title: 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.
abstract: OBJECTIVE
  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.
authors.affiliation: Cardiac Catheterization Laboratory, Tucson VA Medical Center, Tucson, Arizona 85723, USA.
authors.forename: Douglass A
authors.initials: DA
authors.lastname: Morrison
authors.forename: Gulshan
authors.initials: G
authors.lastname: Sethi
authors.forename: Jerome
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authors.lastname: Sacks
authors.forename: William
authors.initials: W
authors.lastname: Henderson
authors.forename: Frederick
authors.initials: F
authors.lastname: Grover
authors.forename: Steven
authors.initials: S
authors.lastname: Sedlis
authors.forename: Rick
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authors.lastname: Esposito
authors.forename: Kodagundi B
authors.initials: KB
authors.lastname: Ramanathan
authors.forename: Darryl
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authors.lastname: Weiman
authors.forename: J David
authors.initials: JD
authors.lastname: Talley
authors.forename: Jorge
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authors.lastname: Saucedo
authors.forename: Tamim
authors.initials: T
authors.lastname: Antakli
authors.forename: Venki
authors.initials: V
authors.lastname: Paramesh
authors.forename: Stuart
authors.initials: S
authors.lastname: Pett
authors.forename: Sarah
authors.initials: S
authors.lastname: Vernon
authors.forename: Vladimir
authors.initials: V
authors.lastname: Birjiniuk
authors.forename: Frederick
authors.initials: F
authors.lastname: Welt
authors.forename: Mitchell
authors.initials: M
authors.lastname: Krucoff
authors.forename: Walter
authors.initials: W
authors.lastname: Wolfe
authors.forename: John C
authors.initials: JC
authors.lastname: Lucke
authors.forename: Sundeep
authors.initials: S
authors.lastname: Mediratta
authors.forename: David
authors.initials: D
authors.lastname: Booth
authors.forename: Charles
authors.initials: C
authors.lastname: Barbiere
authors.forename: Dan
authors.initials: D
authors.lastname: Lewis
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D001026:Coronary Artery Bypass; D006801:Humans; D008875:Middle Aged; D017202:Myocardial Ischemia / Q000401:mortality* / Q000601:surgery / Q000628:therapy*; D016032:Randomized Controlled Trials as Topic; D012042:Registries; D016896:Treatment Outcome