Healthcare Industry News: Acute Coronary Syndrome
News Release - October 23, 2006
New Randomized Clinical Trial Results Show the Cypher(R) Sirolimus-Eluting Coronary Stent Outperformed the Taxus Stent in Long Coronary LesionsWASHINGTON, Oct. 23 (HSMN NewsFeed) -- Results from a multicenter, prospective, randomized clinical trial indicate that the CYPHER® Stent performed better than the Taxus Stent in procedures involving long coronary lesions, which are considered some of the most complex blockages to treat with balloon angioplasty. The final results from the LONG-DES-II Study were presented here today during a Late Breaking Clinical Trial Plenary Session at the Transcatheter Cardiovascular Therapeutics (TCT) Conference.
In this 500-patient trial, the CYPHER® Stent significantly outperformed the Taxus Stent in the primary endpoint, which was binary in-segment restenosis (a measure of reblockage) at six-month angiographic follow-up. According to the data, 3.3 percent of the patients who received a CYPHER® Stent developed binary in-segment restenosis versus 14.6 percent of the patients who received a Taxus Stent (p=0.001).
"The LONG-DES-II Study provides compelling evidence supporting the use of the CYPHER® Stent in long coronary lesions," said Seung-Jung Park, M.D., Ph.D., Principal Investigator of this study and Chief of Interventional Cardiology, Asan Medical Center, Seoul, Korea. "These results deserve attention as patients with very long lesions are among the most difficult to treat and tend to be at higher risk of restenosis."
At nine-month clinical follow-up, the CYPHER® Stent was found to be significantly better than the Taxus Stent at reducing the need for a second procedure. The rate of target lesion revascularization (TLR or re-treatment in the same location) was 2.4 percent for the CYPHER® Stent versus 7.2 percent for the Taxus Stent (p=0.012). The difference in target vessel revascularization (TVR or re-treatment in the same vessel) also reached statistical significance, with the CYPHER® Stent registering a 3.2 percent rate and the Taxus Stent rate totaling 7.6 percent (p=0.03). It is also noteworthy that in this very challenging population, device and procedural success were identical between the two drug-eluting stents.
The study authors concluded that while efficacy rates in this study favored the CYPHER® Stent over the Taxus Stent, the incidence of death, myocardial infarction (heart attack) or stent thrombosis was similarly low for both groups in a complex patient population with a high prevalence of Acute Coronary Syndrome.
The LONG-DES-II Study (percutaneous treatment of LONG native coronary lesions with Drug-Eluting Stent-II) was conducted across five medical centers in Korea and included 250 patients in the CYPHER® Stent arm and 250 patients in the Taxus Stent arm. Lesion length needed to be at least 25 mm. It is estimated that long lesions such as these comprise approximately 20 percent of cases treated by interventional cardiologists today.
"The LONG-DES-II Study adds to the growing body of data helping interventional cardiologists to determine the best treatment option for their patients," said Dennis Donohoe, M.D., Vice President, Worldwide Clinical and Regulatory Affairs, Cordis Corporation. "Results of randomized controlled clinical trials like the LONG-DES-II Study are the highest level of clinical evidence used to compare medical therapies and have consistently demonstrated the performance of the CYPHER® Stent."
Preliminary results of this trial were presented at the American College of Cardiology's 55th Annual Scientific Session (ACC.06) in March.
Cordis Corporation is one of the sponsors of the LONG-DES-II Study, along with the Korean Ministry of Health and Welfare.
The CYPHER® Stent is indicated in the United States for improving coronary luminal diameter in patients with symptomatic ischemic disease due to discrete de novo lesions of length less than or equal to 30 mm in native coronary arteries with a reference vessel diameter of less than or equal to 2.5 to less than or equal to 3.5 mm.
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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