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"In the HORIZONS AMI trial, the outcomes provide definitive evidence that,in patients with AMI, drug-eluting stents were superior in efficacy tobare-metal stents and had a comparable safety profile at one year," said GreggW. Stone, M.D., CRF Chairman, Professor of Medicine and the Director ofResearch and Education at the Center for Interventional Vascular Therapy atNew York Presbyterian-Hospital/Columbia University Medical Center andPrincipal Investigator of the HORIZONS AMI trial.
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"Outcomes from prior registry studies of drug-eluting stents compared tobare-metal stents in AMI patients have been conflicting; this is the firstprospective, large, international randomized clinical trial and providesconclusive evidence on this subject," continued Dr. Stone. "The findings fromthe HORIZONS AMI trial will have a major impact on how decisions are maderegarding drug-eluting and bare-metal stents in the highest risk patients inthis trial, those in the early hours of a heart attack. This study removesmuch of the uncertainty and concern about the efficacy and safety ofdrug-eluting stents in this clinical setting. Moreover, all of the patientsin this trial will be followed for five years to ensure that these favorableresults 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 theTAXUS Express(R) Stent, p=0.92). There was a statistically significant 41percent reduction in revascularization in the TAXUS Express group (7.5 percentfor 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 toprovide the medical community with relevant data they can use in combinationwith their own clinical judgment to decide optimal treatment strategies forpatients," said Donald S. Baim, M.D., Chief Medical and Scientific Officer ofBoston Scientific. "The HORIZONS trial provides valuable insight into thebenefits of the TAXUS Express Stent in a high-risk patient population."
The safety and effectiveness of the TAXUS Express Stent has not beenestablished in patients with AMI.
Boston Scientific is a worldwide developer, manufacturer and marketer ofmedical devices whose products are used in a broad range of interventionalmedical specialties. For more information, please visit:http://www.bostonscientific.com.
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Factors that may cause such differences include, among other things:future economic, competitive, reimbursement and regulatory conditions; newproduct introductions; demographic trends; intellectual property; litigation;financial market conditions; and, future business decisions made by us and ourcompetitors. All of these factors are difficult or impossible to predictaccurately and many of them are beyond our control. For a further list anddescription of these and other important risks and uncertainties that mayaffect our future operations, see Part I, Item 1A -- Risk Factors in our mostrecent Annual Report on Form 10-K filed with the Securities and ExchangeCommission, which we may update in Part II, Item 1A -- Risk Factors inQuarterly Reports on Form 10-Q we have filed or will file thereafter. Wedisclaim any intention or obligation to publicly update or revise anyforward-looking statements to reflect any change in our expectations or inevents, conditions, or circumstances on which those expectations may be based,or that may affect the likelihood that actual results will differ from thosecontained in the forward-looking statements. This cautionary statement isapplicable to all forward-looking statements contained in this document.CONTACT: Paul Donovan 508-650-8541 (office) 508-667-5165 (mobile) Media Relations Boston Scientific Corporation Larry Neumann 508-650-8696 (office) Investor Relations Boston Scientific Corporation
SOURCE Boston Scientific Corporation
