Clinical investigators at the American College of Cardiology's 56th Annual Scientific Session (ACC.07) reported today that the clinical benefit of the CYPHER® 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® 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® 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® 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® 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® Stent has provided significant benefits for many patients since we initiated the SIRIUS Trial."
In this long-term follow-up, the CYPHER® 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® Stent was 9.4 percent versus 24.2 percent for the BMS (p<0.0001), and the MACE rate for the CYPHER® 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® 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® 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® 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® 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® 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® 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® Stent that will assist them in making informed treatment decisions."
The SIRIUS (Sirolimus-coated BX VELOCITY® Balloon-Expandable Stent in Treatment of Patients with De Novo Coronary Artery Lesions) Trial, sponsored by Cordis Corporation, served as a pivotal study for the U.S. approval of the CYPHER® Stent in 2003 and is the longest running U.S.-based study for a drug-eluting stent.In the double-blinded, multi-center randomized trial, patients were divided into two treatment groups: 533 patients received the CYPHER® Stent and 525 patients received a BMS. Of the original 1,058 participants, 93.8 percent of patients (501 patients receiving the CYPHER® Stent and 491 patients receiving a BMS) participated in the five-year follow up.
About the CYPHER® Stent
The CYPHER® Stent has been chosen by cardiologists worldwide to treat approximately three million patients with coronary artery disease. The safety and efficacy of the device is supported by a robust clinical trial program that includes more than 70 studies that examine the performance of the CYPHER® Stent in a broad range of patients.
Developed and manufactured by Cordis Corporation, the CYPHER® Stent is currently available in more than 80 countries and has the broadest clinical experience and longest-term clinical follow-up of any drug-eluting stent. The next version of sirolimus-eluting stent, the CYPHER® SELECT™ Sirolimus-eluting Coronary Stent, was launched in Europe, Asia Pacific, Latin America and Canada in 2003. The CYPHER® SELECT® Plus Stent, the third version of a sirolimus-eluting coronary stent, received CE Mark in 2006 and is currently available in many markets outside the United States.
For more complete information on indications, contraindications, warnings and precautions, see the Instructions for Use available at www.cypherstent.com
About Cordis Corporation
Cordis Corporation, a Johnson & Johnson company, is a worldwide leader in the development and manufacture of interventional vascular technology. Through the company's innovation, research and development, Cordis partners with interventional cardiologists worldwide to treat millions of patients who suffer from vascular disease. More information about Cordis Corporation can be found at www.cordis.com
*Cordis Corporation has entered into an exclusive worldwide license with Wyeth for the localized delivery of sirolimus in certain fields of use, including delivery via vascular stenting. Sirolimus, the active drug released for the stent, is marketed by Wyeth Pharmaceuticals, a division of Wyeth, under the name Rapamune®. Rapamune is a trademark of Wyeth Pharmaceuticals.
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