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Nicholas G. Smedira
Cornelius M. Dyke
Michael Jurmann
Devinder S. Bhatia
Harry L. McCarthy, II
Bruce D. Spiess
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J Thorac Cardiovasc Surg 2006;131:686-692
© 2006 The American Association for Thoracic Surgery

Evolving Technology

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

Nicholas G. Smedira, MD a , * , Cornelius M. Dyke, MD d , Andreas Koster, MD c , Michael Jurmann, MD c , Devinder S. Bhatia, MD e , Tingfei Hu, MS a , Harry L. McCarthy, II, BS, CCP b , A. Michael Lincoff, MD a , Bruce D. Spiess, MD b , Solomon Aronson, MD f

a Cleveland Clinic Foundation, Cleveland, Ohio
b VCURES/Virginia Commonwealth University Medical Center, Richmond, Va
c Deutsches Herzzentrum, Berlin, Germany
d Gaston Memorial Hospital, Gastonia, NC
e Houston North West Medical Center, Houston, Tex
f Duke University Medical Center, Durham, NC

Received for publication July 7, 2005; revisions received October 10, 2005; accepted for publication October 20, 2005.

* Address for reprints: Nicholas G. Smedira, MD, Cleveland Clinic Foundation, 9500 Euclid Ave/Desk F24, Cleveland, OH 44195. (Email: smedirn{at}ccf.org).

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.

Abbreviations and Acronyms ACT = activated clotting time; CABG = coronary artery bypass grafting; EVOLUTION = EValuation of Patients during coronary artery bypass graft Operations: Linking UTilization of bivalirudin to Improved Outcomes and New anticoagulant strategies; HIT = heparin-induced thrombocytopenia; MI = myocardial infarction; OPCAB = off-pump coronary artery bypass grafting; REPLACE = Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events; TIMI = thrombolysis in myocardial infarction


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