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Special Report

Drug-Eluting Stents in Preclinical Studies

Updated Consensus Recommendations for Preclinical Evaluation

Robert S. Schwartz, MD; Elazer Edelman, MD, PhD; Renu Virmani, MD; Andrew Carter, DO; Juan F. Granada, MD; Greg L. Kaluza, MD; Nicolas A.F. Chronos, MBBS; Keith A. Robinson, PhD; Ron Waksman, MD; Judah Weinberger, MD; Gregory J. Wilson, MD and Robert L. Wilensky, MD

From the Minneapolis Heart Institute and Foundation (R.S.S), Minneapolis, Minn.; Harvard-MIT Division of Health Sciences and Technology (E.E.), Cambridge, Mass.; CV Path International Registry of Pathology (R.V.), Gaithersburg, Md.; D3 Consultants (A.C.), Las Vegas, Nev.; Cardiovascular Research Foundation (J.F.G., G.L.K.), New York, N.Y.; St Joseph’s Translational Research Institute (N.A.F.C., KA.R.), Atlanta, Ga.; Washington Hospital Center (R.W.), Washington DC; Columbia University (J.W.), New York, N.Y.; University of Toronto (G.J.W.), Research Institute, the Hospital for Sick Children, Toronto, Ontario, Canada; University of Pennsylvania Health System (R.L.W.), Philadelphia, Pa.

Correspondence to Robert S. Schwartz, MD, Minneapolis Heart Institute Foundation, 920 E. 28th Street, Suite 600, Minneapolis, MN 55407. E-mail rss{at}rsschwartz.com

Received May 13, 2008; accepted August 13, 2008.

Coronary drug-eluting stents are commonplace in clinical practice with acceptable safety and efficacy. Preclinical evaluation of novel drug-eluting stent technologies has great importance for understanding safety and possibly efficacy of these technologies, and well-defined preclinical testing methods clearly benefit multiple communities within the developmental, testing, and clinical evaluation chain. An earlier consensus publication enjoyed widespread adoption but is in need of updating. This publication is an update, presenting an integrated view for testing drug-eluting technologies in preclinical models, including novel devices such as bioabsorbable coatings, totally bioabsorbable stents, bifurcation stents, and stent-free balloon-based drug delivery. This consensus document was produced by preclinical and translational scientists and investigators engaged in interventional technology community. The United States Food and Drug Administration (USFDA) recently issued a Draft Guidance for Industry Document for Drug-Eluting Stents. This expert consensus document is consistent with the Food and Drug Administration guidance. The dynamic nature of this field mandates future modifications and additions that will be added over time.

Key Words: drugs • restenosis • stents