Healthcare Industry News: C-SIRIUS
News Release - November 6, 2006
Clinical Studies to be Presented at American Heart Association Scientific Sessions Demonstrate Growing Body of Efficacy and Safety Data for the CYPHER(R) Sirolimus-Eluting Coronary StentData to Include Analyses on Diabetics, and Patients With Multiple Sites of Blockage or Experiencing a Heart Attack
MIAMI, Nov. 6 (HSMN NewsFeed) -- The long-term safety and efficacy of the CYPHER® Sirolimus-eluting Coronary Stent in a variety of coronary conditions, including those with diabetes, will be highlighted at this year's American Heart Association Scientific Session in Chicago, November 12-15. Three-year data will also be presented from the ARTS II trial, which compares the use of the CYPHER® Stent to bypass surgery. This study includes some of the most complex patients ever studied in a drug-eluting stent trial.
"We are especially looking forward to long-term data that demonstrate efficacy of the CYPHER® Stent out to four years, as well as safety endpoints including incidence of major adverse cardiac events in all patients and in major subgroups including diabetic and other complex patients," said Dennis Donohoe, M.D., Worldwide Vice President, Clinical and Regulatory Affairs, Cordis Corporation. "With each medical conference, we learn more and more about the benefits of the CYPHER® Stent in a variety of patients with coronary artery disease."
Gunter Breithardt, M.D., University Hospital, Munster, Germany, will present the NEW-SIRIUS pooled data analysis of 452 patients from of the E-SIRIUS and C-SIRIUS multi-center randomized, controlled trials performed in Europe and Canada. These data will be presented Tuesday, November 14, 2006 10:45am - 11:00am.
The findings by Dr. Breithardt add to the growing body of clinical evidence regarding the efficacy and safety of the CYPHER® Stent in patients with diabetes, including data from the recent Transcatheter Cardiovascular Therapeutics conference (TCT) and the publication of the ISAR-Diabetes study earlier this year in the prestigious New England Journal of Medicine.
Professor Patrick Serruys, M.D., of the Thoraxcenter, Rotterdam, recently reported at TCT consistent findings on the safety of the CYPHER® Stent in diabetics based on a preliminary analysis of data from more than 7,000 patients in Rotterdam. "After three year follow-up, we observed comparable mortality rates among diabetic patients treated with either bare metal stents or the CYPHER® Stent," he said.
At AHA, Dr. Serruys will present data from the ARTS II trial, which examines the use of the CYPHER® Stent in complex patients, including a large number of diabetics, three years after stent implantation. These data will be presented on Tuesday, November 14 at the Council on Clinical Cardiology Dinner.
Other AHA Scientific Sessions presentations include:
-- Monday, November 13, 2006 9:15am - 9:30am. 2217 Stent Thrombosis after Primary Angioplasty for Acute Myocardial Infarction: Insights from the Typhoon Trial
-- Monday, November 13, 2006 3:45pm - 4:00pm. 2643 The Impact of Gender on the Clinical Outcome after Percutaneous Coronary Revascularization: A Report from the ARTS II Trial
-- Tuesday, November 14, 2006 4:15pm - 4:30pm. 3241 Drug-Eluting Stents for the Treatment of Chronic Total Occlusion: A Comparison of Serial Angiographic Follow-Up with Sirolimus, Paclitaxel, Zotarolimus and Tacrolimus-Eluting Stent: Multicenter Registry in Asia
-- Tuesday, November 14, 2006 4:30pm - 4:45pm. 3252 Sirolimus-Eluting Stents Versus Bare-Metal Stents in Patients with In-Stent Restenosis. Pooled Results from Two Randomized Studies.
About the CYPHER® Stent
More than 2 million worldwide patients with coronary artery disease have been treated with the CYPHER® Stent. The safety and efficacy of the device is supported by a robust clinical trial program that includes more than 70 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 first next-generation drug-eluting stent, the CYPHER SELECT(TM) Stent, was launched in Europe, Asia Pacific, Latin America and Canada in 2003. The CYPHER SELECT(TM) Plus Stent, the first third-generation drug-eluting stent, received the CE mark in June 2006 and is now available in many markets outside the United States.
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. More information about Cordis Corporation can be found at http://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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