Original title: Bivalirudin versus heparin in patients treated with percutaneous coronary Intervention: a meta-analysis of randomised trials. Reference: Salvatore Cassese et al. EuroIntervention 2014;10-online publish-ahead-of-print August 2014.

Current recommendations for the use of bivalirudin in PCI patients are mostly based on studies comparing bivalirudin vs. heparin combined with glycoprotein IIb/IIIa inhibitors. Whether bivalirudin is superior to heparin alone has not yet been established. This meta-analysis studied the safety and efficacy of bivalirudin vs. heparin in PCI patients without a planned administration of glycoprotein IIb/IIIa inhibitors. 

Primary end points at 30 days were death and major bleeding; secondary end points, also at 30 days, included AMI incidence, definite in-stent thrombosis and urgent revascularization of target vessel. 10 studies were analyzed including 18065 patients randomized to bivalirudin (n=9033) vs heparin (n=9032). 

At 30 days, both drugs showed similar mortality rates (OR 1.09 CI 95% 0.83 to 1.41; p=0.54) and AMI rates (OR 1.10 CI 95% 0.83 to 1.46; p=0.50) with a tendency to a greater need of urgent target vessel revascularization in patients treated with bivalirudin (OR 1.37 CI 95% 0.96 to 1.96; p=0.08).

Bleeding risk turned out to be significantly lower with bivalirudin (OR 0.57 CI 95% 0.40 to 0.80; p=0.001) and this reduction was even more patent the higher the heparin dose. On the contrary, the risk of definite stent thrombosis was higher with bivalirudin (OR 2.09 CI 95% 1.26 to 3.47; p=0.005), and especially the risk of acute thrombosis (OR 3.48 CI 95% 1.66 to 7.28; p<0.001).

Conclusion

Bivalirudin and heparin showed a similar mortality risk in the context of PCI. Bivalirudin reduced bleeding risk significantly at the expense of a higher risk of acute stent thrombosis.

Editorial Comment

The first randomized trials and meta-analysis showed bivalirudin significantly reduced bleeding complications in the context of PCI. Based on this evidence, bivalirudin received a class I recommendation in the guidelines as antiplatelet agent in the PCI context. However, all of these studies compared a fixed combination of heparin and glycoprotein IIb/IIIa inhibitors. 

The problem is that glycoprotein inhibitors in the daily practice are used only in case of rescue, and not as a planned routine strategy, which undermines the applicability of these first studies that earned bivalirudin a class I recommendation. In addition, when we look at the newest and most powerful antiplatelet agents and the evident reduction of bleeding with the radial approach, we understand why bivalirudin has lately been under such scrutiny. 

SOLACI