Healthcare Industry News: stent thrombosis
News Release - November 14, 2006
Study Favors TAXUS(R) Stent Over Cypher(R) Stent and Bare-Metal Stents in Diabetic PatientsLower re-intervention rates for the TAXUS Stent in diabetic patients
NATICK, Mass., and CHICAGO, Nov. 14 (HSMN NewsFeed) -- Boston Scientific Corporation (NYSE: BSX ) today welcomed a presentation by Joost Daemen, M.D., and Patrick Serruys, M.D., entitled "The Long Term Efficacy of Sirolimus-eluting (SES) and Paclitaxel-eluting stents (PES) as Compared to Bare Metal Stents (BMS) in Patients With Diabetes Mellitus." Data were presented from the T-SEARCH/RESEARCH study, a 708-patient, real-world registry managed from the Thoraxcenter, Erasmus University Medical Center in Rotterdam, The Netherlands. The study reports that the TAXUS® Stent (PES) exhibited a lower re-intervention rate and equal or lower instances of death or heart attack than the Cypher® Stent (SES) and bare-metal stents (BMS). The data were presented at the annual American Heart Association (AHA) Scientific Sessions in Chicago.
The study reported two-year results, which trended in favor of the TAXUS Stent compared to the Cypher Stent and BMS in both target vessel revascularization (TVR) and major adverse cardiac events (MACE) rates. The TVR rate for the TAXUS Stent was 9.7 percent compared to 15.3 percent for the Cypher Stent (p=0.06) and 19.5 percent for BMS (p=0.0034). Rates of TVR for the Cypher Stent and BMS were comparable (p=0.97). The study also reported rates of MACE with the TAXUS Stent of 21.2 percent compared to 28.9 percent for the Cypher Stent (p=0.058 PES vs. SES) and 29.7 percent for BMS (p=0.04 PES vs. BMS). The presenter concluded that the MACE data showed no benefit to SES as compared to BMS in the study's patient population, and that there was a trend toward better TVR outcomes with PES.
Two-year cumulative incidence of mortality was comparable among the three stent groups, with rates of 11.5 percent for the TAXUS Stent, 13.3 percent for the Cypher Stent and 9.8 percent for BMS. The two-year stent thrombosis rate for the TAXUS Stent was lower than that of the Cypher Stent (2.4 percent versus 4.4 percent), however, the difference was not statistically significant (p=0.29). stent thrombosis for BMS was 0.8 percent, which was not significantly different from TAXUS (p=0.18). stent thrombosis for Cypher at two years was significantly higher compared to BMS (p=0.015).
"This study provides further insight into the strong performance of the TAXUS Stent in diabetic patients and adds to the growing body of TAXUS Stent data in this difficult-to-treat patient population," said Paul LaViolette, Chief Operating Officer of Boston Scientific. "These results are particularly compelling because they represent patients with multiple complexities, the kind physicians treat every day in real-world settings. We are also pleased that the data demonstrated that the safety profile of the TAXUS Stent was comparable to -- or better than -- that of bare-metal stents."
Diabetic patients generally have more long-term complications than interventional cardiology patients as a whole, making results in diabetic patients with heart disease worthy of note when evaluating overall stent performance. The important and growing diabetic patient subset accounts for more than one-quarter of all coronary interventional procedures in the United States.
The Company is currently sponsoring the collection of clinical data to support an application to the U.S. Food and Drug Administration to expand the TAXUS Stent's labeled indications for use in the United States to include diabetic patients. The safety and effectiveness of the TAXUS Express(TM) Stent have not been established in patients with diabetes.
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devises 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. Boston Scientific 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 new product development and commercialization, clinical trials, intellectual property, regulatory approvals, competitive offerings, Boston Scientific's over all business strategy, and other factors described in Boston Scientific's filings with the Securities and Exchange Commission.
Source: Boston Scientific
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