Thrombolysis for wake-up stroke versus non-wake-up unwitnessed stroke: EOS individual patient data meta-analysis

BACKGROUND: Stroke with unknown time of onset can be categorized into 2 groups; wake-up stroke (WUS) and unwitnessed stroke with an onset time unavailable for reasons other than wake-up (non-wake-up unwitnessed stroke, non-WUS). We aimed to assess potential differences in the efficacy and safety of...

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Hauptverfasser: Kamogawa, Naruhiko (VerfasserIn) , Miwa, Kaori (VerfasserIn) , Toyoda, Kazunori (VerfasserIn) , Jensen, Märit (VerfasserIn) , Inoue, Manabu (VerfasserIn) , Yoshimura, Sohei (VerfasserIn) , Fukuda-Doi, Mayumi (VerfasserIn) , Kitazono, Takanari (VerfasserIn) , Boutitie, Florent (VerfasserIn) , Ma, Henry (VerfasserIn) , Ringleb, Peter A. (VerfasserIn) , Wu, Ona (VerfasserIn) , Schwamm, Lee H. (VerfasserIn) , Warach, Steven (VerfasserIn) , Hacke, Werner (VerfasserIn) , Davis, Stephen M. (VerfasserIn) , Donnan, Geoffrey A. (VerfasserIn) , Gerloff, Christian (VerfasserIn) , Thomalla, Götz (VerfasserIn) , Koga, Masatoshi (VerfasserIn) , Bendszus, Martin (VerfasserIn)
Dokumenttyp: Article (Journal)
Sprache:Englisch
Veröffentlicht: Mar 2024
In: Stroke
Year: 2024, Jahrgang: 55, Heft: 4, Pages: 895-904
ISSN:1524-4628
DOI:10.1161/STROKEAHA.123.043358
Online-Zugang:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1161/STROKEAHA.123.043358
Verlag, lizenzpflichtig, Volltext: https://www.ahajournals.org/doi/10.1161/STROKEAHA.123.043358
Volltext
Verfasserangaben:Naruhiko Kamogawa, Kaori Miwa, Kazunori Toyoda, Märit Jensen, Manabu Inoue, Sohei Yoshimura, Mayumi Fukuda-Doi, Takanari Kitazono, Florent Boutitie, Henry Ma, Peter Ringleb, Ona Wu, Lee H. Schwamm, Steven Warach, Werner Hacke, Stephen M. Davis, Geoffrey A. Donnan, Christian Gerloff, Götz Thomalla, Masatoshi Koga, Evaluation of Unknown Onset Stroke Thrombolysis Trials (EOS) Investigators: : Bastian Cheng, Martin Bendszus...

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245 1 0 |a Thrombolysis for wake-up stroke versus non-wake-up unwitnessed stroke  |b EOS individual patient data meta-analysis  |c Naruhiko Kamogawa, Kaori Miwa, Kazunori Toyoda, Märit Jensen, Manabu Inoue, Sohei Yoshimura, Mayumi Fukuda-Doi, Takanari Kitazono, Florent Boutitie, Henry Ma, Peter Ringleb, Ona Wu, Lee H. Schwamm, Steven Warach, Werner Hacke, Stephen M. Davis, Geoffrey A. Donnan, Christian Gerloff, Götz Thomalla, Masatoshi Koga, Evaluation of Unknown Onset Stroke Thrombolysis Trials (EOS) Investigators: : Bastian Cheng, Martin Bendszus... 
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520 |a BACKGROUND: Stroke with unknown time of onset can be categorized into 2 groups; wake-up stroke (WUS) and unwitnessed stroke with an onset time unavailable for reasons other than wake-up (non-wake-up unwitnessed stroke, non-WUS). We aimed to assess potential differences in the efficacy and safety of intravenous thrombolysis (IVT) between these subgroups. METHODS: Patients with an unknown-onset stroke were evaluated using individual patient-level data of 2 randomized controlled trials (WAKE-UP [Efficacy and Safety of MRI-Based Thrombolysis in Wake-Up Stroke], THAWS [Thrombolysis for Acute Wake-Up and Unclear-Onset Strokes With Alteplase at 0.6 mg/kg]) comparing IVT with placebo or standard treatment from the EOS (Evaluation of Unknown-Onset Stroke Thrombolysis trial) data set. A favorable outcome was prespecified as a modified Rankin Scale score of 0 to 1 at 90 days. Safety outcomes included symptomatic intracranial hemorrhage at 22 to 36 hours and 90-day mortality. The IVT effect was compared between the treatment groups in the WUS and non-WUS with multivariable logistic regression analysis. RESULTS: Six hundred thirty-four patients from 2 trials were analyzed; 542 had WUS (191 women, 272 receiving alteplase), and 92 had non-WUS (42 women, 43 receiving alteplase). Overall, no significant interaction was noted between the mode of onset and treatment effect (P value for interaction=0.796). In patients with WUS, the frequencies of favorable outcomes were 54.8% and 45.5% in the IVT and control groups, respectively (adjusted odds ratio, 1.47 [95% CI, 1.01-2.16]). Death occurred in 4.0% and 1.9%, respectively (P=0.162), and symptomatic intracranial hemorrhage in 1.8% and 0.3%, respectively (P=0.194). In patients with non-WUS, no significant difference was observed in favorable outcomes relative to the control (37.2% versus 29.2%; adjusted odds ratio, 1.76 [0.58-5.37]). One death and one symptomatic intracranial hemorrhage were reported in the IVT group, but none in the control. CONCLUSIONS: There was no difference in the effect of IVT between patients with WUS and non-WUS. IVT showed a significant benefit in patients with WUS, while there was insufficient statistical power to detect a substantial benefit in the non-WUS subgroup. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: CRD42020166903. 
650 4 |a Brain ischemia 
650 4 |a Female 
650 4 |a Fibrinolytic agents 
650 4 |a Humans 
650 4 |a Intracranial hemorrhages 
650 4 |a intravenous alteplase 
650 4 |a intravenous thrombolysis 
650 4 |a ischemic stroke 
650 4 |a Stroke 
650 4 |a Thrombolytic therapy 
650 4 |a Tissue plasminogen activator 
650 4 |a Treatment outcome 
650 4 |a unknown-onset stroke 
650 4 |a wake-up stroke 
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700 1 |a Wu, Ona  |e VerfasserIn  |4 aut 
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