title: Percutaneous coronary intervention versus coronary bypass surgery in United States veterans with diabetes.
abstract: OBJECTIVE
  This study sought to determine the optimal coronary revascularization strategy in patients with diabetes with severe coronary disease.
  
  
  BACKGROUND
  Although subgroup analyses from large trials, databases, and meta-analyses have found better survival for patients with diabetes with complex coronary artery disease when treated with surgery, a randomized trial comparing interventions exclusively with drug-eluting stents and surgery in patients with diabetes with high-risk coronary artery disease has not yet been reported.
  
  
  METHODS
  In a prospective, multicenter study, 198 eligible patients with diabetes with severe coronary artery disease were randomly assigned to either coronary artery bypass grafting (CABG) (n = 97) or percutaneous coronary intervention (PCI) with drug-eluting stents (n = 101) and followed for at least 2 years. The primary outcome measure was a composite of nonfatal myocardial infarction or death. Secondary outcome measures included all-cause mortality, cardiac mortality, nonfatal myocardial infarction, and stroke.
  
  
  RESULTS
  The study was stopped because of slow recruitment after enrolling only 25% of the intended sample size, leaving it severely underpowered for the primary composite endpoint of death plus nonfatal myocardial infarction (hazard ratio: 0.89; 95% confidence interval: 0.47 to 1.71). However, after a mean follow-up period of 2 years, all-cause mortality was 5.0% for CABG and 21% for PCI (hazard ratio: 0.30; 95% confidence interval: 0.11 to 0.80), while the risk for nonfatal myocardial infarction was 15% for CABG and 6.2% for PCI (hazard ratio: 3.32; 95% confidence interval: 1.07 to 10.30).
  
  
  CONCLUSIONS
  This study was severely underpowered for its primary endpoint, and therefore no firm conclusions about the comparative effectiveness of CABG and PCI are possible. There were interesting differences in the components of the primary endpoint. However, the confidence intervals are very large, and the findings must be viewed as hypothesis generating only. (Coronary Artery Revascularization in Diabetes; NCT00326196).
authors: Roudebush VA Medical Center, Indiana University School of Medicine, Indianapolis, Indiana 46202, USA. mkamales@iupui.edu
authors: Masoor
authors: M
authors: Kamalesh
authors: Thomas G
authors: TG
authors: Sharp
authors: X Charlene
authors: XC
authors: Tang
authors: Kendrick
authors: K
authors: Shunk
authors: Herbert B
authors: HB
authors: Ward
authors: James
authors: J
authors: Walsh
authors: Spencer
authors: S
authors: King
authors: Cindy
authors: C
authors: Colling
authors: Thomas
authors: T
authors: Moritz
authors: Kevin
authors: K
authors: Stroupe
authors: Domenic
authors: D
authors: Reda
mesh_terms: D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects / Q000379:methods / Q000401:mortality; D057186:Comparative Effectiveness Research; D001026:Coronary Artery Bypass / Q000009:adverse effects / Q000379:methods / Q000401:mortality; D003324:Coronary Artery Disease / Q000150:complications / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000150:complications / Q000175:diagnosis; D054855:Drug-Eluting Stents; D057239:Early Termination of Clinical Trials; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009026:Mortality; D009203:Myocardial Infarction / Q000453:epidemiology / Q000209:etiology; D011183:Postoperative Complications / Q000453:epidemiology*; D011184:Postoperative Period; D020521:Stroke / Q000453:epidemiology / Q000209:etiology; D016019:Survival Analysis; D014481:United States; D014493:United States Department of Veterans Affairs