Prospective, randomized study of cutting balloon angioplasty versus conventional balloon angioplasty for the treatment of hemodialysis access stenoses.

OBJECTIVE: The aim of this trial was to compare the rates of patency achieved by cutting and conventional balloon angioplasty to treat hemodialysis access stenoses.

METHODS: End-stage renal failure patients (at three tertiary referral centers) with significant hemodialysis access stenoses were prospectively randomized to have percutaneous transluminal angioplasty (PTA) by either cutting or conventional balloons. Patients with more than one hemodynamically significant stenosis were excluded. Kaplan-Meier method was used to compare the primary assisted patency rates for the two groups.

RESULTS: The study randomized 623 patients into two groups, and the duration of follow-up was 15 ± 3 months. In the cutting balloon angioplasty group, the clinical success rate was 89% (282 of 316 stenoses). In the conventional balloon angioplasty group, the clinical success rate was 86% (265 of 307 stenoses; P = .637). Assisted primary patency for cutting PTA was statistically significantly higher at 6 months and 1 year (86% and 63%) than that for conventional PTA (56% and 37%, respectively; P = .037) in the treatment of stenosis of the graft-to-vein anastomosis. In the venous stenosis subgroup, equivalent primary assisted patency at 6 months and 1 year was observed for cutting PTA (84% and 55%) and conventional PTA (70% and 46%, respectively; P = .360). In the intragraft stenosis subgroup, primary assisted patency was equivalent at 6 months and 1 year for cutting PTA (67% and 39%) and conventional PTA (62% and 49%, respectively; P = .371). In the arterial anastomotic stenosis subgroup, assisted primary patency at 6 months and 1 year was equivalent for cutting PTA (70% and 30%) and conventional PTA (75% and 33%, respectively; P = .921).

CONCLUSIONS: Cutting balloon angioplasty proved to be a safe and effective treatment of graft-to-vein anastomotic stenosis, with significantly higher patency than that of conventional balloon angioplasty.