Tissue Eng Regen Med.
2024 Jul;21(5):723-735. 10.1007/s13770-024-00646-0.
Efficacy and Safety Evaluation of Tacrolimus-Eluting Stent in a Porcine Coronary Artery Model
- Affiliations
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- 1The Korea Cardiovascular Stent Research Institute, Chonnam National University, Gwangju, Korea
- 2The Cardiovascular Convergence Research Center of Chonnam National University Hospital Designated by Korea Ministry of Health and Welfare, Gwangju, Korea
- 3The Research Institute of Medical Sciences, Chonnam National University, Gwangju, Korea
- 4Department of Cardiovascular Medicine, Chonnam National University Hospital, Gwangju, Korea
- 5Department of Cardiovascular Medicine, Chonnam National University Medical School, Gwangju, Korea
- 6Futuristic Animal Resource & Research Center, Korea Research Institute of Bioscience and Biotechnology, Ochang, Korea
- 7CGBio Co. Ltd., Seoul, Korea
- 8Department of Cardiovascular Center, Gwangju Veterans Hospital, Gwangju, Korea
- KMID: 2557867
- DOI: http://doi.org/10.1007/s13770-024-00646-0
Abstract
- BACKGROUND
A drug-eluting stent (DES) is a highly beneficial medical device used to widen or unblock narrowed blood vessels. However, the drugs released by the implantation of DES may hinder the re-endothelialization process, increasing the risk of late thrombosis. We have developed a tacrolimus-eluting stent (TES) that as acts as a potent antiproliferative and immunosuppressive agent, enhancing endothelial regeneration. In addition, we assessed the safety and efficacy of TES through both in vitro and in vivo tests.
METHODS
Tacrolimus and Poly(lactic-co-glycolic acid) (PLGA) were applied to the metal stent using electrospinning equipment. The surface morphology of the stent was examined before and after coating using a scanning electron microscope (SEM) and energy dispersive X-rays (EDX). The drug release test was conducted through high-performance liquid chromatography (HPLC). Cell proliferation and migration assays were performed using smooth muscle cells (SMC). The stent was then inserted into the porcine coronary artery and monitored for a duration of 4 weeks.
RESULTS
SEM analysis confirmed that the coating surface was uniform. Furthermore, EDX analysis showed that the surface was coated with both polymer and drug components. The HPCL analysis of TCL at a wavelength of 215 nm revealed that the drug was continuously released over a period of 4 weeks. Smooth muscle cell migration was significantly decreased in the tacrolimus group (54.1% ± 11.90%) compared to the non-treated group (90.1% ± 4.86%). In animal experiments, the stenosis rate was significantly reduced in the TES group (29.6% ± 7.93%) compared to the bare metal stent group (41.3% ± 10.18%). Additionally, the fibrin score was found to be lower in the TES group compared to the group treated with a sirolimus-eluting stent (SES).
CONCLUSION
Similar to SES, TES reduces neointimal proliferation in a porcine coronary artery model, specifically decreasing the fibrins score. Therefore, tacrolimus could be considered a promising drug for reducing restenosis and thrombosis.
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