Unanswered Questions — Drug-Eluting Stents and the Risk of Late Thrombosis

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Abstract
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 in the public domain.

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