New Study Results Suggest Better Outcomes With The CYPHER® Sirolimus-Eluting Coronary Stent Than Brachytherapy In Patients With In-Stent Reblockage
SISR Nine-Month Outcomes Presented at TCT 2005
Washington, D.C. (October 17, 2005) – Results from the SISR trial, a multi-center, randomized study of the CYPHER® Sirolimus-eluting Coronary Stent versus radiation from within a vessel (brachytherapy) in patients with bare-metal in-stent reblockage (restenosis), were presented today at the Transcatheter Cardiovascular Therapeutics (TCT 2005) Scientific Symposium. The study showed that patients who received the CYPHER® Stent had a significantly lower incidence of target vessel failure (TVF) at nine months post-procedure compared with patients who received brachytherapy. The SISR trial was sponsored by Cordis Corporation.
"The results were very strong in the drug-eluting stent arm of the study," said principal investigator David R. Holmes, Jr., M.D., professor of Medicine at the Mayo Clinic College of Medicine. "The CYPHER® Stent showed excellent results in these complex patient cases, which have challenged physicians for years."
A large, multicenter, randomized study involving 384 patients, the Sirolimus-eluting
CYPHER® Stent Versus Intravascular Brachytherapy In the Treatment of Patients
with In-Stent Restenotic Coronary Artery Lesions, or SISR trial, showed that
the CYPHER® Stent had a lower incidence of target vessel failure (TVF), the primary
endpoint of the study, compared to intravascular brachytherapy in complex patients.
TVF is defined as cardiac death, heart attack (myocardial infarction), or the
need to re-open the artery (target vessel revascularization, or TVR) at nine
months.
| Nine-Month Events |
CYPHER® Stent (n=259) |
Brachytherapy (n=125) |
P value |
|
Target vessel failure
|
12.4 %
|
21.8 %
|
0.023
|
|
MACE
|
10.0 %
|
19.2 %
|
0.015
|
|
Target lesion revascularization
|
8.5 %
|
19.2 %
|
0.004
|
The nine-month results of the SISR data were highlighted today in a late-breaking session at TCT, highlighted by Dr. Holmes and moderated by Martin B. Leon, M.D., and Patrick W. Serruys, M.D. The results revealed that the CYPHER® Stent resulted in fewer Major Adverse Cardiac Events (MACE) by significantly decreasing the need for TLR procedures (8.5 percent versus 19.2 percent; p=0.004).
"The results from the data presented today at TCT continue to build on our body of evidence for treating complex patients," said Brian Firth, M.D., Ph.D., vice president of Medical Affairs and Health Economics, Cordis Corporation. "The CYPHER® Stent continues to demonstrate excellent outcomes in clinical trials and in the real world."
Information on the CYPHER® Stent-related studies being presented at TCT 2005 can be found at www.tct2005.com.
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 |
