Drug coated versus non-compliant balloon angioplasty in a failing native arteriovenous access

Abstract

Background: Stenosis due to neointimal hyperplasia is the main reason of failing arteriovenous fistula (AVF). Percutaneous endovascular procedures are widely applied for treatment of failing dialysis circuit. Both drug-coated balloon (DCB) and non-compliant balloon (NCD) 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 AVF.
Methods: This is a single-centre randomized clinical study, 53 patients presented with failing dialysis access are assessed for eligibility. 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 patients are treated with DCB and 14 patient are treated with NCB angioplasty. The primary endpoint of the study is anatomical success (less than 30% residual stenosis of the target lesion). Secondary endpoints include duplex assessment of dialysis circuit flow rate, complications (minor and major), target lesion primary patency (TLPP), target lesion assisted primary patency (TLAPP), target lesion secondary patency (TLSP), cumulative primary and assisted primary patency, as well as intervention free survival during 12 months follow up.
Results: In DCB group, the mean age of 55.1 years; while the mean age in NCB group is 54.6 years. There are no preoperative differences in patient risk factors between both groups. Anatomical success rate is achieved in 100% of both groups. TLPP between DCB and NCB groups at 12 months (61.5% vs 57.1%) are comparable (P = 0.81), as well as TLAPP at 12 months (61.5% vs 64.3%; P = 0.88). TLSP between DCB and NCB at 12 months (69.2% vs 64.3%) are also comparable (P = 0.78). Successful endovascular angioplasty for all circuit restenosis are performed in one DCB patient and three NCB patients. Rates of overall fistula restenosis are 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.