Bivalirudin Anticoagulant Therapy With or Without Platelet Glycoprotein IIb/IIIa Inhibitors During Transcatheter Coronary Interventional Procedures: A Meta-Analysis

The safety and effectiveness of using the direct thrombin inhibitor bivalirudin during transcatheter coronary interventional procedures remains uncertain. This study aimed to systematically assess anticoagulation with bivalirudin alone or bivalirudin plus glycoprotein (GP) IIb/IIIa inhibitors (bivalirudin-based anticoagulant therapy) in patients undergoing percutaneous coronary intervention (PCI) procedures by a meta-analysis of randomized controlled trials (RCTs). Systematical searches of the MEDLINE, EMBASE, and Cochrane databases were conducted. RCTs comparing bivalirudin-based anticoagulant therapy with a comparable heparin therapy in patients undergoing PCI were eligible. Risk ratios (RRs) with 95% confidence intervals (CIs) served as summary statistics. A total of 38,096 patients from 17 RCTs were randomized to the bivalirudin group (n = 18,878) or heparin group (n = 19,218) in the meta-analysis. No significant differences in death, myocardial infarction or reinfarction, ischemia-driven revascularization, or in-stent thrombosis were observed between the 2 groups (all P > 0.05). Notably, bivalirudin-based therapy showed a highly significant 34% decrease in the incidence of major bleeding (RR = 0.66; 95% CI 0.54–0.81; P < 0.001) and a 28% reduction in the need for blood transfusion (RR = 0.72; 95% CI 0.56–0.91; P < 0.01). Meta-regression analyses demonstrated that additional administration of GP IIb/IIIa receptor inhibitors (P = 0.01), especially eptifibatide (P = 0.001) and tirofiban (P = 0.002), was likely to increase the major bleeding risk associated with bivalirudin. Bivalirudin, in comparison to heparin, is associated with a markedly lower risk of major bleeding, and the additional use of GP IIb/IIIa inhibitors may weaken this benefit.