Preclinical Evaluation of an Everolimus-Eluting Bioresorbable Vascular Scaffold Via a Long-Term Rabbit Iliac Artery Model.
Tissue Eng Regen Med
; 20(2): 239-249, 2023 04.
Article
em En
| MEDLINE
| ID: mdl-36881249
ABSTRACT
BACKGROUND:
Biodegradable poly (l-lactic acid) (PLLA), a bio safe polymer with a large elastic modulus, is widely used in biodegradable medical devices. However, because of its poor mechanical properties, a PLLA strut must be made twice as thick as a metal strut for adequate blood vessel support. Therefore, the mechanical properties of a drug-eluting metal-based stents (MBS) and a bioresorbable vascular scaffolds (BVS) were evaluated and their safety and efficacy were examined via a long-term rabbit iliac artery model.METHODS:
The surface morphologies of the MBSs and BVSs were investigated via optical and scanning electron microscopy. An everolimus-eluting (EE) BVS or an EE-MBS was implanted into rabbit iliac arteries at a 1.11 stent-to-artery ratio. Twelve months afterward, stented iliac arteries from each group were analyzed via X-ray angiography, optical coherence tomography (OCT), and histopathologic evaluation.RESULTS:
Surface morphology analysis of the EE coating on the MBS confirmed that it was uniform and very thin (4.7 µm). Comparison of the mechanical properties of the EE-MBS and EE-BVS showed that the latter outperformed the former in all aspects (radial force (2.75 vs. 0.162 N/mm), foreshortening (0.24% vs. 1.9%), flexibility (0.52 vs. 0.19 N), and recoil (3.2% vs. 6.3%). At all time points, the percent area restenosis was increased in the EE-BVS group compared to the EE-MBS group. The OCT and histopathological analyses indicate no significant changes in strut thickness.CONCLUSION:
BVSs with thinner struts and shorter resorption times should be developed. A comparable long-term safety/efficacy evaluation after complete absorption of BVSs should be conducted.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Stents Farmacológicos
/
Everolimo
Limite:
Animals
Idioma:
En
Ano de publicação:
2023
Tipo de documento:
Article