Anticoagulation with bivalirudin for off-pump coronary artery bypass grafting: The results of the EVOLUTION-OFF study

被引:69
作者
Smedira, NG
Dyke, CM
Koster, A
Jurmann, M
Bhatia, DS
Hu, TF
McCarthy, HL
Lincoff, AM
Spiess, BD
Aronson, S
机构
[1] Cleveland Clin Fdn, Cleveland, OH 44195 USA
[2] Duke Univ, Med Ctr, Durham, NC USA
[3] Houston NW Med Ctr, Houston, TX USA
[4] Gaston Mem Hosp, Gastonia, NC USA
[5] Deutsch Herzzentrum Berlin, Berlin, Germany
[6] Virginia Commonwealth Univ, Med Ctr, VCURES, Richmond, VA USA
关键词
D O I
10.1016/j.jtcvs.2005.10.049
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Objectives: Unfractionated heparin has many shortcomings, including indirect and partial inhibition of thrombin, antibody formation, and platelet activation. Bivalirudin, a short- acting direct thrombin inhibitor, avoids these limitations and has superior outcomes during percutaneous revascularization. This trial was performed to evaluate the safety and efficacy of bivalirudin in off- pump coronary artery bypass grafting. Methods: An open- label, multicenter randomized trial compared heparin with protamine reversal to bivalirudin in patients undergoing off- pump coronary artery bypass. The primary objective was safety as demonstrated by similar rates of procedural success defined as freedom from a composite of death, myocardial infarction, stroke, and repeat revascularization. Twenty- one institutions randomized 105 patients to receive bivalirudin and 52 patients to receive heparin. Results: The mean age was 65 years for both groups. The bivalirudin group had more grafts: 3.0 +/- 1 versus 2.5 +/- 1. Procedural success rates at 30 days were identical in bivalirudin- and heparin- treated patients ( 93%). Operative times, total blood loss, reoperations for bleeding, and major adverse events were not significantly different. Strokes were more frequent in the heparin group: 5.5% versus 0; P = .05. Mortality was 2% in each group. Repeat revascularization was required in 3% of bivalirudin- and 2% of the heparin- treated patients. Conclusions: For patients undergoing off- pump coronary artery bypass grafting, bivalirudin was an effective anticoagulant, without excessive bleeding and with a safety profile similar to that of heparin. Further trials are warranted to assess whether anticoagulation with bivalirudin improves clinical outcomes.
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收藏
页码:686 / 692
页数:7
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