Chicago, IL (April 02, 2003) -- Cordis Corporation, a Johnson & Johnson company, today reported results from its C-SIRIUS clinical trial showing 100 percent reduction in in-stent restenosis at eight months, 91 percent reduction in late loss, and 64 percent improvement in minimum lumen diameter when using the CYPHER™ Sirolimus- eluting Coronary Stent as compared to the conventional bare metal stent control. These data, which were all statistically significant (p<.0001), were presented by Principal Investigator Erick Schampaert, M.D., Hospital Sacre-Coeur de Montreal, Canada, during the late breaking clinical trial section at the American College of Cardiology 52nd Annual Scientific Session in Chicago, IL.
"These results for C-SIRIUS are excellent, particularly considering the study's very challenging patient population. The study included 24 percent diabetics, as well as patients with long lesions and smaller vessels compared with patients studied in previous CYPHER™ Stent trials," said Dr. Schampaert. "The CYPHER™ Stent provides an exceptional treatment option for a broad range of patients."
The C-SIRIUS study is a multi-center, randomized, double-blind clinical trial that involved 100 patients at eight Canadian centers. Based on SIRIUS, the pivotal U.S. trial, C-SIRIUS treated patients with an average lesion length of 14.5 mm and 2.65 reference vessel diameter (RVD). The study, funded by Cordis Corporation, further advances the body of clinical evidence supporting the CYPHER™ Stent.
Consistent with prior reported studies, patients saw an improved event-free survival rate of 96 percent at 270 days in patients treated with a CYPHER™ Stent, which is significantly superior (P < 0.05) to the 82 percent event-free survival rate for patients treated with the conventional bare metal stent in the control arm of the study.
Additionally, as seen in RAVEL and SIRIUS, two earlier landmark clinical trials conducted by Cordis Corporation, the CYPHER™ Stent demonstrated these consistent results in a broad range of lesion types and patient subsets.
"We are pleased with the consistent excellent results we are seeing worldwide with our CYPHER™ Stent clinical studies," said Robert W. Croce, company group chairman of Johnson & Johnson, with global responsibility for the Cordis cardiovascular business franchise. "This is an important study for Canada and our global clinical program, which began more than six years ago and continues to document the consistent clinical outcomes of the CYPHER™ Stent."
About the CYPHER™ Stent
With more than 40 clinical trials conducted or in progress, the CYPHER™ Stent remains the most studied drug-eluting stent today with the largest body of publicly presented clinical evidence. An investigational device in the U.S., the CYPHER™ Stent received European CE Mark approval in April 2002, and is now available in nearly 60 countries worldwide.
Preclinical research has shown that sirolimus uniquely provides for normal re-endothelialization (does not interfere with endothelial cell coverage of the stent) while inhibiting smooth muscle cell proliferation. Cordis chose sirolimus for its cytostatic properties. Unlike a cytotoxic drug, which kills cells, a cytostatic agent prevents cells from dividing without destroying them, leaving them in a quiescent, or resting, state.
Sirolimus, the active drug released from the stent, is a naturally occurring substance marketed by Wyeth Pharmaceuticals, a division of Wyeth, under the name Rapamune®. Cordis 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. Rapamune® is a trademark of Wyeth Pharmaceuticals.
About Cordis Corporation
For more than 40 years, Cordis Corporation, a Johnson & Johnson company, has pioneered less-invasive treatments for vascular disease. Technological innovation and a deep understanding of the medical marketplace and the needs of patients have made Cordis the world's leading developer and manufacturer of breakthrough products for interventional medicine, minimally invasive computer-based imaging, and electrophysiology. Today, 5,300 Cordis employees worldwide share a strong commitment to continue the company's groundbreaking work in the fight against vascular disease. For more information, please visit www.cordis.com.
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Note: The CYPHER Sirolimus-eluting Coronary Stent is an investigational device limited by federal (U.S.) law to investigational use in the United States.
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