Intracranial Haemorrhage and Haemorrhagic Stroke in Patients with Atrial Fibrillation on Edoxaban in ETNA-AF-Europe
- 1Cardiovascular Division, Pisa University Hospital, 56124 Pisa, Italy
- 2Daiichi Sankyo Europe GmbH, 81379 Munich, Germany
- 3Institute of Cardiovascular Sciences, University of Birmingham, Birmingham B15 2TT, UK
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.
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BibTeX
@article{morrone2026intracranial,
title = {{Intracranial Haemorrhage and Haemorrhagic Stroke in Patients with Atrial Fibrillation on Edoxaban in ETNA-AF-Europe}},
author = {Doralisa Morrone and Richa Chhabra and Eva-Maria Fronk and Jose Souza and Paulus Kirchhof and Raffaele De Caterina and on behalf of the ETNA-AF-Europe Investigators},
journal = {Journal of Clinical Medicine},
year = {2026},
month = nov,
doi = {10.3390/jcm15218575},
url = {https://www.mdpi.com/2077-0383/15/21/8575},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Intracranial Haemorrhage and Haemorrhagic Stroke in Patients with Atrial Fibrillation on Edoxaban in ETNA-AF-Europe
AU - Doralisa Morrone
AU - Richa Chhabra
AU - Eva-Maria Fronk
AU - Jose Souza
AU - Paulus Kirchhof
AU - Raffaele De Caterina
AU - on behalf of the ETNA-AF-Europe Investigators
PY - 2026
DA - 2026/11/03
JO - Journal of Clinical Medicine
DO - 10.3390/jcm15218575
UR - https://www.mdpi.com/2077-0383/15/21/8575
AB - 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.
SN - 2077-0383
ER -