Treatment with a sustained-release sirolimus-eluting balloon (SLR) for patients with failing arteriovenous fistulas (AVFs) was associated with higher target-lesion primary patency (TLPP) through to two-year follow-up, with a favourable safety profile to high-pressure plain balloon angioplasty alone.
These were the headline findings from the SAVE trial, presented at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) annual congress (5–9 September, Copenhagen, Denmark). The two-year analysis of the prospective, multicentre, single-blinded randomised controlled trial investigating the Selution SLR (Cordis) drug-eluting balloon (DEB) were presented by Konstantinos Katsanos (Patras University Hospital, Patras, Greece).
Highlighting baseline patient characteristics, Katsanos noted that diabetes mellitus, hypertension and hyperlipidaemia were prevalent across groups, comorbidities that are “well expected” of this patient population. He detailed that, between DEB and plain balloon angioplasty groups, AVF characteristics were equally spilt between brachiocephalic and radiocephalic stenoses.
Patients with clinically significant AVF stenosis were randomised to receive either high-pressure balloon angioplasty followed by treatment with the Selution SLR sirolimus-eluting balloon or high-pressure plain balloon angioplasty alone. Patients underwent scheduled follow-up with duplex ultrasound assessment of access volumetric blood flow, while clinical and safety outcomes were evaluated through two years. The primary endpoint was functional TLPP at six months.
At six months, functional TLPP was significantly higher in the Selution SLR group than in the plain balloon angioplasty group (78% vs. 58.5%; p=0.026), with the treatment benefit maintained through two years (p=0.023). Site-stratified Cox regression demonstrated an approximately two-fold higher risk of patency loss in the plain balloon angioplasty group compared with the SLR group at two years (hazard ratio [HR] 2.14, 95% confidence interval [CI]: 1.18–3.91; p=0.013).
Katsanos stated that access volumetric blood flow consistently favoured the Selution SLR group across all follow-up visits, with an adjusted geometric mean ratio of 1.18 versus plain balloon angioplasty (95% CI: 0.99–1.41; p=0.061) based on a longitudinal mixed-effects model. All-cause mortality was low and comparable between groups (7.1% vs. 9.5% at two years), with no device- or procedure-related serious adverse events reported in either treatment arm.
Summarising the final analysis of the SAVE trial, Katsanos closed his talk, stating: “This is the first prospective randomised controlled trial in dysfunctional AVF offering a complete set of independently core-lab adjudicated performance metrics including elective angiographic and functional [flow rate] assessment.”
