Study Finds Excellent Results in Patients
with Long Lesions Treated with Multiple
and
Overlapping CYPHER® Sirolimus-Eluting Stents
Washington, DC (October 20, 2005) - A detailed analysis of data pooled across four drug-eluting stent clinical trials finds that high risk patients with long coronary blockages had better clinical outcomes with multiple, overlapping or non overlapping, CYPHER® Stents than those patients who received bare metal stents.
Dr. Campbell Rogers of Brigham & Women's Hospital in Boston presented the data during the Cardiovascular Research Foundation's (CRF) 17th Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.
The analysis from the SIRIUS, E-SIRIUS, C-SIRIUS and DIRECT Trials included 271 patients who received multiple, long stents, at least two stents 18 millimeters or longer, in a single vessel.
There was no evidence of increased total or non Q-wave MI rates for CYHER® Stent-treated patients who received multiple long stents, overlapping or non overlapping, compared to a well-matched bare metal stent control group at 30 days post procedure. Additionally, the 30-day non Q-wave MI rate was significantly lower for the CYPHER® stent-treated patients compared to those treated with bare metal stents (0% vs 3.6%, p= 0.028).
According to Dr. Rogers, the detailed angiographic analysis is consistent with the clinical findings in that it shows that the lesions treated with multiple long CYPHER® Stents had significantly fewer side branch occlusions than those treated with multiple long bare metal stents.
The data demonstrated that the use of multiple long, CYPHER® Stents resulted in a lower overall Major Adverse Cardiac Event (MACE) at 30 days post procedure than the bare metal control arm: 1.3 percent for the CYPHER® Stent group vs. 3.6 percent for the conventional bare metal stent control group. The nine-month safety summary, which includes death and heart attack (Q Wave and Non Q Wave), also showed positive results in favor of the CYPHER® Stent: 7.6 percent vs. 37.8 percent. Thrombosis rates at nine-months were comparable between the drug-eluting stent and the bare metal stent arm with 0.6 percent for the CYPHER® Stent patients and 0.9 percent for the bare metal stent cohort.
Efficacy rates were also strong in the CYPHER® Stent arm with a nine-month target lesion revascularization rate of 5.7 percent for the CYPHER® Stent vs. 35.1 percent for bare metal; target vessel revascularization rates were 13.3 percent for the CYPHER® Stent and 36.0 for the bare metal stent group.
"The outstanding data presented at this year's TCT has reinforced the clinical differentiation for the CYPHER® Stent in both clinical trials and in the real world," said Dennis Donohoe, M.D., vice president of clinical research and regulatory affairs, Cordis Corporation. "The analysis conducted on this high risk patient group is another example of the strong performance of the CYPHER® Stent across a broad range of challenging cases."
About the CYPHER® Stent
The CYPHER® Stent has been chosen by cardiologists worldwide to treat more than 1.5 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 40 studies, inclusive of independent clinical trials, 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 longest-term clinical follow-up of any drug-eluting stent. The CYPHER SELECT™ Sirolimus-eluting Coronary Stent, which is the first next generation drug-eluting stent, was launched in Europe, Asia Pacific, Latin America and Canada in 2003. More information about the CYPHER® Stent can be found at www.cypherusa.com.
About Cordis Corporation
Cordis Corporation, a Johnson & Johnson company, is a worldwide leader in developing and manufacturing interventional vascular technology. Through the company's innovation, research and development, physicians worldwide are better able to treat the millions of patients who suffer from vascular disease.
*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.
SOURCE Cordis Corporation |
