WARREN, N.J.--(BUSINESS WIRE)--In patients with diabetes, the CYPHER® Sirolimus-eluting Coronary Stent outperformed the Taxus® Stent with significantly lower rates of in-segment restenosis (a reblockage within the stented area), target lesion revascularization (TLR; the need for another interventional procedure) and major adverse events (MACE, a composite of death, heart attack and TLR) at nine months according to clinical data appearing recently in the Journal of the American College of Cardiology.
In this multi-center randomized clinical trial, the six month rate of in-segment restenosis was more than five times lower for the CYPHER® Stent compared to the Taxus® Stent (4.0 percent vs. 20.8 percent respectively) (p < 0.001). Most important for patients and physicians, key clinical outcomes measures were about four times lower for the CYPHER® Stent -- at nine-months, clinically driven TLR for the CYPHER® Stent was 1.5 percent compared to 6.0 percent for the Taxus® Stent (p=0.032) while the composite clinical endpoint of MACE was 2.0 percent for the CYPHER® Stent compared to 8.0 percent for the Taxus® Stent (p=0.010).
“These data provide interventional cardiologists with valuable new information about the use of drug-eluting stents in patients with diabetes, whose coronary artery disease presents such therapeutic challenges,” said Seong-Wook Park, M.D., PhD, F.A.C.C., and Principal Investigator of this trial. Dr. Park is from the Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. Cordis has no financial relationship with Dr. Park.
“The significant reduction in restenosis associated with the CYPHER® Stent, which translated to better outcomes for patients in terms of TLR and overall MACE, is impressive. It also is encouraging to note the data in this study on the safety of the CYPHER® Stent in this difficult-to-treat patient population,” Dr. Park continued.
There was no difference between the two drug-eluting stents in the rates of death or myocardial infarction (heart attack). The rate of death was 0 percent for the CYPHER® Stent vs. 0.5 percent for the Taxus® Stent (p=0.999). The incidence of heart attack between the two groups was 0.5 percent (p=0.999).
The study included a total of 400 patients divided evenly between the CYPHER® Stent and the Taxus® Stent (200 each) from five academic medical centers in Korea between May 2005 and March 2006. All patients had clinically defined diabetes. This study was supported by the Cardiovascular Research Foundation (Korea) and a grant from the Korean Ministry of Health and Welfare.
“This study adds to the growing body of clinical evidence about the CYPHER® Stent in diabetics with coronary artery disease,” said Campbell Rogers, M.D., Chief Technology Officer, Cordis Corporation. “These data are consistent with other recently reported clinical trial data that clearly indicate that the CYPHER® Stent performs differently than the Taxus® Stent in diabetics, which has been a topic of discussion and debate within the medical community for some time.”
The CYPHER® Stent does not have an approved indication for use in patients with diabetes in the United States.
About the CYPHER® Stent
The CYPHER® 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® Stent in a broad range of patients.
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®. Rapamune is a trademark of Wyeth Pharmaceuticals.
-- The third party trademarks used herein are trademarks of their respective owners.
Contact:
Cordis Corporation Christopher Allman, 305-586-6024
Source: Cordis Corporation
