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Randomized Clinical Trial of Cutting Balloon Angioplasty versus High-Pressure Balloon Angioplasty in Hemodialysis Arteriovenous Fistula Stenoses Resistant to Conventional Balloon Angioplasty
Affiliation:1. Duke–National University of Singapore Graduate Medical School, Singapore;2. Department of Diagnostic Radiology, Singapore General Hospital, Singapore;3. Department of General Surgery, Singapore General Hospital, Singapore;4. Department of Renal Medicine, Singapore General Hospital, Singapore;5. Department of Medicine, Duke–National University of Singapore Graduate Medical School, Singapore;1. Division of Cardiology, Bucheon St. Mary''s Hospital, The Catholic University College of Medicine, Bucheon, South Korea;2. Division of Cardiology, Cardiovascular Research Institute, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea;3. Severance Biomedical Science Institute, Yonsei University College of Medicine, Seoul, South Korea;1. Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, Canada;2. Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Canada;3. Department of Medicine, University of Toronto, Toronto, Canada;4. Department of Medicine, University of Otago Christchurch, Christchurch, New Zealand;5. Cochrane Kidney and Transplant, Centre for Kidney Research, The Children’s Hospital at Westmead, Westmead, Australia;6. Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy;7. Diaverum Academy, Bari, Italy;8. Diaverum Medical Scientific Office, Lund, Sweden;9. Sydney School of Public Health, University of Sydney, Sydney, Australia;1. Cardiovascular Center, Kaohsiung Veterans General Hospital, #386 Ta-Chung First Road, Kaohsiung, Taiwan 813-62;2. Department of Nephrology, Kaohsiung Veterans General Hospital, #386 Ta-Chung First Road, Kaohsiung, Taiwan 813-62;3. Medical Education and Research, Kaohsiung Veterans General Hospital, #386 Ta-Chung First Road, Kaohsiung, Taiwan 813-62;4. Department of Internal Medicine, Kaohsiung Veterans General Hospital, #386 Ta-Chung First Road, Kaohsiung, Taiwan 813-62;5. Department of Biological Sciences, National Sun Yat-Sen University, Kaohsiung;6. School of Medicine, National Yang-Ming University, Taipei;7. College of Health and Nursing, Meiho University, Pingtung, Taiwan;1. Department of Medicine, Leonard M. Miller School of Medicine, University of Miami, Miami, FL;2. DeWitt Daughtry Family Department of Surgery, Leonard M. Miller School of Medicine, University of Miami, Miami, FL;3. Division of Nephrology, Leonard M. Miller School of Medicine, University of Miami, Miami, FL;4. Section of Interventional Nephrology, Leonard M. Miller School of Medicine, University of Miami, Miami, FL;1. Division of Vascular and Interventional Radiology, Department of Medical Imaging, University of Toronto, University Health Network, 585 University Ave., NCSB 1C- 553, Toronto, ON, Canada M5G 2N2;2. Fresenius Vascular Care, Berwyn, Pennsylvania;1. Interventional Radiology Department, Patras University Hospital, Patras, Achaia 26500, Greece.;2. Nephrology Department, Patras University Hospital, Patras, Achaia 26500, Greece.;3. Interventional Radiology Department, Guy’s and St. Thomas Hospitals National Health Service Foundation Trust, London, United Kingdom.
Abstract:PurposeTo 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 MethodsIn 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.ResultsClinical 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.ConclusionsPrimary 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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