Healthcare Industry News: stent thrombosis
News Release - April 3, 2006
One-Year Data From World's Largest Completed Drug-Eluting Stent Registry Further Supports Safety and Efficacy of the Cypher(R) Sirolimus-Eluting Coronary Stent in Complex, Real-World PatientsThe e-CYPHER(SM) Registry Manuscript Published in the Journal Circulation
MIAMI, April 3 (HSMN NewsFeed) -- One-year follow-up data from the world's largest completed drug-eluting stent registry, consisting of more than 15,000 patients, found that the CYPHER® Sirolimus-eluting Coronary Stent demonstrates the same level of safety and efficacy in clinical practice as in randomized, controlled clinical trials. The results were published in the March 21 issue of the medical journal Circulation.
Specifically, the e-CYPHER(SM) Registry found that real-world treatment with the CYPHER® Stent in a wide range of patients -- including a large number of patients with diabetes (28.6 percent) -- resulted in low rates in the need for repeat procedures (target lesion revascularizations or TLR), major adverse cardiovascular events (MACE) such as heart attack and death, and in-stent blood clots (late stent thrombosis).
"As the largest drug-eluting stent registry to be completed in the world, the e-CYPHER(SM) Registry is a window into the real-world treatment of patients with the CYPHER® Stent on a scale that is usually only found in the pharmaceutical industry," said Philip Urban, M.D., F.E.S.C., the lead author of the e-CYPHER(SM) Registry manuscript and Director of Invasive Cardiology, La Tour Hospital, Geneva, Switzerland. "The positive data from the e-CYPHER(SM) Registry is highly encouraging and suggests that the safety and efficacy outcomes of the CYPHER® Stent across a broad range of complex patient populations that are being treated in routine clinical practice today are very similar to the excellent outcomes observed in clinical trials."
The e-CYPHER(SM) Registry reported that the overall patient population had cumulative MACE and TLR rates at 12 months of 5.8 percent and 3.1 percent, respectively, which are in line with data received from randomized clinical trials of the CYPHER® Stent.
The Registry found that the rate of stent thrombosis with the CYPHER® Stent was 0.87 percent at one year and did not appear to be affected by total stent length or termination of dual antiplatelet therapy. At one-year follow- up, 57 percent of patients were no longer on dual antiplatelet therapy. In his analysis, Dr. Urban noted that this rate was comparable to the late stent thrombosis rate for a bare metal stent and confirmed by the long-term data from such randomized clinical trials as RAVEL, SIRIUS and E-SIRIUS.
"The e-CYPHER(SM) Registry provides important observational evidence on the consistent performance of the CYPHER® Stent in treating patients with a broad range of real-world cases and clinical situations," said Dennis Donohoe, M.D., Vice President, Worldwide Clinical and Regulatory Affairs, Cordis Corporation. "As the Registry is another resource for physicians to evaluate the clinical outcomes of patients treated with the CYPHER® Stent, we are pleased to see that the Registry data echoes those of controlled, randomized clinical trials, which provide the highest level of clinical evidence."
About the e-CYPHER(SM) Registry
The e-CYPHER(SM) Registry is the largest Internet-based post marketing surveillance registry to be completed of its kind and is designed to assess the safety, efficacy and reliability of the CYPHER® Stent in daily clinical practice. With clinical follow-ups occurring at thirty days, six months and one year, the registry enrolled 15,524 patients, of which 15,157 were analyzed and treated with one or more CYPHER® Stents. Patients were from 41 countries throughout Latin America, Europe, Middle East and Asia Pacific, and were treated between April 2002 and July 2004. A total of 20,503 CYPHER® Stents were implanted to treat 18,295 lesions during this time period. One- year follow-up data from the e-CYPHER(SM) Registry was available for 13,069 patients.
An independent review committee adjudicated adverse events and endpoints.
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 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.
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