Serious Adverse Events and Their Impact on Functional Outcome in Acute Ischemic Stroke in the WAKE-UP Trial-Reference-Cited by-同舟云学术

Serious Adverse Events and Their Impact on Functional Outcome in Acute Ischemic Stroke in the WAKE-UP Trial

Published:2021-12 Issue:12 Volume:52 Page:3768-3776
ISSN:0039-2499
Container-title:Stroke
language:en
Short-container-title:Stroke

Author:

Lettow Iris¹^ORCID,Jensen Märit¹^ORCID,Schlemm Eckhard¹^ORCID,Boutitie Florent¹²,Quandt Fanny,Cheng Bastian¹,Ebinger Martin³⁴,Endres Matthias⁴⁵,Fiebach Jochen B.⁴,Thijs Vincent⁶⁷,Lemmens Robin⁸⁹¹⁰,Muir Keith W.¹¹,Nighoghossian Norbert¹²,Pedraza Salvador¹³,Simonsen Claus Z.¹⁴,Gerloff Christian¹,Thomalla Götz¹,

Affiliation:

1. Klinik und Poliklinik für Neurologie, Kopf- und Neurozentrum, University Medical Center Hamburg-Eppendorf, Germany (I.L., M.J., E.S., F.Q., B.C., C.G., G.T.).

2. Hospices Civils de Lyon, Service de Biostatistique, France (F.B.).

3. Klinik für Neurologie, Medical Park Berlin Humboldtmühle, Germany (M. Ebinger).

4. Centrum für Schlaganfallforschung Berlin (CSB), Charité - Universitätsmedizin Berlin, Germany (M. Ebinger, M. Endres, J.B.F.).

5. Klinik und Hochschulambulanz für Neurologie, Charité-Universitätsmedizin Berlin, Germany (M. Endres).

6. Stroke Division, Florey Institute of Neuroscience and Mental Health, University of Melbourne, Victoria, Australia (V.T.).

7. Austin Health, Department of Neurology, Australia (V.T.).

8. Department of Neurology, University Hospitals Leuven, Belgium (R.L.).

9. KU Leuven – University of Leuven, Department of Neurosciences, Experimental Neurology, Belgium (R.L.).

10. VIB, Center for Brain & Disease Research, Laboratory of Neurobiology, Campus Gasthuisberg, Belgium (R.L.).

11. Institute of Neuroscience & Psychology, University of Glasgow, University Avenue, Glasgow G12 8QQ, United Kingdom (K.W.M.).

12. Department of Stroke Medicine, Hospices Civils de Lyon, Université Claude Bernard Lyon 1, France (N.N.).

13. Department of Radiology, Institut de Diagnostic per la Image (IDI), Hospital Dr Josep Trueta, Institut d’Investigació Biomèdica de Girona (IDIBGI), Parc Hospitalari Martí i Julià de Salt - Edifici M2, Italysa (S.P.).

14. Department of Neurology, Aarhus University Hospital, Denmark (C.Z.S.).

Abstract

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 <0.001). Higher age ( 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.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Subject

Advanced and Specialized Nursing,Cardiology and Cardiovascular Medicine,Neurology (clinical)

Link

https://www.ahajournals.org/doi/pdf/10.1161/STROKEAHA.120.033425

Reference29 articles.

1. Medical and Neurological Complications of Ischemic Stroke

2. Pneumonia and urinary tract infection after acute ischaemic stroke: a tertiary analysis of the GAIN International trial

3. Predictors of In-Hospital Mortality and Attributable Risks of Death After Ischemic StrokeThe German Stroke Registers Study Group

4. Complications following Acute Ischemic Stroke

5. Medical complications after stroke

Cited by 4 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Current practice and attitudes of stroke physicians towards rhythm-control therapy for stroke prevention: results of an international survey;Neurological Research and Practice;2023-07-06

2. Early rhythm-control therapy for atrial fibrillation in patients with a history of stroke: a subgroup analysis of the EAST-AFNET 4 trial;The Lancet Neurology;2023-01

3. Stroke–Heart Syndrome: Recent Advances and Challenges;Journal of the American Heart Association;2022-09-06

4. Assessing NIHSS and MRS Scores in Patients with an Unknown Onset Time of Stroke Symptoms:A Historical Cohort Study;INT J EARLY CHILD SP;2022