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Drug-coated balloon overcomes in-stent restenosis
Date:3/31/2008

y offer a simpler alternative. This drug-eluting balloon is coated with paclitaxel, the same medication that coats the Taxus stent. The balloon is inflated for about 30 seconds inside the narrowed artery, and the paclitaxelwhich has a natural attraction to cellsquickly moves from the surface of the balloon into the arterial cells.

Not only does the drug-eluting balloon avoid a second layer of metal inside the artery, the carrier that is used to bind paclitaxel to the balloon is iopromide, a commonly used contrast agent. This avoids concerns about the arterys reaction to the polymers used to bind paclitaxel and other anti-restenosis medications to drug-eluting stents.

The study was conducted at the Center for Cardiovascular Diseases in Rotenburg an der Fulda, Germany. Dr. Unverdorben and his colleagues recruited 131 patients with restenosis in a bare-metal stent, randomly assigning them to treatment with the Sequent Please drug-eluting balloon (DEB) or the Taxus drug-eluting stent (DES). Five patients were excluded for protocol violations, and four patients in the stent group were actually treated with the drug-eluting balloon. This left, for the as-treated analysis, 66 patients in the DEB group and 60 patients in the DES group.

The researchers initially analyzed the data according to each patients original treatment assignment (the intention-to-treat analysis). After an average of six months of follow-up, late-lumen lossthe amount of tissue that grew from the vessel wall into the arterial lumenwas significantly less in the patients treated with the DEB (0.20 mm vs. 0.45 mm, p=0.02). When the data were analyzed according the treatment each patient actually received, the results were even more promising. Late-lumen loss remained significantly better with the drug-eluting balloon. In addition, a finding of significant renarrowing in the treated segment was less common in the DEB group (3.4 percent vs. 20.4 percent, p=0.007), as was the need
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Contact: Kathy Boyd David
pr@scai.org
717-422-1181
Weber Shandwick Worldwide
Source:Eurekalert

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