Landmark trial provides new insight for physicians
NATICK, Mass. and WASHINGTON, Oct. 15 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) today announced results from an analysis of the HORIZONS AMI trial. The HORIZONS AMI trial, sponsored by the Cardiovascular Research Foundation (CRF) with research grant support from Boston Scientific and The Medicines Company (Nasdaq: MDCO) is designed to determine the safety and efficacy of the TAXUS(R) Express2(TM) Paclitaxel-Eluting Coronary Stent System compared to bare-metal stenting in patients experiencing an acute myocardial infarction (AMI), commonly referred to as a heart attack. With 3,006 patients enrolled globally, the HORIZONS AMI trial will provide the medical community with critical data from one of the largest randomized clinical trials ever performed in patients with heart attacks. Heart attack patients are often treated with bare-metal stents and are a more complicated patient population at higher risk of death. Analysis of the data was presented at CRF's 20th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, D.C.
"In the HORIZONS AMI trial, the outcomes provide definitive evidence that, in patients with AMI, drug-eluting stents were superior in efficacy to bare-metal stents and had a comparable safety profile at one year," said Gregg W. Stone, M.D., CRF Chairman, Professor of Medicine and the Director of Research and Education at the Center for Interventional Vascular Therapy at New York Presbyterian-Hospital/Columbia University Medical Center and Principal Investigator of the HORIZONS AMI trial.
"Outcomes from prior registry studies of drug-eluting stents compared to bare-metal stents in AMI patients have been conflicting; this is the first prospective, large, international randomized clinical trial and provides conclusive evidence on this subject," continued Dr. Stone. "The findings from the HORIZONS AMI trial will have a major impact on how decisions are made regarding drug-eluting and bare-metal stents in the highest risk patients in this trial, those in the early hours of a heart attack. This study removes much of the uncertainty and concern about the efficacy and safety of drug-eluting stents in this clinical setting. Moreover, all of the patients in this trial will be followed for five years to ensure that these favorable results are maintained."
One-year results showed comparable overall safety outcomes (death, stroke, myocardial infarction or stent thrombosis) between the two treatment groups (8.0 percent for the Express(R) bare-metal stent versus 8.1 percent for the TAXUS Express(R) Stent, p=0.92). There was a statistically significant 41 percent reduction in revascularization in the TAXUS Express group (7.5 percent for the Express Stent versus 4.5 percent for the TAXUS Express Stent, p=0.002).
"Our investments in drug-eluting stent clinical trials are designed to provide the medical community with relevant data they can use in combination with their own clinical judgment to decide optimal treatment strategies for patients," said Donald S. Baim, M.D., Chief Medical and Scientific Officer of Boston Scientific. "The HORIZONS trial provides valuable insight into the benefits of the TAXUS Express Stent in a high-risk patient population."
The safety and effectiveness of the TAXUS Express Stent has not been established in patients with AMI.
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: http://www.bostonscientific.com.
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Boston Scientific Corporation
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|SOURCE Boston Scientific Corporation|
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