Healthcare Industry News: CYPHER
News Release - March 12, 2006
New Data Suggest Differences in Clinical Performance Between the CYPHER(R) Sirolimus-Eluting Coronary Stent and the Taxus Stent in Long Complex LesionsATLANTA, March 12 (HSMN NewsFeed) -- Data from a multi-center, prospective randomized controlled clinical trial suggests that the CYPHER® Sirolimus- eluting Coronary Stent outperformed the Taxus Stent in procedures involving long coronary lesions, which are considered some of the most complex blockages to treat with angioplasty. The results from the LONG DES-II Study were presented here today at the American College of Cardiology Conference Annual Scientific Session.
The LONG DES-II Study (percutaneous treatment of long native coronary lesions with Drug-Eluting Stents II) was designed to compare the angiographic in-segment binary restenosis rate of CYPHER® Stent vs. the Taxus Stent at six months. The study was conducted across five medical centers in Korea and included 500 patients (250 in the CYPHER® Stent arm and 250 in the Taxus Stent arm). Lesion length needed to be > 25 mm. It is estimated that long lesions such as these comprise approximately 20 percent of cases treated by interventional cardiologists today.
"In this study, the CYPHER® Stent showed better outcomes than the Taxus Stent in these complex, long lesions. Patients with very long lesions are among the most difficult to treat and tend to be at higher risk of restenosis," said Seung-Jung Park, M.D., Ph.D., FACC, Principal Investigator of this study and Chief of Interventional Cardiology, ASAN Medical Center, Seoul, Korea. "These findings provide important new information for clinicians to consider when choosing the best treatment for these types of complex patients."
Myeong-Ki Hong, M.D., Ph.D., Associate Professor of Medicine, Division of Cardiology, Department of Internal Medicine, University of Ulsan, College of Medicine, Seoul, Korea, presented the findings today on Dr. Park's behalf. The ASAN Medical Center is the teaching affiliate hospital of Ulsan University, also in Korea.
In this study, the patients received a mean total stent length of about 41 mm. Patients receiving the CYPHER® Stent had significantly less in-stent late loss than patients treated with the Taxus Stent (0.05 plus or minus 0.22 loss index for the CYPHER® Stent vs. 0.25 plus or minus 0.35 loss index for the Taxus Stent; p<0.001) and 71 percent less in-segment restenosis than patients treated with the Taxus Stent (3 percent for the CYPHER® Stent vs. 10.3 percent for the Taxus Stent; p=0.007).
Additionally, patients treated with the CYPHER® Stent had significantly larger minimal in-stent diameter (vessel opening) at follow-up than patients treated with the Taxus Stent (2.39 plus or minus 0.46 mm for the CYPHER® Stent vs. 2.04 plus or minus 0.65 for the Taxus Stent; p<0.001), which is important for blood flow, and a lower average in-stent diameter stenosis (blockage) than those treated with the Taxus Stent (13.0 plus or minus 17.8 percent for the CYPHER® Stent vs. 23.6 plus or minus 20.7 percent for the Taxus Stent; p<0.001) at late follow-up.
Secondary endpoints included in-segment and in-stent restenosis at six months as well as Major Adverse Cardiac Events (MACE), an important safety and efficacy outcome measure which comprises all-cause death, myocardial infarction (heart attack) and target lesion revascularization (TLR or retreatment). At the nine-month clinical follow-up, MACE rates were 3 percent for the CYPHER® Stent versus 7.8 percent for the Taxus Stent (p=0.027).
"The LONG DES-II trial provides additional clinical evidence that continues to differentiate the CYPHER® Stent from the Taxus Stent," said Dennis Donohoe, M.D., Vice President, Worldwide Clinical and Regulatory Affairs, Cordis Corporation.
"Results of randomized controlled clinical trials, like this LONG DES-II Study, are the highest level of clinical evidence used to compare two products. To date, in every randomized clinical trial comparing angiographic follow up of the CYPHER® Stent to the Taxus Stent, the CYPHER® Stent has demonstrated a significant difference in important angiographic measurements. Furthermore, in multiple meta-analyses of these trials, the CYPHER® Stent has demonstrated significant differences in important clinical outcomes, such as target lesion revascularization. The clinical body of knowledge for the CYPHER® Stent continues to show impressive and sustained clinical outcomes for patients and physicians."
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 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) Sirolimus-eluting Coronary 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.
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