Healthcare Industry News: Bare-Metal
News Release - September 6, 2006
Data Suggest the Cypher(R) Sirolimus-Eluting Coronary Stent Provides Sustained Clinical Benefits In Patients With Coronary Artery Disease Compared to Bare Metal StentsBARCELONA, Spain, Sept. 6 (HSMN NewsFeed) -- At four years, the CYPHER® Sirolimus-eluting Coronary Stent continues to provide long-term clinical benefits (safety and efficacy) compared to Bare-Metal stents in patients with coronary artery disease. These data from the E-SIRIUS trial were reported here today at the World Congress of Cardiology. The E-SIRIUS trial is one of the longest-running European studies comparing the safety and efficacy of a drug-eluting stent to a Bare-Metal stent.
"The four-year results of E-SIRIUS increase our knowledge and understanding of the important role a drug-eluting stent, like the CYPHER® Stent, plays in our treatment of patients with coronary artery disease especially in challenging patients like those involved in this trial," said Joachim Schofer, M.D., Director, Hamburg University Cardiovascular Center, Germany and Principal Investigator, E-SIRIUS trial. "The long-term safety and efficacy of the CYPHER® Stent seen in this trial are impressive."
Target lesion revascularization, the need to re-intervene to open an artery, was reduced 73 percent in patients receiving the CYPHER® Stent compared to those receiving a Bare-Metal stent (7.4 percent vs. 27.1 percent, p<0.001). In patients receiving the CYPHER® Stent, major adverse cardiac events, also known as MACE, were reduced by more than half (54 percent) compared to patients receiving a Bare-Metal stent (16 percent vs. 34.5 percent, p<0.001). The definition of MACE in the study included all-cause death, heart attack (myocardial infarction) and target lesion revascularization by either heart bypass surgery (CABG) or another intervention (PCI).
The E-SIRIUS trial is a double blind, multi-center, controlled, randomized trial designed to compare restenosis (re-blockage) rates between the CYPHER® Stent and Bare-Metal stents. It involved 352 patients from 35 European clinical centers. Patients enrolled in the study were considered to be at a moderate to high clinical risk for restenosis due to a previous heart attack or smoking.
Late stent thrombosis or blood clots were rare in the four years of this study (2 in the CYPHER® Stent arm vs. 0 in the Bare-Metal stent control group, which is not statistically significant).
"It is always important to consider long-term clinical data when determining which drug-eluting stent is best for a patient," said Dennis Donohoe, M.D., Vice President, Worldwide Clinical and Regulatory Affairs, Cordis Corporation. "The results presented today from this important clinical trial reaffirmed the long-term safety and efficacy benefits of the CYPHER® Stent compared to Bare-Metal stents."
Eight and nine-month results of E-SIRIUS were published in Lancet in October 2003. Cordis Corporation funded the E-SIRIUS trial.
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 60 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. CYPHER SELECT(TM) Plus, the first third-generation drug-eluting stent, received the CE mark in June 2006 and will be made available in many markets outside the United States on Sept. 20, 2006.
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. More information about Cordis Corporation can be found at http://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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