Sage Journals: Discover world-class research

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.

Keywords

Haemodialysis fistula stenosis paclitaxel drug-eluting balloon angioplasty

Get full access to this article

View all access options for this article.

References

Besarab

Resolved: fistulas are preferred to grafts as initial vascular access for dialysis. Pro J Am Soc Nephrol 2008; 19(9): 1629–1631.

Vassalotti

Jennings

Beathard

et al . Fistula first breakthrough initiative: targeting catheter last in fistula first. Semin Dial 2012; 25(3): 303–310.

Rajan

Bunston

Misra

et al . Dysfunctional autogenous hemodialysis fistulas: outcomes after angioplasty – are there clinical predictors of patency? Radiology 2004; 232(2): 508–515.

Beathard

Arnold

Jackson

et al . Aggressive treatment of early fistula failure. Kidney Int 2003; 64(4): 1487–1494.

Clark

Hirsch

Jindal

et al . Outcome and prognostic factors of restenosis after percutaneous treatment of native hemodialysis fistulas. J Vasc Interv Radiol 2002; 13(1): 51–59.

Bountouris

Kritikou

Degermetzoglou

et al . A review of percutaneous transluminal angioplasty in hemodialysis fistula. Int J Vasc Med 2018; 2018: 1420136.

Swinnen

Zahid

Burgess

DC.

Paclitaxel drug-eluting balloons to recurrent in-stent stenoses in autogenous dialysis fistulas: a retrospective study. J Vasc Access 2015; 16(5): 388–393.

Mauri

Orav

Candia

et al . Robustness of late lumen loss in discriminating drug-eluting stents across variable observational and randomized trials. Circulation 2005; 112(18): 2833–2839.

Fahrtash

Kairaitis

Gruenewald

et al . Defining a significant stenosis in an autologous radio-cephalic arteriovenous fistula for hemodialysis. Semin Dial 2011; 24(2): 231–238.

10.

Swinnen

Lean Tan

Allen

et al . Juxta-anastomotic stenting with aggressive angioplasty will salvage the native radiocephalic fistula for dialysis. J Vasc Surg 2015; 61(2): 436–442.

11.

Angiolillo

Sabata

Alfonso

et al . ‘Candy wrapper’ effect after drug-eluting stent implantation: deja vu or stumbling over the same stone again? Catheter Cardiovasc Interv 2004; 61(3): 387–391.

12.

Neuen

Gunnarsson

Webster

et al . Predictors of patency after balloon angioplasty in hemodialysis fistulas: a systematic review. J Vasc Interv Radiol 2014; 25(6): 917–924.

13.

Rajan

Sidhu

Noel-Lamy

et al . Elastic recoil after balloon angioplasty in hemodialysis accesses: does it actually occur and is it clinically relevant? Radiology 2016; 279(3): 961–967.

14.

Patane

Giuffrida

Morale

et al . Drug-eluting balloon for the treatment of failing hemodialytic radiocephalic arteriovenous fistulas: our experience in the treatment of juxta-anastomotic stenoses. J Vasc Access 2014; 15(5): 338–343.

15.

Kitrou

Spiliopoulos

Katsanos

et al . Paclitaxel-coated versus plain balloon angioplasty for dysfunctional arteriovenous fistulae: one-year results of a prospective randomized controlled trial. J Vasc Interv Radiol 2015; 26(3): 348–354.

16.

Cildag

Koseoglu

Akdam

et al . The primary patency of drug-eluting balloon versus conventional balloon angioplasty in hemodialysis patients with arteriovenous fistula stenoses. Jpn J Radiol 2016; 34(10): 700–704.

17.

Boitet

Massy

Goeau-Brissonniere

et al . Drug-coated balloon angioplasty for dialysis access fistula stenosis. Semin Vasc Surg 2016; 29(4): 178–185.

18.

Trerotola

. At the Society of Interventional Radiology (SIR) on the 17–22 March 2018, Los Angeles, CA, USA.

19.

Serruys

Luijten

Beatt

et al . Incidence of restenosis after successful coronary angioplasty: a time-related phenomenon. A quantitative angiographic study in 342 consecutive patients at 1, 2, 3, and 4 months. Circulation 1988; 77(2): 361–371.

20.

Thomas

Katib

et al . A comprehensive renal vascular access clinic results in improved patient outcomes and reduced costs. ANZ J Surg 2018; 88(3): 185–190.

Supplementary Material

Please find the following supplemental material available below.

For Open Access articles published under a Creative Commons License, all supplemental material carries the same license as the article it is associated with.

For non-Open Access articles published, all supplemental material carries a non-exclusive license, and permission requests for re-use of supplemental material or any part of supplemental material shall be sent directly to the copyright owner as specified in the copyright notice associated with the article.

0.00 MB

0.15 MB

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