Objectives Recently, several randomised trials comparing bivalirudin with heparin plus glycoprotein IIb/IIIa inhibitors (GPIs) in patients undergoing percutaneous coronary intervention (PCI) had been published. The purpose of this study was to perform an up-to-date meta-analysis of randomised trials on the efficacy and safety of bivalirudin versus heparin plus GPIs in patients undergoing PCI.

Methods All published clinical randomised trials comparing heparin plus GPIs with bivalirudin in patients undergoing PCI were included. The literature was searched through electronic databases which contained MEDLINE, Pubmed, Elsevier, Cochrane clinical trials and Clinical Trials.gov database from January 2000 to December 2011.

Results Ten randomised trials enrolling 21,932 patients were included. Compared with heparin plus GPIs, bivalirudin associated with lower rates of major bleeding (P < 0.00001), minor bleeding (P < 0.00001), long-term mortality (P = 0.02), and short-term net clinical adverse events (P = 0.004). There were no significantly different rates of the major adverse cardiovascular events (≤ 30 days: P = 0.26; > 30 days: P = 0.10) and myocardial infarction events (≤30 days: P = 0.19; > 30 days: P = 0.84) between two groups. However, bivalirudin administration resulted in an increased long-term incidence of target vessel revascularisation (P = 0.02) and a high trend in individual definition of revascularisation (P = 0.07).

Conclusions Among the patients undergoing PCI, anticoagulation with bivalirudin results in lower rates of bleeding, long-term death, and short-term net clinical adverse events, but similar MI and MACE events compared with heparin plus GPIs. Even though the long-term risk of target vessel revascularisation in bivalirudin group is relatively higher.