Drug-eluting versus plain balloon angioplasty for haemodialysis vascular access stenosis: a retrospective analysis
DOI:
https://doi.org/10.48750/acv.710Keywords:
Haemodialysis, Arteriovenous fistula, Vascular access, Drug-eluting balloon, Plain old balloon angioplastyAbstract
INTRODUCTION: Arteriovenous fistulas (AVFs) and grafts (AVGs) are the preferred vascular access for hemodialysis, but they often become dysfunctional because of stenosis. Although plain old balloon angioplasty (POBA) remains the standard treatment, drug-coated balloons (DEBs) have been proposed to reduce restenosis. However, their long-term efficacy in this setting remains uncertain.
METHODS: We conducted a retrospective, single-center study of 96 patients who underwent index percutaneous transluminal angioplasty (PTA) for dysfunctional AVFs or AVGs between November 2018 and July 2025, comparing POBA with paclitaxel-coated DEBs. We excluded patients with prior interventions or stents. The primary endpoint was primary patency at 6 and 12 months, defined as the time from the index angioplasty to the first clinically driven reintervention at the treated lesion, thrombosis, or surgical revision. Secondary endpoints included secondary patency and overall mortality. We used Kaplan-Meier survival analysis and Cox regression.
RESULTS: Of 96 patients (median age 62.5 years; 53.1% female), 81.3% had AVFs. POBA's were used in 79 cases, and DEBs in 17. Technical success was achieved in 93/96 patients (96.9%), with no significant difference between the POBA and DEB groups (96.2% vs. 100.0%; p = 1.0). Clinical success was 94.9% vs. 94.1% (p = 1.0). No significant difference in primary patency was observed between POBA and DEB at 6 months (58% vs. 43.8%) or 12 months (38% vs. 37.5%). Secondary patency and mortality rates were also similar. Multivariate analysis identified female sex as associated with an increased risk of primary patency loss (HR = 1.86; 95% CI: 1.08-3.19; p = 0.025), whereas balloon type was not associated with primary patency loss (POBA vs. DEB: HR = 1.00; 95% CI: 0.52-1.93; p = 0.991). Access type was not statistically significant (AVG vs. AVF: HR = 1.85; 95% CI: 1.00-3.45; p = 0.052). We did not include periprocedural complications in the multivariable model because of the small number of events.
CONCLUSION: DEB angioplasty did not show a significant advantage over POBA in maintaining primary patency at 6 or 12 months. Female sex and procedural complications were associated with a higher risk of primary patency loss, whereas balloon type was not associated with the outcome. Access type showed a borderline, non-significant association with primary patency loss. Larger prospective studies are needed to further assess the role of DEBs in vascular access maintenance.
Downloads
References
Kitrou PM, Katsanos K, Spiliopoulos S, Karnabatidis D, Siablis D. Drug-eluting versus plain balloon angioplasty for the treatment of failing dialysis access: Final results and cost-effectiveness analysis from a prospective randomized controlled trial. Eur J Radiol. 2015;84:418-23.
Liao MT, Chen MK, Hsieh MY, Yeh NL, Chien KL, Lin CC, et al. Drug-coated balloon versus conventional balloon angioplasty of hemodialysis arteriovenous fistula or graft: A systematic review and meta-analysis of randomized controlled trials. PLoS One. 2020;15:e0231463.
Chen X, Liu Y, Wang J, Zhao J, Singh N, Zhang WW. A systematic review and meta-analysis of the risk of death and patency after application of paclitaxel-coated balloons in the hemodialysis access. J Vasc Surg. 2020;72:2186-196.
Lok CE, Huber TS, Lee T, Shenoy S, Yevzlin AS, Abreo K, et al. KDOQI Clinical Practice Guideline for Vascular Access: 2019 Update. Am J Kidney Dis. 2020;75:S1-164.
Lookstein R, Haraguchi H, Suemitsu K, Isogai N, Gallo V, Madassery S, et al. IN.PACT AV Access Randomized Trial of Drug-Coated Balloons for Dysfunctional Arteriovenous Fistulae: Clinical Outcomes through 36 Months. J Vasc Interv Radiol. 2023;34:2093-102.
Karunanithy N, Robinson EJ, Calder F, Dorling A, Peacock JL, Wang Y, et al. Paclitaxel-assisted balloon angioplasty of venous stenosis in haemodialysis access: PAVE RCT. Efficacy and Mechanism Evaluation. NIHR Journals Library; 2021;8:1-36.
Soon SXY, Tan RY, Pang SC, Yap CQ, Patel A, Gogna A, et al. RangerTM paclitaxel-coated balloon versus conventional balloon angioplasty for treatment of failing arteriovenous fistulas and grafts in haemodialysis patients: A retrospective cohort study. J Vasc Access. 2023;24:1032-41.
Trerotola SO, Saad TF, Roy-Chaudhury P. The Lutonix AV Randomized Trial of Paclitaxel-Coated Balloons in Arteriovenous Fistula Stenosis: 2-Year Results and Subgroup Analysis. J Vasc Interv Radiol. 2020;31:1-14.
Tang TY, Soon SXY, Yap CQ, Chan SL, Choke ETC, Chong TT. Utility of Sirolimus Coated Balloons for Salvaging Dysfunctional Arteriovenous Fistulae: One Year Results From the MATILDA trial. Eur J Vasc Endovasc Surg. 2021;62:316-7.
Rokoszak V, Syed MH, Salata K, Greco E, de Mestral C, Hussain MA, et al. A systematic review and meta-analysis of plain versus drug-eluting balloon angioplasty in the treatment of juxta-anastomotic hemodialysis arteriovenous fistula stenosis. J Vasc Surg. 2020;71:1046-1054. el.arteriovenous fistula stenosis. J Vasc Surg. 2020;71:1046.1054.
