This systematic review pooled three randomized trials involving 407 adults undergoing cardiac surgery, comparing bivalirudin with unfractionated heparin for anticoagulation. Reexploration for hemorrhage, the primary outcome, did not differ significantly between groups (risk ratio 1.38, 95% confidence interval 0.42–4.48). No observable differences were reported in thromboembolic events, mortality, or postoperative transfusion requirements. All included trials had some concern for risk of bias, although interstudy heterogeneity was low across comparisons. The review also identified variability in bivalirudin dosing and therapeutic monitoring as limitations.
The pooled trials did not establish a difference in major postoperative outcomes. The wide confidence interval for reexploration leaves substantial uncertainty and does not establish equivalence or safety.
Study limitation: Only 407 patients were pooled, with risk-of-bias concerns and variable bivalirudin dosing and monitoring.
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