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New
Treatment for In-Stent Restenosis: A Balloon Coated with Paclitaxel |
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November 16, 2006 -- A small German study of 52 patients was published in the New England Journal of Medicine today that has the potential for significantly improving the treatment of in-stent restenosis. When stents are placed in the coronary arteries, they sometimes restenose -- tissue starts growing inside of the stent and the artery begins to close up again. Drug eluting stents have reduced this restenosis rate, but the problem, called "in-stent restenosis", still occurs. The treatments currently used to reopen these reblocked stents are "plain-old" balloon angioplasty (or POBA), brachytherapy radiation, delivered to the stent via a specialized catheter, and the placement of another stent inside of the closed one. These techniques have met with a variety of success -- brachytherapy is seldom used today since the placement of a drug-eluting stent inside of the closed one has shown to be superior, although technically it is an "off label" use. What Dr. Scheller of Universitätsklinikum des Saarlandes in Homburg and his co-researchers found was that a balloon catheter, coated with the drug paclitaxel (the same drug used in Boston Scientific's Taxus stent), achieved significant improvements in treating in-stent restenosis. When compared to using an uncoated balloon (POBA) which showed a restenosis rate of 43%, the paclitaxel-coated balloon had a 5% recurrence at 12 months. The novelty of this approach is that no new stent is placed and none of the problems of having a stent inside of a stent were present. What may have implications for future treatment of in-stent restenosis, as well as primary angioplasty, is that the dose release of paclitaxel was initially much higher than the levels achieved with drug-eluting stents, but the time of treatment was far less, only one minute, while the inflated balloon was in contact with the arterial wall. Furthermore, patients were given dual antiplatelet therapy (Plavix plus aspirin) for only a month. Yet the results for restenosis were very low, and achieved without placing a permanent metallic stent. In an accompanying editorial ("Treatment of In-Stent Restenosis: Back to the Future") Dr. Edoardo Camenzind, whose September presentation at the World Congress of Cardiology sparked the current controversy over drug-eluting stents, finds it interesting that the original angioplasty device, a simple balloon catheter, a device that has fallen out of fashion and is currently only used as a way to inflate stents, may now provide a less invasive way of preventing restenosis. All agree that much larger studies are, of course, required, but that this is a direction which needs to be pursued.
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