In the international, large-scale prospective HORIZONS-AMI trial (Principal Investigator: Gregg Stone, MD), 3,602 patients were randomized to bivalirudin monotherapy vs. UFH+GPI. Of these, 1,445 patients underwent primary PCI of the LAD, whereas 1,884 patients underwent primary PCI of only non-LAD lesions. The occurrence of MACE (death, reinfarction, ischemic target vessel revascularization or stroke), major bleeding and net adverse clinical events (NACE = MACE or major bleeding) at 12 months were assessed in the two groups.
In comparing patients undergoing LAD versus non-LAD primary PCI, the rates of net adverse clinical events (19.3% vs. 15.4%), MACE (14.1% vs. 10.3%), death (5.6% vs. 2.8%) and cardiac death (4.2% vs. 1.9%) were significantly higher (all p<0.05) in LAD patients, whereas the rates of major bleeding (8.4% vs. 7.3%, p=0.27) and stent thrombosis (3.4% both) did not significantly differ.
Patients with LAD lesions were also randomized to treatment with bivalirudin (N=699) or UFH+GPI (N=746). The baseline clinical and angiographic features were well matched between these groups. "In patients treated with bivalirudin as compared to UFH+GPI, NACE (18.3% vs. 20.2%, p=0.31) and MACE (14.0% vs. 14.2%, p=0.90) did not significantly differ, whereas major bleeding (6.5% vs. 10.1%, p=0.01) and cardiac death (3.0% vs. 5.3%, p=0.04) were significantly lower in bivalirudin treated patients," said Dr. Whrle.
Patients undergoing primary PCI of LAD as compared to non-LAD lesions had significantly higher one-year rates of NACE, MACE, death and cardiac death. In patients undergoing PCI of LAD lesions, anticoagulation with bivalirudin monotherapy rather than unfractionated heparin + GPI resulted in significant lower rates of major bleeding and cardiac
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Cardiovascular Research Foundation