%0 Journal Article
%T Multicentre, randomised, blinded, control trial of drug
%A Christopher Leo
%A David Burgess
%A David Farlow
%A David Huber
%A Farshid Niknam
%A Gabriel Cassorla
%A George Larcos
%A Jan ¡°John¡± Swinnen
%A Kerry Hitos
%A Laurencia M Villalba
%A Lukas Kairaitis
%A Richard Allen
%A Simon Gruenewald
%J The Journal of Vascular Access
%@ 1724-6032
%D 2019
%R 10.1177/1129729818801556
%X Endovascular treatment of autogenous arteriovenous haemodialysis fistula stenosis has high reintervention rates. We investigate the effect of drug-eluting balloons in the treatment of recurrent haemodialysis fistula stenosis. This is a randomised, controlled, investigator-initiated and run, prospective, blinded, multicentre trial. Patients with recurrent autogenous arteriovenous haemodialysis fistula stenosis received standard endovascular treatment plus drug-eluting balloon or standard endovascular treatment plus uncoated balloon (Sham). Primary endpoint was late lumen loss in trial area on ultrasound at 6 weeks, 3, 6 and 12£¿months. Secondary endpoints were freedom from reintervention to the Index Trial Area and decline in fistula flow (Qa). Interim analysis was performed at 6£¿months (unblinded due to timeliness). Patients with 132 recurrent stenoses (48% in bare Nitinol stents) were randomised with 70 receiving drug-eluting balloon and 62 Sham. At 6£¿months, decline in late lumen loss was 0.23£¿¡À£¿0.03£¿mm/month for Sham and 0.045£¿¡À£¿0.03£¿mm/month for drug-eluting balloon arm, a significant difference (0.18£¿mm, p£¿=£¿0.0002). At 12£¿months, this difference persisted at 0.12£¿mm (p£¿=£¿0.0003). At 6£¿months, significant difference in late lumen loss for instent restenoses (p£¿=£¿0.0004) was observed, with non-significant difference for unstented restenoses (p£¿=£¿0.065). Mean time for freedom from reintervention was 10.14£¿months for Sham versus 42.39£¿months for drug-eluting balloon (p£¿=£¿0.001). The same was shown for instent (p£¿=£¿0.014) and unstented (p£¿=£¿0.029) restenoses. Qa decline rate at 6£¿months was 36.89£¿mL/min/month (Sham) and 0.41£¿mL/min (drug-eluting balloon). The difference was significant (36.48£¿mL/min; p£¿=£¿0.02) and persisted to 12£¿months (p£¿=£¿0.44). Paclitaxel drug-eluting balloon significantly delays restenosis after angioplasty for recurrent autogenous arteriovenous haemodialysis fistula stenosis, persisting to 12£¿months. Drug-eluting balloon significantly increases freedom from reintervention at 12£¿months with these effects true in stented and unstented fistulas
%K Haemodialysis
%K fistula
%K stenosis
%K paclitaxel
%K drug-eluting balloon
%K angioplasty
%U https://journals.sagepub.com/doi/full/10.1177/1129729818801556