HORIZONS-AMI Finds Bivalirudin Reduces Cardiac Mortality in STEMI Patients Undergoing Primary PCI

January 7, 2014—Data on the reduction in cardiac mortality with bivalirudin in patients with and without major bleeding from the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) clinical trial were published by Gregg W. Stone, MD, et al in the Journal of the American College of Cardiology (2014:63:15–20).

The study's purpose was to determine whether, in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI), the reduction in cardiac mortality in those taking bivalirudin compared with unfractionated heparin plus a glycoprotein IIb/IIIa inhibitor (UFH + GPI) can be fully attributed to reduced bleeding. The background of the study is that the association between hemorrhagic complications and mortality may explain the survival benefit with bivalirudin.

The investigators concluded that bivalirudin reduces cardiac mortality in patients with STEMI undergoing primary PCI, an effect that can only partly be attributed to prevention of bleeding. Further studies are required to identify the nonhematologic benefits of bivalirudin.

As summarized in Journal of the American College of Cardiology, a total of 3,602 STEMI patients undergoing primary PCI were randomized to bivalirudin versus UFH + GPI. Three-year cardiac mortality was analyzed in patients with and without major bleeding.

The investigators found that when compared with UFH + GPI, bivalirudin resulted in lower 3-year rates of major bleeding (6.9% vs 10.5%; hazard ratio [HR], 0.64; 95% confidence interval [CI], 0.51 to 0.8; P < .0001) and cardiac mortality (2.9% vs 5.1%; HR, 0.56; 95% CI, 0.4 to 0.8; P = .001).

Three-year cardiac mortality was reduced in bivalirudin-treated patients with major bleeding (20 fewer deaths with bivalirudin; 5.8% vs 14.6%; P = .025) and without major bleeding (18 fewer deaths with bivalirudin; 2.6% vs 3.8%; P = .048). In a fully adjusted multivariable model accounting for major bleeding and other adverse events, bivalirudin was still associated with a 43% reduction in 3-year cardiac mortality (adjusted HR, 0.57; 95% CI, 0.39 to 0.83; P = .003), reported the investigators in Journal of the American College of Cardiology.