Bivalirudin during Primary PCI in Acute Myocardial Infarction

Bivalirudin during Primary PCI in Acute Myocardial Infarction

May 22, 2008 | Gregg W. Stone, M.D., Bernhard Witzenbichler, M.D., Giulio Guagliumi, M.D., Jan Z. Peruga, M.D., Bruce R. Brodie, M.D., Dariusz Dudek, M.D., Ran Kornowski, M.D., Franz Hartmann, M.D., Bernard J. Gersh, M.B., Ch.B., D.Phil., Stuart J. Pocock, Ph.D., George Dangas, M.D., Ph.D., S. Chiu Wong, M.D., Ajay J. Kirtane, M.D., Helen Parise, Sc.D., and Roxana Mehran, M.D., for the HORIZONS-AMI Trial Investigators*
The HORIZONS-AMI trial evaluated the safety and efficacy of bivalirudin compared to heparin plus glycoprotein IIb/IIIa inhibitors in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI. The study randomly assigned 3602 patients to receive either bivalirudin alone or heparin plus glycoprotein IIb/IIIa inhibitors. The primary endpoints were major bleeding and combined adverse clinical events (major bleeding or major adverse cardiovascular events). Bivalirudin resulted in a significantly lower 30-day rate of net adverse clinical events (9.2% vs. 12.1%; relative risk, 0.76; P=0.005) due to a lower rate of major bleeding (4.9% vs. 8.3%; relative risk, 0.60; P<0.001). Bivalirudin also reduced 30-day rates of death from cardiac causes (1.8% vs. 2.9%; relative risk, 0.62; P=0.03) and death from all causes (2.1% vs. 3.1%; relative risk, 0.66; P=0.047). The trial found that bivalirudin improved event-free survival at 30 days by significantly reducing major bleeding, with similar rates of major adverse cardiovascular events compared to heparin plus glycoprotein IIb/IIIa inhibitors.The HORIZONS-AMI trial evaluated the safety and efficacy of bivalirudin compared to heparin plus glycoprotein IIb/IIIa inhibitors in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI. The study randomly assigned 3602 patients to receive either bivalirudin alone or heparin plus glycoprotein IIb/IIIa inhibitors. The primary endpoints were major bleeding and combined adverse clinical events (major bleeding or major adverse cardiovascular events). Bivalirudin resulted in a significantly lower 30-day rate of net adverse clinical events (9.2% vs. 12.1%; relative risk, 0.76; P=0.005) due to a lower rate of major bleeding (4.9% vs. 8.3%; relative risk, 0.60; P<0.001). Bivalirudin also reduced 30-day rates of death from cardiac causes (1.8% vs. 2.9%; relative risk, 0.62; P=0.03) and death from all causes (2.1% vs. 3.1%; relative risk, 0.66; P=0.047). The trial found that bivalirudin improved event-free survival at 30 days by significantly reducing major bleeding, with similar rates of major adverse cardiovascular events compared to heparin plus glycoprotein IIb/IIIa inhibitors.
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[slides and audio] Bivalirudin during primary PCI in acute myocardial infarction.