Drug Eluting Balloon (DEB) vs Plain Old Balloon Angioplasty (POBA) in the Treatment of Failing Dialysis Access
Status:
Completed
Trial end date:
2018-07-31
Target enrollment:
Participant gender:
Summary
Background Conventional percutaneous transluminal angioplasty is still considered standard
treatment for treatment of dysfunctional haemodialysis fistulas and grafts. The most
important drawback with this treatment is frequent restenosis leading to a high number of
secondary procedures. There is conflicting evidence in the literature regarding primary or
secondary treatment with drug eluting balloons (DEB). These balloons deliver Paclitaxel
locally, which acts as an antiproliferative drug and may improve treatment outcomes.
Methods This study was conducted as a prospective 1:1 randomized single centre clinical
trial. Participants had primary or re-stenotic lesions in native upper extremity
arteriovenous fistulas or at the graft-venous anastomosis. Patients were randomized to direct
primary dilatation, with either a standard balloon or a DEB. The primary effectiveness
endpoints were freedom from target lesion revascularization (TLR), access circuit
revascularization or thrombosis, functional status of access circuit at 12 months. Secondary
endpoints were procedural complications, procedural success, follow up survival and time to
target lesion revascularization.