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Two-Year Outcomes From Large Head-to-Head Clinical Trial Indicate Similar Safety Profile in Diabetic Patients for Cypher(R) Sirolimus-Eluting Coronary Stent and Taxus Stent
Date:9/4/2007

rctions, non-Q wave myocardial infarctions, emergent bypass surgery and target lesion revascularizations (a subsequent procedure to reopen an artery). The MACE rate for the CYPHER(R) Stent was 15.5 percent while the MACE rate for the Taxus Stent was 14.1 percent (p=0.77).

At the World Congress of Cardiology 2006, the REALITY Trial investigators reported a stent thrombosis rate for the Taxus Stent that was significantly higher than the rate for the CYPHER(R) Stent in the overall patient population (2.5 percent for the Taxus Stent versus 0.9 percent for the CYPHER(R) Stent; p log-rank=0.02). While the difference between the protocol-defined stent thrombosis rate for each drug-eluting stent in the diabetic patient subgroup did not reach statistical significance, the rate for the Taxus Stent remained numerically higher than the rate for the CYPHER(R) Stent (3.1 percent for the Taxus Stent versus 1.1 percent for the CYPHER(R) Stent; p log-rank=0.16).

These numerically lower rates of cardiac death, Q-wave myocardial infarction and stent thrombosis favoring the CYPHER(R) Stent were also seen in diabetic patients who required insulin therapy.

"Diabetic patients remain one of the most complex patient populations to treat for coronary artery disease," said David E. Kandzari, M.D., F.A.C.C., F.S.C.A.I., Chief Medical Officer, Cordis Corporation. "This analysis provides additional and relevant information to doctors regarding the long- term efficacy and safety outcomes in diabetic patients treated with either the CYPHER(R) Stent or the Taxus Stent."

The analysis involved 375 diabetic patients, which represented 28 percent of the patients enrolled in the REALITY Trial. The REALITY Trial was comprised of 1,386 moderately complex patients from 90 centers in Europe, Latin America and Asia. These patients were randomly selected to receive either the CYPHER(R) Stent or the Taxus Stent. In the end, the CYPHER(R) Stent was used in 684 patients and 970 artery blo
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SOURCE Cordis Corporation
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