A Randomised Trial of Paclitaxel Coated Balloons for Arteriovenous Fistula Stenosis with Blinded Re-intervention Criteria
Year: 2026
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: 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.
Authors: Raphaël Coscas, Lamiae Grimaldi, Lucie Mercier, Éric Picard, Angel Ferrario, Joseph Touma, Alexandros Mallios, Marc Sznajder, Lionelle Nkam, Ziad A. Massy, Isabelle Aichoun, Karim Belattar, Iannis Ben Abdallah, Yves Castier, Raphaël Coscas, Alessandro Costanzo, Costantino Del Giudice, Nawal Derridj, Elsa Faure, Khalil El Karoui, Mostafa El Hajjam, Angel Ferrario, Mihaela Giol, Yann Goueffic, Philippe Goy, Danielle Guez, Lamiae Grimaldi, Rabih Houbballah, Gilles Hufnagel, Madalina Jacota, Marielle Le Roux, Alexandros Mallios, Ziad A. Massy, Lionelle Nkam, Gaelle Pelle, Quentin Pellenc, Eric Picard, Quentin Raimbourg, Maxime Raux, Jacques Ropers, Jean Senemaud, Marc Sznadjer, Vania TACHER, Joseph Touma, Luc Turmel
Institutions: Hôpital américain de paris, Inserm, Université de Versailles Saint-Quentin-en-Yvelines, Université Paris-Saclay, Assistance Publique – Hôpitaux de Paris, Centre de recherche en Epidémiologie et Santé des Populations, Hôpital Ambroise-Paré, Hôpital Paul-Brousse, Centre Hospitalier Universitaire de Nîmes, Clinique Les Fontaines, Université Paris-Est Créteil, Centre Hospitalier Universitaire Henri-Mondor, Hôpitaux Universitaires Henri-Mondor, Les Hôpitaux de Chartres, Hôpital Paris Saint-Joseph
Language: English
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,000
OpenAlex ID: W7166706408