A first report from the SAVE prospective, multicentre, single-blinded randomised controlled trial of the Selution Sustained Limus Release (SLR; Cordis) drug-eluting balloon (DEB) in patients with failing arteriovenous fistula (AVF) undergoing haemodialysis has demonstrated “significantly higher efficacy” compared with plain balloon angioplasty, with a higher target lesion primary patency (TLPP) at six-month follow-up.
Konstantinos Katsanos (Patras University Hospital, Rion, Greece) presented these data during the FIRST@CIRSE session at this year’s Cardiovascular and Interventional Radiological Society of Europe (CIRSE) annual congress (13–17 September, Barcelona, Spain).
A total of 84 patients were randomised to either standard high-pressure balloon angioplasty followed by local application of Selution SLR, or high-pressure balloon angioplasty with no further lesion treatment. The primary safety endpoint was defined as freedom from any serious adverse event involving the patient’s arteriovenous access at 30 days. The primary efficacy endpoint was TLPP, defined as freedom from clinically driven target lesion revascularisation (CD-TLR) or access-circuit thrombosis at six months.
Patients were enrolled across three sites in Greece and Singapore. Eligibility criteria included at least one previous successful dialysis access session, stenosis >50% at the outflow vein with clinical circuit dysfunction, and lesions ≤7mm in diameter and ≤80mm in length. Patients had an average age of 63.8 years in the DEB arm and 65 years in the plain balloon angioplasty arm. The number of pre-treatment devices used was 1.5±0.7 in the DEB group and 1.3±0.5 in the plain balloon angioplasty group.
Reporting results, Katsanos noted 100% device success in both groups. In the DEB arm, a 95.2% rate of clinical success was observed compared with 92.9% in the plain balloon angioplasty arm.
For the primary efficacy endpoint, a 78% TLPP rate was achieved in the Selution SLR group at six months, compared with 58.5% in the plain balloon angioplasty group (p=0.026), with an odds ratio (OR) of 3.1 (95% confidence interval [CI]: 1.1–8.9). Using Kaplan–Meier curves, Katsanos added that, at 180 days, an 82.5% TLPP rate was observed in the DEB arm compared with 67.5% in the plain balloon angioplasty group (p=0.036).
Freedom from serious adverse events at 30 days was 92.9% in the DEB arm and 100% in the plain balloon angioplasty arm (p=0.08). CD-TLR occurred in 17.1% of patients in the DEB arm compared with 31.7% in those treated with plain balloon angioplasty (p=0.03).
“Selution SLR showed significantly higher efficacy versus uncoated angioplasty at six-month follow-up,” Katsanos underlined. “This was also associated with improved angiographic follow-up but, most importantly, with improved physiological function, as reflected by the higher minimal lumen diameter and the significantly higher volume flow rate of the fistula at six months.” Volume flow rate was reported as 1,061.7ml/min with Selution SLR versus 823.7ml/min in the control group (p=0.03).
In the discussion, Katsanos was asked whether lesion preparation had any bearing on the results of the SAVE trial, to which he responded: “Yes—you first prepare the lesion by adequate balloon angioplasty and then deliver sirolimus with Selution SLR.”
“In all cases you must achieve the best angioplasty effect first and then decide whether to upgrade to the DCB. In this study, we performed high-pressure balloon angioplasty with balanced diameter sizing in both study arms, and then applied Selution SLR in the active intervention group,” he explained. “It is imperative to obtain a very good angioplasty effect to begin with.”
