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Two-Year Patient Registry Results Support Safety and Efficacy of,Cypher Sirolimus-Eluting Coronary Stent in 'Real World' Uses

NEW ORLEANS, March 26, 2007 /PRNewswire/ -- A large patient registry of "real world" uses for the CYPHER(R) Sirolimus-eluting Coronary Stent reported favorable safety and efficacy outcomes at two-year follow-up, according to clinical investigators at the of Cardiology's 56th Annual Scientific Session (ACC.07).

The MATRIX Registry is a prospective, single-arm study designed to evaluate the outcomes of percutaneous coronary intervention (PCI or balloon angioplasty) with the CYPHER(R) Stent in everyday medical practice out to five years. Sponsored by Cordis Corporation, the registry reports on clinical data from 1,522 consecutive patients in whom the CYPHER(R) Stent was implanted, including high percentages of complex patient populations that are not currently within the approved labeling, such as patients with diabetes (33.8 percent), or history of heart attack (33.4 percent), balloon angioplasty (44.6 percent) or bypass surgery (21 percent). Overall, 86 percent of the interventions involved a specific patient or lesion characteristic not currently within the approved labeling for the CYPHER(R) Stent, and would be considered "off-label."

"The MATRIX Registry provides invaluable information to help physicians assess the long-term safety of the CYPHER(R) Stent in 'real world' patient populations," said Principal Investigator George D. Dangas, M.D., Ph.D., Associate Professor of Medicine, The Cardiovascular Research Foundation/Columbia University Medical Center, who presented the results.

In spite of the overall patient and lesion complexity, the MATRIX Registry indicated low frequency of adverse events with the CYPHER(R) Stent throughout the two years of patient follow-up. Applying the Academic Research Consortium (ARC) definition of stent thrombosis, the investigators reported a 0.7 percent rate of definite stent thrombosis and a 1.1 percent rate of definite/probable stent thrombosis. Total mo
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