Healthcare Industry News: drug-eluting stent
News Release - September 21, 2007
The CYPHER(R) Sirolimus-Eluting Coronary Stent Outperforms the Taxus Stent in Small Coronary Vessels According to New Clinical Data Analysis Published in the Journal of the American College of CardiologyWARREN, N.J.--(HSMN NewsFeed)--The CYPHER® Sirolimus-eluting Coronary Stent reduced by more than half the rate of major adverse cardiac events (MACE) compared to the Taxus Stent in small coronary vessels according to data appearing this week in the Journal of the American College of Cardiology.
In a randomized controlled trial of more than 1,000 patients, the CYPHER® Stent reduced MACE by 55 percent (10.4 percent vs. 21.4 percent; p=0.004), mainly driven by a 69 percent reduction of target lesion revascularization (TLR) (6.0 percent vs. 17.7 percent; p=0.001) compared with the Taxus Stent at two years. There were no significant differences between the two stents with respect to death, cardiac death or heart attack at two years. In this study, reference diameter of vessels ranged from less than or equal to 2.75 vs. more than 2.75 mm.
"Percutaneous coronary intervention (PCI) in small vessel disease is associated with an increased risk of major adverse cardiac events," said David Kandzari, M.D., F.A.C.C., F.S.C.A.I, Chief Medical Officer, Cordis Corporation. "This randomized clinical trial, the highest form of clinical evidence, found that there were significant differences between the performance of these two products in small and often difficult to treat vessels."
In large and mixed coronary vessels, the differences between the CYPHER® Stent and the Taxus Stent were less pronounced, although numerically lower with the CYPHER® stent. In these two patient groups, rates of MACE (large: 10.4 percent vs. 13.1 percent; p=0.33; mixed: 16.7 percent vs. 18.0 percent; p=0.83) and TLR (large: 6.9 percent vs. 8.6 percent; p=0.47; mixed: 16.7 percent vs. 15.4 percent; p=0.86) were similar.
"Randomized controlled trials, like SIRTAX, and meta-analyses of randomized controlled trials are the two most appropriate ways to assess similarities and differences between two products or therapies," said Dr. Kandzari. "Results of this randomized controlled trial highlight the consistency of the CYPHER® stent efficacy in varied clinical settings and patient subgroups. It also continues building on the growing body of clinical evidence suggesting a difference in these two drug-eluting stents, especially as patient and lesion complexity increases, such as in small coronary vessel disease."
In the United States, the CYPHER® Stent is currently approved for use in native coronary arteries with a diameter of more than 2.50mm and less than 3.50mm.
The SIRTAX study is an independent, randomized, 1,012 patient comparison of the CYPHER® Stent with the Taxus Stent for coronary revascularization. It included not only patients with angina but also a large percentage of patients who were suffering from an acute heart attack (myocardial infarction) at the time of stent placement, a patient group not currently within the approved U.S. indications.
In the subgroup analysis, the investigators studied the impact of vessel size on angiographic and long-term clinical outcomes after PCI. The study analyzed 503 patients who received the CYPHER® Stent and 509 patients who received the Taxus Stent.
About the CYPHER® Stent
The CYPHER® Stent has been chosen by cardiologists worldwide to treat approximately three 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 70 studies 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 broadest clinical experience and longest-term clinical follow-up of any drug-eluting stent. The next version of sirolimus-eluting stent, the CYPHER® SELECT(TM) Sirolimus-eluting Coronary Stent, was launched in Europe, Asia Pacific, Latin America and Canada in 2003. The CYPHER® SELECT(TM) Plus Stent, the third version of a sirolimus-eluting coronary stent, received CE Mark in 2006 and is currently available in many markets outside the United States.
For more complete information on indications, contraindications, warnings and precautions, see the Instructions for Use available at www.cypherstent.com.
About Cordis Corporation
Cordis Corporation, a Johnson & Johnson company, is a worldwide leader in the development and manufacture of interventional vascular technology. Through the company's innovation, research and development, Cordis partners with interventional cardiologists worldwide to treat millions of patients who suffer from vascular disease. More information about Cordis Corporation can be found at 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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