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

Abstract 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 ® and Xience ® ) 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 P 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.