Efficacy and safety of bivalirudin for percutaneous coronary intervention in acute coronary syndromes: a meta-analysis of randomized-controlled trials

The efficacy and safety of bivalirudin in patients undergoing percutaneous coronary intervention (PCI) for treatment of acute coronary syndromes (ACS) remains controversial despite recent evidence from large randomized-controlled trials (RCTs). Thus, this systematic review and meta-analysis sought to investigate the efficacy and safety of bivalirudin as compared to heparin in patients with ACS undergoing PCI. Medline/PubMed, Cochrane Central Register of Controlled Trials, and Clinical Trials.gov databases were searched for RCTs. Primary endpoint was MACE consisting of all-cause death, myocardial infarction, and stroke within 30 days. Secondary endpoints were components of the primary endpoint and stent thrombosis. The primary safety endpoint was major bleeding. We identified 12 RCTs comprising 33,844 patients. Between bivalirudin and heparin, there were no significant differences for MACE (OR 1.06; 95% CI 0.96-1.17; p = 0.24), death, myocardial infarction, and stent thrombosis. Similar results were seen following stratification by use of glycoprotein inhibitors (GPI). Major bleeding trended to be less frequent in patients treated with bivalirudin. However, no safety benefit for bivalirudin was seen when use of GPI was balanced between groups (OR 0.88; 95% CI 0.67-1.16; p = 0.35; p for heterogeneity < 0.01). Compared with heparin, bivalirudin was associated with a similar incidence of ischemic events following PCI for ACS. An association of bivalirudin with decreased bleeding was not seen with balanced use of GPI.