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REALITY Trial Data Suggest Drug-Eluting Stents
Differ Significantly in Rate of
Blood Clot Formation - Stent Thrombosis


Orlando, FL (March 6, 2005) – Results from the REALITY trial presented today at the American College of Cardiology Annual Scientific Session found that the CYPHER® Sirolimus-eluting Coronary Stent was associated with development of significantly fewer blood clots at the stent site (stent thromboses) than the Taxus Paclitaxel-eluting Coronary Stent* (p=0.020).

Stent thrombosis is a severe complication of stenting and can result in heart attacks and death. Patients who received stents are typically prescribed anti-platelet therapy to reduce the risk of stent thrombosis. In this trial, compliance with dual anti-platelet therapy was extremely high (99 percent for the Taxus Stent vs. 97 percent for the CYPHER® Stent).

"In this study, the incidence of stent thrombosis was 78 percent lower with the CYPHER® Stent than with the Taxus Stent," said principal investigator Marie-Claude Morice, M.D., head of Interventional Cardiology at the Institut Hospitalier Jacques Cartier, Massy, France. "As this is the first head-to-head trial to observe a difference in the rate of stent thrombosis, these results raise concerns and demand further investigation."

The study also demonstrated that both CYPHER® Stent and Taxus Stent were equally deliverable. The study also demonstrated that both products were efficacious, at comparable rates, in preventing in-segment binary restenosis (re-clogging), which was the primary endpoint of the study, in moderately complex patients.

"While we see that the two drug-eluting stents were comparable in terms of the primary endpoint of restenosis, we also observed that patients who received the CYPHER® Stent had a significantly larger vessel diameter inside the stent after eight months of follow-up, which is important because the vessel diameter determines the amount of blood that is delivered to the heart muscle," noted Dr. Morice.

The REALITY trial is one of several randomized controlled trials, including the ISAR-DIABETES and SIRTAX studies, comparing the two drug-eluting stents in different patient populations to be presented this week during the international meeting.

Data Trends Favorable for CYPHER® Stent
Several key angiographic (medical imaging) measurements favored the CYPHER® Stent at the eight month follow-up endpoint of the study. The minimum lumen diameter was significantly larger, while the late loss (a measure of tissue in-growth into the stent) and mean percent diameter stenosis were both significantly lower with the CYPHER® Stent. These important measures highlight the outstanding efficacy of the CYPHER® Stent at preventing vessel from re-clogging over time.

"There is a growing body of meaningful and predictive data to examine about the CYPHER® Stent," said Dennis Donohoe, M.D., vice president, Worldwide Regulatory and Clinical Affairs, Cordis Corporation. "Time and again, researchers continue to find that the CYPHER® Stent offers benefit for many types of patients and lesions in the near- and long-term, improving health and quality of life."

About The REALITY Trial
Sponsored by Cordis Corporation, a Johnson & Johnson company, the REALITY Trial is a prospective, randomized study involving 1,386 patients at 90 hospitals centers in Europe, Latin America and Asia. In the REALITY trial, patients were included if they had up to two de novo (new) lesions with a primary lesion of at least 15 mm in length in small vessels (2.25 to 3.0 mm in diameter).

The two study arms were well balanced in terms of standard patient characteristics including age, sex and prior heart attack. Patients were also well balanced in terms of number of diseased arteries and the location of the lesions. On average, patients receiving the CYPHER® Stent had 1.91 stents while those receiving Taxus had 1.94 stents.

About the CYPHER® Stent
The CYPHER® Stent continues to break new ground in fighting one of the most formidable challenges in the treatment of heart disease: restenosis (reblockage). Developed and manufactured by Cordis Corporation, the CYPHER® 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 research, development and innovation, physicians worldwide are better able to treat the millions of patients who suffer from vascular disease. For more information about Cordis Corporation, please visit www.cordis.com.

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.

*Taxus is a trademark of SciMed Life Systems, Inc.

SOURCE

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