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.