A Randomised Trial of Paclitaxel Coated Balloons for Arteriovenous Fistula Stenosis with Blinded Re-intervention Criteria
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Raphaël Coscas1, Lamiae Grimaldi2, Lucie Mercier3
1Department of Vascular Surgery, Ambroise Paré University Hospital, Assistance Publique-Hôpitaux de Paris, Boulogne-Billancourt, France; Department of Vascular Surgery, American Hospital of Paris, Neuilly-sur-Seine, France; UMR 1018, Inserm-Paris11 - CESP, Versailles Saint-Quentin-en-Yvelines University, Paris-Saclay University, Paul Brousse Hospital, Villejuif, France.
Objective:
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) for the treatment of arteriovenous fistula stenosis.
Methods:
One hundred and fifty patients with an arteriovenous fistula stenosis were included, and 145 were randomised 1:1 in the Angioplastie au Ballon Imprégné de paclitaxel vs. angioplastie Standard pour le traitement des Sténoses sur fistule artérioveineuse trial; ClinicalTrials.gov identifier: NCT02753998 (ABISS) 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.
Results:
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 = .090; 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).
Conclusion:
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.
