Sirolimus–Eluting Resorbable Magnesium Scaffold for the Treatment of Patients With Infrapopliteal Arteries Disease: Three-Year Results

Abstract

Introduction:

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 been 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.

Materials and Methods:

This investigator-initiated single-center retrospective study, analyzed all patients with symptomatic peripheral arterial occlusive disease (Rutherford class of symptoms 2–5) treated with the Magmaris RMS from 2016 to 2023, for the treatment of infrapopliteal arterial lesions with postangioplasty 50% or more residual stenosis. Technical success, degree of residual stenosis after scaffold implantation, incidences of target lesion primary patency, clinically driven target lesion revascularization (CDTLR), major limb amputation, and all-cause mortality are provided up to 36 months.

Results:

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.

Conclusion:

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.

Clinical Impact

Resorbable magnesium scaffold (RMS) are an innovation in the treatment of residual stenoses or dissections after angioplasty in the infrapopliteal arteries. They offer mechanical support and drug elution during the healing phase of the artery wall; and then disappear, leaving the artery free of any rigid implant, once the resorption is completed. RMS thus allow the restoration of artery motion and endothelial function. This study provides efficacy and safety information up to 3 years after RMS implantation in severe lesions of the leg arteries and is the largest study in the field of resorbable scaffold for below the knees arteries, as well as the first evaluating magnesium-based alloy scaffolds. It shows immediate and long-term clinical success, well beyond the entire resorption of the RMS.