{
  "abstract": "Background/Objectives: ETNA-AF-Europe was a post-authorization, prospective, non-interventional study evaluating edoxaban in atrial fibrillation (AF). Here, we assessed annualized rates of intracranial haemorrhage, haemorrhagic stroke, and ischaemic stroke in subpopulations of edoxaban-treated patients with AF. Methods: We assessed overall annualized adjudicated event rates over 4 years, including subpopulations stratified by age, renal/hepatic impairment, chronic concomitant anti-platelet use, and CHA2DS2-VASc score. Results: Overall, 13,164 patients were included, with a median (interquartile range) age of 75.0 (68.0, 80.0) years. Overall annualized intracranial haemorrhage rates were 0.18%/year and remained ≤0.24%/year in high-risk subpopulations, with minor rate increases observed with age (<65 years: 0.07%/year, ≥65–<75 years: 0.16%/year, ≥75 years: 0.23%/year) and CHA2DS2-VASc score (0–1: 0.04%/year, 2–4: 0.19%/year, >4: 0.24%/year). Overall annualized haemorrhagic stroke rates were 0.08%/year and remained ≤0.10%/year in high-risk subpopulations, with minor rate increases observed with age (<65 years: 0.06%/year, ≥65–<75 years: 0.08%/year, ≥75 years: 0.09%/year) and CHA2DS2-VASc score (0–1: 0.00%/year, 2–4: 0.09%/year, >4: 0.10%/year). Overall annualized ischaemic stroke rates were 0.49%/year and remained ≤1.05%/year in high-risk subpopulations; however, rates increased notably with age (<65 years: 0.21%/year, ≥65–<75 years: 0.34%/year, ≥75 years: 0.68%/year) and CHA2DS2VASc score (0–1: 0.15%/year, 2–4: 0.43%/year, >4: 1.05%/year). Conclusions: Annualized intracranial haemorrhage, haemorrhagic stroke, and ischaemic stroke rates in ETNA-AF-Europe were low and demonstrated no meaningful increases with renal/hepatic impairment and chronic concomitant antiplatelet use. Minor rate increases observed with higher CHA2DS2-VASc scores and increasing age were much less steep for haemorrhagic stroke than for ischaemic stroke.",
  "abstract_shown": true,
  "affiliations": [
    "Cardiovascular Division, Pisa University Hospital, 56124 Pisa, Italy",
    "Daiichi Sankyo Europe GmbH, 81379 Munich, Germany",
    "Institute of Cardiovascular Sciences, University of Birmingham, Birmingham B15 2TT, UK"
  ],
  "article_type": null,
  "arxiv": null,
  "author_total": 7,
  "authors": [
    {
      "affs": [
        0
      ],
      "name": "Doralisa Morrone",
      "orcid": "0000-0002-9667-6931"
    },
    {
      "affs": [
        1
      ],
      "name": "Richa Chhabra"
    },
    {
      "affs": [
        1
      ],
      "name": "Eva-Maria Fronk",
      "orcid": "0009-0007-4249-0684"
    },
    {
      "affs": [
        1
      ],
      "name": "Jose Souza"
    },
    {
      "affs": [
        2
      ],
      "name": "Paulus Kirchhof",
      "orcid": "0000-0002-1881-0197"
    },
    {
      "affs": [
        0
      ],
      "name": "Raffaele De Caterina",
      "orcid": "0000-0003-1637-574X"
    },
    {
      "name": "on behalf of the ETNA-AF-Europe Investigators"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/9rt0npe4pqj2n.bib",
  "cited_by": 0,
  "doi": "10.3390/jcm15218575",
  "fulltext_url": null,
  "id": "9rt0npe4pqj2n",
  "issns": [
    "2077-0383"
  ],
  "landing_url": "https://www.mdpi.com/2077-0383/15/21/8575",
  "language": null,
  "licence": "CC-BY-4.0",
  "licence_label": "CC BY 4.0",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by/4.0/",
  "metadata_licence": null,
  "native_subjects": [],
  "openalex": null,
  "pdf_url": null,
  "pmcid": null,
  "pmid": null,
  "published": "2026-11-03",
  "publisher": "MDPI AG",
  "ris": "https://research.draconitic.com/paper/9rt0npe4pqj2n.ris",
  "sources": [
    {
      "first_seen": "2026-11-05T00:21:10Z",
      "native_id": "10.3390/jcm15218575",
      "source": "crossref",
      "url": "https://www.mdpi.com/2077-0383/15/21/8575"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "journal-openalex:F27",
      "subfield": "general"
    }
  ],
  "title": "Intracranial Haemorrhage and Haemorrhagic Stroke in Patients with Atrial Fibrillation on Edoxaban in ETNA-AF-Europe",
  "title_text": "Intracranial Haemorrhage and Haemorrhagic Stroke in Patients with Atrial Fibrillation on Edoxaban in ETNA-AF-Europe",
  "type": "peer-reviewed",
  "updated_at": "2026-11-06T00:21:25Z",
  "url": "https://research.draconitic.com/paper/9rt0npe4pqj2n",
  "venue": "Journal of Clinical Medicine",
  "versions": []
}