Efficacy and Safety Evaluation of Tacrolimus-Eluting Stent in a Porcine Coronary Artery Model

Park Dae Sung; Na Mi Hyang; Jeong Myung Ho; Sim Doo Sun; 진유정; Kee Hae Jin; Kim Munki; Kim Jeong Ha; Hong Young Joon; Cho Kyung Hoon; Hyun Dae Young; Oh Seok; Lim Kyung Seob; 변대흥; Kim Jeong Hun

doi:10.1007/s13770-024-00646-0

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저자정보: Park Dae Sung (Cardiovascular Research Center, Chonnam National University Hospital, Gwangju, Korea.) Na Mi Hyang (The Cardiovascular Convergence Research Center of Chonnam National University Hospital) Jeong Myung Ho (Department of Cardiology, Chonnam National University Hospital, Chonnam National University Medical School, Gwangju, Korea.) Sim Doo Sun (Department of Cardiology, Chonnam National University Hospital, Chonnam National University Medical School, Gwangju, Korea.) 진유정 (전남대학교병원) Kee Hae Jin (The Cardiovascular Convergence Research Center of Chonnam National University Hospital) Kim Munki (The Cardiovascular Convergence Research Center of Chonnam National University Hospital) Kim Jeong Ha (The Cardiovascular Convergence Research Center of Chonnam National University Hospital) Hong Young Joon (Department of Cardiology, Chonnam National University Hospital, Chonnam National University Medical School, Gwangju, Korea.) Cho Kyung Hoon (Department of Cardiology, Chonnam National University Hospital, Chonnam National University Medical School, Gwangju, Korea.) Hyun Dae Young (Department of Cardiology, Chonnam National University Hospital, Gwangju, Korea.) Oh Seok (The Cardiovascular Convergence Research Center of Chonnam National University Hospital) Lim Kyung Seob (Futuristic Animal Resource and Research Center, Korea Research Institute of Bioscience and Biotechnology, Ochang, Korea) 변대흥 ((주) 시지바이오) Kim Jeong Hun (Department of Cardiology, Chonnam National University Hospital)

저널정보: 한국조직공학과 재생의학회 조직공학과 재생의학 조직공학과 재생의학 제21권 제5호

발행연도: 2024.7

수록면: 723 - 735 (13page)

DOI: 10.1007/s13770-024-00646-0

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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.

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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