Abstract

Background:Recent data suggest that Bivalirudin provides ischemic protection superior to Heparin,and comparable to Heparin plus glycoprotein IIb/IIIa inhibitors, with significantly fewer bleeding complications. Whetherthis advantage persists in large population has not beenfully defined.

Objective: This study systematically evaluates clinical outcomes of treatment with Bivalirudinvs Heparin in patients of acute coronary syndrome undergoing Percutaneous coronary interventions (PCI).

Methods: We analyzed prospective, randomized controlled trials via electronic searches that have reported clinical outcomes at 7 and 30 days. The outcomes were major bleeding, net clinical outcomes and Major Adverse Cardiac Events – MACE. Data from individual trials were combined by a meta analysis method of Mantel-Haenszelcalculate a relative risk (RR) and 95% confidence interval (95%CI) across the studies.Theheterogeneity across the trials was assessed through χ² statistic, I² andvisual inspection of the forest plots.

Results: This meta-analysis involved a total of 30,088 patients (Bivalirudin, n=15,105; Heparin, n=14,983). Compared with Heparin, Bivalirudin was associated with a lower risk of major bleeding (RR 0.38; 95%CI 0.29-0.48 at 7 days and RR 0.67;95%CI 0.60-0.75 at 30 days), net clinical outcomes (RR 0.56; 95%CI 0.47-0.66 at 7 days and RR 0.89; 95%CI 0.83-0.96 at 30 days) and MACE (RR 0.78; 95%CI 0.63-0.96 at 7 days). There was no significant difference in case of MACE at 30 days (RR 1.02; 95%CI 0.93-1.11).  Heterogeneity was observed across the trials that reported major bleeding (χ²=14.71, 5 df, p=0.01, I²=66%) at 30 days, but not at 7 days for reported major bleeding, and also for net clinical outcomes and MACE both at 7 days and 30 days.

Conclusion: This analysis further supports that Bivalirudin provides significantimprovement in net clinical outcomes and MACE with a significant reduction of bleedingcomplications.