NATICK, Mass., Sept. 25 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) today announced three-year follow-up data from the HORIZONS-AMI trial. The trial, sponsored by the Cardiovascular Research Foundation (CRF) with grant support from Boston Scientific and The Medicines Company (Nasdaq: MDCO), is designed to determine the safety and efficacy of the TAXUS® Express2™ Paclitaxel-Eluting Coronary Stent System compared to bare-metal stenting in patients experiencing an acute myocardial infarction (AMI), or heart attack. With 3,006 patients enrolled worldwide, HORIZONS-AMI is the largest randomized trial to compare the use of drug-eluting stents to bare-metal stents for AMI patients. Analysis of the data was presented by Gregg W. Stone, M.D., Professor of Medicine and the Director of Research and Education at the Center for Interventional Vascular Therapy at the Columbia University Medical Center/New York-Presbyterian Hospital and Principal Investigator of the trial, at CRF’s annual Transcatheter Cardiovascular Therapeutics scientific symposium in Washington, D.C.
“Follow-up data from the HORIZONS-AMI trial continue to show that, in patients with AMI, paclitaxel-eluting stents were superior in efficacy to bare-metal stents and had a comparable safety profile,” said Dr. Stone. “Significant reductions in measures of re-intervention at three years were observed with no evidence of late catch-up.”
HORIZONS-AMI demonstrated that the TAXUS Express Stent significantly reduced clinical and angiographic restenosis compared to an otherwise identical bare-metal Express® control stent. After three years follow-up, the primary efficacy endpoint of ischemia-driven target lesion revascularization (TLR) was 9.4 percent for patients treated with TAXUS Express vs. 15.1 percent for bare-metal Express (p<0.001), a relative reduction of 40 percent. The secondary efficacy endpoint of ischemia-driven target vessel revascularization (TVR) was 12.4 percent for TAXUS Express vs. 17.6 percent for bare-metal Express (p<0.001), a relative reduction of 32 percent.
The primary safety endpoint of major adverse cardiac events (MACE) at three years was comparable for TAXUS Express and bare-metal Express patients (13.6 percent vs. 12.9 percent, respectively, p=0.66), which is consistent with findings at one and two years. Individual rates of death, repeat heart attack, stroke and stent thrombosis between the two groups through three years of follow-up were also comparable.
“Results from the HORIZONS-AMI trial continue to show the impressive benefits of paclitaxel-eluting stent technology in this important high-risk AMI patient population,” said Keith D. Dawkins, M.D., Senior Vice President and Chief Medical Officer for Boston Scientific’s Cardiology, Rhythm and Vascular Group. “Boston Scientific continues to support large clinical trials that provide the medical community data that can be used in combination with broader clinical judgment to develop optimal treatment strategies for challenging patient subsets.”
The TAXUS Express Stent and the Express Stent are not specifically indicated by the U.S. Food and Drug Administration for use in patients with AMI.
About Boston Scientific
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: www.bostonscientific.com.
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