Symptomatic infrapopliteal arterial disease often requires challenging endovascular interventions. Percutaneous transluminal angioplasty with stent placement to settle residual stenosis or dissections remains the standard of care for infrapopliteal endovascular intervention. Concerns have raised about permanent artery rigidification by stainless steel stents. Drug-eluting resorbable scaffolds combine the mechanical support in the acute phase and the delivery of an antirestenotic drug overtime, then fully resorb leaving the vessel free from permanent metallic implant. This study investigated the performance of the Magmaris sirolimus-eluting resorbable magnesium scaffold (RMS) in the management of infra-popliteal, severely diseased leg arteries.

This investigator-initiated single center retrospective study, analysed all patients with symptomatic peripheral arterial occlusive disease (Rutherford class of symptoms 2 to 5) treated with the Magmaris RMS from 2016 to 2023, for the treatment of infrapopliteal artery disease. Technical success, degree of residual stenosis after scaffold implantation, incidences of clinically-driven target lesion revascularization (CDTLR), major limb amputation and all-cause mortality are provided up to 36 months.

Hundred eleven patients (69.4% male, age 79 ± 10) were treated with 141 Magmaris RMS for infrapopliteal lesions (92.3% proximal third of leg). Target lesions had a mean degree of stenosis of 92 %, with 52.2 % of occlusion and 58.5 % of moderate or severe calcification. The mean degree of stenosis after angioplasty remained 60.1 ± 15.8 % and fell to 4.8 ± 9.6 % after scaffold implantation. Freedom from CDTLR was 95.5%, 93.4%, 90.4% and 87.9%% at 6, 12, 24 and 36 months. Freedom from limb major amputation was 98.2%, 98.1%, 96.4% and 95.5% and mortality was 7.6%, 10.6%, 24.2% and 28.8% at 6, 12, 24 and 36 months.

This study suggests that the Magmaris RMS has adequate mechanical properties, drug elution and resorption time to be safely applied to atherosclerotic infrapopliteal arteries with promising clinical results. These data show that metallic resorbable scaffold may constitute a valuable addition to current option for infrapopliteal arteries management.