IF02 - Drug-Coated Balloon and Percutaneous Old Balloon Angioplasty for Hemodialysis Arteriovenous Graft Outlet Stenosis: A Single Centre Randomized Controlled Study

Objectives: To evaluate target lesion primary patency and access circuit primary patency between drug-coated balloon (DCB) and percutaneous old balloon angioplasty (POBA) in stenotic arteriovenous graft (AVG) outlet.

Methods: A total of 60 patients with AVG outlet stenosis (mean age 68 years old, 28 men, 32 women) were enrolled in this randomised study, and randomly selected to be treated with either paclitaxel-coated balloon angioplasty (n=30) or POBA (n=30), from March 2016 to September 2018. DCB used was Medtronic® In.Pact Admiral DCB. Primary outcomes were lesion primary patency at 6 months, 9 months, 12 months, 18 months and 24 months, and access circuit primary patency at 6 months, device success (defined as < 30% residual stenosis post-angioplasty), and clinical success (defined as at least one successful dialysis session post-angioplasty). Secondary outcomes were access circuit primary patency at 12 months and minor and major procedural-related complications.
Statistical analysis was performed by using the Kaplan-Meier product limit estimator, and hazard ratio was calculated by using Cox proportional hazards regression.

Results: 6-month target lesion primary patency in DCB- and POBA-treated patients was 76% and 45% respectively (p= 0.018). Target lesion primary patency in DCB and POBA arm was 59% and 38%, respectively at 9 months (p=0.115), and 55% and 28% respectively at 12 months (p=0.033). Circuit primary patency in DCB- and POBA-treated patients was 72% and 48% respectively at 6 months (p= 0.060), and 38% and 21% respectively at 12 months (p= 0.149). Device and clinical success were 100% in both arms. There was no complication in both treatment arm.

Conclusions: DCB is effective in preventing recurrent AVG venous anastomosis stenosis at 6 months and 12 months compared to POBA.