Bivalirudin versus heparin for percutaneous coronary intervention: an updated meta-analysis of randomized controlled trials.

AIMS: Given controversy over anticoagulation regimens for percutaneous coronary intervention (PCI), we performed an updated meta-analysis of randomized controlled trials (RCTs) to compare bivalirudin versus heparin.

METHODS AND RESULTS: Medline/Pubmed and Cochrane CENTRAL were searched for all RCTs comparing bivalirudin with provisional glycoprotein IIb/IIIa inhibitor (GPI) use versus heparin with provisional or routine GPI use for PCI. Pooled estimates of 30day outcomes, presented as risk ratios (RR) [95% confidence intervals], were generated with random-effect models. Our analysis included 14 studies with 30,446 patients that were randomized to bivalirudin with provisional GPI use (n=14,869) versus heparin with provisional (n=6451) or routine GPI use (n=9126). There was no significant difference between anticoagulation with bivalirudin compared with heparin for death (RR 0.95 [0.78-1.14]) or myocardial infarction (RR 1.10 [0.97-1.25]). Early stent thrombosis was significantly greater with bivalirudin compared with heparin (RR 1.61 [1.18-2.20], p=0.003), especially in patients undergoing primary PCI (2.15 [1.15-4.03], p=0.02). However, bivalirudin reduced the risk of major bleeding (RR 0.59 [0.51-0.70], p<0.0001) and TIMI major bleeding (RR 0.59 [0.48-0.72], p<0.0001) compared with heparin. Meta-regression analysis demonstrated that bleeding risk with use of heparin significantly increases with increasing GPI use (p=0.02).

CONCLUSION: Meta-analysis of 14 RCTs with 30,446 patients demonstrated that bivalirudin is associated with higher risk of stent thrombosis but lower risk of major bleeding compared with heparin.