title: Safety and Efficacy of New Sirolimus-eluting Stent Models in a Preclinical Study.
abstract: OBJECTIVE
  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.
authors.affiliation: 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.
authors.forename: Rodrigo
authors.initials: R
authors.lastname: Estévez-Loureiro
authors.affiliation: Grupo Cardiovascular (HemoLeon), Fundación Investigación Sanitaria en León y del Instituto de Biomedicina (IBIOMED), Universidad de León, Hospital de León, León, Spain.
authors.forename: Armando
authors.initials: A
authors.lastname: Pérez de Prado
authors.affiliation: Grupo Cardiovascular (HemoLeon), Fundación Investigación Sanitaria en León y del Instituto de Biomedicina (IBIOMED), Universidad de León, Hospital de León, León, Spain.
authors.forename: Claudia
authors.initials: C
authors.lastname: Pérez-Martínez
authors.affiliation: Grupo Cardiovascular (HemoLeon), Fundación Investigación Sanitaria en León y del Instituto de Biomedicina (IBIOMED), Universidad de León, Hospital de León, León, Spain.
authors.forename: Carlos
authors.initials: C
authors.lastname: Cuellas-Ramón
authors.affiliation: Grupo Cardiovascular (HemoLeon), Fundación Investigación Sanitaria en León y del Instituto de Biomedicina (IBIOMED), Universidad de León, Hospital de León, León, Spain.
authors.forename: Marta
authors.initials: M
authors.lastname: Regueiro-Purriños
authors.affiliation: Grupo Cardiovascular (HemoLeon), Fundación Investigación Sanitaria en León y del Instituto de Biomedicina (IBIOMED), Universidad de León, Hospital de León, León, Spain.
authors.forename: José M
authors.initials: JM
authors.lastname: Gonzalo-Orden
authors.affiliation: Grupo Cardiovascular (HemoLeon), Fundación Investigación Sanitaria en León y del Instituto de Biomedicina (IBIOMED), Universidad de León, Hospital de León, León, Spain.
authors.forename: María
authors.initials: M
authors.lastname: López-Benito
authors.affiliation: Life Vascular Devices (LVD) Biotech, iVascular, Barcelona, Spain.
authors.forename: María
authors.initials: M
authors.lastname: Molina-Crisol
authors.affiliation: Life Vascular Devices (LVD) Biotech, iVascular, Barcelona, Spain.
authors.forename: Luis
authors.initials: L
authors.lastname: Duocastella-Codina
authors.affiliation: Grupo Cardiovascular (HemoLeon), Fundación Investigación Sanitaria en León y del Instituto de Biomedicina (IBIOMED), Universidad de León, Hospital de León, León, Spain.
authors.forename: Felipe
authors.initials: F
authors.lastname: Fernández-Vázquez
mesh_terms: D000818:Animals; D017023:Coronary Angiography; D023903:Coronary Restenosis / Q000000981:diagnostic imaging / Q000517:prevention & control; D003331:Coronary Vessels / Q000000981:diagnostic imaging; D004195:Disease Models, Animal; D054855:Drug-Eluting Stents; D007166:Immunosuppressive Agents / Q000008:administration & dosage* / Q000494:pharmacology; D011474:Prosthesis Design; D011897:Random Allocation; D020123:Sirolimus / Q000008:administration & dosage* / Q000494:pharmacology; D034421:Sus scrofa; D013552:Swine
chemical_list: D007166:Immunosuppressive Agents; D020123:Sirolimus
keywords: Drug-eluting stent; Modelo preclínico; Preclinical model; Reparación vascular; Restenosis; Stent liberador de fármaco; Vascular healing