Multicentre, randomised, blinded, control trial of drug-eluting balloon vs Sham in recurrent native dialysis fistula stenoses.

Abstract

BACKGROUND:

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.

METHODS:

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).

RESULTS:

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 ± 0.03 mm/month for Sham and 0.045 ± 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).

CONCLUSION:

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.

• Authors: Jan John Swinnen, Kerry Hitos, Lukas Kairaitis, Simon Gruenewald, George Larcos, David Farlow, David Huber, Gabriel Cassorla, Christopher Leo, Laurencia M Villalba, Richard Allen, Farshid Niknam, David Burgess
• Journal: The journal of vascular access (J Vasc Access) Vol. 20 Issue 3 Pg. 260-269 (May 2019) ISSN: 1724-6032 [Electronic] United States
• PMID: 30227772 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Cardiovascular Agents
• Coated Materials, Biocompatible
• Paclitaxel

Topics

• Aged
• Angioplasty, Balloon (adverse effects, instrumentation)
• Arteriovenous Shunt, Surgical (adverse effects)
• Cardiovascular Agents (administration & dosage)
• Coated Materials, Biocompatible
• Equipment Design
• Female
• Graft Occlusion, Vascular (diagnostic imaging, etiology, physiopathology, therapy)
• Humans
• Male
• Middle Aged
• New South Wales
• Paclitaxel (administration & dosage)
• Recurrence
• Renal Dialysis
• Time Factors
• Treatment Outcome
• Ultrasonography, Interventional
• Vascular Access Devices
• Vascular Patency