Original article Safety and Efficacy of New Sirolimus-eluting Stent Models in a Preclinical Study Rodrigo Este ´ vez-Loureiro, a, * Armando Pe ´ rez de Prado, a Claudia Pe ´ rez-Martı ´nez, a Carlos Cuellas-Ramo ´ n, a Marta Regueiro-Purrin ˜os, a Jose ´ M. Gonzalo-Orden, a Marı ´a Lo ´ pez-Benito, a Marı ´a Molina-Crisol, b Luis Duocastella-Codina, b and Felipe Ferna ´ ndez-Va ´ zquez a a Grupo Cardiovascular (HemoLeon), Fundacio ´n Investigacio ´n Sanitaria en Leo ´n y del Instituto de Biomedicina (IBIOMED), Universidad de Leo ´n, Hospital de Leo ´n, Leo ´n, Spain b Life Vascular Devices (LVD) Biotech, iVascular, Barcelona, Spain Rev Esp Cardiol. 2015;68(12):1118–1124 Article history: Received 17 December 2014 Accepted 18 February 2015 Available online 21 July 2015 Keywords: Preclinical model Drug-eluting stent Restenosis Vascular healing A B S T R A C T Introduction and objectives: Initial 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. Methods: Sixty stents (conventional stent, new sirolimus-eluting stents: drug-eluting stents 1, 2 and 3; Cypher W and Xience W ) were randomly placed in the coronary arteries of 20 Large White domestic pigs. Angiographic and histomorphometric studies were done 28 days later. Results: The 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. Conclusions: The 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. ß 2015 Sociedad Espan ˜ola de Cardiologı ´a. Published by Elsevier Espan ˜a, S.L.U. All rights reserved. Seguridad y eficacia de nuevos modelos de stents liberadores de sirolimus en el modelo preclı´nico Palabras clave: Modelo preclı ´nico Stent liberador de fa ´ rmaco Restenosis Reparacio ´n vascular R E S U M E N Introduccio ´n y objetivos: En el proceso de mejora de los polı ´meros, las plataformas y los sistemas de liberacio ´n de fa ´ rmacos en los nuevos disen ˜os de stents farmacoactivos, el ana ´ lisis preclı ´nico inicial es obligatorio. El objetivo es analizar la eficacia y la seguridad de nuevos modelos de stents farmacoactivos en comparacio ´n con un stent convencional y stents farmacoactivos comercializados en el modelo experimental de arteria coronaria sana porcina. Me ´todos: Se implantaron aleatoriamente 60 stents (stent convencional, nuevos stents liberadores de sirolimus: stents liberadores de fa ´ rmaco 1, 2 y 3; Cypher W y Xience W ) en las arterias coronarias de 20 cerdos dome ´ sticos raza Large White. Se realizo ´ estudio angiogra ´ fico e histomorfome ´ trico a los 28 dı ´as. Resultados: Los stents se implantaron en proporcio ´n stent/arteria de 1,34  0,15, sin diferencias significativas entre grupos. Los nuevos stents mostraron menos pe ´ rdida tardı ´a y restenosis angiogra ´ fica que los convencionales (p = 0,006 y p < 0,001 respectivamente). Todas las nuevas plataformas presentaron menos a ´ rea neointimal y restenosis histolo ´ gica que los stents convencionales (p < 0,001 para cada variable), sin diferencias con los farmacoactivos comercializados. En cuanto a la seguridad, todos los stents farmacoactivos mostraron menos endotelizacio ´n que los convencionales, salvo el stent liberador de fa ´ rmaco 3 (p = 0,084). Asimismo, la inflamacio ´n observada fue menor con el stent liberador de fa ´ rmaco 3 que con los dema ´ s. * Corresponding author: Cardiologı ´a Intervencionista, Hospital de Leo ´ n, Altos de Nava s/n, 24008 Leo ´ n, Spain. E-mail address: roiestevez@hotmail.com (R. Este ´ vez-Loureiro). http://dx.doi.org/10.1016/j.rec.2015.02.028 1885-5857/ß 2015 Sociedad Espan ˜ ola de Cardiologı ´a. Published by Elsevier Espan ˜a, S.L.U. All rights reserved. Document downloaded from https://www.revespcardiol.org/, day 26/11/2021. This copy is for personal use. Any transmission of this document by any media or format is strictly prohibited. Document downloaded from https://www.revespcardiol.org/, day 26/11/2021. This copy is for personal use. Any transmission of this document by any media or format is strictly prohibited.