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Study says rare allergic reactions to drug-eluting stents may raise risk for heart attack

ORLANDO -- Stents, tiny wire mesh tubes, are routinely used to prop arteries open after angioplasty clears them of potentially heart attack causing plaque. In the past, stented arteries often eventually closed up again with fatty deposits, a process called restenosis. However, since their FDA approval in 2003, stents coated with sirolimus (a pharmaceutical agent that prevents excess tissue growth) have been shown to greatly reduce restenosis. But some people suffer from rare, allergic-type reactions to the sirolimus-eluting stents (SES).

According to research presented by Emory scientists at the American College of Cardiology's 54th annual Scientific Sessions in Orlando today, these hypersensitivity reactions to SES should be caught and treated early -- because those allergic to components of the drug-eluting stents appear to have a higher risk of cardiovascular complications, including heart attacks.

"Reports of stent thrombosis first raised suspicion of possible hypersensitivity allergic reactions. After more than 50 reports of hypersensitivity reactions to SES were received by the FDA through the medical device reporting system, the FDA issued a warning in the fall of 2003," says Emory Heart Center Interventional Cardiology Fellow Fadi Alameddine, MD. "We studied the frequency of hypersensitive reactions to SES to see whether they were linked to major adverse cardiovascular outcomes."

Dr. Alameddine, lead author of the research presented at a poster session today, notes that hypersensitivity to SES could be caused by the stent's metal, polymer, or sirolimus. In order to evaluate whether allergic reactions might result from components of the Cypher drug eluting stent made by Cordis, a team of Emory researchers examined data collected from a U.S. registry of patients implanted with the Cypher SES. Out of 2067 patients who received the Cypher stents between August and December of 2003, 39 patients (1.9%) had what appeared to be all
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Contact: Sherry Baker
emoryheartnews@aol.com
404-377-1398
Emory University Health Sciences Center
7-Mar-2005


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