No Net Clinical Benefit for Bivalirudin During Percutaneous Coronary Intervention

In a randomized comparison of bivalirudin and heparin, a significant reduction in bleeding events in the bivalirudin group did not translate into reductions in overall morbidity or mortality.

The use of bivalirudin, a direct thrombin inhibitor, to prevent thrombosis during percutaneous coronary intervention is based primarily on study results demonstrating reduced bleeding compared with unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor. In the present multicenter, double-blind study, 4570 patients with normal enzyme levels undergoing PCI for stable or unstable angina were randomly assigned to receive bivalirudin or unfractionated heparin (without a glycoprotein IIb/IIIa inhibitor). All participants received clopidogrel (600 mg) at least 2 hours before the procedure.

The primary quadruple composite endpoint — death, MI, or urgent target-vessel revascularization within 30 days; or major bleeding during the index hospita…

Reviewing Author

Howard C. Herrmann, MD

Disclosures

Consultant/Advisory BoardAffluent Medical; Artedrone; Caranx; Johnson & Johnson; Medtronic; Prolifagen; Wells Fargo

EquityMicrointerventional Devices, Inc.

RoyaltiesUniversity of Pennsylvania

Grant/Research SupportAbbott Vascular; Edwards Lifesciences; Johnson & Johnson; Medtronic

Editorial BoardsCatheterization and Cardiovascular Interventions; Journal of the American College of Cardiology; Circulation: Cardiovascular Interventions; JACC Cardiovascular Interventions; JACC Case Reports; JSCAI