Randomized Clinical Trial of Cutting Balloon Angioplasty versus High-Pressure Balloon Angioplasty in Hemodialysis Arteriovenous Fistula Stenoses Resistant to Conventional Balloon Angioplasty

Purpose: To compare the efficacy and safety of cutting balloon angioplasty (CBA) versus high-pressure-balloon angioplasty (HPBA) for the treatment of hemodialysis autogenous fistula stenoses resistant to conventional percutaneous transluminal angioplasty (PTA). Materials and Methods : In a prospective randomized clinical trial involving patients With dysfunctional stenotic hemodialysis arteriovenous fistulas (AVFs), patients were random-lied to receive CBA or HPBA if conventional PTA had suboptimal results (ie, residual stenosis > 30%). A total of 516 patients consented to participate-ill the study from October 2008 to September 2011, 85% of whom (n = 439) had technically successful conventional PTA The remaining 71, patients (mean age, 60 y; 49 men) With suboptimal PTA results Were eventually randomized 36 to the CBA arm and 35 to the HPBA arm. Primary and secondary target lesion, patencies were determined by Kaplan-Meier analysis. Results: Clinical success rates were 100% in both arms. Primary target lesion patency rates at 6 months were 66.4% rand 39.9% for CA and HPBA, respectively (P = .01). Secondary target lesion patency rates at 6 months were 96.5% for (BA and 80.0% for HPBA (P = .03). There was a single major complication of venous perforation following CBA. The 30,day mortality rate Was 1.4%, with one non procedure-related death in the HPBA group. Conclusions: Primary and secondary target lesion patency rates of CA were statistically superior to those of HPBA following suboptimal conventional PTA. For AVF stenoses resistant to conventional PTA, CBA may be,a better second-line treatment given its superior patency rates.