Current situation and overview of resorbable magnesium scaffolds: a perspective for overcoming the remaining issues of polymeric bioresorbable scaffold.

Abstract

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.