(Circulation. 1999;100:896-898.)
© 1999 American Heart Association, Inc.
Editorials |
Stent-Versus-Stent Equivalency Trials
Are Some Stents More Equal Than Others?
From Harvard-MIT Division of Health Sciences and Technology (E.R.E.), Cambridge Mass, and Brigham and Women's Hospital, Harvard Medical School (C.R.), Boston, Mass.
Correspondence to Dr Elazer R. Edelman, MIT, 16-343, Cambridge, MA 02139. E-mail eedelman@mit.edu
Key Words: Editorials • stents • arteries • restenosis
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Introduction |
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New endovascular stent designs are displacing tried-and-true devices for use in an ever-broader array of lesions. Yet disagreement remains as to which device is most advantageous and whether design determines outcome. Preclinical research says that this should be the case, but clinical trials have failed to validate design dependence. Is this yet another demonstration of the dichotomy between preclinical and clinical experience, or can divergent data be reconciled?
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Bench-Top Data |
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More than 50 different stent configurations are available, with 12 having received regulatory approval in the United States and a larger number in Europe. The very processes of industrial development and federal regulatory evaluation support the importance of design. Stents are made from a spectrum of materials with a range of manufacturing techniques, providing variable surfaces, dimensions, surface coverage, and strut configurations. Classifications have been proposed, but the number of parameters involved may doom the number of subsets to approach the number of designs. Moreover, each device seems to have a unique optimal mode of placement. It is not surprising, then, that differences have been reported in flexibility, tracking ability, expansion, radiovisibility, side-branch access, and resistance to compression and recoil for different devices. Regulatory approval includes safety standards for toxicity, biocompatibility, structural and material analysis, and fatigue testing, and it has been suggested that hoop strength, surface cracking, uniformity of expansion, and other features become standardized as well.
The evolution of stent design, which has produced increasingly safer
and easier-to-use devices, indicates that there is not a single safety
threshold but rather
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