Trial Shows New Stent Reduces Restenosis to Zero

A trial has shown that a new sirolimus-eluting stent dramatically reduces late loss and and the incidence of restenosis to zero after placement in patients with coronary artery disease. Called RAVEL, the study involved 238 patients at 19 centers in Europe and Latin America.

About half of the patients received a conventional Bx stent, while the other half received a sirolimus-eluting stent called Cypher. The reduction of hyperplasia resulted in an event-free survival rate of 97% at 210 days in the sirolimus group of patients, compared to a 73% event-free survival for patients treated with a conventional Bx stent. Other trials are underway in more than 1,450 patients.

Sirolimus, the drug released from the stent, is a naturally occurring antibiotic used to prevent renal transplant rejection. The drug prevents cell replication rather than killing cells. Cypher is the product of Cordis Corp., a company of Johnson & Johnson (New Brunswick, NJ, USA). Cordis has an exclusive license from Wyeth-Ayerst Laboratories for delivery of sirolimus by stent.

"If longer-term follow-up establishes the durability of the clinical outcome observed at 210 days, drastic changes in policy and the strategy of treating coronary artery disease will occur,” said Prof. Patrick Serruys, M.D., of Erasmus University in Rotterdam (The Netherlands), who helped pioneer early clinical work with this new technology.




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