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document
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 randomized to receive CBA or HPBA if conventional PTA had suboptimal results ( ie , residual stenosis > 30 % ) . A total of 516 patients consented to participate in 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 % and 39.9 % for CBA and HPBA , respectively ( P = .01 ) . Secondary target lesion patency rates at 6 months were 96.5 % for CBA 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 CBA 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 .
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Intervention_Surgical
cutting balloon angioplasty
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Intervention_Surgical
high-pressure balloon angioplasty
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Intervention_Surgical
cutting balloon angioplasty ( CBA ) versus high-pressure balloon angioplasty ( HPBA )
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Intervention_Surgical
CBA
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Intervention_Surgical
HPBA
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Intervention_Physical
CBA
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Intervention_Physical
CBA
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Intervention_Physical
HPBA
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Intervention_Physical
CBA
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Intervention_Physical
HPBA
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Intervention_Physical
CBA
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Intervention_Physical
HPBA
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Intervention_Physical
CBA
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Intervention_Physical
HPBA
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Intervention_Physical
CBA
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Outcome_Other
efficacy and safety
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Outcome_Other
Clinical success rates
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Outcome_Physical
Primary target lesion patency rates
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Outcome_Physical
Secondary target lesion patency rates
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Outcome_Adverse-effects
major complication
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Outcome_Adverse-effects
venous perforation
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Outcome_Mortality
30-day mortality rate
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Participant_Condition
hemodialysis arteriovenous fistula stenoses resistant to conventional balloon angioplasty .
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Participant_Condition
hemodialysis autogenous fistula stenoses resistant to conventional percutaneous transluminal angioplasty ( PTA )
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Participant_Condition
dysfunctional , stenotic hemodialysis arteriovenous fistulas ( AVFs )
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Participant_Sample-size
516
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Participant_Sample-size
439
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Participant_Sample-size
71
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Participant_Age
mean age , 60 y
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Participant_Sample-size
49