A Randomised Trial of Paclitaxel Coated Balloons for Arteriovenous Fistula Stenosis with Blinded Re-intervention Criteria
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.
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BibTeX
@article{coscas2026randomised,
title = {{A Randomised Trial of Paclitaxel Coated Balloons for Arteriovenous Fistula Stenosis with Blinded Re-intervention Criteria}},
author = {Raphaël Coscas and Lamiae Grimaldi and Lucie Mercier and Éric Picard and Angel Ferrario and Joseph Touma and Alexandros Mallios and Marc Sznajder and Lionelle Nkam and Ziad A. Massy and Isabelle Aichoun and Karim Belattar and Iannis Ben Abdallah and Yves Castier and Raphaël Coscas and Alessandro Costanzo and Costantino del Giudice and Nawal Derridj and Elsa Faure and Khalil El Karoui and Mostafa El Hajjam and Angel Ferrario and Mihaela Giol and Yann Goueffic and Philippe Goy and Danielle Guez and Lamiae Grimaldi and Rabih Houbballah and Gilles Hufnagel and Madalina Jacota and Marielle Le Roux and Alexandros Mallios and Ziad A. Massy and Lionelle Nkam and Gaelle Pelle and Quentin Pellenc and Eric Picard and Quentin Raimbourg and Maxime Raux and Jacques Ropers and Jean Senemaud and Marc Sznadjer and Vania Tacher and Joseph Touma and Luc Turmel},
journal = {Eur J Vasc Endovasc Surg},
year = {2026},
month = oct,
doi = {10.1016/j.ejvs.2026.06.048},
url = {https://hal.science/hal-05845223v1},
note = {CC BY},
}
RIS
TY - JOUR
TI - A Randomised Trial of Paclitaxel Coated Balloons for Arteriovenous Fistula Stenosis with Blinded Re-intervention Criteria
AU - Raphaël Coscas
AU - Lamiae Grimaldi
AU - Lucie Mercier
AU - Éric Picard
AU - Angel Ferrario
AU - Joseph Touma
AU - Alexandros Mallios
AU - Marc Sznajder
AU - Lionelle Nkam
AU - Ziad A. Massy
AU - Isabelle Aichoun
AU - Karim Belattar
AU - Iannis Ben Abdallah
AU - Yves Castier
AU - Raphaël Coscas
AU - Alessandro Costanzo
AU - Costantino del Giudice
AU - Nawal Derridj
AU - Elsa Faure
AU - Khalil El Karoui
AU - Mostafa El Hajjam
AU - Angel Ferrario
AU - Mihaela Giol
AU - Yann Goueffic
AU - Philippe Goy
AU - Danielle Guez
AU - Lamiae Grimaldi
AU - Rabih Houbballah
AU - Gilles Hufnagel
AU - Madalina Jacota
AU - Marielle Le Roux
AU - Alexandros Mallios
AU - Ziad A. Massy
AU - Lionelle Nkam
AU - Gaelle Pelle
AU - Quentin Pellenc
AU - Eric Picard
AU - Quentin Raimbourg
AU - Maxime Raux
AU - Jacques Ropers
AU - Jean Senemaud
AU - Marc Sznadjer
AU - Vania Tacher
AU - Joseph Touma
AU - Luc Turmel
PY - 2026
DA - 2026/10/30
JO - Eur J Vasc Endovasc Surg
DO - 10.1016/j.ejvs.2026.06.048
UR - https://hal.science/hal-05845223v1
AB - 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.
SN - 1532-2165
ER -