PurposeTo investigate the efficacy of paclitaxel drug-eluting balloons (PEB) versus standard balloon angioplasty (BA) in stenosis of native hemodialysis arteriovenous fistulas (AVFs).Materials and MethodsA total of 96 patients with ESRD (mean ± SD age 57.0 ± 9.1 years, 63.5% were males) who underwent endovascular treatment with PEB angioplasty (n = 32) and BA (n = 64) for a dysfunctional native AVF were included. Clinical success, complications, primary patency and postoperative recurrence parameters were recorded in each group.ResultsPrimary patency rate at 6 months was significantly higher in PEB than in BA group (96.9 vs. 20.3%, p < 0.001), while the two groups had similar primary patency rates at 9 months (66.8 vs. 50.0%) and 12 months (6.3% for each). No significant difference was noted between PEB and BA groups in terms of the rate (21.9% and. 31.3%), time (median 220 vs. 152.5 days) and reasons (reocclusion in 18.8 vs. 28.1%) for dysfunction recurrence as well as the number of recurrent treatments. AVF dysfunction recurrence was more likely in younger age AVF (median 4 vs. 23 months, p < 0.001 in PEB, and 8.5 vs. 20.5 months p = 0.001 in SBA) and in AVF ≤ 6 months in both SBA and PEB groups (71.4 vs. 12.0%, p = 0.005 in PEB, 40.0 vs. 2.3%, p < 0.001).ConclusionIn conclusion, our findings emphasize favorable safety and efficacy of PEB and BA in the management of dysfunctional hemodialysis AVFs with similar rates of post-PTA recurrence of AVF dysfunction. Nonetheless, there was a nonsignificant tendency for lower rate and a delay for recurrent dysfunction in patients treated with PEB and a significant association younger AVF age with an increased risk of post-PTA recurrence of AVF dysfunction.Level of Evidence3, Retrospective cohort study.