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

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

doi:10.1093/ageing/afaf091

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

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

^*Corresponding author for this work

Abstract

BACKGROUND: 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.

METHODS: 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.

RESULTS: 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.

CONCLUSION: 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.

Original language	English
Article number	afaf091
Journal	Age and Ageing
Volume	54
Issue number	4
ISSN	0002-0729
DOIs	https://doi.org/10.1093/ageing/afaf091
Publication status	Published - 28 Mar 2025

Keywords

Humans
Female
Male
Aged
Cerebral Hemorrhage/chemically induced
Anticoagulants/adverse effects
Risk Factors
Multimorbidity
Denmark/epidemiology
Aged, 80 and over
Administration, Oral
Risk Assessment
Vitamin K/antagonists & inhibitors
Middle Aged
oral anticoagulants (OAC)
stroke
intracerebral haemorrhage
direct oral anticoagulant (DOAC)
older people

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Grundtvig, J., Gaist, D., Christensen, L., Ovesen, C., Havsteen, I., Iversen, H. K., Christensen, T., Lilja-Cyron, A., Kruuse, C., Ægidius, K., Rosenbaum, S., Meden, P., Marstrand, J., Steiner, T., & Christensen, H. (2025). Risk-factors and multimorbidity in oral anticoagulant-related intracerebral haemorrhage: a comparison of patients in pivotal trials and real life. Age and Ageing, 54(4), Article afaf091. https://doi.org/10.1093/ageing/afaf091

Grundtvig, J, Gaist, D, Christensen, L , Ovesen, C , Havsteen, I , Iversen, HK , Christensen, T , Lilja-Cyron, A , Kruuse, C, Ægidius, K, Rosenbaum, S, Meden, P, Marstrand, J, Steiner, T & Christensen, H 2025, 'Risk-factors and multimorbidity in oral anticoagulant-related intracerebral haemorrhage: a comparison of patients in pivotal trials and real life', Age and Ageing, vol. 54, no. 4, afaf091. https://doi.org/10.1093/ageing/afaf091

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

abstract = "BACKGROUND: 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.METHODS: 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.RESULTS: 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.CONCLUSION: 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.",

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author = "Josefine Grundtvig and David Gaist and Louisa Christensen and Christian Ovesen and Inger Havsteen and Iversen, \{Helle K\} and Thomas Christensen and Alexander Lilja-Cyron and Christina Kruuse and Karen {\AE}gidius and Sverre Rosenbaum and Per Meden and Jacob Marstrand and Thorsten Steiner and Hanne Christensen",

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doi = "10.1093/ageing/afaf091",

language = "English",

volume = "54",

journal = "Age and Ageing",

issn = "0002-0729",

publisher = "Oxford University Press",

number = "4",

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TY - JOUR

T1 - Risk-factors and multimorbidity in oral anticoagulant-related intracerebral haemorrhage

T2 - a comparison of patients in pivotal trials and real life

AU - Grundtvig, Josefine

AU - Gaist, David

AU - Christensen, Louisa

AU - Ovesen, Christian

AU - Havsteen, Inger

AU - Iversen, Helle K

AU - Christensen, Thomas

AU - Lilja-Cyron, Alexander

AU - Kruuse, Christina

AU - Ægidius, Karen

AU - Rosenbaum, Sverre

AU - Meden, Per

AU - Marstrand, Jacob

AU - Steiner, Thorsten

AU - Christensen, Hanne

PY - 2025/3/28

Y1 - 2025/3/28

N2 - BACKGROUND: 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.METHODS: 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.RESULTS: 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.CONCLUSION: 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.

AB - BACKGROUND: 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.METHODS: 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.RESULTS: 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.CONCLUSION: 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.

KW - Humans

KW - Female

KW - Male

KW - Aged

KW - Cerebral Hemorrhage/chemically induced

KW - Anticoagulants/adverse effects

KW - Risk Factors

KW - Multimorbidity

KW - Denmark/epidemiology

KW - Aged, 80 and over

KW - Administration, Oral

KW - Risk Assessment

KW - Vitamin K/antagonists & inhibitors

KW - Middle Aged

KW - oral anticoagulants (OAC)

KW - stroke

KW - intracerebral haemorrhage

KW - direct oral anticoagulant (DOAC)

KW - older people

UR - https://www.scopus.com/pages/publications/105003152688

U2 - 10.1093/ageing/afaf091

DO - 10.1093/ageing/afaf091

M3 - Journal article

C2 - 40237713

SN - 0002-0729

VL - 54

JO - Age and Ageing

JF - Age and Ageing

IS - 4

M1 - afaf091

ER -

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

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Keywords

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