Stent Registry Safety Data Favors Taxus(R) Over Cypher(R) In The Most Complex Diabetic Patients

Main Category: Diabetes
Article Date: 19 Mar 2006 - 0:00 PDT

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Boston Scientific Corporation (NYSE: BSX) today welcomed results from the independent, multi-center STENT registry, the largest prospective, comparative real world drug-eluting stent study ever reported. The study included follow-up on 5,566 patients at eight coronary centers in the United States who received either a TAXUS(R) Express2(R) paclitaxel-eluting coronary stent system or a Cypher(R) Stent system, including 1,182 diabetic patients, nearly 500 of whom were insulin-treated diabetics. Among insulin-treated diabetics, the results demonstrated a numerical trend toward improved survival and lower overall Major Adverse Cardiac Events (MACE) rate for patients who received a TAXUS stent system versus those who received a Cypher stent system. The results were presented at the American College of Cardiology's (ACC) inaugural "Innovation in Intervention: the i2 Summit" in Atlanta.

Among the study's diabetic patients, the TAXUS stent system was used in more complex lesions. The TAXUS patients had a slightly higher ACC risk score, smaller vessels and longer lesions than Cypher patients.

Despite the higher complexity of the TAXUS patients, the results favored the TAXUS stent system over the Cypher stent system in each of the study's MACE categories for insulin-treated diabetics. The MACE rate was a composite of death (2.1 percent for TAXUS versus 5.7 percent for Cypher), myocardial infarction (MI, or heart attack) (1.3 percent for TAXUS versus 1.9 percent for Cypher), and target vessel revascularization (TVR) (3.4 percent for TAXUS versus 4.2 percent for Cypher). The overall MACE rate also trended in favor of TAXUS (6.0 percent versus 10.7 percent for Cypher).

"In insulin-treated diabetics there is a slight separation in outcomes favoring the TAXUS stent system, although this did not reach statistical significance," said Charles Simonton, M.D., chairman of the executive steering committee for the STENT registry. "We plan continued enrollment to further investigate this apparent difference in outcomes."

"Previous studies have confirmed that paclitaxel and sirolimus have different mechanisms of action, and this study provides additional favorable data regarding the performance of paclitaxel in the treatment of insulin-treated diabetics," said Paul LaViolette, Chief Operating Officer of Boston Scientific. "These data provide further support for our belief that the TAXUS stent system should be the preferred choice for the treatment of complex lesions." STENT (Strategic Transcatheter Evaluation of New Therapies) is the first U.S., multi-center, prospective registry initiated to evaluate the long-term efficacy and safety of paclitaxel- and sirolimus-eluting coronary stents among real-world patients and clinical situations.

Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties.
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