Author + information
- Received August 7, 2012
- Revision received October 19, 2012
- Accepted November 12, 2012
- Published online February 26, 2013.
- Masoor Kamalesh, MD⁎,⁎ (, )
- Thomas G. Sharp, MD⁎,
- X. Charlene Tang, MD, PhD†,
- Kendrick Shunk, MD, PhD‡,
- Herbert B. Ward, MD, PhD§,
- James Walsh, MD, PhD⁎,
- Spencer King III, MD∥,
- Cindy Colling, RPh, MS¶,
- Thomas Moritz, MS†,
- Kevin Stroupe, PhD†,
- Domenic Reda, PhD†,
- VA CARDS Investigators
- ↵⁎Reprint requests and correspondence:
Dr. Masoor Kamalesh, Krannert Institute of Cardiology, Veterans Affairs Medical Center, 1481 West 10th Street, Indianapolis, Indiana 46202
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)
This study was supported by the Department of Veterans Affairs Cooperative Studies Section.
Dr. Shunk has received research support from InfraReDx, Siemens Medical Systems, Gilead Sciences, and Abbott Vascular. Dr. King has received honoraria as a member of the data safety monitoring boards of Merck & Company, Wyeth, nContact Surgical, and Medtronic and has equity in and is a consultant for Celonova Biosciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Other site investigators for the Veterans Affairs Coronary Artery Revascularization in Diabetes Study are listed in the Appendix.
- Received August 7, 2012.
- Revision received October 19, 2012.
- Accepted November 12, 2012.
- American College of Cardiology Foundation