Chronic limb-threatening ischemia (CLTI) carries high risk of restenosis, reintervention, and limb loss, yet durable below-the-knee treatment options remain limited. The LIFE-BTK randomized controlled trial, published in Circulation, compared a drug-eluting resorbable scaffold (DRS) with percutaneous transluminal angioplasty (PTA) in 261 patients.

At two years, the composite efficacy endpoint was achieved in 68.8% of patients treated with the drug-eluting resorbable scaffold compared with 45.4% of those treated with angioplasty (P=0.0004). The endpoint was defined as freedom from target limb amputation, vessel occlusion, clinically driven target lesion revascularization, or binary restenosis.Binary restenosis occurred in 28.5% of scaffold-treated patients compared with 48.2% after angioplasty (P=0.005). Clinically driven revascularization was lower with DRS (9.7% vs 18.6%, P=0.034).

Safety outcomes were comparable, with the primary safety endpoint achieved in : 91.6% of DRS patients and 95.6% of PTA (P=0.16). Limb salvage rates were high in both groups (94.7% vs 97.3%, P=0.34). Scaffold treatment independently predicted efficacy (OR 0.27, P=0.0003).

These findings support the drug-eluting resorbable scaffold as a durable endovascular option for selected CLTI patients with noncomplex, mildly to moderately calcified infrapopliteal lesions. Broader validation in more complex populations remains necessary.