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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

While no significant differences were found, results showed CYPHER(R) Stent

had lower mortality and heart attack rates

VIENNA, Austria, Sept. 4 /PRNewswire/ -- A subgroup analysis of diabetic patient data from a two-year randomized controlled trial comparing the CYPHER(R) Sirolimus-eluting Coronary Stent to the Taxus Stent showed no statistically significant differences in safety outcomes between the two drug- eluting stents. The authors of the analysis, presented today at the European Society of Cardiology Congress 2007 (ESC Congress 2007), also reported that in the CYPHER(R) Stent arm there were numerically lower rates of cardiac mortality, blood clots and heart attack rates than in the Taxus Stent arm, although these differences did not reach statistical significance.

"In this analysis of head-to-head randomized controlled trial data, both drug-eluting stents yielded similar safety outcomes and the CYPHER(R) Stent presented safety rates in some areas that were numerically lower," Giulio Guagliumi, M.D., from the Ospedale Riuniti Di Bergamo in Bergamo, Italy, who presented the results on behalf of the REALITY Trial investigators.

The cardiac death rates were 1.6 percent for the CYPHER(R) Stent and 4.7 percent for the Taxus Stent (p=0.14). The rate of Q-wave myocardial infarction (heart attacks that involve the full thickness of the heart wall) was 0.0 percent for the CYPHER(R) Stent and 1.6 percent for the Taxus Stent (p=0.25). In addition, the rates of non-Q wave myocardial infarctions (heart attacks that do not involve the full thickness of the heart wall) were 4.8 percent for the CYPHER(R) Stent and 5.2 percent for the Taxus Stent (p=1.00). None of these numerical differences in favor of the CYPHER(R) Stent reached statistical significance.

Both drug-eluting stents were also equivalent in terms of major adverse cardiac events (MACE), which in this study were defined to include cardiac deaths, Q-wave myocardial infa
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SOURCE Cordis Corporation
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