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Patient-Reported Quality of Life after Intravenous Alteplase for Stroke in the WAKE-UP Trial

Publikation: Bidrag til tidsskrift/Konferencebidrag i tidsskrift /Bidrag til avis › Tidsskriftartikel › Forskning › peer review

DOI

  • Märit Jensen, University of Hamburg
    • ,
  • Susanne Sehner, University of Hamburg
    • ,
  • Bastian Cheng, University of Hamburg
    • ,
  • Eckhard Schlemm, University of Hamburg
    • ,
  • Fanny Quandt, University of Hamburg
    • ,
  • Ewgenia Barow, University of Hamburg
    • ,
  • Karl Wegscheider, University of Hamburg
    • ,
  • Florent Boutitie, Hospices Civils de Lyon, Universite Claude Bernard Lyon 1
    • ,
  • Martin Ebinger, Centrum für Schlaganfallforschung Berlin (CSB), Medical Park Berlin Humboldtmu¨hle
    • ,
  • Matthias Endres, Centrum für Schlaganfallforschung Berlin (CSB), Charité-Universitätsmedizin Berlin, German Center for Neurodegenerative Diseases, German Centre for Cardiovascular Research, Excellence Cluster NeuroCure
    • ,
  • Jochen B. Fiebach, Centrum für Schlaganfallforschung Berlin (CSB)
    • ,
  • Vincent Thijs, University of Melbourne
    • ,
  • Robin Lemmens, KU Leuven, Flanders Institute for Biotechnology
    • ,
  • Keith W. Muir, University of Glasgow
    • ,
  • Norbert Nighoghossian, Universite Jean Monnet Saint-Etienne, Hospices Civils de Lyon
    • ,
  • Salvador Pedraza, University of Girona
    • ,
  • Claus Z. Simonsen
  • Götz Thomalla, University of Hamburg
    • ,
  • Christian Gerloff, University of Hamburg

Background and ObjectivesIntravenous alteplase improves functional outcome after acute ischemic stroke. However, little is known about the effects on self-reported health-related quality of life (HRQoL).MethodsWAKE-UP was a multicenter, randomized, placebo-controlled trial of MRI-guided intravenous alteplase in stroke with unknown onset time. HRQoL was assessed using the EuroQol five-dimensional questionnaire (EQ-5D) at 90 days, comprising the EQ-5D index and the EQ visual analogue scale (VAS). Functional outcome was assessed by the modified Rankin Scale (mRS). We calculated the effect of treatment on EQ-5D index and EQ VAS using multiple linear regression models. Mediation analysis was performed on stroke survivors to explore the extent to which the effect of alteplase on HRQoL was mediated by functional outcome.ResultsAmong 490 stroke survivors, the EQ-5D index was available for 452 (92.2%), of whom 226 (50%) were assigned to treatment with alteplase and 226 (50%) to placebo. At 90 days, mean EQ-5D index was higher, reflecting a better health state, in patients randomized to treatment with alteplase than with placebo (0.75 vs 0.67) with an adjusted mean difference of 0.07 (95% CI 0.02-0.12, p = 0.005). In addition, mean EQ VAS was higher with alteplase than with placebo (72.6 vs 64.9), with an adjusted mean difference of 7.6 (95% CI 3.9-11.8, p < 0.001). Eighty-five percent of the total treatment effect of alteplase on the EQ-5D index was mediated using the mRS score while there was no significant direct effect. By contrast, the treatment effect on the EQ VAS was mainly through the direct pathway (60%), whereas 40% was mediated by the mRS.DiscussionAssessment of patient-reported outcome measures reveals a potential benefit of intravenous alteplase for HRQoL beyond improvement of functional outcome.Trial Registration InformationClinicalTrials.gov number, NCT01525290; EudraCT number, 2011-005906-32.

OriginalsprogEngelsk
TidsskriftNeurology
Vol/bind100
Nummer2
Sider (fra-til)E154-E162
ISSN0028-3878
DOI
StatusUdgivet - 10 jan. 2023

Bibliografisk note

Funding Information:
WAKE-UP received funding from the European Union Seventh Framework Program [FP7/2007–2013] under grant agreement n°278276 (WAKE-UP). The European Union Seventh Framework Program [FP7/2007–2013] had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Publisher Copyright:
© American Academy of Neurology.

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