Healthcare Industry News: CYPHER
News Release - March 12, 2006
Newly Published Data Suggest Better Outcomes With the CYPHER(R) Sirolimus-Eluting Coronary Stent Than Brachytherapy in Patients With In-Stent ReblockageMIAMI LAKES, Fla., March 12 (HSMN NewsFeed) -- Data appearing today suggests that patients who received the CYPHER® Sirolimus-Eluting Coronary Stent had a significantly lower incidence of target vessel failure (TVF) -- defined as cardiac death, heart attack (myocardial infarction), or the need to re-open the artery (target vessel revascularization or TLR) -- compared with patients who received radiation from within a vessel (brachytherapy). In this trial, the CYPHER® Stent was compared to brachytherapy for the treatment of blockage (restenosis) in patients who already have a bare metal stent. These data appeared today in the prestigious Journal of the American Medical Association.
The SISR Trial (A Randomized Trial Comparing Sirolimus-Eluting Stent with Vascular Brachytherapy for the Treatment of In-Stent Restenosis Within Bare Metal Stents) is a multi-center, randomized study of 384 patients from 26 academic and community health centers in the United States. Cordis Corporation sponsored the trial.
"In-stent restenosis following placement of a bare metal stent remains a significant clinical problem, and while brachytherapy remains the only approved therapy for this condition, the results of this study indicate that the CYPHER® Stent produced better outcomes than brachytherapy at nine months," said David R. Holmes, Jr., M.D., Principal Investigator and Professor of Medicine, The Mayo Clinic College of Medicine, Rochester, MN. "The CYPHER® Stent showed excellent results in these complex patients."
In this study, the rate of TVF, the primary endpoint of the study, was reduced from 21.6 percent in patients receiving brachytherapy to 12.4 percent in patients receiving the CYPHER® Stent (p=0.023) at nine months post procedure. According to the study authors, this reduction was driven largely by the decrease in the need for TLR in patients receiving the CYPHER® Stent (8.5 percent for the CYPHER® Stent arm vs. 19.2 percent for the brachytherapy arm; p=0.004).
Major Adverse Cardiac Events (MACE), which are defined as death, either Q-wave or non-Q-way heart attack (myocardial infarction), emergency bypass surgery or TLR, was also lower in patients receiving the CYPHER® Stent compared to those receiving brachytherapy (10 percent in the CYPHER® Stent arm vs. 19.2 percent in the brachytherapy arm; p=0.015).
"The results from this trial continue to build on our body of evidence for treating complex patients with the CYPHER® Stent," said Dennis Donohoe, M.D., Vice President, Clinical and Regulatory Affairs, Cordis Corporation. "The CYPHER® Stent continues to demonstrate excellent outcomes in clinical trials and in the real world."
About the CYPHER® Stent
The CYPHER® Stent has been chosen by cardiologists worldwide to treat more than 1.7 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 Cordis sponsored clinical trials, in addition to many 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(TM) 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 http://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.
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