JAMA Article Says TAXUS® Stents Superior to Brachytherapy in the Treatment of In-Stent Restenosis
NATICK, Mass., March 15, 2006 -- Boston
Scientific Corporation (NYSE: BSX - News) today welcomed an article in the Journal
of the American Medical Association (JAMA) on the TAXUS V ISR (in-stent restenosis)
clinical trial that found the TAXUS® Express2™ paclitaxel-eluting stent
system achieved superior outcomes in the treatment of in-stent restenosis compared
to those patients treated with radiation-based brachytherapy. The results of
the study were published in today's edition of JAMA.
The study (TAXUS V ISR) showed that compared with brachytherapy, implantation of paclitaxel-eluting stents reduced the nine-month rate of target vessel revascularization (the need for a repeat procedure in the stented area) from 17.5 percent to 10.5 percent and target lesion revascularization rate from 13.9 percent to 6.3 percent. The study also demonstrated an 11.5 percent rate of Major Adverse Cardiac Events (MACE) for the TAXUS stent group, as compared to a 20.1 percent rate for the control group.
"The results from this trial in concert with other studies, indicate that drug-eluting stents should now be considered the treatment of choice for most patients with ISR of previously implanted bare-metal stents. Paclitaxel- eluting stents significantly reduce clinical and angiographic restenosis and improve event-free survival compared with beta-source intracoronary radiation. For patients with bare-metal stents who develop in-stent restenosis, the availability of drug-eluting stents represents a safe therapy resulting in a high rate of nine-month event-free survival, a reassuring option for an otherwise difficult-to-treat cohort of patients. Further studies are required to demonstrate the long-term safety and durability of this approach," the authors conclude.
The study included 396 patients at 37 sites in the United States and was designed to assess the TAXUS stent slow-release formulation paclitaxel-eluting coronary stent system in reducing in-stent restenosis (the regrowth of diseased tissue into a previously stented artery) versus intracoronary brachytherapy (radiation delivered directly to the lesion). An additional 25 patients were enrolled in a registry arm. It had a primary endpoint of nine- month target vessel revascularization.
CAUTION - The TAXUS® Express2™ paclitaxel-eluting stent system is considered investigational in the United States for use in treating in-stent restenosis and for this indication is limited by Federal Law to investigational use only.
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.
This press release contains forward-looking statements. The Company wishes to caution the reader of this press release that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, risks associated with clinical trials, the regulatory approval process, commercialization of new technologies, intellectual property, and other factors described in the Company's filings with the Securities and Exchange Commission.
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Boston Scientific Corporation
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Boston Scientific Corporation
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Source: Boston Scientific Corporation |
