Long-term safety and efficacy of endovascular therapy in the lower extremity

Vollständiger Abstract

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Aim Endovascular therapy has become the preferred revascularization method for lower extremity arterial disease (LEAD), offering reduced procedural morbidity compared with open surgery. However, real-world data on its long-term durability and safety in complex lesions remain limited. This study aimed to evaluate the long-term safety and efficacy of endovascular treatment in patients with LEAD, focusing on primary patency, freedom from clinically driven target lesion revascularization (CD-TLR), and amputation-free survival (AFS). Methods This multicenter, retrospective study included 150 patients treated between January 2018 and December 2023 at tertiary cardiovascular centers. Patients with femoropopliteal and tibial arterial disease who underwent endovascular revascularization with plain balloon angioplasty, drug-coated balloons (DCBs), drug-eluting stents (DESs), or atherectomy were analyzed. Kaplan–Meier curves were used for survival analysis, and Cox regression was used to identify predictors of restenosis and patency loss. Results During a mean follow-up of 38 ± 14 months, primary patency rates were 82%, 61%, and 47% at 1, 3, and 5 years, respectively. Freedom from CD-TLR was 89%, 74%, and 59%, and the 5-year amputation-free survival was 77%. Major amputation occurred in 9.3%. Diabetes mellitus, chronic total occlusion, and absence of drug-coated device use were independent predictors of restenosis. Conclusion Endovascular treatment provides satisfactory long-term results for LEAD with respect to limb salvage and safety. Although restenosis remains a concern, durable patency and favorable AFS rates support endovascular management as an effective first-line approach for appropriately selected patients.