Tissue Eng Regen Med.
2023 Apr;20(2):239-249. 10.1007/s13770-023-00518-z.
Preclinical Evaluation of an Everolimus-Eluting Bioresorbable Vascular Scaffold Via a Long-Term Rabbit Iliac Artery Model
- Affiliations
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- 1The Korean Cardiovascular Stent Research Institute, Jangsung 57248, Republic of Korea
- 2The Cardiovascular Convergence Research Center of Chonnam National University Hospital Designated by the Korean Ministry of Health and Welfare, Gwangju 61469, Republic of Korea
- 3The Research Institute of Medical Sciences, Chonnam National University, Gwangju 61469, Republic of Korea
- 4Department of Cardiology, Chonnam National University Hospital, Gwangju 61469, Republic of Korea
- 5The Futuristic Animal Research Center, The Korean Research Institute of Bioscience and Biotechnology, Ochang 28116, Republic of Korea
- 6CGBio Co. Ltd., Seoul, Republic of Korea
- KMID: 2541490
- DOI: http://doi.org/10.1007/s13770-023-00518-z
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.
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