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Safety and Efficacy of an Innovative Everolimus-Coated Balloon in a Swine Coronary Artery Model
Background: Drug-coated balloons have been used as a non-stenting treatment in coronary and peripheral artery disease. Until recently, only sirolimus- and paclitaxel-coated balloons have been investigated in clinical trials. We evaluated the safety and efficacy of an innovative everolimus-coated bal...
Autores principales: | , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
MDPI
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10607937/ https://www.ncbi.nlm.nih.gov/pubmed/37895434 http://dx.doi.org/10.3390/life13102053 |
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author | Katsouras, Christos S. Tousis, Alexandros Vasilagkos, Georgios Semertzioglou, Arsen Vratimos, Athanassios Samara, Ioanna Karanasiou, Georgia Loukas, Vasileios S. Tsigkas, Grigorios Fotiadis, Dimitrios Michalis, Lampros K. Davlouros, Periklis Moulas, Anargyros N. |
author_facet | Katsouras, Christos S. Tousis, Alexandros Vasilagkos, Georgios Semertzioglou, Arsen Vratimos, Athanassios Samara, Ioanna Karanasiou, Georgia Loukas, Vasileios S. Tsigkas, Grigorios Fotiadis, Dimitrios Michalis, Lampros K. Davlouros, Periklis Moulas, Anargyros N. |
author_sort | Katsouras, Christos S. |
collection | PubMed |
description | Background: Drug-coated balloons have been used as a non-stenting treatment in coronary and peripheral artery disease. Until recently, only sirolimus- and paclitaxel-coated balloons have been investigated in clinical trials. We evaluated the safety and efficacy of an innovative everolimus-coated balloon (ECB) in a swine coronary artery model. Methods: thirty-two swine coronary arteries were prepared through dilatation with a non-coated angioplasty balloon in a closed-chest model. During a period of 90 days, the following four groups (four animals per group, two coronary arteries per animal) were compared for safety and efficacy: A, Rontis ECB with 2.5 μg/mm(2) of drug per balloon surface; B, Rontis ECB with 7.5 μg/mm(2); C, Rontis Europa Ultra bare balloon; and D, Magic Touch, Concept Medical, sirolimus-coated balloon with a drug load of 1.3 μg/mm(2). Results: Differences in local biological effects (arterial reaction scores) and surface of intimal area (mm(2)) were not statistically significant between the treatment groups. Numerically, group A showed the lowest intimal area and intimal mean thickness, while group B showed the lowest stenosis among all groups. Conclusions: ECB was safe and effective in a porcine coronary artery model. The dose of everolimus may play a role in the biocompatibility of the balloon. |
format | Online Article Text |
id | pubmed-10607937 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | MDPI |
record_format | MEDLINE/PubMed |
spelling | pubmed-106079372023-10-28 Safety and Efficacy of an Innovative Everolimus-Coated Balloon in a Swine Coronary Artery Model Katsouras, Christos S. Tousis, Alexandros Vasilagkos, Georgios Semertzioglou, Arsen Vratimos, Athanassios Samara, Ioanna Karanasiou, Georgia Loukas, Vasileios S. Tsigkas, Grigorios Fotiadis, Dimitrios Michalis, Lampros K. Davlouros, Periklis Moulas, Anargyros N. Life (Basel) Article Background: Drug-coated balloons have been used as a non-stenting treatment in coronary and peripheral artery disease. Until recently, only sirolimus- and paclitaxel-coated balloons have been investigated in clinical trials. We evaluated the safety and efficacy of an innovative everolimus-coated balloon (ECB) in a swine coronary artery model. Methods: thirty-two swine coronary arteries were prepared through dilatation with a non-coated angioplasty balloon in a closed-chest model. During a period of 90 days, the following four groups (four animals per group, two coronary arteries per animal) were compared for safety and efficacy: A, Rontis ECB with 2.5 μg/mm(2) of drug per balloon surface; B, Rontis ECB with 7.5 μg/mm(2); C, Rontis Europa Ultra bare balloon; and D, Magic Touch, Concept Medical, sirolimus-coated balloon with a drug load of 1.3 μg/mm(2). Results: Differences in local biological effects (arterial reaction scores) and surface of intimal area (mm(2)) were not statistically significant between the treatment groups. Numerically, group A showed the lowest intimal area and intimal mean thickness, while group B showed the lowest stenosis among all groups. Conclusions: ECB was safe and effective in a porcine coronary artery model. The dose of everolimus may play a role in the biocompatibility of the balloon. MDPI 2023-10-13 /pmc/articles/PMC10607937/ /pubmed/37895434 http://dx.doi.org/10.3390/life13102053 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Article Katsouras, Christos S. Tousis, Alexandros Vasilagkos, Georgios Semertzioglou, Arsen Vratimos, Athanassios Samara, Ioanna Karanasiou, Georgia Loukas, Vasileios S. Tsigkas, Grigorios Fotiadis, Dimitrios Michalis, Lampros K. Davlouros, Periklis Moulas, Anargyros N. Safety and Efficacy of an Innovative Everolimus-Coated Balloon in a Swine Coronary Artery Model |
title | Safety and Efficacy of an Innovative Everolimus-Coated Balloon in a Swine Coronary Artery Model |
title_full | Safety and Efficacy of an Innovative Everolimus-Coated Balloon in a Swine Coronary Artery Model |
title_fullStr | Safety and Efficacy of an Innovative Everolimus-Coated Balloon in a Swine Coronary Artery Model |
title_full_unstemmed | Safety and Efficacy of an Innovative Everolimus-Coated Balloon in a Swine Coronary Artery Model |
title_short | Safety and Efficacy of an Innovative Everolimus-Coated Balloon in a Swine Coronary Artery Model |
title_sort | safety and efficacy of an innovative everolimus-coated balloon in a swine coronary artery model |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10607937/ https://www.ncbi.nlm.nih.gov/pubmed/37895434 http://dx.doi.org/10.3390/life13102053 |
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