PURPOSE: To evaluate the effectiveness of local delivery of heparin via hydrogel-coated balloons in the treatment of vascular stenoses associated with hemodialysis access. MATERIALS AND METHODS: This was a randomized, prospective trial comparing treatment with hydrogel-coated balloon catheters delivered with heparin coating (n = 33) and without (n = 26). All patients were undergoing hemodialysis, and all stenoses involved the venous anastomosis of a dialysis graft or a native vein. The heparin-treated balloons were soaked in concentrated heparin and delivered in a protected manner to help prevent washout of heparin. RESULTS: The mean primary patencies were 143 days with heparin treatment and 214 days without heparin (P = .174). The mean assisted primary patencies were 165 days with heparin and 194 days without (P = .315). The mean secondary patencies were 351 days with heparin and 384 without (P = .81). CONCLUSION: In this population with this technique, the treatment outcome of venous outflow stenosis in patients with dialysis grafts is not improved with local delivery of heparin.
RCT Entities:
PURPOSE: To evaluate the effectiveness of local delivery of heparin via hydrogel-coated balloons in the treatment of vascular stenoses associated with hemodialysis access. MATERIALS AND METHODS: This was a randomized, prospective trial comparing treatment with hydrogel-coated balloon catheters delivered with heparin coating (n = 33) and without (n = 26). All patients were undergoing hemodialysis, and all stenoses involved the venous anastomosis of a dialysis graft or a native vein. The heparin-treated balloons were soaked in concentrated heparin and delivered in a protected manner to help prevent washout of heparin. RESULTS: The mean primary patencies were 143 days with heparin treatment and 214 days without heparin (P = .174). The mean assisted primary patencies were 165 days with heparin and 194 days without (P = .315). The mean secondary patencies were 351 days with heparin and 384 without (P = .81). CONCLUSION: In this population with this technique, the treatment outcome of venous outflow stenosis in patients with dialysis grafts is not improved with local delivery of heparin.
Authors: Pietro Ravani; Robert R Quinn; Matthew J Oliver; Divya J Karsanji; Matthew T James; Jennifer M MacRae; Suetonia C Palmer; Giovanni F M Strippoli Journal: Cochrane Database Syst Rev Date: 2016-01-07