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Volume 356:981-984 March 8, 2007 Number 10
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Unanswered Questions — Drug-Eluting Stents and the Risk of Late Thrombosis
William H. Maisel, M.D., M.P.H.

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After recognizing coronary drug-eluting stents as a "breakthrough technology" and granting them expedited review status, the Food and Drug Administration (FDA) approved two such devices for use in 2003 (Cordis's sirolimus-eluting Cypher stent) and 2004 (Boston Scientific's paclitaxel-eluting Taxus stent). Cardiologists quickly embraced the new technology; by the end of 2004, drug-eluting stents were used in nearly 80% of percutaneous coronary interventions in the United States, and within 3 years, several million drug-eluting stents had been implanted worldwide. Recently, however, concerns about an increased risk of late stent thrombosis have arisen and have been exacerbated by insufficient and conflicting information . . . [Full Text of this Article]


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Dr. Maisel is a cardiologist at Beth Israel Deaconess Medical Center and an assistant professor of medicine at Harvard Medical School — both in Boston. Dr. Maisel is also chair of the FDA Circulatory System Devices Advisory Panel.

This article (10.1056/NEJMp068305) was published at www.nejm.org on February 12, 2007.


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