Qian Yi, Chen Yan, Jiang Jimiao, Pei Jia, Li Junfei, Niu Jialin, Zhu Jinzhou, Yuan Guangyin
School of Materials Science and Engineering, Shanghai Jiao Tong University, Shanghai, 200240, China.
Department of Vascular & Cardiology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200025, China.
Bioact Mater. 2024 Nov 25;45:231-245. doi: 10.1016/j.bioactmat.2024.11.022. eCollection 2025 Mar.
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.
在本研究中，将可生物降解的锌 - 铜 - 锰合金支架植入猪冠状动脉18个月，系统地研究了其体内生物安全性、有效性以及降解行为。结果显示，植入后1个月靶血管实现了快速内皮化。虽然在早期观察到管腔直径减小和局部炎症，但植入支架的血管可随时间逐渐恢复。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有效性。植入后未发现对血液指标有不良影响，也未发现锌、铜或锰元素的局部蓄积，未观察到贴壁不良和血栓形成，表明支架具有良好的生物安全性。支架在6个月时可保持基本结构和机械完整性，18个月时仅剩余约26%的支架体积，提示降解速率理想。总体而言，锌 - 铜 - 锰合金支架在临床应用中显示出巨大优势和前景。
