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An FDA panel on Thursday and Friday will examine whether drug-eluting stents increase the risk of life-threatening blood clots and whether the potential risk outweighs the benefits of the stents for some patients, the Wall Street Journal reports. Drug-coated stents, which are sold in the U.S. by Boston Scientific and Johnson & Johnson, are designed to prevent scar tissue from forming in arteries after angioplasty. However, recent studies have suggested the devices might increase the risk of thrombosis compared with bare-metal stents (Wilde Mathews, Wall Street Journal, 12/4). A study by Cleveland Clinic physician Deepak Bhatt, published Wednesday in the American Journal of Medicine, found that drug-coated stents had five times the risk of blood clots as bare-metal stents (Marchione, AP/Arizona Daily Star, 12/4). In addition, a study published online Monday in the Journal of the American College of Cardiology found that patients who received the devices doubled their risk of a heart attack or heart-related death after they stopped taking the anticlotting medication Plavix, compared with patients who received bare-metal stents. Plavix is marketed by Bristol-Myers Squibb in the U.S. and Sanofi-Aventis in the rest of the world. The panel might examine whether FDA should require longer studies of drug-coated stents and might recommend that FDA restrict the use of drug-coated stents already on the market, the Journal reports. In addition, the panel might recommend that patients who receive the devices take Plavix for longer than the current recommendation of six months or less (Wall Street Journal, 12/4). David Williams of Brown University said physicians already are urging patients to take Plavix for longer periods of time, adding, "We're saying indefinite for some patients even though we have no idea what that means" in terms of safety. According to Spencer King, a past president of the American College of Cardiology, Plavix can increase the risk of serious bleeding, which could put patients at risk of a blood clot if they have to stop taking the drug to prevent excessive bleeding before surgeries (AP/Arizona Daily Star, 12/4).
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