Seguchi Masaru, Sakakura Kenichi, Taniguchi Yousuke, Fujita Hideo
Division of Cardiovascular Medicine, Saitama Medical Center, Jichi Medical University, 1-847 Amanuma, Omiya-ku, Saitama, Saitama, 330-8503, Japan.
Cardiovasc Interv Ther. 2025 Apr;40(2):245-254. doi: 10.1007/s12928-024-01070-w. Epub 2024 Dec 21.
Bioresorbable scaffolds (BRS) were developed as an innovative solution to overcome the limitations of metallic stents. While polymeric BRS initially demonstrated comparable clinical outcomes to drug-eluting stent (DES) in clinical trials, subsequent large-scale studies revealed that patients implanted with polymeric BRS experienced higher rates of scaffold thrombosis (ScT) and target lesion failure compared to those with metallic stents. Resorbable magnesium scaffolds (RMS) have emerged as a promising alternative owing to magnesium's natural degradability and favorable mechanical properties. Learning from the mechanism of polymeric BRS failure and through continuous improvements, recent clinical trials have shown promising clinical performance for RMS technology. However, comparative studies between RMS and DES have continued to highlight the remaining challenges with RMS, particularly in regard to late lumen loss. Recent advancements in third-generation RMS show improvements in strut thickness and homogeneous degradation, which enhances sustained structural integrity throughout the degradation process. Based on encouraging results from a first-in-human trial of the latest version of RMS, a randomized controlled trial has been initiated to compare the outcomes between metallic stents and the latest RMS, with patient enrollment already underway. This review aims to explore the limitations of polymeric BRS and provide an overview of the current developments and future potential of magnesium-based BRS.
生物可吸收支架(BRS)作为一种创新解决方案被开发出来,以克服金属支架的局限性。虽然聚合物BRS在临床试验中最初显示出与药物洗脱支架(DES)相当的临床结果,但随后的大规模研究表明,与金属支架植入患者相比,植入聚合物BRS的患者发生支架血栓形成(ScT)和靶病变失败的比率更高。可吸收镁支架(RMS)由于镁的天然可降解性和良好的机械性能而成为一种有前途的替代方案。从聚合物BRS失败的机制中吸取教训并通过不断改进,最近的临床试验显示RMS技术具有良好的临床性能。然而,RMS与DES之间的比较研究继续凸显RMS仍然存在的挑战,特别是在晚期管腔丢失方面。第三代RMS的最新进展显示在支柱厚度和均匀降解方面有所改进,这在整个降解过程中增强了持续的结构完整性。基于最新版本RMS首次人体试验的令人鼓舞的结果,已启动一项随机对照试验,以比较金属支架和最新RMS之间的结果,患者招募工作已经在进行中。本综述旨在探讨聚合物BRS的局限性,并概述镁基BRS的当前发展和未来潜力。