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BUSINESS - PHARMA - CORONARY ARTERY STENT SAFETY

Johnson and Johnson demonstrates coronary stent safety

Four-year clinical results from the RAVEL trial show sustained clinical benefits with the CYPHER® Sirolimus-Eluting Coronary Stent, data presented at EuroPCR

 

BY A CORRESPONDENT

Paris, France, May 24, 2005: Four-year follow-up data from the landmark RAVEL trial presented today at the EuroPCR Congress showed that the CYPHER® Sirolimus-eluting Coronary Stent continues to demonstrate sustained safety and clinical benefits for patients with coronary artery disease.

Patients who received the CYPHER® Stent maintained a significantly lower incidence of revascularization (repeat procedures) and Major Adverse Cardiac Events (MACE) rates, including death, heart attack and target lesion revascularizations, for up to four years after implantation compared to patients who received bare metal stents (BMS). The RAVEL trial was sponsored by Cordis Corporation, a Johnson & Johnson company.

"Since the first data from the RAVEL trial were released, the impressive initial clinical and angiographic outcomes from the study further supported with four years of clinical follow up, confirm the impressive safety and efficacy profile of the CYPHER® Stent year after year," said presenter J. Eduardo Sousa, M.D. of the Dante Pazzanese Institute, Sao Paulo, Brazil. "The four-year data provides physicians with further time-tested clinical evidence for using sirolimus-eluting stents to treat patients."

A randomized study involving 238 patients in 19 centers across Europe and Latin America, RAVEL was the first double-blinded trial to demonstrate that a sirolimus-eluting stent virtually suppress post-stenting angiographic late loss at six months. In the study there was no restenosis or target lesion revascularization at the six month follow-up.

At 48 months, patients who received the CYPHER® Stent continued to experience excellent event-free survival rates compared to the BMS control arm. Event-free target vessel revascularization rates for CYPHER® Stent- treated patients were 91.8 percent, versus 73.4 percent in the control group (p<0.001). Furthermore, stent-related side effect rates – including stent thrombosis and late stent thrombosis – continued to remain at zero for CYPHER® Stent patients.

Event-free MACE rates were all significantly different at four years (77.5 percent for CYPHER® Stent patients versus 65.0 percent for the control group; p-value = 0.04).

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. 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 one million patients worldwide. With more than 40 clinical trials conducted or in progress worldwide, the CYPHER® Stent remains the most studied drug-eluting stent today.

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®. Rapamune® is a trademark of Wyeth Pharmaceuticals.

BY A CORRESPONDENT
 

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