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(Circulation. 2007;115:2990-2994.)
© 2007 American Heart Association, Inc.

Special Report

Drug-Eluting Stents "Deliver Heartburn"

How Do We Spell Relief Going Forward?

Mitchell W. Krucoff, MD; Ashley Boam, MSBE; Daniel G. Schultz, MD

From the Duke University Medical Center/Duke Clinical Research Institute, Durham, NC (M.W.K.), and Center for Devices and Radiologic Health, United States Food and Drug Administration, Rockville, Md (A.B., D.G.S.).

Correspondence to Mitchell W. Krucoff, MD, Duke University Medical Center, Room A3006, 508 Fulton St, Durham, NC 27705. E-mail kruco001@mc.duke.edu

Key Words: device approval process • stents • thrombosis

An extract of the first 250 words of the full text is provided, because this article has no abstract.

"Breakthrough" technologies may produce rare or unexpected performance issues in postmarket use, especially when rapid market penetration into large patient populations outpaces the development of clinical knowledge. Although high-profile meetings or news media coverage may help draw attention to such issues, ultimately it is careful scientific consideration of safety and effectiveness issues, with transparent public access, that will help physicians and patients make decisions about how and when these technologies are best used in the practice of medicine. To this end, a 2-day special advisory panel on drug-eluting stent (DES) thrombosis was convened in December 2006 by the US Food and Drug Administration (FDA), as has recently been summarized by Laskey et al¹ and by Farb and Boam.²

Since the first safety alerts in 2003 to 2004 raised concerns that DES might be associated with an increase in rare but often catastrophic thrombotic events, public, professional, and regulatory attention has been focused on delineating the basis for this concern.³ In the spring of 2006, new reports of increased stent thrombosis rates with DES at the European Society of Cardiology in Barcelona led to a cascade of published reports and opinions^4–7 that were characterized in The Wall Street Journal headline as "Coated Stents Deliver Heartburn."⁸ The article did not specify whether the reference was to heartburn in already-stented patients, cardiologists, DES manufacturers, the FDA, or Wall Street itself. In fact, the issues surrounding DES touch on all of the above.

The FDA panel’s proceedings served a key purpose by publicly reviewing . . . [Full Text of this Article]

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