Lincoff AM et al. (2004) Long-term efficacy of bivalirudin and provisional glycoprotein IIb/IIIa blockade vs heparin and planned glycoprotein IIb/IIIa blockade during percutaneous coronary revascularization. JAMA 292: 696–703

The Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE)-2 trial showed that the direct thrombin inhibitor bivalirudin, with provisional glycoprotein (Gp) IIb/IIIa inhibition, was noninferior to heparin plus planned Gp IIb/IIIa inhibition in preventing acute ischemic end points at 30 days. Major in-hospital bleeding rates were significantly reduced using the bivalirudin strategy, although concerns were raised about a small excess of periprocedural non-Q-wave myocardial infarctions (MI) in this group. Long-term (6 month and 1 year) results from this 6,010-patient trial have now been reported.

A trend towards a lower death rate was shown in the bivalirudin group at 6 months and at 1 year, although MI and revascularization rates tended to be lower in the heparin group at the 6-month stage. None of these trends was statistically significant. Subgroup analysis showed that the trend towards better survival with bivalirudin was greatest in 'high risk' patients.

The authors conclude that bivalirudin with provisional Gp IIb/IIIa blockade and heparin plus planned Gp IIb/IIIa blockade offer comparable long-term clinical outcomes. They note that the statistically significant reduction in bleeding observed in patients receiving bivalirudin may offset the nonsignificant increase in early MI rate in these patients. Furthermore, bivalirudin offers advantages in terms of cost savings and ease of administration.