New Study Suggests Better Patient Outcomes with CYPHER Sirolimus-Eluting Coronary Stent than with Taxus Stent in Real-World Clinical SettingsRegistry Analysis Published in Journal Heart Finds Taxus Stent, Implantation of Multiple Stents and Small Vessel Size To Be Independent Predictors of Need for Another Procedure
MIAMI LAKES, Fla., June 4, 2007 /PRNewswire via COMTEX News Network/ -- An analysis of data from the Western Denmark Heart Registry found that patients who received the CYPHER(R) Sirolimus-eluting Coronary Stent to open a clogged artery were less likely to need another procedure at that same lesion site (a clinical event called target lesion revascularization or TLR) than patients who received a Taxus Stent. The analysis was published in the June 1 issue of the journal Heart.
The authors of the analysis sought to identify risk factors for symptom- driven TLR when patients were treated with the CYPHER(R) Stent or the Taxus Stent in a real-world scenario. From Jan. 1, 2003 to May 18, 2005, 4,432 patients in Western Denmark were treated with a drug-eluting stent (CYPHER(R) Stent: 2,728 patients; Taxus Stent: 1,704 patients). Use of a Taxus Stent (odds ratio of 1.43; p=0.022), implantation of multiple stents per lesion (odds ratio of 1.62; p=0.008) and stent implantation in small vessels (odds ratio of 1.42; p=0.049) were found to be independent predictors of the need for TLR at nine months after the procedure.
"The major new finding of this study was that the use of the Taxus Stent was an independent predictor of TLR for a real-world population of patients treated with the CYPHER(R) Stent and the Taxus Stent," said Michael Maeng, M.D., Principal Investigator, from Aarhus University Hospital, Denmark.
When the lesions were divided into subgroups according to vessel size, the CYPHER(R) Stent yielded a 20 percent relative reduction of TLR in large vessels (2.4 percent versus 3.0 percent in arteries with a reference diameter equal to or greater than 2.8 mm; p=not significant) and a 40 percent relative reduction of TLR in small vessels (2.9 percent versus 4.8 percent in vessels less than 2.8 mm in diameter; p=0.046) compared to the Taxus Stent.
In the United States, the CYPHER(R) Stent is indicated for previously untreated lesions that are less than 30 mm in length with a reference vessel diameter ranging from more than 2.50 mm to less than 3.50 mm.
"Studies have shown that TLR is not benign. These registry findings provide additional assurance to the interventional cardiology community regarding the efficacy of the CYPHER(R) Stent to prevent the need for repeat revascularizations in a real-world clinical setting," said David E. Kandzari, M.D., F.A.C.C., F.S.C.A.I., Chief Medical Officer, Cordis Cardiology Division of Cordis Corporation.
About the CYPHER(R) Stent
The CYPHER(R) Stent has been chosen by cardiologists worldwide to treat approximately three 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 70 studies 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 broadest clinical experience and longest-term clinical follow-up of any drug-eluting stent. The next version of sirolimus-eluting stent, the CYPHER(R) SELECT(TM) Sirolimus- eluting Coronary Stent, was launched in Europe, Asia Pacific, Latin America and Canada in 2003. The CYPHER(R) SELECT(TM) Plus Stent, the third version of a sirolimus-eluting coronary stent, received CE Mark in 2006 and is currently available in many markets outside the United States.
For more complete information on indications, contraindications, warnings and precautions, see the Instructions for Use available at www.cypherstent.com.
About Cordis Corporation
Cordis Corporation, a Johnson & Johnson company, is a worldwide leader in the development and manufacture of interventional vascular technology. Through the company's innovation, research and development, Cordis partners with interventional cardiologists worldwide to treat 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(R). Rapamune is a trademark of Wyeth Pharmaceuticals.
SOURCE Cordis Corporation
Mariela Melendez of Cordis Corporation, +1-786-313-2776, cell, +1-786-218-4084, firstname.lastname@example.org; or Todd Ringler of Edelman, +1-617-872-1235, email@example.com
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Posted: June 2007