{
  "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.",
  "abstract_shown": true,
  "affiliations": [],
  "article_type": null,
  "arxiv": null,
  "author_total": 45,
  "authors": [
    {
      "name": "Raphaël Coscas"
    },
    {
      "name": "Lamiae Grimaldi"
    },
    {
      "name": "Lucie Mercier"
    },
    {
      "name": "Éric Picard"
    },
    {
      "name": "Angel Ferrario"
    },
    {
      "name": "Joseph Touma"
    },
    {
      "name": "Alexandros Mallios"
    },
    {
      "name": "Marc Sznajder"
    },
    {
      "name": "Lionelle Nkam"
    },
    {
      "name": "Ziad A. Massy"
    },
    {
      "name": "Isabelle Aichoun"
    },
    {
      "name": "Karim Belattar"
    },
    {
      "name": "Iannis Ben Abdallah"
    },
    {
      "name": "Yves Castier"
    },
    {
      "name": "Raphaël Coscas"
    },
    {
      "name": "Alessandro Costanzo"
    },
    {
      "name": "Costantino del Giudice"
    },
    {
      "name": "Nawal Derridj"
    },
    {
      "name": "Elsa Faure"
    },
    {
      "name": "Khalil El Karoui"
    },
    {
      "name": "Mostafa El Hajjam"
    },
    {
      "name": "Angel Ferrario"
    },
    {
      "name": "Mihaela Giol"
    },
    {
      "name": "Yann Goueffic"
    },
    {
      "name": "Philippe Goy"
    },
    {
      "name": "Danielle Guez"
    },
    {
      "name": "Lamiae Grimaldi"
    },
    {
      "name": "Rabih Houbballah"
    },
    {
      "name": "Gilles Hufnagel"
    },
    {
      "name": "Madalina Jacota"
    },
    {
      "name": "Marielle Le Roux"
    },
    {
      "name": "Alexandros Mallios"
    },
    {
      "name": "Ziad A. Massy"
    },
    {
      "name": "Lionelle Nkam"
    },
    {
      "name": "Gaelle Pelle"
    },
    {
      "name": "Quentin Pellenc"
    },
    {
      "name": "Eric Picard"
    },
    {
      "name": "Quentin Raimbourg"
    },
    {
      "name": "Maxime Raux"
    },
    {
      "name": "Jacques Ropers"
    },
    {
      "name": "Jean Senemaud"
    },
    {
      "name": "Marc Sznadjer"
    },
    {
      "name": "Vania Tacher"
    },
    {
      "name": "Joseph Touma"
    },
    {
      "name": "Luc Turmel"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/6a2htxwrw69r3.bib",
  "cited_by": 1,
  "doi": "10.1016/j.ejvs.2026.06.048",
  "fulltext_url": null,
  "id": "6a2htxwrw69r3",
  "issns": [
    "1532-2165"
  ],
  "landing_url": "https://hal.science/hal-05845223v1",
  "language": "en",
  "licence": "CC-BY",
  "licence_label": "CC BY",
  "licence_source": "journal",
  "licence_url": "https://creativecommons.org/licenses/by/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "hal",
      "0.sdv"
    ],
    [
      "openalex",
      "3604|Central Venous Catheters and Hemodialysis"
    ]
  ],
  "openalex": "W7166706408",
  "pdf_url": "https://www.ejves.com/article/S1078-5884(26)00629-5/pdf",
  "pmcid": null,
  "pmid": "42379345",
  "published": "2026-10-30",
  "publisher": null,
  "ris": "https://research.draconitic.com/paper/6a2htxwrw69r3.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T12:18:03Z",
      "native_id": "hal-05845223",
      "source": "hal",
      "url": "https://hal.science/hal-05845223v1"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "journal-openalex:2746|Peripheral Artery Disease Management",
      "subfield": "surgery"
    }
  ],
  "title": "A Randomised Trial of Paclitaxel Coated Balloons for Arteriovenous Fistula Stenosis with Blinded Re-intervention Criteria",
  "title_text": "A Randomised Trial of Paclitaxel Coated Balloons for Arteriovenous Fistula Stenosis with Blinded Re-intervention Criteria",
  "type": "peer-reviewed",
  "updated_at": "2026-11-01T12:20:45Z",
  "url": "https://research.draconitic.com/paper/6a2htxwrw69r3",
  "venue": "Eur J Vasc Endovasc Surg",
  "versions": []
}