Healthcare Industry News: C-SIRIUS
News Release - November 6, 2006
TAXUS Long-Term Data Excels in Diabetic PatientsNATICK, Mass., Nov. 6 (HSMN NewsFeed) -- Boston Scientific Corporation (NYSE: BSX ) today presented a four-year update of its key randomized, controlled clinical trials (TAXUS II, IV, V and VI) in 3,445 patients, comparing the TAXUS® stent to bare-metal control stents. Included in this number were 840 diabetic patients. The important and growing diabetic patient subset accounts for more than one-quarter of all coronary interventional procedures in the United States. Although diabetic patients generally have more long-term complications than interventional cardiology patients as a whole, in this meta-analysis the diabetic patients assigned to receive the TAXUS stent had equal or lower all-cause mortality at four years compared to patients assigned to receive a bare-metal control stent. The TAXUS stent diabetic patients also experienced a 50 percent relative decrease in the need for repeat procedures to treat restenosis, or re-narrowing, within the stent. In addition, an analysis of 10 studies with a total of 4,187 diabetic patients showed that patients who received the TAXUS stent experienced a 25 percent relative reduction in the need for repeat procedures to treat restenosis, compared to those who received the Cypher® stent sold by Johnson & Johnson's Cordis unit.
At the recent Transcatheter Cardiovascular Therapeutics (TCT) 2006 Scientific Symposium, Professor Patrick Serruys, M.D., Ph.D., of the Thoraxcenter in Rotterdam presented data from an independent meta-analysis of Cordis' four-year data from its key randomized, controlled clinical trials (RAVEL, SIRIUS, E-SIRIUS and C-SIRIUS), which included 428 diabetic patients. This meta-analysis showed that diabetic patients randomized to receive the Cypher stent had a highly significant 8.2 percent absolute increase in all-cause mortality at four years follow-up, compared to those randomized to receive the bare-metal BX Velocity(TM) control stent.
The findings of increased death and increased need for repeat revascularization procedures in diabetic patients treated with the Cypher stent were further echoed in data from several independent registries also presented recently at TCT 2006. These registries include a 499-diabetic patient study from Kaiser Permanente, a 1,162-diabetic patient study from the Prairie Heart Institute of Springfield, IL, and a 342-diabetic patient study from Centro Cuore Columbus in Milan, all of which indicated higher rates of death and repeat revascularization for the Cypher stent than the TAXUS stent.
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.
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. 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 overall business strategy, and other factors described in Boston Scientific's filings with the Securities and Exchange Commission.
Source: Boston Scientific
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