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SIR 2026

Scientific Session

Dialysis Interventions

Session: Dialysis & Transplant

300 - Does Drug-coated Balloon Angioplasty for All Significant Dialysis Access Arteriovenous Fistula Stenoses Improve Circuit Patency? A Randomized Controlled Trial

Wednesday, April 15, 2026
12:00 PM - 12:09 PM ET
Purpose: RCTs comparing drug-coated balloon (DCB) to plain balloon angioplasty in hemodialysis arteriovenous fistulas (AVF) have shown mixed results. This could potentially be due to heterogeneous trial designs, different study populations, or the lack of a DCB “class-effect”. We aim to compare the efficacy of the Ranger DCB (Boston Scientific; Marlborough, Massachusetts, USA) to plain balloon for angioplasty of all stenoses in the peripheral circuit of dysfunctional AVF.

Materials and Methods: This prospective, single-center, blinded RCT recruited participants with new or recurrent stenoses in the peripheral circuit of failing mature AVF. Participants with hemodynamically significant central vein stenoses or AVF thrombosis were excluded. After successful angioplasty of all AVF stenoses in the peripheral circuit (lesion preparation achieving < 30% residual stenosis), 94 participants (72 male, 76.6%; mean age 66.8 ± 9.5 years) were randomized to DCB or plain balloon in a 1:1 ratio, stratified by the number of AVF stenoses (single versus multiple). The primary outcome measure was clinically driven 6-month access circuit primary patency (ACPP). Participant follow-up for patency was up to 12 months post recruitment.

Results: There was no statistically significant difference in 6-month ACPP between both arms (DCB: 75.6%, plain balloon: 70.5%, p = 0.76). At 9 and 12 months, the ACPP was higher in the DCB arm compared to plain balloon arm but did not reach statistical significance (9 months: 61.4% vs 42.9%, p = 0.13, 12 months: 48.8% vs 31.7%, p = 0.18). However, Kaplan-Meier survival analysis revealed a statistically significant difference in the ACPP survival curves between the groups up to 12 months follow-up (p = 0.037), possibly due to divergence in ACPP curves after 6 months.

Conclusion: This RCT comparing DCB to plain balloon for treatment of all stenoses in the peripheral AVF circuit did not meet its 6-
month ACPP primary endpoint. However, Kaplan-Meier survival analysis suggests a possible benefit with DCB beyond 6 months of treatment.