"Clinical investigators at the American College of Cardiology's 56th Annual Scientific Session (ACC.07) reported today that the clinical benefit of the CYPHER(R) Sirolimus-eluting Coronary Stent compared to a bare-metal stent (BMS) in the SIRIUS Trial was preserved from the initial nine-month follow-up out to five years. In addition, no differences were observed between the CYPHER(R) Stent and the BMS in the safety measures of myocardial infarction (heart attack), death or stent thrombosis (blood clots)."

" At five-year follow-up, patients in the CYPHER(R) Stent arm experienced significantly lower rates of target vessel failure (TVF), the primary endpoint of the trial, than those who received the BMS (22.5 percent for the CYPHER(R) Stent versus 34.7 percent for the BMS; p<0.0001). In the trial, TVF was defined as a composite of cardiac death, myocardial infarction and target vessel revascularization (TVR, or re-treatment of the blocked vessel)."

" "Our findings reinforce the existing body of evidence supporting the long-term benefits of the CYPHER(R) Stent as an effective treatment for coronary artery disease," said Co-principal Investigator Martin B. Leon, M.D., Chairman Emeritus, Cardiovascular Research Foundation and Associate Director, Center for Interventional Vascular Therapy, Columbia University Medical Center. "The CYPHER(R) Stent has provided significant benefits for many patients since we initiated the SIRIUS Trial.""

" In this long-term follow-up, the CYPHER(R) Stent also demonstrated lower rates of target lesion revascularization (TLR, or re-treatment at the same arterial site) and major adverse cardiac events (MACE), which include myocardial infarction and death, compared to the BMS. The TLR rate for the CYPHER(R) Stent was 9.4 percent versus 24.2 percent for the BMS (p<0.0001), and the MACE rate for the CYPHER(R) Stent was 20.3 percent versus 33.5 percent for the BMS (p<0.0001). These five-year outcomes support the previously reported results of the trial."

" There was no significant difference in the overall rate of stent thrombosis between the CYPHER(R) Stent and the BMS, regardless of the definition of stent thrombosis employed. The definitions include the original SIRIUS Trial protocol definition and the Academic Research Consortium (ARC) definition. At 5 years, the protocol definition identified a rate of 1.0 percent stent thrombosis for the CYPHER(R) Stent versus 0.8 percent for the BMS (p=0.75). The definite/probable ARC definition identified a stent thrombosis rate of 1.2 percent for the CYPHER(R) Stent versus 1.8 percent for the BMS (p=0.43). While the data demonstrated slight numeric differences in the timing of such events between the CYPHER(R) Stent and the BMS, at no point throughout the five-year period were the differences statistically significant."

" In addition, there was no significant difference in the mortality or the myocardial infarction rates between the CYPHER(R) Stent and the BMS at five-year follow-up. The mortality rate was 8.4 percent for both stents, while the myocardial infarction rate for the CYPHER(R) Stent was 6.2 percent, compared to 6.5 percent for the BMS (p=0.90)."

" "The data presented throughout ACC.07 reinforce the importance of evidence-based medical decisions," said David E. Kandzari, M.D., F.A.C.C., F.S.C.A.I., Chief Medical Officer, Cordis Cardiology Division of Cordis Corporation. "As previously announced, Cordis is expanding the 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 informed treatment decisions.""

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