TCT2008 Concludes With Presentation Of Positive Data For The CYPHER(R) Sirolimus-eluting Coronary Stent

Main Category: Medical Devices / Diagnostics
Also Included In: Cardiovascular / Cardiology
Article Date: 31 Oct 2008 - 6:00 PDT

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This year's Transcatheter Cardiovascular Therapeutics annual meeting, also known as TCT2008, concluded recently with two important data presentations on studies that resulted in significant clinical differences between the CYPHER® Sirolimus-eluting Coronary Stent and Medtronic's Endeavor® Stent. In both SORT OUT III and the Western Denmark Heart Registry, the CYPHER® Stent was associated with significantly lower rates of stent thrombosis and revascularization (the need for another procedure) than the Endeavor® Stent.

In the randomized trial SORT OUT III, the incidence of heart attacks (myocardial infarction: Hazard Ratio (95% CI) 3.47 (1.14 - 10.5) p=0.03) and definite stent thrombosis (Hazard Ratio (95% CI) 4.62 (1.33 - 16.1) p=0.02) were significantly lower in patients receiving the CYPHER® Stent compared to those receiving the Endeavor® Stent. While the mortality rates were similarly low between the two products (approximately 2.0 percent each), the CYPHER® Stent was associated also with significantly less ischemia-driven target lesion revascularization at nine months than the Endeavor® Stent (Hazard Ratio (95% CI) 4.19 (2.10 - 8.35) p< 0.0001). SORT OUT III involved more than 2,300 patients.

"SORT OUT III once again demonstrates excellent sustained clinical outcomes for the CYPHER® Stent and further shows that there are important differences between drug-eluting stents, in this case the CYPHER® Stent and the Endeavor® Stent," said Campbell Rogers, M.D., Chief Scientific Officer and Head, Global Research and Development, Cordis Corporation.

The SORT OUT III data were followed at TCT2008 by the Western Denmark Heart Registry, which also included the CYPHER® Stent and the Endeavor® Stent. At two years of follow up, the CYPHER® Stent had significantly lower rates of all-cause mortality (Adjusted RR (95% CI) = 1.34 (1.04 - 1.71) p=0.02), lower rates of definite stent thrombosis in treated lesions (Adjusted RR (95% CI) = 1.78 (1.06 - 3.00) p< 0.05), and target lesion revascularization (Adjusted RR (95% CI) = 2.25 (1.42 - 3.56) p=0.0005) than the Endeavor® Stent.

"There now have been five different sets of data from randomized clinical trials and registries -- Endeavor III, SORT OUT III, ISAR TEST III, the SCAAR diabetes data and the Western Denmark Registry - in which the CYPHER® Stent outperformed the Endeavor® Stent in key outcome measures," Dr. Rogers noted.

In another clinical trial - ZEST AMI - the CYPHER® Stent had less late loss and a lower rate of restenosis compared to the Taxus® Stent and the Endeavor® Stent in patients undergoing angioplasty for the treatment of a heart attack. The three products were comparable in terms of major adverse cardiac events or MACE, which was the primary endpoint of the study. The CYPHER SELECT® Plus Sirolimus-eluting Coronary Stent, a third generation of the CYPHER® Stent now available outside the U.S. and Japan, recently received CE Mark in the European Union for the treatment of heart attack (acute myocardial infarction).

"We continue to be gratified by the outstanding performance of CYPHER® compared with other drug-eluting stents. The breadth of clinical safety and efficacy data and the long-term follow-up data on patient outcomes associated with the CYPHER® Stent are unmatched by the competition, and this gap continues to widen," Dr. Rogers concluded.

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 http://www.cypherstent.com.

About Cordis Corporation

Cordis Corporation, a Johnson & Johnson company (NYSE:JNJ), 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 http://www.cordis.com.

Note: 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.

Cordis Corporation