Two-Year Clinical Outcomes of Critical Limb-Threatening Ischemia Versus Claudication After Femoropopliteal Endovascular Therapy: An Analysis from K-VIS ELLA Registry

Abstract

Background/Objectives: Endovascular therapy (EVT) is the treatment of choice for femoropopliteal artery (FPA) disease manifesting as critical limb-threatening ischemia (CLTI) or intermittent claudication (IC). This study aimed to compare the clinical outcomes of patients with CLTI with those of patients with IC after EVT in a real-world setting. Methods: In total, 1924 patients with FPA disease (CLTI: n = 812, IC: n = 1112) from the K-VIS ELLA (Korean Vascular Intervention Society Endovascular Therapy in Lower Limb Artery Diseases) registry who underwent EVT between 2006 and 2021 were analyzed. The primary endpoint was defined as target limb amputation or clinically driven (CD) target extremity revascularization (TER) 2 years after the procedure. Results: The incidence of the primary endpoint after inverse probability of treatment weighting (IPTW) was significantly higher in the CLTI group (hazard ratio [HR], 1.314; 95% confidence interval [CI], 1.105-1.561; p = 0.002). The incidences of loss of clinical patency, major adverse limb events (MALEs), and all-cause mortality were also higher in the CLTI group (hazard ratio [HR], 1.312; 95% confidence interval [CI], 1.157-1.488; p < 0.001). However, the risk of repeat percutaneous transluminal angioplasty (PTA) was similar between the groups (HR, 1.014; 95% CI, 0.833-1.234; p = 0.920). The use of drug-coated balloons (DCBs) was associated with favorable primary outcomes in both groups, particularly in patients with IC (HR: 0.429, 95% CI: 0.25-0.734; p = 0.002). Conclusions: Patients with CLTI undergoing EVT for FPA disease experienced worse clinical outcomes than those with IC, although the repeat PTA rates were similar. The use of DCBs showed promising results in both groups.