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Investigational anti-restenosis drug pimecrolimus disappoints
Date:3/31/2008

CHICAGO, Ill. (March 31, 2008) A new medication that researchers had hoped would reduce the risk of arterial renarrowing after stenting has turned in a disappointing performance in a multicenter clinical trial, but the multi-reservoir stent that was used to deliver the drug is still considered promising.

Pimecrolimus, an anti-inflammatory medication, was expected to reduce arterial inflammation and, therefore, the overgrowth of scar tissue, or neointimal hyperplasia, that causes in-stent restenosis. Instead, patients treated with pimecrolimus-eluting stents fared far worse than patients treated with stents that delivered a combination of pimecrolimus and paclitaxel, or paclitaxel alone, according to the Randomized, Multi-Center Study of the Pimecrolimus-Eluting and Pimecrolimus/Paclitaxel-Eluting Coronary Stent System in Patients with De Novo Lesions of the Native Coronary Arteries (GENESIS). Paclitaxel is also an anti-restenosis medication, but it works by inhibiting cell division, rather than by reducing arterial inflammation.

The GENESIS study was terminated early by its sponsors. The data gathered to that point are being reported today in a Late-Breaking Clinical Trials session at the SCAI Annual Scientific Sessions in Partnership with ACC i2 Summit (SCAI-ACCi2) in Chicago. SCAI-ACCi2 is a scientific meeting for practicing cardiovascular interventionalists sponsored by the Society for Cardiovascular Angiography and Interventions (SCAI) in partnership with the American College of Cardiology (ACC).

Despite pre-clinical data suggesting marked efficacy of pimecrolimus in suppressing neointimal hyperplasia, the extent of tissue growth and resulting rates of target vessel revascularization at six months were high in patients treated with this drug, said Stefan Verheye, MD, PhD, co-director of the catheterization laboratories at Antwerp Cardiovascular Center, ZNA Middelheim Hospital, Antwerp, Belgium.

The GENESIS study was als
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Contact: Kathy Boyd David
pr@scai.org
717-422-1181
Weber Shandwick Worldwide
Source:Eurekalert

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