Serious adverse events and their impact on functional outcome in acute ischemic stroke in the WAKE-UP trial
| Autor: | Eckhard Schlemm, Robin Lemmens, Norbert Nighoghossian, Bastian Cheng, Salvador Pedraza, Martin Ebinger, Vincent Thijs, Christian Gerloff, Claus Z Simonsen, Florent Boutitie, Märit Jensen, Götz Thomalla, Fanny Quandt, Keith W. Muir, Iris Lettow, Matthias Endres, Jochen B. Fiebach |
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| Přispěvatelé: | Universitaetsklinikum Hamburg-Eppendorf = University Medical Center Hamburg-Eppendorf [Hamburg] (UKE), Hospices Civils de Lyon (HCL), Laboratoire de Biométrie et Biologie Evolutive - UMR 5558 (LBBE), Université Claude Bernard Lyon 1 (UCBL), Université de Lyon-Université de Lyon-Institut National de Recherche en Informatique et en Automatique (Inria)-VetAgro Sup - Institut national d'enseignement supérieur et de recherche en alimentation, santé animale, sciences agronomiques et de l'environnement (VAS)-Centre National de la Recherche Scientifique (CNRS), Université de Lyon, Charité - UniversitätsMedizin = Charité - University Hospital [Berlin], German Research Center for Neurodegenerative Diseases - Deutsches Zentrum für Neurodegenerative Erkrankungen (DZNE), Austin Health, University of Melbourne, University Hospitals Leuven [Leuven], Catholic University of Leuven - Katholieke Universiteit Leuven (KU Leuven), Campus Gasthuisberg, University of Glasgow, Cardiovasculaire, métabolisme, diabétologie et nutrition (CarMeN), Université de Lyon-Université de Lyon-Hospices Civils de Lyon (HCL)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta - Girona Biomedical Research Institute (IDIBGI), Aarhus University Hospital, CarMeN, laboratoire |
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Male
medicine.medical_specialty [SDV]Life Sciences [q-bio] 03 medical and health sciences 0302 clinical medicine Magnetic resonance imaging Double-Blind Method Fibrinolytic Agents Internal medicine parasitic diseases medicine magnetic resonance imaging pneumonia Humans 030212 general & internal medicine Adverse effect adverse drug event Acute ischemic stroke thrombolytic therapy Aged Ischemic Stroke Advanced and Specialized Nursing Ischemic stroke medicine.diagnostic_test Wake up stroke business.industry wake-up stroke Recovery of Function Pneumonia Middle Aged medicine.disease 3. Good health [SDV] Life Sciences [q-bio] Thrombolytic therapy Adverse drug event Tissue Plasminogen Activator Cardiology Female Neurology (clinical) Cardiology and Cardiovascular Medicine business Wake-up stroke 030217 neurology & neurosurgery |
| Zdroj: | Lettow, I, Jensen, M, Schlemm, E, Boutitie, F, Quandt, F, Cheng, B, Ebinger, M, Endres, M, Fiebach, J B, Thijs, V, Lemmens, R, Muir, K W, Nighoghossian, N, Pedraza, S, Simonsen, C Z, Gerloff, C, Thomalla, G & the WAKE-UP investigators 2021, ' Serious adverse events and their impact on functional outcome in acute ischemic stroke in the WAKE-UP trial ', Stroke, vol. 52, no. 12, pp. 3768-3776 . https://doi.org/10.1161/STROKEAHA.120.033425 Stroke Stroke, American Heart Association, 2021, 52 (12), pp.3768-3776. ⟨10.1161/strokeaha.120.033425⟩ Stroke, 2021, 52 (12), pp.3768-3776. ⟨10.1161/strokeaha.120.033425⟩ |
| ISSN: | 0039-2499 1524-4628 |
| DOI: | 10.1161/STROKEAHA.120.033425 |
| Popis: | Background and Purpose: During the first days and weeks after an acute ischemic stroke, patients are prone to complications that can influence further treatment, recovery, and functional outcome. In clinical trials, severe complications are recorded as serious adverse events (SAE). We analyzed the effect of SAE on functional outcome and predictors of SAE in the randomized controlled WAKE-UP trial (Efficacy and Safety of MRI-Based Thrombolysis in Wake-Up Stroke). Methods: We performed a post hoc analysis of WAKE-UP, a multicenter, randomized, placebo-controlled clinical trial of magnetic resonance imaging-guided intravenous thrombolysis with alteplase in patients with acute ischemic stroke and unknown time of onset. Functional outcome was assessed by the modified Rankin Scale 90 days after the stroke. SAE were reported to a central safety desk and recorded and categorized by organ system using Medical Dictionary for Regulatory Activities terminology. We used logistic regression analysis to determine the effect of SAE on functional outcome and linear multiple regression analysis to identify baseline predictors of SAE. Results: Among 503 patients randomized, 199 SAE were reported for n=110 (22%) patients. Of those patients who did suffer a SAE, 20 (10%) had a fatal outcome. Patients suffering from at least one SAE had a lower odds of reaching a favorable outcome (modified Rankin Scale score of 0–1) at 90 days (adjusted odds ratio, 0.36 [95% CI, 0.21–0.61], P P =0.04) and male sex ( P =0.01) were predictors for the occurrence of SAE. Conclusions: SAEs were observed in about one in 5 patients, were more frequent in elderly and male patients and were associated with worse functional outcome. These results may help to assess the risk of SAE in future stroke trials and create awareness for severe complications after stroke in clinical practice. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01525290. URL: https://eudract.ema.europa.eu ; Unique identifier: 2011-005906-32. |
| Databáze: | OpenAIRE |
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