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(Circulation. 2006;113:2262-2265.)
© 2006 American Heart Association, Inc.

Editorial

Pushing Drug-Eluting Stents Into Uncharted Territory

Simpler Than You Think—More Complex Than You Imagine

Campbell Rogers, MD; Elazer R. Edelman, MD, PhD

From the Cardiovascular Division, Department of Medicine, Brigham and Women’s Hospital, Boston, and Harvard-MIT Division of Health Sciences and Technology, Cambridge (C.R., E.R.E.), Mass.

Correspondence to Drs Campbell Rogers and Elazer Edelman, Brigham and Women’s Hospital, 75 Francis St, Boston, MA 02115. E-mail crogers@mit.edu and ere@mit.edu

Key Words: Editorials • registries • restenosis • stents • failure

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

	Introduction

 

Failures are the preparation for...victories.

Ralph Waldo Emerson¹

Mechanical failure is a characteristic of a material or device and not necessarily an indication of inadequacy. All devices will fail under some specific stress. It is only failure at the lowest levels of stress that may represent inadequacy. Stress on a material, for example, rises with strain until a critical load is exceeded, at which point the material fatigues and loses mechanical integrity. Failure analysis, the science by which these conditions are rigorously defined, is an important component of device design, development, and use. Once the transition point to failure is identified, material use can be restricted to the zone of safety or modified so as to have this zone expanded. Just as the characterization of a material is incomplete unless pushed to the limits of load bearing, characterization of an implantable device is incomplete unless preclinical and clinical environments test the limits of device functionality. It was in this light in 1999 that we noted the impossibility of defining the functional limits of novel bare metal stents in head-to-head trials, which, by necessity, could only include lesions into which the predicate device (the Palmaz-Schatz stent, Cordis, Warren, NJ) could be placed.² Glimpses of superiority of 1 bare metal stent over another were only possible via registry data, "real world" reports, or small studies comparing advanced stent designs³ where more diverse patients and lesions could be considered and more granular determination of lesion- or patient-specific predictors of failure determined.

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