Healthcare Industry News:  drug-eluting stent 

Devices Interventional Cardiology

 News Release - September 5, 2006

Two-Year Data Suggest Different Rates of Blood Clots and Heart Attacks Between the CYPHER(R) Sirolimus-Eluting Coronary Stent and the Taxus Stent

Latest Results of REALITY Trial Presented at World Congress of Cardiology 2006

BARCELONA, Sept. 5 (HSMN NewsFeed) -- Patients who receive the CYPHER® Sirolimus-eluting Coronary Stent were less prone to experience heart attacks (Q-wave myocardial infarctions) or blood clots (stent thromboses) than patients treated with the Taxus Stent, according to two-year data from a prospective, randomized, multi-center study. The latest results from the REALITY Trial were unveiled here today at the World Congress of Cardiology.

"drug-eluting stents have made it possible for more patients to receive less invasive treatments for cardiovascular disease," said Antonio Colombo, M.D., from San Raffaele Hospital and Centro Cuore Columbus Hospital in Milan, Italy, one of the REALITY investigators and the presenter of the results. "As discussions over the safety of these devices take place, studies such as REALITY, can help physicians select the best treatment option for their patients."

Less than 1 percent (0.9 percent) of the patients in the CYPHER® Stent arm of the REALITY Trial experienced stent thrombosis. In contrast, 2.5 percent of the patients in the Taxus Stent arm suffered a blood clot (p=0.02).

In addition, patients treated with the CYPHER® Stent suffered a Q-wave myocardial infarction (a heart attack affecting the full thickness of the heart wall) much less frequently than those receiving the Taxus Stent (0.1 percent vs. 1.5 percent; p=0.006).

Major adverse cardiac events or MACE, which in this study were defined to include cardiac deaths, Q-wave myocardial infarctions, non-Q wave myocardial infarctions (heart attacks that do not involve the full thickness of the heart wall), target lesion revascularizations (re-interventions to reopen an artery) using bypass surgery or angioplasty, were also tracked. A composite of these did not show a statistical difference between the two drug-eluting stents.

"These results underscore once again that not all drug-eluting stents are created equal," said Dennis Donohoe, M.D., Vice President, Worldwide Clinical and Regulatory Affairs, Cordis Corporation. "The unsurpassed safety and efficacy of the CYPHER® Stent is consistently supported by a robust clinical trial program that examine its performance in a broad range of patients, including complex cases."

The CYPHER® Stent clinical trial program includes more than 60 studies, with many additional independent clinical trials, and hundreds of publications in the most respected peer reviewed journals.

The REALITY Trial involved 1,386 moderately complex patients from 90 centers in Europe, Latin America and Asia. These patients were randomly selected to receive either the CYPHER® Stent or the Taxus Stent. In the end, the CYPHER® Stent was used in 684 patients and 970 artery blockages, while the Taxus Stent was used in 669 patients and 941 artery blockages.

Cordis Corporation sponsored the REALITY 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 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.


Source: Cordis

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