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


METHODS
Forty-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.


RESULTS
Technical 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).


CONCLUSIONS
Compared with high-pressure balloon angioplasty, cutting balloon angioplasty does not improve postinterventional primary patency of de novo stenotic lesions in autogenous arteriovenous fistulae.
Department of Radiology, 501 Smyth Rd., Ottawa, ON, Canada K1H 8L6. Electronic address: prasuli@rogers.com.
Pasteur
P
Rasuli
Department of Radiology, 501 Smyth Rd., Ottawa, ON, Canada K1H 8L6.
Vikash S
VS
Chennur
Department of Radiology, 501 Smyth Rd., Ottawa, ON, Canada K1H 8L6.
Michael J
MJ
Connolly
Department of Radiology, 501 Smyth Rd., Ottawa, ON, Canada K1H 8L6.
Adnan
A
Hadziomerovic
Department of Radiology, 501 Smyth Rd., Ottawa, ON, Canada K1H 8L6.
Francois E
FE
Pomerleau
Department of Radiology, 501 Smyth Rd., Ottawa, ON, Canada K1H 8L6.
Stephen E
SE
Ryan
Department of Nephrology, 501 Smyth Rd., Ottawa, ON, Canada K1H 8L6.
Gordon J
GJ
French
Department of Radiology, 501 Smyth Rd., Ottawa, ON, Canada K1H 8L6.
Kevin
K
O'Kelly
Department of Radiology, 501 Smyth Rd., Ottawa, ON, Canada K1H 8L6.
Rima
R
Aina
Department of Radiology, 501 Smyth Rd., Ottawa, ON, Canada K1H 8L6.
Paula
P
Champagne
Ottawa Hospital Research Institute Method Centre, The Ottawa Hospital, University of Ottawa, 501 Smyth Rd., Ottawa, ON, Canada K1H 8L6.
William
W
Petrcich
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000800:Angioplasty, Balloon / Q000379:methods*; D001166:Arteriovenous Shunt, Surgical / Q000009:adverse effects*; D005260:Female; D006085:Graft Survival; D006801:Humans; D008297:Male; D008875:Middle Aged; D006435:Renal Dialysis / Q000009:adverse effects*; D016037:Single-Blind Method; D016896:Treatment Outcome; D020246:Venous Thrombosis / Q000175:diagnosis / Q000209:etiology* / Q000601:surgery*; D055815:Young Adult