Format

Send to

Choose Destination
Rev Esp Cardiol (Engl Ed). 2015 Dec;68(12):1118-24. doi: 10.1016/j.rec.2015.02.028. Epub 2015 Jul 21.

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

Author information

1
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.
2
Grupo Cardiovascular (HemoLeon), Fundación Investigación Sanitaria en León y del Instituto de Biomedicina (IBIOMED), Universidad de León, Hospital de León, León, Spain.
3
Life Vascular Devices (LVD) Biotech, iVascular, Barcelona, Spain.

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<.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.

KEYWORDS:

Drug-eluting stent; Modelo preclínico; Preclinical model; Reparación vascular; Restenosis; Stent liberador de fármaco; Vascular healing

PMID:
26206247
DOI:
10.1016/j.rec.2015.02.028
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Ediciones Doyma, S.L.
Loading ...
Support Center