Critical limb-threatening ischemia (CLTI) represents the most advanced stage of peripheral artery disease and remains challenging to treat due to small vessel caliber, diffuse calcification, microvascular dysfunction, and the long-term limitations of permanent metallic stents. Bioresorbable scaffolds (BRS) were introduced to provide temporary mechanical support while eliminating chronic vessel caging, allowing physiologic vessel recovery and preserving options for future reintervention. Over the past decade, BRS have evolved from early polymeric platforms to next-generation magnesium and radiopaque polymer systems with improved radial strength, visibility, and resorption kinetics. However, their clinical performance in CLTI and the comparative outcomes between BRS have not been comprehensively summarized. This review evaluates the clinical outcomes and performance of various BRS in CLTI.

This systematic review followed PRISMA 2020 guidelines and included studies evaluating BRS in CLTI patients. Extracted data included study characteristics, patient demographics, lesion features, scaffold type, and major outcomes: primary patency, clinically driven target-lesion revascularization (CD-TLR), wound healing, and limb salvage. Outcomes were compared across generations and drug classes.

Across 15 clinical studies including 1,143 patients with CLTI (mean age 69 ± 9 years), lesions averaged 25 mm in length, and 55% exhibited moderate–severe calcification. Technical success exceeded 97% across all platforms, with high deliverability even in diffusely diseased and calcified vessels. Bailout metallic stenting was uncommon (3–5%), reflecting adequate acute radial strength of contemporary scaffolds. Overall complication rates were low, with no reported scaffold thrombosis, late recoil, device fracture, or scaffold-related adverse events. Across all generations, 12-month primary patency averaged ~90%, clinically driven target-lesion revascularization (CD-TLR) remained <10%, and limb-salvage consistently exceeded 94%. Early polymeric scaffolds (Absorb BVS, Esprit; Abbott Vascular) achieved 85–95% patency at 1 year and ~80% at 3 years. Magnesium-based sirolimus-eluting scaffolds such as Magmaris RMS maintained 87–95% freedom from CD-TLR through 36 months, with rapid resorption supportive of vessel remodeling. Third-generation sirolimus-eluting radiopaque platforms (Tyrocore MOTIV, ResolV I) demonstrated 88–93% patency and 95–98% limb salvage, with strong performance even in moderate–severe calcium. Amputation-free survival exceeded 90% across studies, and several cohorts noted accelerated wound healing in patients with smaller ulcers. Everolimus- and sirolimus-eluting platforms showed comparable efficacy, suggesting scaffold design, radial strength, and resorption kinetics may exert greater influence on long-term outcomes than drug selection. Dual-antiplatelet therapy durations were short (1–3 months) with no increase in bleeding complications. Collectively, the data demonstrate that bioresorbable scaffolds provide safe implantation, high procedural success, and favorable outcomes even in complex calcified CLTI lesions.

BRS demonstrated durable patency, low CD-TLR, and excellent limb-salvage rates in patients with CLTI, while eliminating the long-term drawbacks of permanent metallic stents. Third-generation magnesium and sirolimus-eluting radiopaque scaffolds represent a meaningful advancement, offering improved mechanical reliability, accelerated and predictable resorption, and enhanced procedural visibility. Larger randomized trials are needed to confirm long-term vessel restoration and guide optimal antiplatelet strategies in this complex and high-risk population.