Clinical Performance of the CYPHER® Stent In Long Lesions, Diabetics and Complex Cases

Main Category: Cardiovascular / Cardiology
Article Date: 25 Sep 2004 - 12:00 PDT


The body of clinical evidence for the CYPHER® Sirolimus-eluting Coronary Stent continues to grow as new data from around the world are presented at the Cardiovascular Research Foundation's (CRF) Sixteenth Annual Scientific Symposium, Transcatheter Cardiovascular Therapeutics (TCT 2004), during the week of September 27th in Washington, DC.

More than 200 presentations, abstracts and posters examine the CYPHER® Stent, which remains the most studied drug-eluting stent available today. Among the key CYPHER® Stent presentations at the international medical conference are a head-to-head drug-eluting stent study that will provide comparative data on the CYPHER® Stent and Taxus Stent; an integrated analysis of major CYPHER® Stent trials; real world data from a wide range of patients; and two studies that tested the product's performance in diabetic patients with coronary artery disease.

"At TCT 2004, doctors will report on important measures of drug-eluting stent safety and efficacy, including major adverse cardiac event rates and target lesion revascularization rates - data which provide insight into how well a stent performs," said Dr. Brian Firth, M.D., Ph.D., vice president of Medical Affairs and Health Economics, Cordis Corporation. "Across patient populations, in studies and in daily practice, the CYPHER® Stent continues to demonstrate positive results. This is reassuring news to doctors and patients seeking a safe, effective treatment to unblock clogged arteries."

Key Presentations include:

CYPHER® Stent versus Taxus Stent

Multicenter Prospective Non-Randomized Registry Study for Drug-Eluting Stent in Very Long Coronary Lesions (CYPHER® versus Taxus): Long-DES Study, Korea - This independent study of 637 patients from eight cardiac centers in Korea evaluated the safety and efficacy of the CYPHER® Stent, Taxus Stent and bare metal stent for long coronary lesions. Primary endpoints are Major Adverse Cardiac Events (MACE) and target lesion revascularization (TLR).

Data to be presented on Monday, September 27 at 11:15 a.m.

BRIDGE Registry, France - A multi-center prospective trial of 1,000 patients that focused on Major Adverse Cardiac Events (MACE) as the primary endpoint in diabetic patients with coronary artery disease who received either the CYPHER® Stent or a conventional bare metal stent.

Data to be presented on Wednesday, September 29 at 11:15 a.m.

About the CYPHER® Stent - Developed and manufactured by Cordis Corporation, the CYPHER® Stent is currently available in more than 80 countries and has been used by doctors to treat more than 900,000 patients worldwide. With more than 40 clinical trials conducted or in progress worldwide, the CYPHER® Stent remains the most studied drug-eluting stent today with the largest body of clinical evidence demonstrating the long-term safety and efficacy of its drug and polymer. In clinical trials, the CYPHER® Stent has been shown to reduce reblockage in the arteries by more than 90 percent over a conventional bare metal stent. More information about the CYPHER® Stent can be found at http://www.cypherusa.com.

Data to be presented on Wednesday, September 29 at 11:35 a.m.

Real World Data: e-CYPHER(SM) Registry - Update on the treatment of diverse patient groups and lesion types with the CYPHER® Stent, as documented in this 15,000 patient global registry.

Data to be presented on Thursday, September 30 at 11:15 a.m.

ISAR-Desire, Germany - This independent, randomized, prospective study of 300 patients compared the use of drug-eluting stents (DES) with balloon angioplasty for treatment of in-stent restenosis (ISR), utilizing the CYPHER® Stent, Taxus Stent and balloon angioplasty.

Data to be presented on Friday, October 1 at 12:00 p.m.

Diabetic Data: DIABETES Trial, Spain - A multi-center, prospective, randomized, controlled trial of the CYPHER® Stent versus bare metal stent in patients with challenging lesions. The purpose of this trial was to test the safety and efficacy of the CYPHER® Stent in diabetic patients with coronary artery disease. The primary endpoint was late loss (re-narrowing of vessel wall after a stent procedure) at eight months follow-up.

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 Corporation 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 Corporation 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.

http://www.jnj.com

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