Bivalirudin Versus Heparin and Protamine in Adult Patients Undergoing Cardiac Surgery: A Systematic Review and Meta-Analysis.

OBJECTIVES

To summarize the evidence on the morbidity, mortality, and transfusion requirements of adult patients undergoing cardiac surgery using bivalirudin for anticoagulation compared to unfractionated heparin (UFH).

MEASUREMENTS AND MAIN

RESULTS

A total of 407 patients in three randomized controlled trial (RCTs) were included for pooled analysis. There was no significant difference in the primary outcome; reexploration for hemorrhage between groups (risk ratio: 1.38, 95% confidence interval: 0.42 to 4.48). There were no observable differences in any of the secondary outcomes; thromboembolic events (myocardial infarction, stroke, pulmonary embolism), mortality, or postoperative transfusion requirements (packed red cells (PRC), platelets, cryoprecipitate, fresh frozen plasma (FFP)). All studies included were assessed to have some concern for risk of bias. Interstudy heterogeneity was low across all comparisons.

CONCLUSION

Bivalirudin has not been shown to have any significant difference to UFH on clinical outcomes in patients undergoing cardiac surgery, and as per current international guidelines, can be considered for safe use in those patients for whom UFH is contraindicated. The study is limited by the bias of the included studies and the variability of bivalirudin drug dosage and its therapeutic monitoring; further, well-powered RCTs are required.