Enrollment Complete in First Randomized Head-to-Head Trial Of Drug-eluting Coronary Stents
REALITY Trial to Compare Performance in Diabetics and Other High-Risk Patients
MIAMI, Feb 18, 2004 -- Cordis Corporation today announced completion of patient enrollment in the first, randomized head-to-head coronary stent trial comparing its new CYPHER™ Sirolimus-eluting Coronary Stent with the Taxus* Express(2)* Paclitaxel-eluting Coronary Stent. Sponsored by Cordis Corporation, a Johnson & Johnson company, the REALITY Trial is a prospective, randomized study involving 1,386 patients at 90 hospital centers in Europe, Asia and Latin America.
Investigators describe the REALITY Trial as expressly designed to compare performance differences between the two drug-eluting stents, particularly in high-risk patient group subsets, such as diabetics and patients with long lesions and small-diameter vessels. Diabetics represent 32% of the study's population.
"The REALITY trial is significant for two reasons," said Principal Investigator, Marie-Claude Morice, M.D., Head of Interventional Cardiology at the Institut Hospitalier Jaques Cartier, Massy, France. "Not only is it the first direct comparison of two drug-eluting coronary stents, but it is also the first drug-eluting stent trial to include a high percentage of diabetic patients. Until now, the subsets of diabetic patients in these trials have been very small, making it difficult to draw meaningful conclusions on the efficacy of one drug-eluting stent versus another in treating diabetic patients. The REALITY trial offers us our first opportunity to get a true picture of the relative performance of these products in a very challenging population."
According to Dennis Donohoe, M.D., Cordis vice president of Regulatory and Clinical Affairs, the introduction of drug-eluting stents has "changed the paradigm for evaluating coronary artery stents."
"In the world of drug-eluting stents, it's about which product can achieve a safe, more durable result in the widest range of patients. Cordis has clinical trial data out to four years documenting the sustained performance and safety of the CYPHER™ Stent. There is no comparable body of long-term data available on the Taxus Stent."
Dr. Donohoe described sirolimus and paclitaxel as "two very different drugs with two very different mechanisms of action."
Inclusion criteria included a primary lesion of at least 15 mm in length in vessels of 2.25 to 3.0 mm in diameter, with a maximum of two treated lesions per patient. The trial endpoint is 8-month angiographic assessment of binary restenosis (reblockage).
Results of the REALITY Trial are anticipated by the end of this year.
About Drug-eluting Coronary Stents
Drug-eluting stents are bare metal stents coated
in a drug-releasing polymer. The stent props the blocked vessel open while the
polymer gradually releases a drug into the vessel wall to stop the growth of
scar tissue, which causes restenosis. The CYPHER Stent releases the drug sirolimus,
which is a cytostatic agent, meaning it stops cells from dividing without destroying
them. It is an anti-rejection medication first used in kidney transplant patients.
The Taxus Stent is coated with a cytotoxic agent, paclitaxel. The CYPHER Stent,
manufactured by Cordis Cardiology, a division of Cordis Corporation, and approved
for U.S. marketing in April 2003, has been used to treat approximately 500,000
patients in more than 80 countries worldwide.
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 in the interventional cardiovascular field. 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.
* Taxus and Express(2) are trademarks of SciMed Life Systems, Inc. The Taxus Express(2) Paclitaxel-eluting Coronary Stent is an investigational device in the United States, limited by Federal law to investigational use only in the United States.
Press Contacts for Cordis Corporation-
Martin E. Schildhouse, +1-786-313-2545,
Jeffrey J. Leebaw, +1-732-524-3350;
Investor Relations - Helen Short, +1-732-524-6491,
Stan Panasewicz, +1-732-524-2524
SOURCE: Cordis Corporation
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