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Most Comprehensive USA Clinical Trial to Date Shows Competing Medicated Stents Work Equally Well

Late-breaking results reported at TCT Conference

CHARLOTTE, NC -- October 26, 2005 -- After completing the most comprehensive U.S.-based study of its kind, Dr. Charles Simonton reported that the performance of two competing coronary stents was "virtually identical" in head-to-head comparisons.

Simonton, a cardiologist associated with the Carolinas Heart Institute at Carolinas Medical Center, summarized his conclusions at the annual TCT (Transcatheter Cardiovascular Therapeutics) meeting in Washington DC. TCT is recognized as the world's largest scientific symposium for healthcare professionals dedicated to interventional and vascular therapy.

Coronary care specialists have known for several years that so called "drug-eluting stents" outperform bare-metal stents in preventing the recurrence of blockage in coronary arteries repaired via angioplasty.

However, only two manufacturers produce drug-eluting stents, which are utilized in more than 750,000 coronary procedures annually, and study results have varied on whether one brand was more effective than the other.

The STENT registry, which now includes approximately 14, 000 patients, is the first of its kind to gather data from multiple sites, including eight medical centers located throughout the Southeast. The registry also includes one of the largest patient follow-up efforts based on a profile of the general populace. Earlier clinical trials focused on patient populations carefully screened to exclude high risk cases.

Since drug-eluting stents were first approved by the FDA in May 2003, follow up comparisons have varied for Taxus(R), manufactured by Boston Scientific, and Cypher(R), manufactured by Cordis Corp., a subdivision of Johnson & Johnson.

The new study, which involves non-proprietary research, shows outcomes the same for TVR (target vessel re-vascularization) and MACE (major adverse cardiac events, such as myocardial infarction, stroke or death, following interventional treatment).

The STENT registry is a partnership of the Dickson Institute for Health Studies at Carolinas HealthCare System (CHS), the Sanger Clinic (a CHS-owned practice where Dr. Simonton is employed), and the Carolinas Heart Institute (a specialized coronary care unit at Carolinas Medical Center).

Most of the early FDA-sanctioned studies relied on data available three or six months post-procedure. The STENT registry coordinated by CHS uses nine-month follow-up, and has a participation rate exceeding 95% of eligible patients.

Centers involved in the study include Carolinas Medical Center (Charlotte NC); High Point Regional Hospital (High Point NC); Holston Valley Medical Center (Kingsport TN); Indiana Heart Institute (Indianapolis IN); LeBauer Cardiovascular Research Foundation (Greensboro NC); McLeod Regional Medical Center (Florence SC); Saint Thomas Hospital (Nashville TN); and Sisters of Charity Providence Hospitals (Columbia SC).

Simonton praised the Carolinas HealthCare System and CHS's partner hospitals for their support of the registry. "This type of study has significant implications for coronary medicine," he said. "The sponsoring institutions are to be commended for taking a national leadership role in this timely effort to enhance the quality of coronary care. It ensures that their patients are among the first to benefit from new research."


SOURCE: Carolinas HealthCare System

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