Purpose: To compare the effectiveness and safety of use of the peripheral cutting balloon (PCB) versus standard percutaneous transluminal angioplasty (PTA) for the treatment of hemodialysis-related stenoses.
Materials and methods: This prospective, randomized multicenter clinical trial included 340 patients with stenotic or thrombosed hemodialysis grafts who were randomized to receive treatment with the PCB or PTA for venous outflow stenosis. One hundred seventy-three patients underwent treatment with the PCB, 101 with stenotic grafts and 72 with thrombosed grafts. PTA was used to treat 167 patients, 94 patients with stenotic grafts and 73 with thrombosed grafts. The follow-up period extended for 6 months.
Results: The procedural success rates were 80.8% and 75.4% for the PCB and PTA groups, respectively (P = .24). With use of the PCB, the primary patency rates of the target lesions were 84.3%, 65.8%, and 47.9% at 1 month, 3 months, and 6 months, respectively. With PTA, the primary patency rates of the target lesions were 77.7%, 63.4%, and 40.5% at 1 month, 3 months, and 6 months, respectively. The primary patency rates of the entire vascular access circuit were 82.6%, 61.0%, and 43.3% at 1 month, 3 months, and 6 months, respectively, with use of the PCB. For patients who were treated with PTA, the primary patency rates of the vascular access circuit were 75.9%, 61.0%, and 36.3% at 1 month, 3 months, and 6 months, respectively. When comparing the PCB and PTA, there was no difference in the 6-month primary patency rates in the target lesion (P = .373) or the entire vascular access circuit (P = .531). There were nine device-related complications in the PCB group (5.2%): five venous ruptures (2.9%), three venous dissections (1.7%), and one case of thrombosis (0.6%). There were no device-related complications in the PTA group.
Conclusion: This prospective, randomized trial comparing use of the PCB versus standard PTA for treatment of hemodialysis-related venous stenoses demonstrated that the PCB provides equivalent 6-month patency to PTA for stenotic and thrombosed grafts.