NATICK, Mass. and SAN FRANCISCO, Sept. 21 /PRNewswire-FirstCall/ -- Boston Scientific Corporation (NYSE: BSX) today welcomed three-year results from the SPIRIT III clinical trial, which continue to reaffirm the proven long-term safety of the Company's portfolio of drug-eluting stents, including the first-generation TAXUS((R)) Express(2)(TM) Paclitaxel-Eluting Coronary Stent System and the XIENCE V(TM) (PROMUS((R))) Everolimus-Eluting Coronary Stent System. The results were presented at the Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in San Francisco 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.
"We are very pleased that our first-generation TAXUS Express Stent continued to perform well against our PROMUS Stent in the SPIRIT III trial at three years," said Donald S. Baim, M.D., Chief Medical and Scientific Officer of Boston Scientific. "The strong outcomes among diabetic patients were particularly impressive."
The results demonstrated that the XIENCE V (PROMUS) and TAXUS Express Stents had comparable safety outcomes through three years, with equivalent rates of cardiac death (1.4% versus 1.6%, p=0.68) and low and equivalent rates of stent thrombosis using the ARC (Academic Research Consortium) definite/probable definition (1.2% and 1.6%, p=0.67). No additional stent thromboses were reported between years two and three for either stent group.
The three-year rate of Ischemia-Driven Target Lesion Revascularization (TLR) was lower for the XIENCE V (PROMUS) Stent as compared to the TAXUS Express Stent (5.4% versus 8.9%, p=0.05), contributing to a benefit for XIENCE V (PROMUS) over the TAXUS Express Stent in the composite endpoints of Major Adverse Cardiac Events (MACE, a composite endpoint of Cardiac Death, Myocardial Infarction (MI) and TLR) (9.1% versus 15.7%, p=0.003) and Target Vessel Failure (TVF, a composite endpoint of Cardiac Death, MI and Ischemia-Drive Target Vessel Revascularization) (13.5% versus 19.2%, p=0.03).
The SPIRIT III results exhibited similar rates of safety and efficacy for the XIENCE V (PROMUS) and TAXUS Express Stents in diabetic patients, with TLR rates of 5.2% versus 4.8% and MACE rates of 10.3% versus 9.4%. The rate of TLR for TAXUS Express diabetic patients was 4.8 percent as compared to 10.5 percent in non-diabetic TAXUS Express patients.
"It is noteworthy that the rate of TLR - which was equivalent for PROMUS and TAXUS Express in diabetic patients - was actually lower in diabetic patients treated with TAXUS Express than in non-diabetics treated with TAXUS Express," added Dr. Baim.
The PROMUS Stent is a private-labeled XIENCE V Everolimus-Eluting Coronary Stent System manufactured by Abbott and distributed by Boston Scientific. SPIRIT III is sponsored by Abbott. TAXUS, TAXUS Express2, Express and PROMUS are trademarks of Boston Scientific Corporation or its affiliates. XIENCE is a trademark of Abbott Laboratories Group of Companies.
The safety and effectiveness of the TAXUS Express Stent has not been established in diabetic patients.
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.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding clinical trials, regulatory approvals, product performance and competitive offerings. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.
Factors that may cause such differences include, among other things: future economic, competitive, reimbursement and regulatory conditions; new product introductions; demographic trends; intellectual property; litigation; financial market conditions; and, future business decisions made by us and our competitors. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A- Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A - Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file thereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions, or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements. This cautionary statement is applicable to all forward-looking statements contained in this document.
CONTACT: Paul Donovan 508-650-8541 (office) 508-667-5165 (cell) Media Relations Boston Scientific Corporation Larry Neumann 508-650-8696 (office) Investor Relations Boston Scientific Corporation
|SOURCE Boston Scientific Corporation|
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