Healthcare Industry News: CYPHER SELECT
News Release - May 16, 2006
Study Suggests Drug-Eluting Stent Type and Vessel Size are Important Predictors of Reblockage in Coronary Artery
Accompanying Editorial Puts Study Results into Broader PerspectiveMIAMI, May 16 (HSMN NewsFeed) -- A comprehensive analysis concluded that vessel size and use of the Taxus Stent are the two most important predictors of reblockage (restenosis) and the need for repeat revascularization. The study also concluded that use of the Taxus Stent had a particular impact on restenosis in small coronary vessels. The study and an accompanying editorial appeared this week in the prestigious journal CIRCULATION.
Data are from patients implanted with the CYPHER® Sirolimus-eluting Coronary Stent and the Taxus Stent between August 2002 and December 2004 at two independent medical centers in Munich, Germany. The principal author of the study was Adnan Kastrati, M.D., Deutsches Herzzentrum and First Medizinische Klinic rechts der Isar, Munich Germany.
In the study, the finding that use of the Taxus Stent was a strong predictor of restenosis in small size vessels is consistent with predictions made by previous studies, based on the models relating late lumen loss to angiographic and clinical restenosis. These studies predicted that different outcomes may be expected from the two drug-eluting stents given the consistently greater suppression of overgrowth of cells lining the vessel wall (neointimal hyperplasia) with the CYPHER® Stent.
The multivariate analysis included 1,845 patients with 2,093 lesions who had successful implantation of either the CYPHER® Stent or the Taxus Stent. A total of 1,031 patients with 1,151 lesions received the CYPHER® Stent while 815 patients with 942 lesions received the Taxus Stent. This study includes the largest number of patients with follow-up angiography reported to date.
In an accompanying editorial by Campbell Rogers, M.D. and Elazer Edelman, M.D., the authors state, "Composite medical devices with a wide range of structural, geometric and pharmacological differences can be shown to produce different clinical effects as the environments in which they are tested become increasingly complex."
Drs. Rogers and Edelman are both in the Cardiology Division, Department of Medicine, Brigham and Women's Hospital (Boston) and Harvard-Massachusetts Institute of Technology, Division of Health Sciences and Technology (Cambridge, MA).
In their editorial, Drs. Rogers and Edelman included data showing that the rates of repeat procedures (target lesion revascularization or TLR) rates differ in multiple randomized controlled clinical trials directly comparing the CYPHER® Stent to the Taxus Stent. As the average rate of TLR in the population increases, reflecting increasing complexity of the population, so the Taxus stent has progressively higher TLR rates than the CYPHER® Stent. In fact, the rate rises 3.5 times faster for the Taxus Stent compared to the CYPHER® Stent.
"This trial and editorial add powerful new information to our understanding of the differences between the CYPHER® Stent and the Taxus Stent," said Dennis Donohoe, M.D., Vice President, Worldwide Clinical and Regulatory Affairs, Cordis Corporation. "To date, there have been 11 randomized clinical trials and three meta analyses -- the highest levels of clinical evidence -- comparing the two drug-eluting stents. With each meta- analysis, the CYPHER® Stent outperformed the Taxus Stent in key performance parameters. Today's analysis by Dr. Kastrati and the editorial by Drs. Rogers and Edelman provide further critical insights into these differences."
About the CYPHER® Stent
The CYPHER® Stent has been chosen by cardiologists worldwide to treat more than two 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 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.
Source: Cordis
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