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Majority of Drug-Coated Stent Use Not Approved by FDA


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Maisel said: "One of the most important questions now being asked in the use of drug-eluting stents is whether the patient is able to take uninterrupted antiplatelet therapy for at least 12 months. Stopping therapy before then can increase risk."

The issue of off-label use of stents is starting to affect medical practice, said Dr. Robert Michler, director of the heart center at Montefiore Medical Center in New York City. "Widespread use in off-label indications has diminished," he said.

"But the full impact has yet to be unraveled because many people are eager to see the data in these articles," Michler said.

Text Continues Below



The widespread off-label use of drug-coated stents "is an enormous public health concern" he added. "It is extremely important for patients and the medical society to understand this issue."

One major problem is that cardiologists often use stents in cases where "the recommended gold standard therapy is coronary bypass surgery," Michler said.

More information

An introduction is drug-eluting stents is provided by the U.S. Food and Drug Administration.

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Copyright © 2007 ScoutNews, LLC. All rights reserved.
Last updated 2/12/2007

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SOURCES: Gregory D. Curfman, M.D., executive editor, New England Journal of Medicine, Boston; Andrew Farb, M.D., medical officer, U.S. Food and Drug Administration, Bethesda, Md.; William Maisel, M.D., cardiologist, Beth Israel Deaconess Medical Center, Boston; Robert Michler, M.D., director of the heart center, Montefiore Medical Center, New York City; March 8, 2007, New England Journal of Medicine


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