Trial Shows Good Results for Sirolimus-Eluting Stent

Preliminary data from a trial evaluating a sirolimus-eluting stent designed to reduce restenosis show good results. The trial is a large-scale randomized, double-blind trial involving 53 US treatment centers and 1,101 patients.

Intravenous ultrasound data on 96 patients showed virtually no in-stent late lumen loss in patients treated with the stent, called Cypher, mirroring the findings of earlier studies. The 2% rate of angiographic in-stent restenosis represented a 94% reduction versus the control, a bare metal stent. The subjects included a high percentage of patients with a significant risk of resentosis, including diabetic patients, patients with hyperlipidemia, hypertension, multivessel disease, and patients who had previously undergone coronary interventions.

Cypher is the product of Cordis Corp. (Miami Lakes, FL, USA). The device has received the CE Mark. Cordis chose sirolimus for its cytostatic, rather than cytotoxic, properties, thereby inhibiting cell proliferation rather than killing the cells.

"The major reductions in angiographic in-stent restenosis and late lumen loss associated with the Cypher sirolimus-eluting stent are proving to be remarkably similar from study to study,” said Martin B. Leon, M.D., of the Cardiovascular Research Foundation at Lenox Hill Hospital (New York, NY, USA) and a co-principal investigator.




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