Clinical outcome of endovascular therapy for femoropopliteal artery lesions in patients with intermittent claudication: Twenty-four-month outcomes from the TALENT registry.

Abstract

The aim of this study was to assess the 24-month clinical outcome of endovascular therapy (EVT) for femoropopliteal (FP) lesions in patients with lifestyle-limiting claudication in a current real-world setting. We retrospectively analyzed data from a clinical database formed by TALENT (Impact Of Tibial Run Off On Clinical Outcome Of Endovascular Therapy In Femoropopliteal Lesions), a prospective, multicenter patient registry. We selected 980 patients (1010 limbs) with symptomatic intermittent claudication (IC) undergoing FP intervention from the TALENT registry between December 1, 2020, and May 1, 2023. The observational end points included the incidence of clinically driven target lesion revascularization (CD-TLR), major adverse limb events (MALEs), major adverse cardiovascular events (MACEs), all-cause of mortality, progression to chronic limb threatening ischemia (CLTI), and changes in self-reported quality-of-life (QOL) measures (Vascular Quality of Life 25). Prognostic predictors for MALE, MACE, CD-TLR, and progression to CLTI were elucidated by Cox proportional hazard regression analysis. A total of 1010 targeted limbs in 980 patients with IC treated with EVT were included in this study. The median follow-up time was 24 months (interquartile range, 24-36 months). At the 24-month follow-up, the cumulative incidence of CD-TLR was 7.15% (95% confidence interval [CI], 5.45%-8.85%), whereas progression to CLTI occurred in only 2.20% of limbs (95% CI, 1.18%-3.22%). Incidence of MALE and MACE were 7.59% (95% CI, 5.85%-9.34%) and 2.04% (95% CI, 1.10%-2.98%), respectively. The all-cause of mortality rate was 5.85% (95% CI, 4.29%-7.41%) and VascuQOL scores showed sustained improvement throughout the follow-up period (3.17 ± 0.84 vs 5.71 ± 1.19; P < .001). Cox regression analysis identified chronic renal insufficiency (CRI) (defined as a glomerular filtration rate of <30 mL/min/1.73 m²), Trans-Atlantic Inter-Society Consensus Document (TASC) II C/D FP lesions, and a history of previous lower extremity intervention as independent risk factors for CD-TLR. Female sex, TASC II C/D FP lesions, and poor pedal runoff (pedal runoff score = 2-3) were identified as independent risk factors for progression to CLTI within 24 months. CRI and TASC II C/D FP lesions were independent risk factors for MALEs. CRI and chronic obstructive pulmonary disease were independent risk factors for MACEs within 24 months. The 24-month clinical outcomes of EVT for FP lesions in patients with lifestyle-limiting IC demonstrated acceptable results, with sustained enhancements in health-related QOL.