The Medicines Company Reports Positive Data From Myocardial Infarction Study
Posted on: Monday, 20 October 2008, 09:00 CDT
The Medicines Company has announced positive one-year follow-up data from the Horizons-AMI trial, which compared Angiomax to heparin plus a platelet glycoprotein IIb/IIIa inhibitor in 3,602 patients presenting with the most severe form of heart attack, known as ST-elevation myocardial infarction undergoing a primary percutaneous coronary intervention strategy.
The Horizons-AMI trial was a prospective, single-blind, randomized, multi-center study conducted in 11 countries. Patients undergoing angioplasty were randomly assigned to receive either Angiomax (bivalirudin) with provisional use of glycoprotein IIb/IIIa inhibitor (GPI) or heparin plus GPI. Patients enrolled in the Horizons-AMI trial also were assigned randomly to receive either Taxus drug-eluting stents or a bare-metal stent.
The two primary endpoints of the trial were major bleeding and net adverse clinical events, a composite of major adverse cardiovascular events (death, reinfarction, stroke or ischemic target vessel revascularization) and major bleeding at 30 days. The major secondary endpoint was major adverse cardiovascular events at 30 days.
The trial demonstrated that Angiomax significantly reduced cardiac-related death by 43%, improved overall survival by 31% and reduced major bleeding complications by 39% compared to heparin plus a platelet GPI in patients undergoing angioplasty. Angiomax showed an absolute reduction of 1.7% in cardiac-related death and 1.4% in all-cause death at one year.
These data also support results of previous studies showing an association between reduced major bleeding in angioplasty patients with greater long-term survival. Angiomax has been shown to result in less bleeding and similar rates of composite ischemia compared to heparin plus GPI in patients undergoing angioplasty for stable angina, unstable angina and non-ST-elevation myocardial infarction.
John Kelley, president and COO of The Medicines Company, said: "The totality of data demonstrates that Angiomax consistently improves outcomes across a broad spectrum of patients undergoing percutaneous coronary intervention (PCI). Angiomax is an innovative and valuable solution for critical care professionals treating heart attack patients undergoing PCI."
Source: Datamonitor
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