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CYPHER(R) Sirolimus Drug-Eluting Stent Remains Unsurpassed in Terms of Clinical Safety and Efficacy
Date:9/30/2010

results of SORT-OUT IV, comparing Cordis Corporation's CYPHER(R) Sirolimus-eluting Coronary Stent and Abbott's XIENCE V (R) Everolimus-eluting Stent in the primary endpoint of MACE (major acute coronary events) at nine months. These findings were presented the week commencing 20th September 2010 at the TCT Congress, one of the largest cardiovascular industry events held annually in Washington DC. This study adds to the unmatched body of clinical safety and efficacy data on the CYPHER(R) Stent with this comparison to the more recently approved XIENCE V(R) Stent in a contemporary setting.

"The SORT OUT consortium has used CYPHER(R) Stent as the comparator in a number of studies and to date, no newer stent has proven a benefit over CYPHER(R) Stent in terms of clinical safety or efficacy," said Campbell Rogers, M.D., Chief Scientific Officer and Head, Global Research and Development, Cordis Corporation. "The clinical safety and efficacy of the CYPHER(R) Stent in this real-world randomized study reinforce the excellent sustained clinical outcomes consistently seen over the last 10 years."

The large randomized trial SORT OUT IV included more than 2,600 patients across a wide range of lesion and patient complexity. The study was designed to test whether the XIENCE V(R) stent is non-inferior to the CYPHER(R) Stent. Both drug-eluting stents performed better than planned for the composite endpoint of MACE (4.9 % for XIENCE V(R) Stent vs. 5.2% for CYPHER(R) Stent); these data support the non-inferiority of the XIENCE V(R) stent over the CYPHER(R) stent (non-inferiority p=0.01) . There was no statistically significant difference in key markers of safety including the incidence of cardiac death (1.9% for XIENCE V(R) Stent vs. 1.4% for CYPHER(R) Stent: p=0.31), myocardial infarction, (1.1% for XIENCE V(R) Stent vs. 1.4% for CYPHER(R) Stent: p=0.48), or definite or probable stent thrombosis (0.9% for XIENCE V(R) Stent vs. 0.9% for CYPHER(R) Stent: p=0.83).


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SOURCE Cordis Corporation
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