Healthcare Industry News: drug-eluting stent
News Release - November 15, 2006
Preliminary Long-Term Clinical Data Show Promising Results for the CYPHER(R) Sirolimus-eluting Coronary Stent in Patients With Multi-Vessel DiseaseCHICAGO, Nov. 15 (HSMN NewsFeed) -- Preliminary three-year clinical data suggest the CYPHER® Sirolimus-eluting Coronary Stent may be a less invasive long-term alternative to coronary artery bypass grafting (CABG) in patients with multi-vessel coronary artery disease. These results were presented last night by Principal Investigator Patrick W. Serruys, M.D., Ph.D., The Thoraxcenter, Erasmus Medical Center, Rotterdam, Netherlands, during an award acceptance speech at the Council on Clinical Cardiology Dinner, American Heart Association Scientific Session 2006.
"For years, physicians have debated the merits of stent procedures versus coronary artery bypass grafting in challenging patients with lesions in two or more vessels," Professor Serruys said. "These preliminary three-year data suggest that percutaneous procedures using the CYPHER® Stent may be a viable alternative to surgery in these patients and much less invasive."
The Arterial Revascularization Therapy Study II (ARTS II Study), sponsored by Cordis Corporation, is an extension of the ARTS I Study, conducted in 1997, which compared results of bare-metal stents to those obtained with CABG.
At three-year follow-up, the MACCE rates (a composite for death, stroke and heart attack, as well as any re-vascularization) of the CYPHER® Stent arm versus the CABG arm were similar. Specifically, 80.2 percent of the patients who received the CYPHER® Stent remained free of MACCE, compared to 83.9 percent of the patients in the CABG arm (p=0.14). In addition, the CYPHER® Stent fared significantly better than the bare-metal stent arm in the same clinical endpoint, as 65.3 percent of the patients who received a bare-metal stent did not experience a MACCE event after three years (p=0.0001).
In addition, the severe event rate (a composite for death, stroke and heart attack) in the CYPHER® Stent arm was lower compared with both the CABG and bare-metal stent arms. Three years after treatment, 91.6 percent of the patients who received the CYPHER® Stent were alive and did not experience a stroke or a heart attack, compared to 89 percent of the patients in the CABG arm and 86.7 percent of the patients in the bare-metal stent arm. The difference between the CYPHER® Stent arm versus the bare-metal stent arm reached statistical significance (p=0.0065).
"Patients with multi-vessel coronary artery disease remain one of the most complex groups to treat," said Dennis Donohoe, M.D., Vice President, Worldwide Clinical and Regulatory Affairs, Cordis Corporation. "The ARTS II data contribute significantly to understanding the performance of the CYPHER® Stent in comparison to bypass surgery and bare-metal stents in this challenging patient population."
ARTS II includes 607 patients from 45 European centers treated with the CYPHER® Stent. Investigators compared the findings for these patients to those from the ARTS I Trial, which included 602 patients treated with coronary bypass grafting and 600 treated with a bare-metal stent.
The CYPHER® Stent has not been indicated for patients with multi-vessel disease in the United States.
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.
* 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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