Comparative Efficacy and Safety of Drug-Coated Balloon Angioplasty versus Conventional Balloon Angioplasty for Arteriovenous Access Stenosis in Hemodialysis Patients

Objective: To compare the safety and efficacy of drug-coated balloon angioplasty (DCBA) versus conventional balloon angioplasty (CBA) in the treatment of autologous arteriovenous fistula (AVF) stenosis in hemodialysis (HD) patients. Methods: A prospective observational cohort study was conducted on 189 hemodialysis (HD) patients aged 18– 80 years with arteriovenous fistula (AVF) stenosis admitted to Nanjing Drum Tower Hospital Group Suqian Hospital from June 2022 to December 2024. The cohort included 107 male (56.6%) and 82 female (43.4%) patients. Patients were stratified into the conventional balloon angioplasty (CBA) group (n = 92) and the drug-coated balloon angioplasty (DCBA) group (n = 97) based on the intervention received. All patients underwent ultrasound-guided percutaneous transluminal angioplasty (PTA), with the DCBA group receiving additional paclitaxel-coated balloon dilation after conventional pre-dilatation. The primary endpoint was 6-month target lesion primary patency (TLPP); secondary outcomes included 3-month TLPP, stenotic segment diameter, HD blood flow, AVF blood flow (AVFB), serum levels of vascular endothelial growth factor-A (VEGF-A), angiotensin II (Ang II), monocyte chemoattractant protein-1 (MCP-1), and complication rates. Results: Baseline characteristics were comparable between the two groups (all P > 0.05). Clinical success rates were 100.00% in both groups. 1-month ( P =0.571) and 3-month ( P =0.350) TLPP showed no significant differences, but the DCBA group had a significantly higher 6-month TLPP (91.75% vs 80.43%, P =0.022). At 1 and 6 months postoperatively, the DCBA group exhibited larger stenotic segment diameter, higher HD blood flow, and higher AVFB than the CBA group (all P 0.05) between the two groups. Conclusion: Our study suggests that DCBA is superior to CBA in treating AVF stenosis, as it improves long-term hemodynamic parameters, suppresses inflammatory factor levels, and enhances 6-month TLPP while maintaining equivalent safety. It may be a preferred intervention for AVF stenosis in HD patients. Keywords: autologous arteriovenous fistula, stenosis, hemodialysis, drug-coated balloon angioplasty, conventional balloon angioplasty, primary patency