Biosafety and efficacy evaluation of a biodegradable magnesium-based drug-eluting stent in porcine coronary artery

Abstract Although the drug-eluting stent (DES) has become the standard for percutaneous coronary intervention (PCI)-based revascularization, concerns remain regarding the use of DES, mainly due to its permanent rigid constraint to vessels. A drug-eluting bioresorbable stent (BRS) was thus developed...

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Autores principales:	Jinzhou Zhu, Xiyuan Zhang, Jialin Niu, Yongjuan Shi, Zhengbin Zhu, Daopeng Dai, Chenxin Chen, Jia Pei, Guangyin Yuan, Ruiyan Zhang
Formato:	article
Lenguaje:	EN
Publicado:	Nature Portfolio 2021
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/d64f5a5a558f4985b72746de66273925
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spelling	oai:doaj.org-article:d64f5a5a558f4985b72746de662739252021-12-02T18:17:53ZBiosafety and efficacy evaluation of a biodegradable magnesium-based drug-eluting stent in porcine coronary artery10.1038/s41598-021-86803-02045-2322https://doaj.org/article/d64f5a5a558f4985b72746de662739252021-04-01T00:00:00Zhttps://doi.org/10.1038/s41598-021-86803-0https://doaj.org/toc/2045-2322Abstract Although the drug-eluting stent (DES) has become the standard for percutaneous coronary intervention (PCI)-based revascularization, concerns remain regarding the use of DES, mainly due to its permanent rigid constraint to vessels. A drug-eluting bioresorbable stent (BRS) was thus developed as an alternative to DES, which can be absorbed entirely after its therapeutic period. Magnesium (Mg)-based BRSs have attracted a great deal of attention due to their suitable mechanical properties, innovative chemical features, and well-proven biocompatibility. However, the primary disadvantage of Mg-based BRSs is the rapid degradation rate, resulting in the early loss of structural support long before the recovery of vascular function. Recently, a new type of patented Mg–Nd–Zn-Zr alloy (JDBM) was developed at Shanghai Jiao Tong University to reduce the degradation rate compared to commercial Mg alloys. In the present investigation, a poly(d,l-lactic acid)-coated and rapamycin eluting (PDLLA/RAPA) JDBM BRS was prepared, and its biosafety and efficacy for coronary artery stenosis were evaluated via in vitro and in vivo experiments. The degree of smooth muscle cell adhesion to the PDLLA/RAPA coated alloy and the rapamycin pharmacokinetics of JDBM BRS were first assessed in vitro. JDBM BRS and commercial DES FIREHAWK were then implanted in the coronary arteries of a porcine model. Neointimal hyperplasia was evaluated at 30, 90, and 180 days, and re-endothelialization was evaluated at 30 days. Furthermore, Micro-CT and optical coherence tomography (OCT) analyses were performed 180 days after stent implantation to evaluate the technical feasibility, biocompatibility, and degradation characteristics of JDBM BRS in vivo. The results show the ability of a PDLLA/RAPA coated JDBM to inhibit smooth muscle cell adhesion and moderate the drug release rate of JDBM BRS in vitro. In vivo, low local and systemic risks of JDBM BRS were demonstrated in the porcine model, with preserved mechanical integrity after 6 months of implantation. We also showed that this novel BRS was associated with a similar efficacy profile compared with standard DES and high anti-restenosis performance. These findings may confer long term advantages for using this BRS over a traditional DES.Jinzhou ZhuXiyuan ZhangJialin NiuYongjuan ShiZhengbin ZhuDaopeng DaiChenxin ChenJia PeiGuangyin YuanRuiyan ZhangNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 11, Iss 1, Pp 1-12 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Jinzhou Zhu Xiyuan Zhang Jialin Niu Yongjuan Shi Zhengbin Zhu Daopeng Dai Chenxin Chen Jia Pei Guangyin Yuan Ruiyan Zhang Biosafety and efficacy evaluation of a biodegradable magnesium-based drug-eluting stent in porcine coronary artery
description	Abstract Although the drug-eluting stent (DES) has become the standard for percutaneous coronary intervention (PCI)-based revascularization, concerns remain regarding the use of DES, mainly due to its permanent rigid constraint to vessels. A drug-eluting bioresorbable stent (BRS) was thus developed as an alternative to DES, which can be absorbed entirely after its therapeutic period. Magnesium (Mg)-based BRSs have attracted a great deal of attention due to their suitable mechanical properties, innovative chemical features, and well-proven biocompatibility. However, the primary disadvantage of Mg-based BRSs is the rapid degradation rate, resulting in the early loss of structural support long before the recovery of vascular function. Recently, a new type of patented Mg–Nd–Zn-Zr alloy (JDBM) was developed at Shanghai Jiao Tong University to reduce the degradation rate compared to commercial Mg alloys. In the present investigation, a poly(d,l-lactic acid)-coated and rapamycin eluting (PDLLA/RAPA) JDBM BRS was prepared, and its biosafety and efficacy for coronary artery stenosis were evaluated via in vitro and in vivo experiments. The degree of smooth muscle cell adhesion to the PDLLA/RAPA coated alloy and the rapamycin pharmacokinetics of JDBM BRS were first assessed in vitro. JDBM BRS and commercial DES FIREHAWK were then implanted in the coronary arteries of a porcine model. Neointimal hyperplasia was evaluated at 30, 90, and 180 days, and re-endothelialization was evaluated at 30 days. Furthermore, Micro-CT and optical coherence tomography (OCT) analyses were performed 180 days after stent implantation to evaluate the technical feasibility, biocompatibility, and degradation characteristics of JDBM BRS in vivo. The results show the ability of a PDLLA/RAPA coated JDBM to inhibit smooth muscle cell adhesion and moderate the drug release rate of JDBM BRS in vitro. In vivo, low local and systemic risks of JDBM BRS were demonstrated in the porcine model, with preserved mechanical integrity after 6 months of implantation. We also showed that this novel BRS was associated with a similar efficacy profile compared with standard DES and high anti-restenosis performance. These findings may confer long term advantages for using this BRS over a traditional DES.
format	article
author	Jinzhou Zhu Xiyuan Zhang Jialin Niu Yongjuan Shi Zhengbin Zhu Daopeng Dai Chenxin Chen Jia Pei Guangyin Yuan Ruiyan Zhang
author_facet	Jinzhou Zhu Xiyuan Zhang Jialin Niu Yongjuan Shi Zhengbin Zhu Daopeng Dai Chenxin Chen Jia Pei Guangyin Yuan Ruiyan Zhang
author_sort	Jinzhou Zhu
title	Biosafety and efficacy evaluation of a biodegradable magnesium-based drug-eluting stent in porcine coronary artery
title_short	Biosafety and efficacy evaluation of a biodegradable magnesium-based drug-eluting stent in porcine coronary artery
title_full	Biosafety and efficacy evaluation of a biodegradable magnesium-based drug-eluting stent in porcine coronary artery
title_fullStr	Biosafety and efficacy evaluation of a biodegradable magnesium-based drug-eluting stent in porcine coronary artery
title_full_unstemmed	Biosafety and efficacy evaluation of a biodegradable magnesium-based drug-eluting stent in porcine coronary artery
title_sort	biosafety and efficacy evaluation of a biodegradable magnesium-based drug-eluting stent in porcine coronary artery
publisher	Nature Portfolio
publishDate	2021
url	https://doaj.org/article/d64f5a5a558f4985b72746de66273925
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Biosafety and efficacy evaluation of a biodegradable magnesium-based drug-eluting stent in porcine coronary artery

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