Bivalirudin reduces adverse clinical events during primary PCI

Patients undergoing percutaneous coronary intervention for ST-segment elevation MI may benefit from bivalirudin alone, compared with heparin plus glycoprotein IIb/IIIa inhibitors.

To determine the safety and efficacy of treatment with bivalirudin alone in high-risk patients, researchers from various sites in the United States and Europe randomly assigned 3,602 patients with ST-segment elevation MI who were undergoing PCI to treatment with either heparin plus a glycoprotein IIb/IIIa inhibitor or bivalirudin alone.

The researchers reported a reduction in the 30-day rate of net adverse clinical events with bivalirudin treatment, compared with heparin plus a glycoprotein IIb/IIIa inhibitor (9.2% vs. 12.1%; RR=0.76; 95% CI, 0.63-0.92). The reduction in net adverse events was due to a lower major bleeding rate (4.9% vs. 8.3%; RR=0.60; 95% CI, 0.46-0.77). Risk of acute stent thrombosis was elevated within 24 hours in the bivalirudin group, but was not present at 30 days.

A lower 30-day rate of death from cardiac causes was reported in the bivalirudin group, compared with the heparin group (1.8% vs. 2.9%; RR=0.62; 95% CI, 0.40-0.95), along with all-cause mortality (2.1% vs. 3.1%; RR=0.66; 95% CI, 0.44-1.00). – by Stacey L. Adams

N Engl J Med.2008;358:2218-2230.