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Risk-factors and multimorbidity in oral anticoagulant-related intracerebral haemorrhage: a comparison of patients in pivotal trials and real life

We hypothesised that morbidity burden was higher in real-life patients with oral anticoagulant-related intracerebral haemorrhage (OAC-ICH) than direct oral anticoagulant (DOAC) trial-life patients (pivotal trial participants) and explored if pre-stroke morbidity was comparable (i) in real-life patie...

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Main Authors: Grundtvig, Josefine (Author) , Gaist, David (Author) , Christensen, Louisa (Author) , Ovesen, Christian (Author) , Havsteen, Inger (Author) , Iversen, Helle K (Author) , Christensen, Thomas (Author) , Lilja-Cyron, Alexander (Author) , Kruuse, Christina (Author) , Ægidius, Karen (Author) , Rosenbaum, Sverre (Author) , Meden, Per (Author) , Marstrand, Jacob (Author) , Steiner, Thorsten (Author) , Christensen, Hanne (Author)
Format: Article (Journal)
Language:English
Published: April 2025
In: Age & ageing
Year: 2025, Volume: 54, Issue: 4, Pages: 1-8
ISSN:1468-2834
DOI:10.1093/ageing/afaf091
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1093/ageing/afaf091
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Author Notes:Josefine Grundtvig, David Gaist, Louisa Christensen, Christian Ovesen, Inger Havsteen, Helle K Iversen, Thomas Christensen, Alexander Lilja-Cyron, Christina Kruuse, Karen Ægidius, Sverre Rosenbaum, Per Meden, Jacob Marstrand, Thorsten Steiner, Hanne Christensen
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Summary:We hypothesised that morbidity burden was higher in real-life patients with oral anticoagulant-related intracerebral haemorrhage (OAC-ICH) than direct oral anticoagulant (DOAC) trial-life patients (pivotal trial participants) and explored if pre-stroke morbidity was comparable (i) in real-life patients on DOAC or vitamin K antagonist (VKA) with ICH, and (ii) in trial-life patients versus real-life patients with OAC-ICH.The COOL-ICH cohort included 401 acute, consecutive patients with OAC-ICH (272 VKA-ICH, 129 DOAC-ICH) from the Capital Region of Denmark. Risk-factors and morbidity in trial-life patients were retrieved from publications.Risk-factors, CHADS2 and Charlson Comorbidity Index were comparable in DOAC vs VKA users in real-life. Pre-stroke modified Rankin Scale (mRS) was higher in DOAC users than in VKA users (median mRS 1 vs 0, P = 0.002). More DOAC users were women (53% vs 39%, P = 0.009). Compared to trial-life patients, age and proportion of women were higher in real-life patients. CHADS2-scores were comparable.In conclusion, burden of risk-factors and comorbidities were similar in real-life patients with DOAC-ICH and VKA-ICH, as well as in real-life patients compared to trial-life patients. However, real-life patients especially those on DOAC, were older and more frequently women than trial-life patients. It is reassuring that burden of comorbidity was similar in real-life and trial-life patients. Nevertheless, this report underlines the importance of recruiting adequate numbers of older people and women to cardio-vascular trials to ensure sufficient safety data to advice prescriptions in these very prevalent sub-groups of patients.
Item Description:Veröffentlicht: 16. April 2025
Gesehen am 06.10.2025
Physical Description:Online Resource
ISSN:1468-2834
DOI:10.1093/ageing/afaf091

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