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

o designed to a novel stent design featuring reservoirs that are filled individually with an active drug and resorbable polymer matrix. This design enables the stent to deliver more than one drug at a time from adjacent reservoirs. In the case of the GENESIS study, the SymBio stent was loaded with two medications that inhibit restenosis by two different pathways. In addition, the reservoirs limit the contact between the polymer and the artery wall.

For the study, Dr. Verheye and his colleagues enrolled 248 patients with single new coronary artery lesions, recruiting them from 18 medical centers in Europe and Israel. Patients were randomly assigned to stenting with the Corio stent, which delivers pimecrolimus; the SymBio stent, which delivers both pimecrolimus and paclitaxel; or the paclitaxel-coated CoStar stent. All of these stents are made with the reservoir design.

After nearly six months of follow-up, shrinkage of the arterial opening inside the stent (in-stent late loss) was greatest with the pimecrolimus-eluting Corio stent (1.40 mm), mid-range with the dual-drug SymBio stent (0.96 mm) and least with the paclitaxel-eluting CoStar stent (0.58 mm), but none of the differences between stents was statistically significant. Other angiographic findings followed the same pattern, including minimal lumen diameter, percent diameter stenosis and restenosis rateas did the findings of intravascular ultrasound at six months.

At six months, 39 percent of patients treated with the Corio stent experienced a major adverse cardiac event (MACE), including a 35 percent rate of repeat procedure in the target artery. With the SymBio stent, those rates were both 14.4 percent, and with the CoStar stent, they were both 2.0 percent. The difference in MACE rates between the CoStar stent and both of the pimecrolimus stents was highly statistically significant (p<0.0001). The rate of stent thrombosis at six months was 2.0 percent with the Corio stent, 1.0 per
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Contact: Kathy Boyd David
pr@scai.org
717-422-1181
Weber Shandwick Worldwide
Source:Eurekalert

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