Randomized clinical trial of cutting balloon angioplasty versus high-pressure balloon angioplasty in hemodialysis arteriovenous fistula stenoses resistant to conventional balloon angioplasty.
J Vasc Interv Radiol
; 25(2): 190-8, 2014 Feb.
Article
in En
| MEDLINE
| ID: mdl-24315548
ABSTRACT
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 ANDMETHODS:
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.Key words
Full text:
1
Database:
MEDLINE
Main subject:
Arteriovenous Shunt, Surgical
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Renal Dialysis
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Angioplasty, Balloon
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Blood Vessel Prosthesis Implantation
/
Graft Occlusion, Vascular
Type of study:
Clinical_trials
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Diagnostic_studies
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Etiology_studies
/
Observational_studies
Limits:
Adolescent
/
Adult
/
Aged
/
Child
/
Child, preschool
/
Female
/
Humans
/
Male
/
Middle aged
Country/Region as subject:
Asia
Language:
En
Journal:
J Vasc Interv Radiol
Journal subject:
ANGIOLOGIA
/
RADIOLOGIA
Year:
2014
Type:
Article
Affiliation country:
Singapore