Drug-Eluting Balloon Angioplasty for the Treatment of Hemodialysis Vascular Access Stenosis (DEBAVAS) (B3AV)

Drug-Eluting Balloon Angioplasty for the Treatment of Hemodialysis Vascular Access Stenosis (DEBAVAS)

Superiority of Drug-eluting Balloon Angioplasty Versus Plain Balloon Angioplasty for the Treatment of Hemodialysis Vascular Access Stenosis : a Multicentre, Randomized, Controlled Trial

Paclitaxel is an antiproliferative drug that can limit vascular intimal hyperplasia. Paclitaxel-coated balloons already have indications in the treatment of peripheral arterial disease. This randomized controlled trial is designed to prove the superiority of a drug-eluting balloon catheter (Paclitaxel-coated balloon) over a plain balloon catheter in the treatment of stenosed autogeneous and prosthetic vascular accesses, in hemodialysis patients. The hypothesis is that use of drug-eluting balloon will improve post-interventional patency of the access, and therefore, limit numbers and days of hospitalization for maintenance of hemodialysis vascular accesses.

Introduction: Half of patients with hemodialysis vascular access will present at least one episode of dysfunction within 1 year after creation, mainly due to intimal hyperplasia and stenosis. Paclitaxel is an antiproliferative drug that can limit intimal hyperplasia in vessels. Paclitaxel-coated balloons already have indications in the treatment of peripheral arterial disease. Main objective: To show that the use of Paclitaxel-coated balloons to treat stenosis of vascular accesses will improve post-interventional patency and reduce numbers and days of hospitalization for access maintenance in hemodialysis vascular access. Hypothesis: Paclitaxel-coated balloon angioplasty (PTX) prolongs primary patency of the access after treatment of vascular access stenosis compared to plain balloon angioplasty (PBA)(standard treatment). Methodology: We designed a prospective, single-blinded, multicenter, randomized, controlled trial, which aim to enroll 120 patients. Patients diagnosed with a stenosis on their dysfunctional vascular access line (brachial-cephalic autogeneous fistula or brachial-axillary prosthetic graft) will be randomized to either arm of the study after completion of a successful pre-dilation with a standard plain balloon catheter. Randomization will be stratified according to type of access (brachial-cephalic autogeneous fistula or brachial-axillary prosthetic graft). Primary outcome measure will be primary patency of the vascular access at 12 months after treatment. Secondary outcome measures will be primary patency at 6 months, assisted-primary and secondary patencies at 6 and 12 months, number of re-interventions and number of days of hospitalization for re-intervention at 12 months. Clinical significance: By prolonging the vascular access lifespan, Paclitaxel-coated balloon angioplasty can limit morbidity and cost of vascular access maintenance for hemodialysis patients.

Patient receiving endovascular treatment of a vascular access stenosis by plain balloon angioplasty (mechanical action, without drug) 2-minutes inflation of the plain balloon on pre-dilated stenosis segment, at nominal pressure

(PacliTaXel-coated balloon angioplasty) Patient receiving endovascular treatment of a vascular access stenosis by drug-eluting balloon angioplasty (mechanical action + antiproliferative drug - Paclitaxel) 2-minutes inflation of the drug-eluting balloon on pre-dilated stenosis segment, at nominal pressure

Primary patency of the vascular access after endovascular angioplasty of a stenosis with drug-eluting balloon compared with treatment with plain-balloon

Inclusion Criteria: Patient must be 18 years of age or older at the time of signing and dating informed consent (no upper age limit), can be male or female. Patient must have a vascular access for hemodialysis (type: brachial-cephalic autogeneous fistula or brachial-axillary prosthetic graft) Patient must have a dysfunction of its vascular access, defined by : dialysis sessions last >4 hours and/or access flow < 400ml/min for fistulae and <600ml for grafts, or 20% decrease in access flow as monitored during dialysis or by Duplex ultrasound scan, and/or dialysis recirculation and/or thrill not perceived and/or pulsatile vascular access and/or bleeding or increased bleeding time after puncture A stenosis >50% of the venous line must be diagnosed on the initial fistulogram A successful plain balloon angioplasty of the stenosis, defined by residual stenosis <30% on control angiogram, without dissection or indication for use of stent or additional surgical procedure, must be completed before inclusion. Exclusion Criteria: Pregnant or nursing woman, or plans to become pregnant during the study. Patient has hyperkalemia >6,5 mmol/L with EKG modifications or acute cardiac insufficiency at the time of inclusion Vascular access has in-stent restenosis Initial fistulogram shows no stenosis Initial fistulogram shows indication for open surgical intervention Control fistulogram (after plain balloon angioplasty) shows indication for stenting or open surgical intervention