ELUDIA drug-eluting stent trial proffers “promising” results

Konstantinos Katsanos

Drug-eluting stents have been examined in a variety of recent studies for the treatment of arteriovenous fistula (AVF) stenosis and failure, from 2018 research by Scott Trerotola (University of Pennsylvania, Philadelphia, USA) and colleagues to that of Narayan Karunanithy (Guy’s and St Thomas’ NHS Trust, London, UK) et al in 2021. Now, findings from the ELUDIA study into the efficacy of ELUVIA polymer-coated low-dose paclitaxel-eluting stents for stenosis treatment have been published in the Journal of Vascular Access (JVA), with its authors describing them as “promising long-term results”.

The study, led by Konstantinos Katsanos (University of Patras, Patras, Greece) enrolled 23 patients across three tertiary hospitals in Greece and Singapore. The researchers designated a primary outcome of long-term patency of the treated lesions and fistula circuits as “successful stent placement with resumption of uninterrupted haemodialysis and without significant vascular restenosis (50% diameter stenosis threshold) or other secondary interventions during follow-up”. Failure of the AVF was defined according to the criteria of the Kidney Outcomes Quality Initiative (KDOQI) guideline.

A total of 23 patients received the stent, with the majority (12) having a brachiocephalic AVF, eight a radiocephalic, and three a transposed brachiobasilic native AVF. The mean age of the AVFs at the time of failure was 33.9±20.4 months, while the treated lesions varied in location: 12 of the included stenoses were in the juxta-anastomotic segment, nine in the outflow veins, and two were cephalic arch lesions, with a mean diameter stenosis of 86±8%.

The median follow-up period was 20 months. Katsanos et al observed during that period that 18 out of the 23 stents remained patent, indicating a cumulative patency rate of 78.3%. Further Kaplan-Meier analysis revealed that the estimated primary patency of the ELUVIA stents was 80.6% at two years. The corresponding fistula circuit demonstrated a primary patency rate of 65.1%.

Katsanos and colleagues conclude that these results are “promising”—but that this is only an observational study. Randomised controlled trials on a much larger scale are required, they say, to more fully examine these stents’ use for access stenosis.


Please enter your comment!
Please enter your name here