Abstract
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<0.001). Serum VEGF-A, AngII, and MCP-1 levels in the DCBA group were significantly lower than those in the CBA group at 1 and 6 months postoperatively (all P<0.001). There were no significant differences in total complication rates (17.53% vs 13.04%, P=0.350) or individual complication incidences (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.