title: Randomized clinical trial of cutting balloon angioplasty versus high-pressure balloon angioplasty in hemodialysis arteriovenous fistula stenoses resistant to conventional balloon angioplasty.
abstract: OBJECTIVE
  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).
  
  
  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.
authors: Duke-National University of Singapore Graduate Medical School, Singapore.
authors: Syed Arafat
authors: SA
authors: Aftab
authors: Duke-National University of Singapore Graduate Medical School, Singapore; Department of Diagnostic Radiology, Singapore General Hospital, Singapore. Electronic address: tay.kiang.hiong@sgh.com.sg.
authors: Kiang Hiong
authors: KH
authors: Tay
authors: Department of Diagnostic Radiology, Singapore General Hospital, Singapore.
authors: Farah G
authors: FG
authors: Irani
authors: Department of Diagnostic Radiology, Singapore General Hospital, Singapore.
authors: Richard Hoau
authors: RH
authors: Gong Lo
authors: Department of Diagnostic Radiology, Singapore General Hospital, Singapore.
authors: Apoorva
authors: A
authors: Gogna
authors: Department of Medicine, Duke-National University of Singapore Graduate Medical School, Singapore.
authors: Benjamin
authors: B
authors: Haaland
authors: Duke-National University of Singapore Graduate Medical School, Singapore; Department of General Surgery, Singapore General Hospital, Singapore.
authors: Seck Guan
authors: SG
authors: Tan
authors: Department of General Surgery, Singapore General Hospital, Singapore.
authors: Siew Png
authors: SP
authors: Chng
authors: Department of General Surgery, Singapore General Hospital, Singapore.
authors: Shanker
authors: S
authors: Pasupathy
authors: Duke-National University of Singapore Graduate Medical School, Singapore; Department of Renal Medicine, Singapore General Hospital, Singapore.
authors: Hui Lin
authors: HL
authors: Choong
authors: Duke-National University of Singapore Graduate Medical School, Singapore; Department of Diagnostic Radiology, Singapore General Hospital, Singapore.
authors: Bien Soo
authors: BS
authors: Tan
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000800:Angioplasty, Balloon / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D001166:Arteriovenous Shunt, Surgical / Q000009:adverse effects* / Q000401:mortality; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects* / Q000401:mortality; D002648:Child; D002675:Child, Preschool; D003251:Constriction, Pathologic; D005260:Female; D006083:Graft Occlusion, Vascular / Q000175:diagnosis / Q000209:etiology / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D011312:Pressure; D011446:Prospective Studies; D012008:Recurrence; D006435:Renal Dialysis; D012846:Singapore; D013997:Time Factors; D016896:Treatment Outcome; D014654:Vascular Patency; D055815:Young Adult
keywords: AV; AVF; AVG; CB; CBA; CI; HPB; HPBA; HR; PTA; arteriovenous; arteriovenous fistula; arteriovenous graft; confidence interval; cutting balloon; cutting balloon angioplasty; hazard ratio; high-pressure balloon; high-pressure balloon angioplasty; percutaneous transluminal angioplasty