• Rev Esp Cardiol (Engl Ed) · Dec 2015

    Safety and Efficacy of New Sirolimus-eluting Stent Models in a Preclinical Study.

    • Rodrigo Estévez-Loureiro, Armando Pérez de Prado, Claudia Pérez-Martínez, Carlos Cuellas-Ramón, Marta Regueiro-Purriños, José M Gonzalo-Orden, María López-Benito, María Molina-Crisol, Luis Duocastella-Codina, and Felipe Fernández-Vázquez.
    • Grupo Cardiovascular (HemoLeon), Fundación Investigación Sanitaria en León y del Instituto de Biomedicina (IBIOMED), Universidad de León, Hospital de León, León, Spain. Electronic address: roiestevez@hotmail.com.
    • Rev Esp Cardiol (Engl Ed). 2015 Dec 1; 68 (12): 1118-24.

    Introduction And ObjectivesInitial preclinical studies are required during the process of improving polymers, platforms, and drug-eluting systems for new coronary stent designs. Our objective was to analyze the efficacy and safety of new drug-eluting stent models compared with a conventional stent and commercialized drug-eluting stents in an experimental model with healthy porcine coronary arteries.MethodsSixty stents (conventional stent, new sirolimus-eluting stents: drug-eluting stents 1, 2 and 3; Cypher(®) and Xience(®)) were randomly placed in the coronary arteries of 20 Large White domestic pigs. Angiographic and histomorphometric studies were done 28 days later.ResultsThe stents were implanted at a stent/artery ratio of 1.34±0.15, with no significant differences between groups. The new stents showed less late loss and angiographic restenosis than conventional stents (P=.006 and P<.001, respectively). Histologically, restenosis and neointimal area were lower with all the new platforms than with the conventional stents (P<.001 for each variable), and no differences were found vs the drug-eluting stents on the market. Safety data showed that endothelialization was lower with drug-eluting stents than with conventional stents, except for drug-eluting stent 3 (P=.084). Likewise, inflammation was lower with drug-eluting stent 3 than with other stents.ConclusionsThe new drug-eluting stent platforms studied are associated with less restenosis than conventional stents and showed no significant differences in safety or efficacy vs commercialized drug-eluting stents.Copyright © 2015 Sociedad Española de Cardiología. Published by Elsevier España, S.L.U. All rights reserved.

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