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(Circulation. 2004;110:2498-2505.)
© 2004 American Heart Association, Inc.

Special Report

Preclinical Evaluation of Drug-Eluting Stents for Peripheral Applications

Recommendations From an Expert Consensus Group

Robert S. Schwartz, MD; Elazer R. Edelman, MD, PhD, For the Consensus Committee; Andrew Carter, DO; Nicolas A. Chronos, MD; Campbell Rogers, MD; Keith A. Robinson, PhD; Ron Waksman, MD; Lindsay Machan, MD; Judah Weinberger, MD; Robert L. Wilensky, MD; Jennifer L. Goode; O.D. Hottenstein; Bram D. Zuckerman, MD; Renu Virmani, MD

From the Minneapolis Heart Institute and Minnesota Cardiovascular Research Institute, Minneapolis, Minn (R.S.S.); Harvard-Massachusetts Institute of Technology Division of Health Sciences and Technology, Cambridge (E.R.R.); Borgess Medical Center, Kalamazoo, Mich (A.C.); Brigham and Women’s Hospital, Boston, Mass (E.R.R., C.R.); University of British Columbia, Vancouver, Canada (L.M.); American Cardiovascular Research Institute, Atlanta, Ga (N.A.C., K.A.R.); Washington Hospital Center, Washington, DC (R.W.); Columbia University, New York, NY (J.W.); University of Pennsylvania Health System, Philadelphia (R.L.W.); Armed Forces Institute of Pathology, Bethesda, Md, and US Food and Drug Administration, Rockville, Md (J.L.G., O.D.H., B.D.Z., R.V.).

Correspondence to Robert S. Schwartz, MD, Minnesota Cardiovascular Research Institute, Minneapolis Heart Institute Foundation, 920 E 28th St, Minneapolis, MN 55407. E-mail rss@rsschwartz.com

Key Words: stents • restenosis • drugs

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

	Introduction

 
Drug-eluting stents implanted in the coronary arteries substantially improve long-term outcomes for restenosis. The utility of the stents in peripheral atherosclerosis is under evaluation. Drug-eluting stent evaluation with coronary arteries appears to be an excellent method for evaluating human safety end points. Predicting clinical efficacy remains unclear, however. Because drug-eluting stents are undergoing development for human peripheral arteries, safety and efficacy questions arise in much the same context as they did for the coronary arteries. As they did with the coronary arteries, the clinical, scientific, regulatory, and commercial communities are seeking acceptable criteria for peripheral device evaluation. Substantial differences in stent requirements and biological effects for bare metal peripheral stents depend on implant site. Different anatomic locations under evaluation include femoral, renal, and neurologic arterial stents, and other peripheral applications such as outflow veins of dialysis arteriovenous fistulae are being evaluated. Peripheral in-stent restenosis is less of a problem in carotid and aortoiliac stents and in iliac veins and in the cavae. In general, the benefit:risk ratio for drug-eluting stents may be less for peripheral stents. It is for this reason that peripheral stent performance should be evaluated carefully.

This document presents an integrated recommendation set for evaluating drug-eluting stents in peripheral vessels with preclinical models. The recommendations encompass study design, experimental performance, and histopathologic evaluations and emphasize the need to evaluate safety and efficacy at multiple points in time. The present document is a consensus of clinical, academic, and commercial groups—all experts in the evaluation of preclinical investigational or . . . [Full Text of this Article]

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