Bivalirudin versus Heparin in ST and non-ST-segment elevation myocardial infarction

Abstract

Abstract Background The registry-based randomized VALIDATE-SWEDEHEART trial compared bivalirudin vs. heparin in patients undergoing percutaneous coronary intervention (PCI) for myocardial infarction (MI). It showed no difference in the composite primary endpoint of death, MI, or major bleeding at 180 days. Methods Analysis of primary and secondary endpoints at two years of follow-up was prespecified in the study protocol. We report here the study results for the extended follow-up time. Results In total, 6006 patients were enrolled, 3005 with ST-segment elevation MI (STEMI) and 3001 with Non-STEMI (NSTEMI), representing 70% of all eligible patients with these diagnoses during the course of the study. The primary endpoint occurred in 14.0% (421 of 3004) in the bivalirudin group compared with 14.3% (429 of 3002) in the heparin group (hazard ratio [HR] 0.97; 95% confidence interval [CI], 0.85 – 1.11; P=0.70) at one year and in 16.7% (503 of 3004) compared with 17.1% (514 of 3002), (HR 0.97; 95% CI, 0.96 – 1.10; P=0.66) at two years (Figure 1). The primary outcome at two years was consistent across all prespecified subgroups, including risk groups with high age, gender, chronic renal failure, diabetes mellitus, and smokers (Figure 2). Conclusions Till two-years follow-up there were no differences in endpoints between patients with MI undergoing PCI and allocated to bivalirudin compared with those allocated to heparin.Figure 1Figure 2