A Randomised Trial of Paclitaxel Coated Balloons in Arteriovenous Fistula Stenosis with Blinded Re-intervention Criteria.

Abstract

The aim of this French physician initiated, multicentre, prospective, randomised trial with blinded criteria for re-intervention was to evaluate the efficacy of paclitaxel coated balloons (DCBs) in the treatment of arteriovenous fistula stenosis. One hundred and fifty patients with an arteriovenous fistula stenosis were included, and 145 were randomised 1:1 in the ABISS trial (Angioplastie au Ballon Imprégné de paclitaxel vs. angioplastie Standard pour le traitement des Sténoses sur fistule artérioveineuse; ClinicalTrials.gov identifier: NCT02753998) between a DCB (Lutonix, BD, Franklin Lakes, NJ, USA) and a placebo balloon. The main outcome was the rate of primary patency loss at 6 months. The primary analysis was performed in the modified intention to treat population. Missing outcome data were handled using a conservative imputation approach. The per-protocol analysis excluded patients who were included by mistake, not treated according to the randomisation arm, lost to follow up, or who missed a visit. In the modified intention to treat analysis, there was no significant difference between the groups regarding primary patency loss at 6 months (31% [22 of 70] in the DCB group vs. 42% [30 of 71] in the placebo group; p = .09; hazard ratio = 0.62 [95% confidence interval {CI} 0.36 - 1.07]). Primary patency loss was lower in the DCB than in the placebo group at 3 months (4.2% vs. 22.5%; p = .002; hazard ratio = 0.18 [95% CI 0.05 - 0.60]), but not at 12 months (58.6% vs. 57.7%; p = .57; hazard ratio = 0.88 [95% CI 0.57 - 1.35]). In the per-protocol analysis, the primary patency loss was significantly lower in the DCB group than in the placebo group (26% [16 of 61] in the DCB group vs. 50% [28 of 56] in the placebo group; p = .004). In the ABISS trial, the use of a DCB was not superior to a placebo balloon at 6 months in the modified intention to treat analysis.