Percutaneous coronary intervention versus coronary bypass surgery in United States veterans with diabetes

Masoor Kamalesh, Thomas G. Sharp, X. Charlene Tang, Kendrick Shunk, Herbert B. Ward, James Walsh, Spencer King, Cindy Colling, Thomas Moritz, Kevin Stroupe, Domenic Reda

Research output: Contribution to journalArticlepeer-review

132 Scopus citations


Objectives: 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)

Original languageEnglish (US)
Pages (from-to)808-816
Number of pages9
JournalJournal of the American College of Cardiology
Issue number8
StatePublished - Feb 26 2013

Bibliographical note

Funding Information:
The study was funded by the VA Cooperative Studies Program and approved by the institutional review board at each site. An investigational device exemption was obtained, and all commercially available drug-eluting stents were allowed once they were approved by the U.S. Food and Drug Administration for use in the study. Treatment crossovers were discouraged but allowed. Patients could withdraw from the study at any time.


  • coronary artery bypass surgery
  • diabetes
  • percutaneous coronary intervention


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