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KMID : 1377020230200020239
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Tissue Engineering and Regenerative Medicine
2023 Volume.20 No. 2 p.239 ~ p.249
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Preclinical Evaluation of an Everolimus-Eluting Bioresorbable Vascular Scaffold Via a Long-Term Rabbit Iliac Artery Model
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Park Dae-Sung
Jeong Myung-Ho
Jin Yu-Jeong
Na Mi-Hyang
Sim Doo-Sun
Kim Mun-Ki
Cho Kyung-Hoon
Hyun Dae-Young
Oh Seok
Kim Jeong-Ha
Lim Kyung-Seob
Park Jun-Kyu
Kim Han-Ki
Hong Young-Joon
Kim Ju-Han
Ahn Young-Keun
Kim Jeong-Hun
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Abstract
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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-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.
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KEYWORD
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Bioresorbable vascular scaffold, Drug-eluting stent, Rabbit iliac artery model, Strut thickness, Safety
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