MIAMI, Fla., Aug. 17--PRNewswire-AsiaNet/
Three studies in this week's editions of the premier peer-reviewed journals New England Journal of Medicine (NEJM; August 18, 2005) and the Journal of the American Medical Association (JAMA; August 17, 2005) support the clinical benefits and safety profile associated with the CYPHER(R) Sirolimus-Eluting Coronary Stent compared to the Taxus stent. The studies were randomized, head-to-head comparisons of the CYPHER(R) Stent and the Taxus stent and examined complex patient groups, including patients with diabetes. The studies are available at www.nejm.org and http://jama.ama-assn.org
Data from the randomized, head to head Sirolimus-eluting and Paclitaxel-eluting Stents for Coronary Revascularization (SIRTAX) study and the Paclitaxel-eluting and Sirolimus-eluting stents to Prevent Restenosis in Diabetic Patients (ISAR-DIABETES) studies, as well as a meta-analysis of six, randomized head to head studies of the two drug-eluting stents, all show significantly improved outcomes with use of the CYPHER(R) Stent. The studies documented that use of the CYPHER(R) Stent consistently resulted in less tissue in-growth (late lumen loss), resulting in a lower incidence of reblockage and the need for repeat procedures, among other benefits.
An associated editorial in the same issue of NEJM, "Healing Achilles -
Sirolimus versus Paclitaxel" suggests that "the data overall, from randomized
clinical trials and from registries, suggest that the currently available sirolimus-eluting stents provide an angiographic and clinical edge over the currently available paclitaxel-eluting stents." It further suggests that the
benefits of the CYPHER(R) Stent may be more marked in patients with more complex disease.
"The studies profiled in the NEJM and JAMA add to the growing body of
evidence about drug-eluting stents and underscore the clinical benefits achieved with the CYPHER(R) Stent," said Brian Firth, M.D., Ph.D., F.A.C.C., Vice President, Medical Affairs and Health Economics Worldwide, Cordis Corporation. "These data will be important to physicians and the patients they
treat."
The studies published this week include:
NEJM Studies: SIRTAX and ISAR-DIABETES
The SIRTAX study is an independent, randomized, 1,012-patient, comparison of the CYPHER(R) Stent with the Taxus stent for coronary revascularization. It included not only patients with angina but also a large percentage of patients who were suffering from an acute heart attack (myocardial infarction) at the time of the stent placement. In this study, the use of the CYPHER(R) Stent as compared with the Taxus stent resulted in significantly fewer major adverse cardiac events (6.2 percent compared to 10.8 percent; p=0.009), primarily by significantly decreasing the need for repeat revascularization procedures (4.8 percent versus 8.3 percent; p=0.03).
ISAR-DIABETES is an independent, randomized study of 250 patients with diabetes and coronary artery disease. It provides critical comparative data on how the CYPHER(R) Stent and Taxus stent perform in a highly complex diabetic
population. The study found that in patients with diabetes and coronary artery
disease, the use of the CYPHER(R) Stent is associated with a marked decrease in the degree of tissue in-growth into the segment that received the stent as compared with use of the Taxus stent (late lumen loss 0.43 mm versus 0.67 mm; p=0.001), with a resulting significant reduction in restenosis (reblockage) (6.9 percent and 16.5 percent; p=0.02). This benefit was observed in both insulin-dependent and non-insulin-dependent diabetics.
JAMA Study: Meta-Analysis
The meta-analysis entitled "Meta-analysis of Randomized Trials:
Sirolimus-eluting Stents versus Paclitaxel-eluting Stents in Patients with Coronary Artery Disease" examined six randomized, head-to-head trials comparing the CYPHER(R) Stent and the Taxus stent. The analysis looked at 3,669 patients with coronary artery disease and concludes that patients receiving the
CYPHER(R) Stent had a significantly lower risk of restenosis (9.3 percent versus 13.1 percent; p=0.001) resulting in a significantly lower incidence of target vessel revascularization (5.1 percent versus 7.8 percent; p=0.001) compared with patients receiving the Taxus stent. Rates of death or myocardial infarction (heart attack) and stent thrombosis (blood clots) were similar.
About the CYPHER(R) Stent
The CYPHER(R) Stent continues to break new ground in fighting one of the
most troublesome challenges in the treatment of heart disease: restenosis. Developed and manufactured by Cordis Corporation, the CYPHER(R) Stent is currently available in 80 countries and has been used by doctors to treat more than 1,000,000 patients worldwide.
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:
Christopher Allman/Cordis Corporation
Cell: (305) 586-6024
Email: [email protected]
Todd Ringler/Edelman
Cell: (617) 872-1235
Email: [email protected]
SOURCE: Cordis Coporation
CONTACT: Christopher Allman of Cordis Corporation,
cell +1-305-586-6024,
[email protected]; or
Todd Ringler of Edelman,
cell +1-617-872-1235,
[email protected],
for Cordis Coporation
Web site: http://www.nejm.org
http://jama.ama-assn.org
--Distributed by AsiaNet (www.asianetnews.net)--