Device Effectiveness for Femoropopliteal Artery Disease Treatment: An Analysis of K-VIS ELLA Registry

Abstract

Background: Although drug-coated balloons (DCBs) and drug-eluting stents (DES) are frequently used for the treatment of femoropopliteal artery (FPA) disease, their mid- or long-term clinical efficacy in real-world practice is still limited.

Objectives: From the K-VIS ELLA (Korean Vascular Intervention Society Endovascular Therapy in Lower Limb Artery Diseases) multicenter registry cohort, clinical outcomes of drug-eluting devices for FPA lesions in comparison with bare-metal stents (BMS) were evaluated.

Methods: Limbs that underwent percutaneous transluminal angioplasty for FPA lesions with plain old balloon angioplasty (POBA, n = 826), BMS (n = 943), DCBs (n = 778), or DES (n = 227) between 2012 and 2020 were included. The primary outcome was target lesion revascularization (TLR) at 2 years. Inverse probability of treatment weighting was used to account for confounding.

Results: After inverse probability of treatment weighting, baseline characteristics were well-balanced among groups. Compared with the 2-year cumulative incidence of TLR with BMS (26.5%), the incidence of TLR was significantly lower in limbs treated with DCBs (15.9%; HR: 0.44; 95% CI: 0.30-0.64; P < 0.001) or DES (15.9%; HR: 0.51; 95% CI: 0.29-0.87; P = 0.014). No significant differences were observed in the risk of TLR between DCBs vs DES (HR: 0.87; 95% CI: 0.51-1.49; P = 0.613) and POBA vs BMS (HR: 0.94; 95% CI: 0.73-1.21; P = 0.626). All-cause mortality was comparable in the 4 groups. Treatment with DCBs showed a more pronounced favorable outcome in limbs with Trans-Atlantic Inter-Society Consensus II type C/D lesions or long lesions (≥150 mm) compared with POBA, BMS, or DES (Pinteraction< 0.05).

Conclusions: In real-world practice, DCBs and DES demonstrated comparably superior midterm outcomes over POBA or BMS in the treatment of FPA lesions.