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Cypher(R) Sirolimus-Eluting Coronary Stent Demonstrates Sustained Clinical Benefits Compared to Bare Metal Stents in Five-Year Randomized Clinical Trial With No Differences in Long-Term Safety
Date:9/3/2007

0.001).

The study also showed both treatment arms to yield similarly low rates of mortality and myocardial infarction. The mortality rates were 8.6 percent for the CYPHER(R) Stent and 7.9 percent for the bare metal stent (p=0.850), the Q- wave myocardial infarction rate for each treatment arm was 1.1 percent (p=1.00) and the non-Q-wave myocardial infarction rates were 7.4 percent for the CYPHER(R) Stent and 5.1 percent for the bare metal stent (p=0.388).

Also importantly, the study did not find a significant difference in the rates of stent thrombosis between the CYPHER(R) Stent and the bare metal stent, regardless of whether protocol or Academic Research Consortium (ARC) definitions were employed. When the protocol definitions were used, the rates of acute and subacute stent thrombosis were 0.0 percent for the bare metal stent and 1.1 percent for the CYPHER(R) Stent (p=0.25). The late stent thrombosis rates were 0.0 percent for the bare metal stent and 1.7 percent for the CYPHER(R) Stent (p=0.12). The definite/probable ARC definition identified a stent thrombosis rate of 4.2 percent for the CYPHER(R) Stent versus 1.7 percent for the bare metal stent (p=0.199). The definite/probable/possible ARC definition yielded a stent thrombosis rate of 6.5 percent for the CYPHER(R) Stent versus 3.5 percent for the bare metal stent (p=0.216). While there were numeric differences in the timing of such events between the CYPHER(R) Stent and the bare metal stent, at no point throughout the five-year period were the differences statistically significant.

"The results presented today reaffirm the long-term clinical benefits of the CYPHER(R) Stent compared to bare metal stents," said David E. Kandzari, M.D., F.A.C.C., F.S.C.A.I., Chief Medical Officer, Cordis Corporation. "As previously announced, Cordis is expanding the E-SIRIUS Trial to eight years of follow-up to provide physicians with longer term data about the CYPHER(R) Stent that will assist them in making inf
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SOURCE Cordis Corporation
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