Preclinical Evaluation of Coronary Stents: Focus on Safety Issues

Armando      Perez de Prado; Claudia      Perez-Martinez; Carlos      Cuellas; Jose      M. Gonzalo-Orden; Alejandro      Diego; Marta      Regueiro; Beatriz      Martinez-Fernandez; Jose      R. Altonaga; J.      Francisco G. Marin; Felipe      Fernandez-Vazquez

Abstract

In recent years, we have witnessed a revolution in the treatment of coronary artery disease. The development and improvement of drug eluting stents (DES) have lowered the incidence of restenosis to one-digit figures. In the search for a superior efficacy, animal models have played a key role. The classical swine model of coronary stenting remains the preferred model to measure restenosis, although the rabbit iliac artery stenting has become an accepted alternative. After widespread clinical use of DES, an unforeseen complication arose: late stent thrombosis. In a back-to-bench step, some data from animal models helped to explain the phenomenon. A delayed and incomplete vascular healing was detected. Toxic and hypersensitivity reactions to polymers and/or drugs seem to be the underlying causes. So, translational research focused on the safety aspect of these devices: development of better drug carriers as absorbable polymers or fully bioresorbable scaffolds, selection of different drugs and assessment of the re-endothelialization process. We review and evaluate the efficacy and safety of coronary stents in different animal models. Further improvements in this field such as, the selection of better animal models (e.g. hyperlipidemic, diabetic, atherosclerotic) that closely mimic the clinical setting and longer follow-up periods to detect late complications are also discussed.

Keywords: Animal model, drug eluting stent, endothelium, inflammation, percutaneous coronary intervention, safety, stent thrombosis vascular healing

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