The Medicines Co Angiomax monotherapy superior to Heparins Plus GP IIb/IIIa combination for net clinical outcome in ACUITY trial (MDCO) 19.46 : Investigators Sunday reported results of the ACUITY trial of The Medicines Company's (MDCO) Angiomax. The trial met its objectives in favor of Angiomax. The results were presented as a late-breakinng trial at the American College of Cardiology Scientific Session. Statistically, ACUITY employed a sequential analysis, and met all levels of testing, including all six of the main pre-specified endpoints. The ACUITY trial showed that Angiomax alone is as effective as more complicated dual drug regimens, and results in significantly less bleeding, which means improved outcomes for patients," said principal investigator Dr. Gregg W. Stone. In the Angiomax monotherapy arm (Arm C), Angiomax demonstrated superiority for the net clinical outcome endpoint versus the heparins (unfractionated or low-molecular weight) plus GP IIb/IIIa inhibitor control arm (Arm A). Net clinical outcome event rates include death, myocardial infarction, revascularization and major bleeding. Major bleeding rates were significantly lower among patients treated with Angiomax versus control. Comparison of ischemic event rates (death, myocardial infarction, revascularization) met the pre-defined criteria for "non-inferiority," a statistical term for establishing one regimen is the same as the other.
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