Once Again, Bivalirudin Alone Bests Heparin plus a GPI

Compared with the combination of heparin and a glycoprotein IIb/IIIa inhibitor (GPI), bivalirudin confers a lower bleeding risk but is also a less potent inhibitor of platelet aggregation. In patients undergoing primary percutaneous coronary intervention (PCI) for ST-segment-elevation myocardial infarction (STEMI), bivalirudin alone produced significantly better clinical outcomes than heparin plus a GPI (JW Cardiol Aug 3 2011). Now, investigators have compared the two strategies in 1717 patients with non-STEMI undergoing early PCI (within 24 hours after admission) in a double-blind, randomized, multicenter study. Participants received aspirin and 600 mg of clopidogrel, followed by either intravenous heparin plus abciximab or bivalirudin.

The rate of the primary composite endpoint — death, large MI, urgent target-vessel revascularization, and major bleeding at 30 days — was 10.9% in the heparin/abciximab group and 11.0% in the bivalirudin group (a nonsignificant difference). The rate of death, any MI, or urgent revascularization was also similar in the two groups. However, major bleeding was more frequent with heparin/abciximab (4.6%) than with bivalirudin (2.6%; relative risk, 1.84; P=0.02). Using TIMI (Thrombolysis in MI) bleeding definitions, major bleeding was similar in the two groups, and minor bleeding was significantly less common with bivalirudin. Almost all procedures were performed with femoral artery access, and closure devices were used in 21% of patients. Profound thrombocytopenia occurred only with heparin/abciximab (1.2%).