ABSTRACT
Objective: Percutaneous endovascular procedures are widely applied for treatment of failing dialysis circuit. Both drug-coated balloon (DCB) and non-compliant balloon (NCB) angioplasty can be employed to treat hemodialysis access dysfunction.
Aim of the work: The goal of this trial is to assess the additional value of using DCB over NCB for the management of failing native arteriovenous fistula (AVF).
Methods: This is a single-centre randomized clinical study. The study was conducted at Vascular Surgery Department, Zagazig University Hospitals-Egypt from January 2017 to December 2020. A total of 27 patients presented with failing AVF, are randomized to 13 patient are treated with DCB and 14 patient are treated with NCB angioplasty. The primary endpoint of the study is anatomical success. Secondary endpoints include duplex assessment of dialysis circuit flow rate, complications (minor and major), target lesion patency rate as well as intervention free survival during 12 months follow up.
Results: Anatomical success rate is achieved in 100% of both groups. target lesion primary patency (TLPP) between DCB and NCB groups at 12 months (61.5% vs 57.1%) are comparable (P = 0.81), as well as target lesion secondary patency (TLSP) between DCB and NCB at 12 months (69.2% vs 64.3%) are also comparable (P = 0.78). Rates of overall fistula restenosis is higher in NCB than DCB group without significance difference.
Conclusion: DCB is promising alternative for failing AVF treatment, as it clinically improves short term access patency, and reduces target lesion restenosis rate but this remains statistically insignificant.