests and correspondence: Dr. Steven P. Sedlis, Section of Cardiology, 12W, VA Medical Center, 423 East 23rd Street, New York, New York 10010, USA.
steven.sedlis{at}med.va.gov

OBJECTIVES: This study compared survival after percutaneous coronary intervention (PCI) with survival after coronary artery bypass graft surgery (CABG) among diabetics in the Veterans Affairs AWESOME (Angina With Extremely Serious Operative Mortality Evaluation) study randomized trial and registry of high-risk patients.

BACKGROUND: Previous studies indicate that CABG may be superior to PCI for diabetics, but no comparisons have been made for diabetics at high risk for surgery.

METHODS: Over five years (1995 to 2000), 2,431 patients with medically refractory myocardial ischemia and at least one of five risk factors (prior CABG, myocardial infarction within seven days, left ventricular ejection fraction <0.35, age >70 years, or an intra-aortic balloon being required to stabilize) were identified. A total of 781 were acceptable for CABG and PCI, and 454 consented to be randomized. The 1,650 patients not acceptable for both CABG and PCI constitute the physician-directed registry, and the 327 who were acceptable but refused to be randomized constitute the patient-choice registry. Diabetes prevalence was 32% (144) among randomized patients, 27% (89) in the patient-choice registry, and 32% (525) in the physician-directed registry. The CABG and PCI survival rates were compared using Kaplan-Meier curves and log-rank tests.

RESULTS: The respective CABG and PCI 36-month survival rates for diabetic patients were 72% and 81% for randomized patients, 85% and 89% for patient-choice registry patients, and 73% and 71% for the physician-directed registry patients. None of the differences was statistically significant.

CONCLUSIONS: We conclude that PCI is a relatively safe alternative to CABG for diabetic patients with medically refractory unstable angina who are at high risk for CABG.

Abbreviations and Acronyms   AWESOME   Angina With Extremely Serious Operative Mortality Evaluation   CABG   coronary artery bypass graft surgery   CAD   coronary artery disease   LVEF   left ventricular ejection fraction   MI   myocardial infarction   PCI   percutaneous coronary intervention   TIMI   Thrombolysis In Myocardial Infarction

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