Sex differences in imaging and clinical characteristics of patients from the WAKE-UP trial.


Journal

European journal of neurology
ISSN: 1468-1331
Titre abrégé: Eur J Neurol
Pays: England
ID NLM: 9506311

Informations de publication

Date de publication:
03 2023
Historique:
revised: 03 11 2022
received: 08 09 2022
accepted: 04 11 2022
pubmed: 10 11 2022
medline: 11 2 2023
entrez: 9 11 2022
Statut: ppublish

Résumé

Sex-based differences in acute ischemic stroke are a well-known phenomenon. We aimed to explore these differences between women and men in the Efficacy and Safety of MRI-Based Thrombolysis in Wake-Up Stroke (WAKE-UP) trial. We compared baseline demographic and imaging characteristics (visual fluid-attenuated inversion recovery [FLAIR] positivity, relative FLAIR signal intensity, collateral status) between women and men in all screened patients. In randomized patients (i.e., those with diffusion-weighted imaging (DWI)-FLAIR mismatch), we evaluated a modifying role of sex on the treatment effect of alteplase in multivariable logistic regression, with treatment adjusted for National Institute of Health Stroke Scale (NIHSS) score and age. Dependent variables were modified Rankin Scale (mRS) score of 0-1 at 90 days and distribution of mRS scores at 90 days. Of 1362 screened patients, 529 (38.8%) were women. Women were older than men, had higher baseline NIHSS scores and smoked less frequently. FLAIR positivity of the DWI lesion was equally present in women (174/529, 33.1%) and men (273/833, 33.3%; p = 1.00) and other imaging variables also did not differ between the sexes. In a total of 503 randomized patients, of whom 178 were women (35.4%), sex did not modify the treatment effect of alteplase on mRS score 0-1 or on the total distribution of mRS scores. As in many other stroke trials, more men than women were included in the WAKE-UP trial, but the presence of a visual DWI-FLAIR mismatch and the relative FLAIR signal intensity did not differ between the sexes. The treatment effect of alteplase was not modified by sex.

Sections du résumé

BACKGROUND AND PURPOSE
Sex-based differences in acute ischemic stroke are a well-known phenomenon. We aimed to explore these differences between women and men in the Efficacy and Safety of MRI-Based Thrombolysis in Wake-Up Stroke (WAKE-UP) trial.
METHODS
We compared baseline demographic and imaging characteristics (visual fluid-attenuated inversion recovery [FLAIR] positivity, relative FLAIR signal intensity, collateral status) between women and men in all screened patients. In randomized patients (i.e., those with diffusion-weighted imaging (DWI)-FLAIR mismatch), we evaluated a modifying role of sex on the treatment effect of alteplase in multivariable logistic regression, with treatment adjusted for National Institute of Health Stroke Scale (NIHSS) score and age. Dependent variables were modified Rankin Scale (mRS) score of 0-1 at 90 days and distribution of mRS scores at 90 days.
RESULTS
Of 1362 screened patients, 529 (38.8%) were women. Women were older than men, had higher baseline NIHSS scores and smoked less frequently. FLAIR positivity of the DWI lesion was equally present in women (174/529, 33.1%) and men (273/833, 33.3%; p = 1.00) and other imaging variables also did not differ between the sexes. In a total of 503 randomized patients, of whom 178 were women (35.4%), sex did not modify the treatment effect of alteplase on mRS score 0-1 or on the total distribution of mRS scores.
CONCLUSION
As in many other stroke trials, more men than women were included in the WAKE-UP trial, but the presence of a visual DWI-FLAIR mismatch and the relative FLAIR signal intensity did not differ between the sexes. The treatment effect of alteplase was not modified by sex.

Identifiants

pubmed: 36349887
doi: 10.1111/ene.15629
pmc: PMC10099623
doi:

Substances chimiques

Tissue Plasminogen Activator EC 3.4.21.68

Types de publication

Journal Article Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

641-647

Informations de copyright

© 2022 The Authors. European Journal of Neurology published by John Wiley & Sons Ltd on behalf of European Academy of Neurology.

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Auteurs

Anke Wouters (A)

Neurology, Amsterdam University Medical Centers location AMC, Amsterdam, the Netherlands.
Department of Neurosciences, Experimental Neurology, KU Leuven - University of Leuven, Leuven, Belgium.
Center for Brain & Disease Research, Laboratory of Neurobiology, VIB, Leuven, Belgium.

Lauranne Scheldeman (L)

Department of Neurosciences, Experimental Neurology, KU Leuven - University of Leuven, Leuven, Belgium.
Center for Brain & Disease Research, Laboratory of Neurobiology, VIB, Leuven, Belgium.
Department of Neurology, University Hospitals Leuven, Leuven, Belgium.

Hannelore Liessens (H)

Department of Neurology, University Hospitals Leuven, Leuven, Belgium.

Patrick Dupont (P)

Department of Neurosciences, Laboratory for Cognitive Neurology, KU Leuven - University of Leuven, Leuven, Belgium.
Leuven Brain Institute, Leuven, Belgium.

Florent Boutitie (F)

Hospices Civils de Lyon, Service de Biostatistique, Université Lyon, Lyon, France.

Bastian Cheng (B)

Klinik und Poliklinik für Neurologie, Kopf- und Neurozentrum, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany.

Martin Ebinger (M)

Center for Stroke Research Berlin (CSB), Charité - Universitätsmedizin Berlin, Berlin, Germany.
Klinik für Neurologie, Medical Park Berlin Humboldtmühle, Berlin, Germany.

Matthias Endres (M)

Center for Stroke Research Berlin (CSB), Charité - Universitätsmedizin Berlin, Berlin, Germany.
Klinik und Hochschulambulanz für Neurologie, Charité- Universitätsmedizin Berlin, Berlin, Germany.
German Center for Cardiovascular Research (DZHK), partner site Berlin, Berlin, Germany.
German Center for Neurodegenerative Diseases (DZNE), partner site Berlin, Berlin, Germany.
ExcellenceCluster NeuroCure, Berlin, Germany.

Jochen B Fiebach (JB)

Center for Stroke Research Berlin (CSB), Charité - Universitätsmedizin Berlin, Berlin, Germany.

Christian Gerloff (C)

Klinik und Poliklinik für Neurologie, Kopf- und Neurozentrum, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany.

Keith W Muir (KW)

Institute of Neuroscience & Psychology, University of Glasgow, Glasgow, UK.

Norbert Nighoghossian (N)

Department of Stroke Medicine, Université Claude Bernard Lyon 1; Hospices Civils de Lyon, Lyon, France.

Salvador Pedraza (S)

Department of Radiology, Institut de Diagnostic per la Image (IDI), Hospital Dr Josep Trueta, Institut d'Investigació Biomedica de Girona (IDIBGI), Parc Hospitalari Marti i Julia de Salt - Edifici M2, Girona, Spain.

Claus Z Simonsen (CZ)

Department of Neurology, Aarhus University Hospital, Aarhus, Denmark.

Vincent Thijs (V)

Stroke Theme, Florey Institute of Neuroscience and Mental Health, University of Melbourne, Heidelberg, Victoria, Australia.
Department of Neurology, Austin Health, Heidelberg, Victoria, Australia.

Götz Thomalla (G)

Klinik und Poliklinik für Neurologie, Kopf- und Neurozentrum, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany.

Robin Lemmens (R)

Department of Neurosciences, Experimental Neurology, KU Leuven - University of Leuven, Leuven, Belgium.
Center for Brain & Disease Research, Laboratory of Neurobiology, VIB, Leuven, Belgium.
Department of Neurology, University Hospitals Leuven, Leuven, Belgium.

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