Paclitaxel Efficacy in Dialysis‐Dependent Peripheral Artery Disease: A National Cohort Analysis

BACKGROUND: Patients undergoing dialysis have a significant risk of peripheral artery disease, limb amputation, and mortality. Paclitaxel-coated devices (PCDs) are used to reduce restenosis after endovascular therapy, but their safety and efficacy in a dialysis-dependent population remain unclear. We aimed to evaluate the association between PCDs and major clinical outcomes in patients with maintenance dialysis undergoing endovascular therapy for symptomatic peripheral artery disease. METHODS: We conducted a nationwide retrospective cohort analysis using the National Health Insurance Research Database in Taiwan. Patients under dialysis receiving endovascular therapy between May 2016 and December 2022 were included. Patients were categorized into PCD and non-PCD groups during the index procedure. Propensity score matching was performed to balance baseline characteristics. The primary outcome was defined as the composite of lower limb amputation or all-cause mortality. Cardiovascular outcomes and clinical-driven reintervention were secondary outcomes. RESULTS: Among 10 235 eligible patients, 1169 (11.4%) received PCDs. After 1:3 matching, 1160 and 3480 patients in the PCD and non-PCD groups were analyzed. PCD use was associated with a significantly lower risk of the primary outcome (47.6% versus 52.2%; hazard ratio [HR], 0.85 [95% CI, 0.77-0.93]). Risks of amputation (20.7% versus 23.8%; subdistribution HR, 0.84 [95% CI, 0.73-0.97]) and all-cause mortality (35.9% versus 38.9%; HR, 0.87 [95% CI, 0.78-0.97]) were also significantly lower with PCD use. Cardiovascular outcomes and clinical-driven reintervention were similar between groups. CONCLUSIONS: Use of PCD in dialysis-dependent patients undergoing endovascular therapy for peripheral artery disease was associated with reduced risk of the composite outcome of amputation and all-cause mortality.