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(Circulation. 2007;115:2352-2357.)
© 2007 American Heart Association, Inc.

Special Reports

Thrombosis in Coronary Drug-Eluting Stents

Report From the Meeting of the Circulatory System Medical Devices Advisory Panel of the Food and Drug Administration Center for Devices and Radiologic Health, December 7–8, 2006^*

Warren K. Laskey, MD; Clyde W. Yancy, MD; William H. Maisel, MD, MPH

From the University of New Mexico Medical School (W.K.L.), Albuquerque; Baylor University Medical Center (C.W.Y.), Dallas, Tex; and Beth Israel Deaconess Medical Center, Harvard Medical School (W.H.M.), Boston, Mass.

Correspondence to Dr William H. Maisel, MD, MPH, Beth Israel Deaconess Medical Center, Cardiovascular Division, 185 Pilgrim Road, Baker 4, Boston, MA 02215. E-mail wmaisel@bidmc.harvard.edu

Key Words: restenosis • stents • thrombosis

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

	Introduction

 
Coronary drug-eluting stents (DES) were first approved for use in the United States in 2003 (Cypher Coronary Sirolimus-Eluting Stent [SES], Cordis Corporation, Miami Lakes, Fla) and 2004 (Taxus Express Paclitaxel-Eluting Stent [PES], Boston Scientific Corporation, Natick, Mass) on the basis of randomized, blinded, controlled studies that demonstrated reduced target vessel failure (Cypher) and target vessel revascularization (TVR) (Taxus) at 9 months. Major adverse cardiac events were also significantly reduced for both DES when compared with bare metal stents (BMS).

Presentations at national and international meetings in 2006 suggested that DES use may be associated with an increase in late (1 year after implantation) stent thrombosis (ST). Other studies suggested that there may be a significant increase in the combined end point of death and myocardial infarction (MI) compared with BMS. In response to these safety concerns, the US Food and Drug Administration (FDA) convened a meeting of the Circulatory System Medical Devices Advisory Panel. Advisory Panels make nonbinding recommendations to the FDA.

	Definitions

 
Panelists recognized the need for a method to assess the true frequency of ST. However, one of the challenges in the assessment of DES ST risk is that the ST definition varies from study to study (Table 1). Differences in these on-protocol definitions of ST make it difficult to pool studies for analysis and to compare one stent to another (sirolimus-eluting versus paclitaxel-eluting). Furthermore, it is important to note that the on-protocol definition of ST for some of the clinical trials that support DES approval . . . [Full Text of this Article]

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