Preclinical Evaluation of an Everolimus-Eluting Bioresorbable Vascular Scaffold Via a Long-Term Rabbit Iliac Artery Model
10.1007/s13770-023-00518-z
- Author:
Dae Sung PARK
1
;
Myung Ho JEONG
;
Yu Jeong JIN
;
Mi Hyang NA
;
Doo Sun SIM
;
Munki KIM
;
Kyung Hoon CHO
;
Dae Young HYUN
;
Seok OH
;
Jeong Ha KIM
;
Kyung Seob LIM
;
Jun-Kyu PARK
;
Han Ki KIM
;
Young Joon HONG
;
Ju Han KIM
;
Youngkeun AHN
;
Jeong Hun KIM
Author Information
1. The Korean Cardiovascular Stent Research Institute, Jangsung 57248, Republic of Korea
- Publication Type:ORIGINAL ARTICLE
- From:
Tissue Engineering and Regenerative Medicine
2023;20(2):239-249
- CountryRepublic of Korea
- Language:English
-
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 1.1:1 stent-toartery 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 lm). 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.
