Biosafety and efficacy evaluation of a biodegradable Zn-Cu-Mn stent: A long-term study in porcine coronary artery

IF 18 1区医学 Q1 ENGINEERING, BIOMEDICAL

Bioactive Materials Pub Date : 2024-11-25 DOI:10.1016/j.bioactmat.2024.11.022

Yi Qian , Yan Chen , Jimiao Jiang , Jia Pei , Junfei Li , Jialin Niu , Jinzhou Zhu , Guangyin Yuan

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Abstract

In this study, biodegradable Zn-Cu-Mn alloy stents were implanted into porcine coronary artery for 18 months, and the in vivo biosafety and efficacy as well as the degradation behavior were systematically studied. Results showed a rapid endothelialization of the target vessel was achieved at 1 month post-implantation. Although the lumen diameter loss and local inflammation were observed at the early stage, the stented blood vessel could gradually recover with time. The lumen diameter was already close to normal range at 12 months, indicating good bioefficacy of the stent. No adverse effect on blood indexes or local accumulation of Zn, Cu or Mn elements were found after implantation, neither the malapposition and thrombosis were observed, which exhibited good biosafety of the stents. The stent could maintain the basic structure and mechanical integrity at 6 months, and remained only approximately 26 % of the stent volume at 18 months, suggesting a desirable degradation rate. In general, the Zn-Cu-Mn alloy stent showed great advantages and prospects in clinical application.

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可生物降解锌-铜-锰支架的生物安全性和疗效评估：猪冠状动脉长期研究

本研究将可生物降解的锌-铜-锰合金支架植入猪冠状动脉 18 个月，系统研究了其体内生物安全性、有效性和降解行为。结果表明，在植入后 1 个月，靶血管就实现了快速内皮化。虽然在早期观察到管腔直径减小和局部炎症，但随着时间的推移，支架血管可以逐渐恢复。12 个月时，管腔直径已接近正常范围，表明支架具有良好的生物效应。植入后未发现对血液指标的不良影响，也未发现锌、铜或锰元素的局部蓄积，更未发现错位和血栓形成，这表明支架具有良好的生物安全性。支架在 6 个月后仍能保持基本结构和机械完整性，在 18 个月后仅残留约 26% 的支架体积，表明降解率较理想。总之，锌-铜-锰合金支架具有很大的优势和临床应用前景。

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来源期刊

Bioactive Materials Biochemistry, Genetics and Molecular Biology-Biotechnology

CiteScore

28.00

自引率

6.30%

发文量

436

审稿时长

20 days

期刊介绍： Bioactive Materials is a peer-reviewed research publication that focuses on advancements in bioactive materials. The journal accepts research papers, reviews, and rapid communications in the field of next-generation biomaterials that interact with cells, tissues, and organs in various living organisms. The primary goal of Bioactive Materials is to promote the science and engineering of biomaterials that exhibit adaptiveness to the biological environment. These materials are specifically designed to stimulate or direct appropriate cell and tissue responses or regulate interactions with microorganisms. The journal covers a wide range of bioactive materials, including those that are engineered or designed in terms of their physical form (e.g. particulate, fiber), topology (e.g. porosity, surface roughness), or dimensions (ranging from macro to nano-scales). Contributions are sought from the following categories of bioactive materials: Bioactive metals and alloys Bioactive inorganics: ceramics, glasses, and carbon-based materials Bioactive polymers and gels Bioactive materials derived from natural sources Bioactive composites These materials find applications in human and veterinary medicine, such as implants, tissue engineering scaffolds, cell/drug/gene carriers, as well as imaging and sensing devices.