Healthcare Industry News: stent thrombosis
News Release - March 13, 2006
New Data Suggest Patients With Bifurcation Lesions Experienced Very Low Serious Event Rates With The CYPHER(R) Sirolimus-Eluting Coronary StentFirst Clinical Trial in This Difficult-to-Treat Patient Population Presented at ACC 2006
ATLANTA, March 13 (HSMN NewsFeed) -- Patients with bifurcated lesions, which are lesions that are spread into two parts at a common vessel juncture and are often difficult to treat, experienced a low rate of serious events at six-months with the CYPHER® Sirolimus-eluting Coronary Stent regardless of the stenting strategy, according to new multi-center, randomized clinical trial data presented today at the 2006 American College of Cardiology (ACC) Scientific Session. The study compared two stenting strategies: stenting main branch only and stenting both main vessel and side branch.
"Bifurcation lesions account for approximately 15 percent of the cases in daily interventional cardiology practice, but until now the optimal stenting strategy for these cases was unknown because of difficulties in assessing the true complexity of the lesion," said Leif Thuesen, M.D., Principal Investigator of the study and cardiologist at the Skejby Hospital at the University of Aarhus. "The results of our study show that the CYPHER® Stent worked extremely well in patients with bifurcation lesions."
Bifurcation lesions involve blockage of both the main coronary artery and an adjoining side-branch vessel, resulting in a more difficult-to-treat lesion. Interventional treatments of these lesions with bare-metal stents, balloon angioplasty or other techniques have resulted in low angiographic success, high complications and high restenosis rates.
The data from this study, "Main Vessel and Side Branch Stenting versus Optional Side Branch Stenting Using Sirolimus-eluting Stents in Bifurcation Lesions," were presented today by Terje Steigen, M.D. from University Hospital of North Norway in Tromso at ACC.
About the Nordic Bifurcation Study
The bifurcation study is a multi-center, randomized study that examined 413 patients with previously untreated (de novo) bifurcation coronary artery lesions. The primary end point of the study was major adverse cardiac events (MACE), which was defined as cardiac death, heart attack (myocardial infarction or MI), blood clots (thrombosis) and re-treatment of the blocked vessel (target vessel revascularization or TVR).
Individual endpoints (MACE) after six months were as follows:
Main Vessel Main Vessel and Stenting Side Branch Stenting (n=207) (n=206) Total death 1.0 percent 1.5 percent Cardiac death 1.0 percent 1.0 percent MI 1.4 percent 1.0 percent Index lesion MI 0.0 percent 1.0 percent Total lesion revascularization 1.4 percent 2.0 percent TVR 1.4 percent 2.5 percent Stent thrombosis 1.0 percent 0.0 percentP-value is not significant in this study.
The patients were divided into two treatment groups -- 207 patients received stenting of the main vessel with the CYPHER® Stent and 206 patients received stenting of the main vessel and the side branch with the CYPHER® Stent. Participating centers included hospitals from Denmark, Sweden, Norway, Finland and Latvia.
"This bifurcation study further supports the use of the CYPHER® Stent in treating difficult-to-treat, real-world patients," said Dennis Donohoe, M.D., Vice President, Worldwide Regulatory and Clinical Affairs, Cordis Corporation. "We are pleased to see positive data on the CYPHER® Stent being presented at ACC, and the outcomes of this study, in particular, add to the mounting clinical evidence supporting the CYPHER® Stent."
Cordis Corporation sponsored this trial.
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 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.
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.