Randomized Controlled Trial for Paclitaxel Coated Balloon Versus Plain Balloon Angioplasty in Dysfunctional Haemodialysis Vascular Access: 12-month outcome from a non-sponsored trial

Abstract Background Plain balloon angioplasty is regarded as the mainstay of treatment for failing vascular access with high success rate but the poor treatment durability creates significant workload and increases patient morbidity. The study aims to compare target lesion primary patency rate at 12-months between paclitaxel-coated balloon (DCB) versus plain balloon angioplasty (POBA) for treatment of dysfunctional vascular access. Methods This non-sponsored randomised trial enrolled 40 patients with dysfunctional dialysis access at a single centre. Patients were randomized into In.Pact Admiral Paclitaxel DCB or POBA after lesion crossing regardless of lesion type. Patients are followed-up under surveillance protocol. Patients, haemodialysis staff and sonographer are blinded to the treatment arms. Twelve-month primary patency rate in both arms are evaluated. Results 40 patients were recruited since June 2016 and were allocated to DCB or POBA group. The mean age is 58 and 57 with comparable demographic parameters. The locations of target lesion were comparable in both groups (juxta and arteriovenous anastomosis, cannulation site, fistula / graft), with similar mean target lesion stenosis 69.8+/- 15.8% for DCB and 69.5+/- 13.6% for POBA (p=0.95) and the lesion length for DCB is 45.8 +/- 38.4mm and 50.2 +/- 33.5 mm for POBA (p=0.70). Patients in DCB performed significantly better in terms of primary patency at 6-months 85% versus 55% (p= 0.007). The superiority in primary patency in DCB group exists at 12-months 65% versus 30% (p=0.007). Conclusion Paclitaxel balloon angioplasty approach provides significant better primary patency in dysfunctional arteriovenous access at 12 months in our non-sponsored randomized trial.