Fistula stenosis: Drug-eluting balloons delay restenosis
Autogenous arteriovenous hemodialysis fistula stenosis requires angioplasty – an intervention that unfortunately is associated with rather high reintervention rates, Australian researchers pose the question: Could drug-eluting balloons improve these rates of restenosis (Swinnen JJ et al, Multicentre, randomised, blinded, control trial of drug-eluting balloon vs Sham in recurrent native dialysis fistula stenoses J Vasc Access 2018; doi: 10.1177/1129729818801556)?
They answer that it can, as the results of the present study show.
The randomized controlled prospective trial included 132 patients with recurrent stenoses, who received standard endovascular treatment plus drug-eluting [paclitaxel] balloon (n=70) or standard endovascular treatment plus uncoated balloon (Sham, n = 62). Primary endpoint was late lumen loss in trial area on ultrasound at six weeks, and three, six and twelve months.
At six months, decline in late lumen loss was 0.23 mm/month for Sham vs. 0.045 mm/month for the drug-eluting balloon arm, a significant difference (p = 0.0002). At twelve months, the observed difference persisted at 0.12 mm (p = 0.0003). Also at six months, the authors observed a significant difference in late lumen loss for restenoses (p = 0.0004). Mean time for freedom from reintervention was significantly longer for patients with drug-eluting balloons: 42.39 months vs. 10.14 months for Sham (p = 0.001). Qa decline rate at six months was 36.89 mL/min/month (Sham) and 0.41 mL/min (drug-eluting balloon). Again, the difference was significant (36.48 mL/min; p = 0.02) and persisted to twelve months (p = 0.44).
Treating autogenous arteriovenous hemodialysis fistula stenosis with a paclitaxel-eluting balloon significantly delays restenosis and significantly increases freedom from reintervention at 12 months.