To: Doc Bones who wrote (16016 ) 3/7/2005 9:19:58 AM From: Doc Bones Respond to of 52153 Data Support Broader Use of Heart Stents [NYT] By BARNABY J. FEDER Published: March 7, 2005 New clinical research results on the performance of stents, reported yesterday at the nation's largest annual meeting for heart doctors, support broader use of the devices, which prop open coronary blood vessels after they are cleared of blockages. The reports at the American College of Cardiology meeting in Orlando, Fla., also suggested that the Boston Scientific Corporation, the market leader, will face increasingly tough competition from two more diversified health care rivals, Johnson & Johnson and Medtronic Inc. "There isn't a clear winner, but the issues with each stent are starting to sort themselves out," said Dr. Charles A. Simonton III, a partner at the Sanger Clinic in Charlotte, N.C. Stents are metal mesh cylinders that have become the largest segment in the cardiology device market, with sales topping $5 billion last year. As an alternative to bypass surgery, cardiologists have increasingly been inserting long tubes called catheters into a vein in the leg, pushing them through the circulatory system to blocked blood vessels around the heart and inflating a balloon at the end of the catheter to open the vessels. The procedure is known as angioplasty. Stents are inserted through the catheter afterward to keep the vessel open. The reports presented yesterday focused on the newest form of the heart stents, which feature polymer coatings impregnated with drugs. The drugs seep out and counter the natural tendency of many vessels to close up again after angioplasty. Two large trials and one smaller one presented yesterday compared Taxus from Boston Scientific and Cypher from Johnson & Johnson, the only two drug-eluting stents approved for use in the United States as well as overseas. The smallest study, conducted in Germany, concluded that Cypher performed better when used in diabetic patients or as replacements for bare metal stents that had failed to prevent reblockage. The larger trials concluded that the stents are equally effective at keeping the vessel clear enough to avoid further intervention. Boston Scientific became the industry leader within weeks of the introduction of Taxus last spring because many doctors believe it often is easier to insert than Cypher. It presented results yesterday from a large clinical trial comparing Taxus to a bare metal stent in groups of patients who are particularly difficult to treat. While the results generally favored Taxus strongly enough to encourage cardiologists to expand their use of it, there was some suggestion that Taxus might be less safe than bare metal stents when multiple stents were being overlapped to treat a particularly long stretch of a vessel. The other long-awaited trial results presented yesterday compared Medtronic's drug-eluting Endeavor stent to the company's bare metal design; as expected, the trial showed substantially improved performance of the drug-coated stent, and is expected to clear the way for marketing of Endeavor in Europe this spring. While some analysts have forecast that Endeavor could be cleared for the American market toward the end of 2006, the company, based in Minneapolis, has said 2007 is more likely. nytimes.com