Profile of bleeding and ischaemic complications with bivalirudin and unfractionated heparin after percutaneous coronary intervention

Aims: The aim of this study was to identify a subset of patients athigh risk of bleeding or myocardial infarction from a percutaneouscoronary intervention and to investigate whether such high-risksubsets derive preferential benefit from heparin or bivalirudin. Methods and results: This study included 4570 patients with coronary artery diseaseenrolled in the Intracoronary Stenting and Antithrombotic Regimen:Rapid Early Action for Coronary Treatment trial and randomizedto receive bivalirudin or heparin. Primary outcomes were in-hospitalincidence of major bleeding and 30-day incidence of myocardialinfarction. Major bleeding, myocardial infarction, and bleedingplus myocardial infarction occurred in 140, 204, and 34 patients,respectively. Older age, female sex, lower body weight, lowcholesterol, multi-lesion intervention, complex lesions, andheparin therapy were independent correlates of increased riskof bleeding. Multi-lesion intervention, unstable angina, andlower body weight correlated independently with increased risksof myocardial infarction. Compared with heparin, bivalirudinwas associated with a reduction in major bleeding (3.1 vs. 4.6%,P = 0.008), but mostly in low-risk patients. A reduction inthe bleeding risk inversely correlated with an increase in therisk of myocardial infarction with bivalirudin (R = –0.61). Conclusion: Bivalirudin and unfractionated heparin have a differential effecton risk of bleeding and myocardial infarction across varioussubsets of patients.