MIAMI, Jan. 31 /PRNewswire/ -- The CYPHER(R) Sirolimus-Eluting Coronary Stent may reduce re-blockage (restenosis) and the occurrence of major adverse cardiac events in patients with complex coronary artery lesions without increasing the risk of blood clots (thrombosis), according to a new study published in the January 17 issue of the Journal of the American College of Cardiology (JACC).
The SCANDSTENT study (Stenting of Coronary Arteries in Non-Stress/Benestent Disease) is the only randomized study examining the CYPHER(R) Stent against bare metal stents that includes complex patients, defined as patients with blockages longer than 15 millimeters, side-branch lesions, ostial lesions, and lesions angled at greater than 45 degrees (angulated lesions).
"In the first six months after receiving a CYPHER(R) Stent, we saw significant clinical and angiographic improvement in these challenging patient cases," said lead investigator Henning Kelbaek, M.D., chief physician, Rigshospitalet, Copenhagen, Denmark. "Longer term follow-up and studies of drug eluting stents in thrombotic lesions are needed, but if these positive outcomes continue there will be few situations in which use of a bare metal stent will be considered favorable."
Dr. Kelbaek and his colleagues randomized 322 patients with chest pain (angina pectoris), lack of oxygen to the heart (unstable angina), and complex lesions to treatment with the CYPHER(R) Stent or a bare metal stent. Investigators found that at six months the CYPHER(R) Stent outperformed the bare metal stent. When comparing the CYPHER(R) Stent group with the bare metal stent group, researchers found improvements in the narrowest vessel size (minimal lumen diameter; 1.63mm versus 2.48mm; p<0.0001), significant reductions in narrowing of the vessel (diameter stenosis; 19.3 percent versus 43.8 percent; p<0.0001), a dramatic reduction in narrowing of the vessel on multiple occasions (>50 percent stenosis in main branch; 2 percent versus 31.9 percent; p<0.0001) and significantly lower rates of target lesion revascularization (2.4 percent versus 29.6 percent; p<0.0001).
The SCANDSTENT study also documented low angiographic and clinical restenosis rates with the CYPHER(R) Stent as compared with a pooled analysis of other CYPHER(R) Stent versus bare metal stent studies, including RAVEL, SIRIUS, DIABETES and SES-SMART studies. The CYPHER(R) Stent was found to reduce angiographic restenosis by 80 percent and target vessel revascularization by 75 percent compared to the bare metal stent group in the pooled analysis. In the SCANDSTENT trial, angiographic restenosis was reduced by 94 percent and target vessel revascularization by 92 percent.
"The SCANDSTENT study reinforces the belief in the strong clinical performance of the CYPHER(R) Stent across a broad range of patients," said Dennis Donohoe, MD, Worldwide Vice President of Clinical Research and Regulatory Affairs, Cordis Corporation. "The positive outcomes seen in this study add to the long-term clinical evidence supporting the CYPHER(R) Stent."
About the CYPHER(R) Stent
The CYPHER(R) Stent has been chosen by cardiologists worldwide to treat more than 1.5 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(R) Stent in a broad range of patients. Developed and manufactured by Cordis Corporation, the CYPHER(R) Stent is currently available in more than 80 countries and has the longest-term clinical follow-up of any drug-eluting stent. The CYPHER SELECT(TM) Sirolimus-eluting Coronary Stent, which is the first next generation drug-eluting stent, was launched in Europe, Asia Pacific, Latin America and Canada in 2003. More information about the CYPHER(R) Stent can be found at 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(R). Rapamune is a trademark of Wyeth Pharmaceuticals.
Media Contacts: Terri Mueller/Cordis Corporation Phone: 786-313-8687 Cell Phone: 305-903-9980 Email: tmueller@crdus.jnj.com Todd Ringler/Edelman Cell Phone: 617-872-1235 Email: todd.ringler@edelman.com
Cordis CorporationCONTACT: Media, Terri Mueller of Cordis Corporation, +1-786-313-8687, orCell Phone, +1-305-903-9980, tmueller@crdus.jnj.com; or Todd Ringler ofEdelman, Cell Phone, +1-617-872-1235, todd.ringler@edelman.com, for CordisCorporation
Web site: http://www.cypherusa.com/