Bivalirudin beneficial in primary PCI for STEMI: HORIZONS-AMI

In patients with ST-segment elevation myocardial infarction who are undergoing primary PCI, the use of bivalirudin alone, as compared with heparin plus a glycoprotein IIb/IIIa inhibitor, results in significantly reduced 30-day rates of major bleeding and increased event-free survival, according to the Harmonizing Outcomes with Revascularization and Stents in Acute MI (HORIZONS-AMI) trial investigators. Previous studies have demonstrated that the direct thrombin inhibitor bivalirudin when used instead of heparin plus glycoprotein IIb/IIIainhibitors, has been shown to reduce major and minor bleeding and thrombocytopenia while resulting in similar rates of ischemia after PCI in patients with stable angina, those with unstable angina, and those withnon—ST-segment elevation myocardial infarction. It is not known whether bivalirudin is safe and effective for patients with ST-segment elevation myocardial infarction who are undergoing primary PCI, the researchers write in their paper published in the New England Journal of Medicine. They randomly assigned 3602 patients with ST-segment elevation myocardial infarction who presented within 12 hours after the onset of symptoms and who were undergoing primary PCI to treatmentwith heparin plus a glycoprotein IIb/IIIa inhibitor or to treatment with bivalirudin alone. The two primary end points of the study were major bleeding and combined adverse clinical events, defined as the combination of major bleeding or major adverse cardiovascular events, including death, reinfarction, target-vessel revascularization or ischemia, and stroke (referred to as net adverse clinical events) within 30 days. At 30 days, patients who were randomly assigned to receive bivalirudin alone had a significantly reduced rate of net clinical adverse events compared with the patients assigned to heparin plus a GPIIb/IIIa inhibitor, at 9.2% versus 12.1%, giving a 24% reduction in the relative risk (RR; p=0.005)....