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Preclinical Evaluation of a Novel Polymer-free Everolimus-eluting Stent in a Mid-term Porcine Coronary Restenosis Model

BACKGROUND: Titanium dioxide films exhibit good biocompatibility and may be effective as drug-binding matrices for drug-eluting stents. We conducted a mid-term evaluation of a novel polymer-free everolimus-eluting stent using nitrogen-doped titanium dioxide film deposition (TIGEREVOLUTION(®)) in com...

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Autores principales: Cho, Kyung Hoon, Jeong, Myung Ho, Park, Dae Sung, Kim, Moonki, Kim, JungHa, Park, Jun-Kyu, Han, Xiongyi, Hyun, Dae Young, Kim, Min Chul, Sim, Doo Sun, Hong, Young Joon, Kim, Ju Han, Ahn, Youngkeun
Formato: Online Artículo Texto
Lenguaje:English
Publicado: The Korean Academy of Medical Sciences 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8524232/
https://www.ncbi.nlm.nih.gov/pubmed/34664799
http://dx.doi.org/10.3346/jkms.2021.36.e259
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author Cho, Kyung Hoon
Jeong, Myung Ho
Park, Dae Sung
Kim, Moonki
Kim, JungHa
Park, Jun-Kyu
Han, Xiongyi
Hyun, Dae Young
Kim, Min Chul
Sim, Doo Sun
Hong, Young Joon
Kim, Ju Han
Ahn, Youngkeun
author_facet Cho, Kyung Hoon
Jeong, Myung Ho
Park, Dae Sung
Kim, Moonki
Kim, JungHa
Park, Jun-Kyu
Han, Xiongyi
Hyun, Dae Young
Kim, Min Chul
Sim, Doo Sun
Hong, Young Joon
Kim, Ju Han
Ahn, Youngkeun
author_sort Cho, Kyung Hoon
collection PubMed
description BACKGROUND: Titanium dioxide films exhibit good biocompatibility and may be effective as drug-binding matrices for drug-eluting stents. We conducted a mid-term evaluation of a novel polymer-free everolimus-eluting stent using nitrogen-doped titanium dioxide film deposition (TIGEREVOLUTION(®)) in comparison with a commercial durable polymer everolimus-eluting stent (XIENCE Alpine(®)) in a porcine coronary restenosis model. METHODS: Twenty-eight coronary arteries from 14 mini-pigs were randomly allocated to TIGEREVOLUTION(®) stent and XIENCE Alpine(®) stent groups. The stents were implanted in the coronary artery at a 1.1–1.2:1 stent-to-artery ratio. Eleven stented coronary arteries in each group were finally analyzed using coronary angiography, optical coherence tomography, and histopathologic evaluation 6 months after stenting. RESULTS: Quantitative coronary analysis showed no significant differences in the pre-procedural, post-procedural, and 6-month lumen diameters between the groups. In the volumetric analysis of optical coherence tomography at 6 months, no significant differences were observed in stent volume, lumen volume, and percent area stenosis between the groups. There were no significant differences in injury score, inflammation score, or fibrin score between the groups, although the fibrin score was zero in the TIGEREVOLUTION(®) stent group (0 vs. 0.07 ± 0.11, P = 0.180). CONCLUSION: Preclinical evaluation, including optical coherence tomographic findings 6 months after stenting, demonstrated that the TIGEREVOLUTION(®) stent exhibited efficacy and safety comparable with the XIENCE Alpine(®) stent, supporting the need for further clinical studies on the TIGEREVOLUTION(®) stent.
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spelling pubmed-85242322021-10-29 Preclinical Evaluation of a Novel Polymer-free Everolimus-eluting Stent in a Mid-term Porcine Coronary Restenosis Model Cho, Kyung Hoon Jeong, Myung Ho Park, Dae Sung Kim, Moonki Kim, JungHa Park, Jun-Kyu Han, Xiongyi Hyun, Dae Young Kim, Min Chul Sim, Doo Sun Hong, Young Joon Kim, Ju Han Ahn, Youngkeun J Korean Med Sci Original Article BACKGROUND: Titanium dioxide films exhibit good biocompatibility and may be effective as drug-binding matrices for drug-eluting stents. We conducted a mid-term evaluation of a novel polymer-free everolimus-eluting stent using nitrogen-doped titanium dioxide film deposition (TIGEREVOLUTION(®)) in comparison with a commercial durable polymer everolimus-eluting stent (XIENCE Alpine(®)) in a porcine coronary restenosis model. METHODS: Twenty-eight coronary arteries from 14 mini-pigs were randomly allocated to TIGEREVOLUTION(®) stent and XIENCE Alpine(®) stent groups. The stents were implanted in the coronary artery at a 1.1–1.2:1 stent-to-artery ratio. Eleven stented coronary arteries in each group were finally analyzed using coronary angiography, optical coherence tomography, and histopathologic evaluation 6 months after stenting. RESULTS: Quantitative coronary analysis showed no significant differences in the pre-procedural, post-procedural, and 6-month lumen diameters between the groups. In the volumetric analysis of optical coherence tomography at 6 months, no significant differences were observed in stent volume, lumen volume, and percent area stenosis between the groups. There were no significant differences in injury score, inflammation score, or fibrin score between the groups, although the fibrin score was zero in the TIGEREVOLUTION(®) stent group (0 vs. 0.07 ± 0.11, P = 0.180). CONCLUSION: Preclinical evaluation, including optical coherence tomographic findings 6 months after stenting, demonstrated that the TIGEREVOLUTION(®) stent exhibited efficacy and safety comparable with the XIENCE Alpine(®) stent, supporting the need for further clinical studies on the TIGEREVOLUTION(®) stent. The Korean Academy of Medical Sciences 2021-09-07 /pmc/articles/PMC8524232/ /pubmed/34664799 http://dx.doi.org/10.3346/jkms.2021.36.e259 Text en © 2021 The Korean Academy of Medical Sciences. https://creativecommons.org/licenses/by-nc/4.0/This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (https://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Article
Cho, Kyung Hoon
Jeong, Myung Ho
Park, Dae Sung
Kim, Moonki
Kim, JungHa
Park, Jun-Kyu
Han, Xiongyi
Hyun, Dae Young
Kim, Min Chul
Sim, Doo Sun
Hong, Young Joon
Kim, Ju Han
Ahn, Youngkeun
Preclinical Evaluation of a Novel Polymer-free Everolimus-eluting Stent in a Mid-term Porcine Coronary Restenosis Model
title Preclinical Evaluation of a Novel Polymer-free Everolimus-eluting Stent in a Mid-term Porcine Coronary Restenosis Model
title_full Preclinical Evaluation of a Novel Polymer-free Everolimus-eluting Stent in a Mid-term Porcine Coronary Restenosis Model
title_fullStr Preclinical Evaluation of a Novel Polymer-free Everolimus-eluting Stent in a Mid-term Porcine Coronary Restenosis Model
title_full_unstemmed Preclinical Evaluation of a Novel Polymer-free Everolimus-eluting Stent in a Mid-term Porcine Coronary Restenosis Model
title_short Preclinical Evaluation of a Novel Polymer-free Everolimus-eluting Stent in a Mid-term Porcine Coronary Restenosis Model
title_sort preclinical evaluation of a novel polymer-free everolimus-eluting stent in a mid-term porcine coronary restenosis model
topic Original Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8524232/
https://www.ncbi.nlm.nih.gov/pubmed/34664799
http://dx.doi.org/10.3346/jkms.2021.36.e259
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