Healthcare Industry News: stent thrombosis
News Release - October 22, 2006
TAXUS(R) Performance Superior to Cypher(R) in Diabetic Patients in Head-to-Head StudyNATICK, Mass., Oct. 22 (HSMN NewsFeed) -- Boston Scientific Corporation (NYSE: BSX ) today announced one-year results from its TC-WYRE (TAXUS® Express2(TM) Stent vs. Cypher Stent: What's Your Real-World Experience?) study, which showed the TAXUS® Express2(TM) paclitaxel-eluting coronary stent to be superior to the Cypher® sirolimus-eluting coronary stent in diabetic patients in a head-to-head study. This study of 1,558 patients was designed to retrospectively compare one-year clinical outcomes in real-world practice among consecutive, unselected patients in 19 centers across the U.S. The results were presented at the Cardiac Research Foundation's (CRF) eighteenth annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, D.C.
The study's primary endpoint was target vessel revascularization (TVR or re-intervention) at one year. The two stents demonstrated comparable TVR rates of 3.2 percent for the TAXUS stent and 4.4 percent (p=0.23) for the Cypher stent. This trend towards lower TVR in the TAXUS stent group was statistically significant in the complex diabetic patient population (2.8 percent for the TAXUS stent compared to 8.5 percent for the Cypher stent, p=0.004).
"These low re-intervention rates are consistent with those we've seen in the STENT registry in the Unites States," said Dr. William O'Neill, University of Miami, and national principal investigator in the TC-WYRE study. "The data are particularly compelling because they represent the patients physicians treat every day in a real-world setting. These patients often present with multiple complexities physicians may not see in a randomized controlled trial setting -- complexities such as diabetes, small vessels, tortuous anatomy and more."
The TC-WYRE study also demonstrated excellent safety outcomes consistent with previous U.S. studies. The major adverse cardiac event (MACE) rates were comparable for the TAXUS stent at 7.2 percent and the Cypher stent at 7.3 percent. In addition, the two groups demonstrated low and comparable overall stent thrombosis rates of 0.9 percent for TAXUS and 0.8 percent for Cypher, with an identical late-stent thrombosis rate of 0.1 percent reported for both stents.
"While some smaller, single-center studies have suggested significant differences between the Cypher stent and the TAXUS stent, these differences have not been borne out by the broader body of clinical data and have been inconsistent with what physicians tell us about their daily practice experience," said Paul LaViolette, Chief Operating Officer of Boston Scientific. "TC-WYRE was designed to capture the real experience physicians are having with the two stents and it corroborates the positive findings on the TAXUS stent from significant studies such as the STENT registry and from the REALITY trial -- the two largest studies of their kind to evaluate TAXUS and Cypher stents head-to-head."
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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