Percutaneous Coronary Intervention Versus Coronary Bypass Surgery in United States Veterans With Diabetes

被引：122

作者：

Kamalesh, Masoor ^{[1
]}

Sharp, Thomas G. ^{[1
]}

Tang, X. Charlene ^{[2
]}

Shunk, Kendrick ^{[3
]}

Ward, Herbert B. ^{[4
]}

Walsh, James ^{[1
]}

King, Spencer, III ^{[5
]}

Colling, Cindy ^{[6
]}

Moritz, Thomas ^{[2
]}

Stroupe, Kevin ^{[2
]}

Reda, Domenic ^{[2
]}

机构：

[1] Indiana Univ Sch Med, Roudebush VA Med Ctr, Indianapolis, IN USA

[2] Hines VA Cooperat Studies Program, Coordinating Ctr, Hines, IL USA

[3] Univ Calif San Francisco, VA Med Ctr, San Francisco, CA 94143 USA

[4] Univ Minnesota, Med Ctr, Minneapolis, MN 55455 USA

[5] St Josephs Heart & Vasc Inst, Atlanta, GA USA

[6] Clin Res Pharm Coordinating Ctr, Cooperat Studies Program, Albuquerque, NM USA

来源：

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY | 2013年 / 61卷 / 08期

关键词：

coronary artery bypass surgery; diabetes; percutaneous coronary intervention; FOLLOW-UP; REVASCULARIZATION; DISEASE; TRIALS;

D O I：

10.1016/j.jacc.2012.11.044

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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) (J Am Coll Cardiol 2013;61:808-16) (C) 2013 by the American College of Cardiology Foundation

引用

页码：808 / 816

页数：9

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