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

Published

Journal Article

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.

Full Text

Duke Authors

Cited Authors

  • Smedira, NG; Dyke, CM; Koster, A; Jurmann, M; Bhatia, DS; Hu, T; McCarthy, HL; Lincoff, AM; Spiess, BD; Aronson, S

Published Date

  • March 2006

Published In

Volume / Issue

  • 131 / 3

Start / End Page

  • 686 - 692

PubMed ID

  • 16515924

Pubmed Central ID

  • 16515924

Electronic International Standard Serial Number (EISSN)

  • 1097-685X

Digital Object Identifier (DOI)

  • 10.1016/j.jtcvs.2005.10.049

Language

  • eng

Conference Location

  • United States