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31st Annual Meeting Abstracts: Bivalirudin is a Safe and Effective Anticoagulant for Off- Pump Coronary Artery Bypass Grafting
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10. Bivalirudin is a Safe and Effective Anticoagulant for Off- Pump Coronary Artery Bypass Grafting
N. G. Smedira1, C. M. Dyke2, A. Koster3, M. Jurmann3, D. S. Bhatia4, H. L. Mc Carthy5, A. M. Lincoff1, B. D. Spiess5. 1Cleveland Clinic, Cleveland, OH, 2Sanger Clinic, Gastonia, SC, 3Deutsches Herzzentrum, Berlin, Germany, 4Houston North West Medical Center, Houston, TX, 5Virginia Commonwealth University Medical Center, Richmond, VA,
| Background: 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. Though pilot data suggest improved patency rates with bivalirudin in OPCAB, experience in cardiac surgery is limited. This trial was performed to evaluate the safety and efficacy of bivalirudin in OPCAB. | | Methods: A multi-center randomized trial compared heparin with protamine reversal to bivalirudin in patients undergoing OPCAB. The primary objective was safety as demonstrated by comparable rates of death, myocardial infarction, stroke and repeat revascularization. Twenty-one institutions enrolled 105 bivalirudin and 52 heparin patients, of which 101 and 56 patients respectively received at least one dose of the study drug. Results presented are for patients receiving drug. | | Results: See the table below. | | Conclusions: Conclusion: For patients undergoing OPCAB, bivalirudin was an effective anticoagulant with a similar safety profile to heparin with protamine reversal. Significantly less bleeding was observed up to 12 hours for patients in the bivalirudin group, and trending toward a lower percentage of transfusions. Further controlled trials are warranted to assess whether anticoagulation with bivalirudin improves clinical outcomes. |
| Bivalirudin | Heparin | p-value | | n=101 | n=56 | | | Mean age | 64.5 | 65.5 | 0.6 | | # of Grafts | 3.0 | 2.5 | 0.001 | | LIMA % | 97 | 93 | 0.9 | | Length of Surgery (min) | 205+/-84 | 194+/-71 | 0.4 | | Median blood loss at 12 hours (ml) | 475 | 800 | 0.008 | | Blood loss at 12 hours, Q1,Q3 | 425, 600 | 500, 900 | | | Reop for Bleeding (%) | 8 | 5 | 0.5 | | Transfused (%) | 46 | 59 | 0.1 | | Death, n/N (%) | 2/100 (2) | 1/56 (2) | 0.9 | | All Peri-op MI''s | 9/101 (9) | 3/56 (5) | 0.4 | | Stroke | 0/98 | 3/55 (6) | 0.02 | | Revascularization | 3/98 (3) | 1/56 (2) | 0.6 |
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