Randomized Trial Comparing the Primary Patency following Cutting Versus High-Pressure Balloon Angioplasty for Treatment of de Novo Venous Stenoses in Hemodialysis Arteriovenous Fistulae

Abstract

PurposeA single-center randomized clinical trial was performed to compare postinterventional primary patency rates achieved by cutting balloon angioplasty and high-pressure balloon angioplasty in the treatment of de novo stenoses within autogenous arteriovenous (AV) fistulae for hemodialysis. Materials and MethodsForty-eight patients undergoing their first angioplasty were prospectively randomized to undergo angioplasty with a cutting balloon or high-pressure balloon 4–8 mm in diameter because cutting balloons larger than 8 mm are not available. Nine patients were excluded after angiography, with seven requiring balloons larger than 8 mm. In the remaining 39 patients, there were 42 stenoses in the following regions: juxtaanastomotic (38%), perianstomotic (38%), midcephalic (9%), and cephalic arch (14%). Patients in the cutting balloon group were younger (mean age difference, 9 y; P = .04), but other demographic variables were comparable (range, P = .08–.89). The mean follow-up period was 8.5 mo (range, 24 d to 32 mo). Kaplan–Meier analysis was used to compare duration of patency. Mann–Whitney rank-sum t test and χ2/Fisher exact tests were used to compare continuous and categoric variables, respectively. ResultsTechnical success was achieved in all 39 patients. At 3, 6, and 12 months, the postinterventional primary patency rates for the cutting balloon group were 61.1% (95% confidence interval [CI], 35.75%–82.70%), 27.7% (95% CI, 9.69%–53.48%), and 11.1% (95% CI, 1.38%–34.71%), respectively, compared with 70.0% (95% CI, 45.72%–88.11%), 42.1% (95% CI, 20.25%–66.50%), and 26.3% (95% CI, 9.15%–51.20%), respectively, for the high-pressure balloon group (P < .3 at each interval). ConclusionsCompared with high-pressure balloon angioplasty, cutting balloon angioplasty does not improve postinterventional primary patency of de novo stenotic lesions in autogenous arteriovenous fistulae.