Healthcare Industry News: paclitaxel
News Release - April 1, 2008
Study Finds Taxus(R) Drug-Eluting Stent Beneficial in Treatment of Large VesselsResults from TAXUS IV and V randomized clinical trials favor DES compared to bare-metal stents
NATICK, Mass. and CHICAGO, April 1, 2008 (HSMN NewsFeed) -- Boston Scientific Corporation (NYSE: BSX ) today welcomed favorable outcomes of one- year data from the Company's TAXUS IV and V randomized clinical trials in patients who received the TAXUS® Express(TM) paclitaxel-Eluting Coronary Stent System compared to patients who received bare-metal stents (BMS). These results add to the growing body of evidence that paclitaxel-eluting stents are clinically beneficial over BMS even in the treatment of large vessels (greater than 3.5 mm), which typically have reduced restenosis risk compared to smaller diameter vessels. David A. Cox, M.D., FACC, presented the TAXUS IV and V results at the SCAI Annual Scientific Sessions in Partnership with the ACC/i2 Summit in Chicago.
In an analysis of TAXUS IV and V one-year clinical events, Dr. Cox reported that patients treated with the TAXUS Stent had significant reductions in one-year revascularization rates in both large and small diameter vessels compared to BMS. Although the absolute magnitude of the efficacy benefit was reduced in large diameter vessels, the relative reduction compared to BMS was maintained.
Results include outcomes from 2,458 patients divided into three groups according to maximal device diameter (defined as the diameter of the largest final stent or post-dilatation balloon utilized): <3.5 mm (n=1,528 patients), >/=3.5mm-<4.0mm (n=655), and >/=4.0mm (n=275). Compared to BMS, patients treated with the TAXUS Stent had lower rates of target lesion revascularization (TLR) at all device diameters: 9.7% vs. 20.4% (p<0.001) for <3.5mm, 4.5% vs. 13.5% (p<0.001) for >/=3.5mm-<4.0mm, and 1.6% vs. 6.5% (p<0.05) for >4.0mm. These rates correspond to reductions of 52.5% for the <3.5mm group, 66.7% for the >/=3.5mm-<4.0mm group, and 75.4% for the >/=4.0mm group, suggesting that although the magnitude of the absolute TLR difference between TAXUS and BMS was reduced in larger diameter vessels, the relative reduction was actually greater. Significant reductions in target vessel revascularization (TVR) and MACE were also reported in both small and larger diameter vessels. There were no statistically significant differences in the incidences of cardiac death, myocardial infarction or stent thrombosis.
"The risk for restenosis with BMS is generally decreased in large vessels, prompting some interventional cardiologists to choose BMS over DES in vessels larger than 3.5mm. However, since larger vessels also surround significant amounts of heart muscle tissue, even small differences in clinical events between BMS and DES may be clinically relevant," said Dr. Cox. "Our analyses of TAXUS IV and V data clearly add to the growing body of evidence that DES still appear clinically beneficial over BMS in the treatment of large vessels."
The safety and effectiveness of the TAXUS Express Stent has not been established in lesions with reference vessel diameters >3.75mm.
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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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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