The 205-patient, randomized, comparative clinical trial found that at six months, patients with bifurcations in the CYPHER® Stent arm were three times less likely to experience restenosis (9 percent for CYPHER® Stent vs. 29 percent for Taxus stent, p=0.05) and undergo TLR (4 percent for CYPHER® Stent vs. 13 percent for Taxus stent, p=0.05) than patients with bifurcations in the Taxus stent arm of the study. The late loss results in the main vessel and adjoining side branch also favored those patients treated with the CYPHER® Stent.
This study was one of many clinical successes in 2005 for the CYPHER Stent. During the year, the CYPHER Stent experienced exponential growth worldwide, driven by numerous positive results from randomized controlled trials as well as meta-analyses of these trials presented at leading medical meetings and published in peer-reviewed journals including the New England Journal of Medicine (NEJM), Journal of the American Medical Association (JAMA), Circulation and the Journal of the American College of Cardiology (JACC). Clinical data results helped re-establish the CYPHER® Stent as the leading drug-eluting stent globally.
"This year brought an impressive volume of positive new data on the CYPHER® Stent," said Dennis Donohoe, MD, Worldwide Vice President, Clinical Research and Regulatory Affairs, Cordis Corporation. "Overwhelmingly, these data have confirmed the unsurpassed long-term efficacy and the trusted safety profile of the CYPHER® Stent and have been instrumental in establishing Cordis Corporation as the worldwide market leader in drug-eluting stents."
In 2005, the SIRTAX study, published in the NEJM, found statistically significant differences favoring the CYPHER® Stent compared with the Taxus stent across a variety of measures, including major cardiac adverse events (MACE), TLR, in-segment late loss and in-segment binary restenosis.
The global REALITY study presented in March documented that the CYPHER® Stent was associated with significantly less late loss compared to the Taxus Stent. In addition, when focused on small vessel diameters, the CYPHER Stent was associated with fewer blood clots at the stent site (stent thromboses) compared to the Taxus stent.
Other trials presented this year also had results favoring the CYPHER Stent compared to the Taxus Stent, including: ISAR-DESIRE and an independent meta-analysis both published in JAMA, and ISAR-DIABETES published in NEJM.
"The ability to achieve a sustained clinical benefit in tough-to-treat patients is a key consideration when choosing a drug-eluting stent," said David R. Holmes, Jr., MD, Professor of Medicine, Mayo Clinic College of Medicine, Rochester, MN. "It is reassuring to see data that documents the CYPHER® Stent performs reliably over the long haul, and does so with a strong safety profile. Results from randomized clinical trials like these are the true benchmarks in evidence-based medicine."
In 2005, data were also presented showing how the CYPHER® Stent performed in trials examining complex lesions. Of note was the PRISON II study, which looked at patients with chronic total occlusions and an analysis of four trials, including the SIRIUS, E-SIRIUS, C-SIRIUS and DIRECT trials, that provided information about use of CYPHER in long coronary blockages when those blockages were treated with multiple, overlapping or non-overlapping CYPHER® Stents, rather than with a bare metal stent. The SISR trial, which featured a randomized trial design, compared CYPHER Stent to radiation within a vessel (brachytherapy).
Finally, a cost-effectiveness analysis of the ARTS I and II trials demonstrated that treatment with the CYPHER® Stent offers potential cost-savings over bypass surgery, a finding that supports the use of drug-eluting stents in treating certain complex patient cases that would have otherwise been directed to surgery. The ARTS II trial was published in JAMA.
"The scientific rigor and high standards attributed to randomized clinical trials has provided interventional cardiologists with a significant degree of clinical evidence on the sustained safety and efficacy of the CYPHER® Stent," said Dr. Donohoe. "Across a broad range of randomized trials, independent studies and patient registries, we continue to see excellent results for the CYPHER® Stent - even in the most challenging lesions."
The positive results from clinical trials coupled with health economic analyses helped to secure important accomplishments in reimbursement in key markets globally. Recently, the French Ministry of Health expanded reimbursement for the CYPHER® Stent and CYPHER SELECT
"We're pleased with the progress achieved in 2005. Since coming to market in 2003, more than 1.5 million patients worldwide have been treated with the CYPHER® Stent," stated Dr. Donohoe. "As we move ahead, we will remain focused on providing ongoing clinical and economic value to the physicians and patients who depend on our medical technology."
About the CYPHER® Stent
The CYPHER® Stent has been chosen by cardiologists worldwide to treat more than 1.5 million patients with coronary artery disease. It 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 stent in vessels of varying complexity. Developed and manufactured by Cordis Corporation, the CYPHER® Stent is currently available in more than 80 countries and has the longest clinical follow-up of any drug-eluting stent. The CYPHER SELECT
More information about the CYPHER® Stent can be found at http://www.cypherusa.com/.
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, more than 7,000 Cordis employees worldwide share a strong commitment to continue the Company's groundbreaking work in the fight against 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®. Rapamune is a trademark of Wyeth Pharmaceuticals.