Healthcare Industry News: stent thrombosis
News Release - September 22, 2009
TAXUS(R) Liberte(R) Stent Continues to Demonstrate Significant Improvements Over TAXUS(R) Express(R) Stent in Small Vessels and Long LesionsThree-year TAXUS ATLAS results show safety and efficacy advantages for Boston Scientific TAXUS Liberte Stent
NATICK, Mass. and SAN FRANCISCO, Sept. 22 (Healthcare Sales & Marketing Network) -- Boston Scientific Corporation (NYSE: BSX ) today announced comprehensive data from the TAXUS ATLAS clinical program, a series of global, prospective, single-arm trials evaluating the TAXUS(R) Liberte(R) Paclitaxel-Eluting Stent System in a variety of lesions and patient groups. Three-year results from the TAXUS ATLAS Small Vessel and Long Lesion Trials continue to show significant advantages for the newer TAXUS Liberte Stent when compared to the first-generation TAXUS(R) Express(R) Stent. The data were presented at the 21(st) annual Cardiovascular Research Foundation's (CRF) annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in San Francisco.
The TAXUS ATLAS Small Vessel Trial was designed to evaluate the long-term safety and efficacy of the 2.25 mm diameter TAXUS(R) Liberte(R)( )Atom((TM)) Stent in small coronary vessels. The TAXUS ATLAS Long Lesion Trial was designed to assess the long-term safety and efficacy of the TAXUS(R) Liberte(R) Long 38 mm Stent in patients with long coronary lesions. Boston Scientific remains the only company to offer both 2.25 mm diameter and 38 mm length drug-eluting coronary stents in the U.S.
Three-year results from the TAXUS ATLAS Small Vessel Trial demonstrated a statistically significant reduction in the rate of Target Lesion Revascularization (TLR) in small vessels treated with the TAXUS Liberte Atom Stent as compared to the TAXUS Express Atom Stent (10.0% vs. 22.1%, p=0.008), representing a 55 percent relative risk reduction. Additionally, the three-year MACE rate for the TAXUS Liberte Atom Stent was 19.5 percent as compared to 32.4 percent for the TAXUS Express Atom Stent (p=0.03), a relative reduction of 40 percent. The composite safety measure of cardiac death or myocardial infarction (MI, commonly referred to as heart attack) remained numerically lower at three years for the TAXUS Liberte Atom Stent as compared to the TAXUS Express Atom Stent (6.5% vs. 7.4%, p=0.79).
"The TAXUS ATLAS Small Vessel Trial showed a sustained and significantly reduced risk of revascularization in small vessels for the TAXUS Liberte Atom Stent as compared to the TAXUS Express Atom Stent out to three years," said Mark A. Turco, M.D., Director of the Center for Cardiac and Vascular Research, Washington Adventist Hospital, and Co-Principal Investigator of the trial. "Positive three-year data from the TAXUS ATLAS Long Lesion Trial showed the TAXUS Liberte Long Stent significantly reduces the risk of MI and cardiac death in long lesions compared to the TAXUS Express Stent, while reporting zero percent stent thrombosis. These data, combined with the previously reported reduction in nine-month late-loss, suggest that these improvements are likely the result of the thinner struts and improved stent geometry of the TAXUS Liberte Stent."
In the TAXUS ATLAS Long Lesion Trial, the TAXUS Liberte Long Stent demonstrated significantly improved safety outcomes when treating long lesions compared to the TAXUS Express Stent. The rate of cardiac death showed a significant 78 percent reduction in patients treated with the TAXUS Liberte Long Stent compared to the TAXUS Express Stent (1.5% vs. 6.7%, p=0.03). Overall MI showed a significant 72 percent reduction at three years in patients receiving a single TAXUS Liberte Long Stent compared to a single TAXUS Express Stent (2.9% vs. 10.4%, p=0.01). This improvement was primarily driven by a significant reduction in non-Q wave MI. The TAXUS Liberte Long Stent had zero stent thrombosis at three years using either the Protocol definition or the ARC definite/probable definition while the control TAXUS Express Stent reported 0.8 percent stent thrombosis (p=0.49) using the Protocol definition and 3.9 percent (p=0.03) using the ARC definition.
"The TAXUS ATLAS studies continue to show that the TAXUS Liberte Stent delivers significant improvements over the TAXUS Express Stent in small vessels and long lesions," said Hank Kucheman, Senior Vice President and Group President, Cardiovascular for Boston Scientific. "TAXUS Stents have been evaluated by the industry's most extensive clinical trial program and the next-generation TAXUS Liberte Stent is the only platform to offer both 2.25 mm and 38 mm drug-eluting stents. TAXUS Liberte continues to be an effective treatment option for coronary artery disease that has earned the confidence of physicians worldwide."
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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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, competitive offerings, product performance and our market position. 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.
Source: Boston Scientific
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