Abstract 4140791: Two-Year Clinical Outcomes of Patients with Critical Limb Ischemia versus Claudication in Femoropopliteal Artery Disease following Endovascular Therapy : An Analysis from K-VIS ELLA Registry

Background: Endovascular therapy (EVT) is a prevalent treatment option for femoropopliteal artery (FPA) disease, manifesting as critical limb ischemia (CLI) or intermittent claudication (IC). However, there is a lack of evidence regarding comparative outcomes between patients with CLI and IC following EVT in real-world settings. Research Questions: This study aimed to investigate the clinical outcomes of patients with native FPA disease, specifically comparing those with CLI and IC at 2 years following the EVT procedure from a real-world multicenter cohort. Methods: From K-VIS ELLA (Korean Vascular Intervention Society Endovascular Therapy in Lower Limb Artery Diseases) multicenter registry cohort, a total of 1924 patients with FPA disease (CLI, n=812; IC, n=1112) between 2006 and 2021 were analyzed. The primary endpoint was target limb amputation or clinically driven (CD)-target extremity revascularization (TER) at 2 years post-procedure. Results: After Inverse Probability of Treatment Weighting (IPTTW), the incidence of the primary endpoint was significantly higher in the CLI group (HR 1.314; 95% CI [1.105-1.561]; p=0.002) compared to the IC group. The incidence of loss of clinical patency, major adverse limb events (MALEs), and all-cause death was also higher in CLI group (HR 1.312; 95% CI [1.157-1.488]; p<0.001). No significant differences were observed in the risk of repeated percutaneous transluminal angioplasty (PTA) (HR 1.014; 95% CI [0.833-1.234]; p=0.920). Treatment with drug-coated balloon (DCB) showed favorable outcomes for the primary endpoint in both groups compared to other treatment modalities, particularly in patients with IC [HR of 0.429 (CI: 0.25-0.734, p=0.002)]. Conclusions: EVT for FPA disease in patients with CLI is associated with worse clinical outcomes compared to those with IC. Nevertheless, the risk of repeated PTA did not differ in both groups. The use of DCB shows promising results in both groups.