Efficacy and Safety of Magnesium-Based Bioresorbable Scaffolds in All Coronary Artery Diseases: A Systematic Review and Proportional Meta-Analysis

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Abstract

Introduction: Coronary artery disease (CAD) is a major global health concern, often managed through percutaneous coronary intervention (PCI) with stent implantation. Metallic stents, such as bare-metal stents (BMS) and drug-eluting stents (DES), function by mechanically propping open the narrowed artery, preventing acute vessel closure and reducing restenosis. However, their permanent presence in the vessel wall can lead to long-term complications. Magnesium-based bioresorbable scaffolds have been developed as a temporary support that provide initial vessel reinforcement similar to metallic stents. Methods: This analysis was registered under PROSPERO ID: 1018671. Primary outcomes were cardiac death, tTarget vessel myocardial infarction, Device-Oriented Composite Endpoint (DOCE), tTarget lesion failure and target lesion revascularization (T-TLF & CD-TLF); secondary outcomes included scaffold thrombosis, restenosis, change in balloon diameter and procedural success. Results:- This proportional meta-analysis followed PRISMA guidelines and included 16 studies (4 RCTs, 12 observational) up to 2025. Pooled analysis demonstrated a cardiac death rate of 0% (95% CI: 0.00–0.00) and a target vessel myocardial infarction (TVMI) rate of 1% (95% CI: 0.01–0.02). Target lesion failure (TLF) occurred in 6% of cases (95% CI: 0.06–0.07), while device-oriented composite endpoint (DOCE) was observed in 9% (95% CI: 0.03–0.14). Total target lesion revascularization (TLR) and clinically driven TLR (CD-TLR) were 7% (95% CI: 0.04–0.09) and 5% (95% CI: 0.03–0.06). Scaffold thrombosis was consistently 0% at 6, 12, and 24 months. Restenosis was reported in 8% of patients (95% CI: 0.04–0.12), while procedural success was exceptionally high at 99% (95% CI: 0.99-1.00). The average increase in balloon diameter was 0.43 mm (95% CI: 0.27–0.59). Conclusion:- This meta-analysis showed favorable safety outcomes, with a 1% rate of target vessel myocardial infarction (TV-MI) and 6% target lesion failure (TLF), consistent with previous DREAMS trials. Unlike earlier bioresorbable scaffolds like ABSORB, which had higher thrombosis rates, Mg-BRS showed 0% scaffold thrombosis and low revascularization needs, indicating improved degradation and endothelial healing. While Mg-BRS may outperform drug-eluting stents in some cases, study heterogeneity and limited long-term data require cautious interpretation and future randomized trials.

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