CLINICAL TRIALS: VIEWPOINT
Preclinical restenosis models and drug-eluting stents
Still important, still much to learn
Robert S. Schwartz, MD, FACC*, ,*,
Nicolas A. Chronos, MBBS and
Renu Virmani, MD
* Minneapolis Heart Institute
Minnesota Cardiovascular Research Institute, Minneapolis, Minnesota
American Cardiovascular Research Institute, Atlanta, Georgia
Armed Forces Institute of Pathology, Bethesda, Maryland
Manuscript received January 26, 2004;
revised manuscript received March 28, 2004,
accepted April 6, 2004.
* Reprint requests and correspondence: Dr. Robert S. Schwartz, Minneapolis Heart Institute, Minnesota Cardiovascular Research Institute, 920 East 28th Street, Suite 300, Minneapolis, Minnesota 55407 (Email: rss{at}rsschwartz.com).
Percutaneous coronary intervention continues to revolutionize the treatment of coronary atherosclerosis. Restenosis remains a significant problem but may at last be yielding to technologic advances. The examination of neointimal hyperplasia in injured animal artery models has helped in our understanding of angioplasty and stenting mechanisms, and as drug-eluting stent (DES) technologies have arrived, they too have been advanced through the study of animal models.These models are useful for predicting adverse clinical outcomes in patients with DESs because suboptimal animal model studies typically lead to problematic human trials. Similarly, stent thrombosis in animal models suggests stent thrombogenicity in human patients. Equivocal animal model results at six or nine months occasionally have been mirrored by excellent clinical outcomes in patients. The causes of such disparities are unclear but may result from differing methods, including less injury severity than originally described in the models. Ongoing research into animal models will reconcile apparent differences with clinical trials and advance our understanding of how to apply animal models to clinical stenting in the era of DESs.
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Abbreviations and Acronyms
| | DES = drug-eluting stent | | IVUS = intravascular ultrasonography | | MLD = minimum lumen diameter | | PRESTO = Prevention of REStenosis with Tranilast and its Outcomes trial |
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