March 26, 2012
/PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) announces its support of the HORIZONS II AMI clinical trial, which is designed to evaluate the safety and efficacy of the PROMUS Element™ Plus Everolimus-Eluting Platinum Chromium (PtCr) Coronary Stent compared to the OMEGA™ Platinum Chromium Bare-Metal Stent in patients experiencing an acute myocardial infarction (AMI), commonly referred to as a heart attack. The trial is co-funded by Boston Scientific Corporation and The Medicines Company (NASDAQ: MDCO). The Cardiovascular Research Foundation (CRF) will act as the Academic Research Organization (ARO). An overview of the trial design was presented at the American College of Cardiology Annual Scientific Sessions by
Gregg W. Stone
, M.D., Professor of Medicine and Director of Research and Education at the Center for Interventional Vascular Therapy at
Medical Center/New York-Presbyterian Hospital and Global Principal Investigator of the trial.
HORIZONS II AMI is a randomized, double-blind, superiority clinical trial that plans to enroll 7,000 to 10,000 patients at up to 400 sites worldwide, making it the largest randomized trial to study coronary stents in heart attack patients. The trial will compare the PROMUS Element Stent to the OMEGA Stent in patients undergoing primary percutaneous coronary intervention (PCI) for ST segment elevation acute myocardial infarction (STEMI). All patients will be pre-treated with Bivalirudin, Aspirin and Prasugrel, and then randomized to Clopidogrel or Prasugrel at 30 days post-procedure. The two primary clinical endpoints are target lesion revascularization (TLR) and stent thrombosis at 12 months. The study is designed to have sufficient power to demonstrate superiority for both endpoints. Clinical follow-up will occur at 30 days, six months, and every 12 months out to three years. The non-inferiority pharmacology endpoint is death, MI, stroke, stent thrombosis or TIMI (thrombolysis in myocardial infarction) major/minor bleeding between one and 15 months. Patient enrollment in the trial is scheduled to begin in late 2012. Data from the trial is expected to be used to support an expanded indication for the PROMUS Element Stent for the treatment of STEMI patients.