What question did this study set out to answer?

This analysis addresses the impact and safety concerns associated with drug-eluting stents in cardiology.

October 13, 2004

Problems with Drug-Eluting Coronary Stents — The FDA Perspective

NMNeal I. MuniCambridge Systematics (United States)TGThomas P. GrossMidlands Technical College

Key Points

This analysis addresses the impact and safety concerns associated with drug-eluting stents in cardiology.
Review of FDA data on approved drug-eluting stents.
Assessment of adverse events linked to sirolimus and paclitaxel-eluting stents.
Both stents have been linked to significant adverse events post-approval, raising safety concerns.

Abstract

The introduction of drug-eluting coronary stents in the United States has rapidly and profoundly affected the field of interventional cardiology. Met with widespread anticipation by the clinical community, drug-eluting stents are now used in a majority of intracoronary stenting procedures, justifying their characterization as a “transforming technology.” However, both such stents that are currently approved by the Food and Drug Administration (FDA), the Cordis Cypher sirolimus-eluting stent and the Boston Scientific Taxus Express2 paclitaxel-eluting stent, have also been associated with highly publicized adverse events after they were approved for marketing, leading some to question their safety. As a by-product of . . .

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