Indications and Treatment Outcomes of Below-the-Knee Peripheral Artery Interventions in the XLPAD Registry

Abstract

There are unresolved questions regarding indications and outcomes of endovascular below-the-knee (BTK) interventions in patients with symptomatic peripheral artery disease (PAD) in real-world clinical practice. We analyzed 884 patients from the multicenter XLPAD registry between 2006 and 2023 with nonstent BTK PAD interventions. Primary outcome: freedom from major adverse limb events (MALE) at 1 year, a composite of all-cause death, major amputation, or clinically driven revascularization. Majority (62.8%) of the BTK interventions were performed for chronic limb threatening ischemia (CLTI), while remaining (37.2%) in patients with intermittent claudication (IC), performed together with an inflow femoropopliteal artery intervention in 58% or involving complex lesion crossings (11.8%). Nearly, 74% were men, mean age 68.0 ± 10.7 years. Mean Rutherford class was 4.65 in CLTI and 2.71 in IC groups. Moderate to severe calcification was present in 25% of cases. Significantly greater number of lesions were treated in the CLTI group (1.84 ± 1.52 vs 2.08 ± 1.61; p = 0.029). Lesion lengths (CLTI: 129.3 ± 85.1 mm vs IC: 115.5 ± 82.5; p = 0.075) were comparable. Nearly, 92% of lesions were treated with balloon angioplasty. Drug-coated balloon use was higher in IC (5% vs 15%, p <0.001), whereas atherectomy use was high in both groups (CLTI: 45.4% vs IC: 49.9%; p = 0.201). Procedural success was similar (CLTI: 92% vs IC: 88.8%; p = 0.098), however 1-year MALE was significantly higher in CLTI patients (30.5% vs 15.8% vs; p <0.0.001), driven by higher all-cause mortality (5.6% vs 2.1% vs; p = 0.014) and major amputations (14% vs 3.7%; p <0.001). Endovascular treatment for BTK PAD is more often performed in patients with CLTI compared with IC, where it is often combined with an inflow artery intervention or complex lesion crossings. Despite similar procedural success, 1-year MALE is significantly higher in CLTI, driven mainly by over a 2-fold increase in all-cause mortality and major amputations.