What Is a Meaningful Difference When Using Infarct Volume as the Primary Outcome?: Results From the HERMES Database-Reference-Cited by-同舟云学术

What Is a Meaningful Difference When Using Infarct Volume as the Primary Outcome?: Results From the HERMES Database

Published:2024-04 Issue:4 Volume:55 Page:866-873
ISSN:0039-2499
Container-title:Stroke
language:en
Short-container-title:Stroke

Author:

Rinkel Leon A.¹²^ORCID,Ospel Johanna M.¹^ORCID,Brown Scott B.³,Campbell Bruce C.V.⁴^ORCID,Dippel Diederik W.J.⁵^ORCID,Demchuk Andrew M.²^ORCID,Majoie Charles B.L.M.⁶^ORCID,Mitchell Peter J.⁷^ORCID,Bracard Serge⁸^ORCID,Guillemin Francis⁹^ORCID,Jovin Tudor G.¹⁰^ORCID,Muir Keith W.¹¹,White Philip¹²,Saver Jeffrey L.¹³^ORCID,Hill Michael D.²,Goyal Mayank²^ORCID,

Affiliation:

1. Department of Neurology, Amsterdam University Medical Centers, the Netherlands (L.A.R.).

2. Department of Clinical Neurosciences, Foothills Medical Center, University of Calgary, AB, Canada (L.A.R., J.M.O., A.M.D., M.D.H., M.G.).

3. BRIGHT Research Partners, Inc, Mooresville, NC (S.B.B.).

4. Department of Medicine and Neurology, Melbourne Brain Centre, Australia (B.C.V.C.).

5. Department of Neurology, Erasmus MC University Medical Center, Rotterdam, the Netherlands (D.W.J.D.).

6. Department of Radiology and Nuclear Medicine, Amsterdam University Medical Centers, University of Amsterdam, the Netherlands (C.B.L.M.M.).

7. Department of Radiology, Royal Melbourne Hospital, University of Melbourne, Australia (P.J.M.).

8. Department of Diagnostic and Interventional Neuroradiology, University of Lorraine and University Hospital of Nancy, France (S.B.).

9. Clinical Epidemiology Center, University of Lorraine and University Hospital of Nancy, Inserm and Université de Lorraine, France (F.G.).

10. Department of Neurology, Stroke Institute, University of Pittsburgh Medical Center Stroke Institute, Presbyterian University Hospital, PA (T.G.J.).

11. Institute of Neuroscience and Psychology, University of Glasgow, Queen Elizabeth University Hospital, United Kingdom (K.W.M.).

12. Translational and Clinical Research Institute, Newcastle University, United Kingdom (P.W.).

13. Neurology and Comprehensive Stroke Center, David Geffen School of Medicine, University of California, Los Angeles (J.L.S.).

Abstract

BACKGROUND: Ischemic stroke lesion volume at follow-up is an important surrogate outcome for acute stroke trials. We aimed to assess which differences in 48-hour lesion volume translate into meaningful clinical differences. METHODS: We used pooled data from 7 trials investigating the efficacy of endovascular treatment for anterior circulation large vessel occlusion in acute ischemic stroke. We assessed 48-hour lesion volume follow-up computed tomography or magnetic resonance imaging. The primary outcome was a good functional outcome, defined as modified Rankin Scale (mRS) scores of 0 to 2. We performed multivariable logistic regression to predict the probability of achieving mRS scores of 0 to 2 and determined the differences in 48-hour lesion volume that correspond to a change of 1%, 5%, and 10% in the adjusted probability of achieving mRS scores of 0 to 2. RESULTS: In total, 1665/1766 (94.2%) patients (median age, 68 [interquartile range, 57–76] years, 781 [46.9%] female) had information on follow-up ischemic lesion volume. Computed tomography was used for follow-up imaging in 83% of patients. The median 48-hour lesion volume was 41 (interquartile range, 14–120) mL. We observed a linear relationship between 48-hour lesion volume and mRS scores of 0 to 2 for adjusted probabilities between 65% and 20%/volumes <80 mL, although the curve sloped off for lower mRS scores of 0–2 probabilities/higher volumes. The median differences in 48-hour lesion volume associated with a 1%, 5%, and 10% increase in the probability of mRS scores of 0 to 2 for volumes <80 mL were 2 (interquartile range, 2–3), 10 (9–11), and 20 (18–23) mL, respectively. We found comparable associations when assessing computed tomography and magnetic resonance imaging separately. CONCLUSIONS: A difference of 2, 10, and 20 mL in 48-hour lesion volume, respectively, is associated with a 1%, 5%, and 10% absolute increase in the probability of achieving good functional outcome. These results can inform the design of future stroke trials that use 48-hour lesion volume as the primary outcome.

Publisher

Ovid Technologies (Wolters Kluwer Health)

Reference27 articles.

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