A randomized controlled trial of cutting balloons versus conventional angioplasty in arteriovenous fistula stenosis

Introduction: Arteriovenous fistulas (AVFs) are the preferred vascular access for hemodialysis but frequently develop stenosis, requiring repeated endovascular interventions. Cutting balloon angioplasty (CBA) is a potential alternative to conventional percutaneous transluminal angioplasty (cPTA), though supporting evidence remains limited. Methods: Single-center randomized controlled trial comparing CBA and cPTA for AVF stenosis. Outcomes included primary and secondary patency at 6 and 12 months, radiological success, and complications. Results: Among 190 patients randomized (CBA: n = 89; cPTA: n = 101), primary patency at 6 and 12 months showed no significant difference (CBA: 78.6%, 56.1%; cPTA: 72.2%, 51.8%; p = 0.53 and p = 0.65). Secondary patency at 12 months was higher in the CBA group (93.9% vs. 78.2%; p = 0.02), with a lower risk of loss by Cox regression (HR = 0.36; 95% CI: 0.14–0.91; p = 0.031). Radiological success favored CBA (84.7% vs. 76.1%; p = 0.025). Access loss due to thrombosis was significantly lower in the CBA group (2.3% vs. 11.1%; p = 0.022), though overall thrombosis rates did not differ. The leading cause of non-salvageability in both groups was an unsatisfactory outcome in the preceding angioplasty (CBA: 2/4; cPTA: 6/11). No significant differences in patency outcomes were observed in subgroup analysis by access type, stenosis location, and excluding patients with prior interventions. Minor complications occurred in 10.3% of procedures, with no major events reported. Conclusion: CBA and cPTA showed similar primary patency, but CBA led to better secondary patency and radiological success. The survival advantage may be associated with better radiological results, leading to fewer resistant stenoses and unsalvageable thrombosis cases. Further prospective trials are warranted to define role of cutting balloons in different clinical scenarios, especially in recurrent or resistant stenoses.