Results

1. HORIZONS AMI Trial Design: HORIZONS AMI was a randomized, open-label trial ofbivalirudin (n = 1,800) or UFH plus glycoprotein (GP) IIb/IIIa inhibitors (n = 1,802) in patients undergoing planned primary PCI for acute MI. Primary endpoints were: 1) composite of major adverse ischemic cardiac events plus major bleeding at 30 days; and 2) major bleeding events at 30 days. • Results • Co-primary endpoint of death, MI, ischemic TVR, stroke, or major bleeding at 30 days ↓ in bivalirudin group, driven by ↓ major bleeding (Figures) • No difference in MACE at 30 days (5.4% for bivalirudin vs. 5.5% for GP IIb/IIIa inhibitor + UFH, p = 1.0) • No difference in stent thrombosis at 30 days (2.5% with bivalirudin vs. 1.9% with GP IIb/IIIa inhibitor + UFH, p = 0.33), but acute stent thrombosis within 24 hours ↑ in bivalirudin group (1.3% vs. 0.3%, p = 0.0009) • Conclusions • Among patients undergoing planned primary PCI for acute MI, use of bivalirudin was associated with reduction in composite of death, MI, TVR, stroke, or major bleeding at 30 days compared with heparin plus GP IIb/IIIa inhibitors, driven by reduction in major bleeding, with no difference in major adverse cardiac events • Results were similar to those of ACUITY trial in patients with acute coronary syndrome • Major limitation of trial was open-label design, with physicians aware of what study drug the patient received Death, MI, Ischemic TVR, Stroke, or Major Bleeding at 30 Days (p = 0.006) Major Bleeding at 30 Days (p < 0.001) % UFH + GP IIb/IIIa Inhibitor Bivalirudin Presented at TCT 2007