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Journal Articles JAMA neurology Year : 2019

Mediation of the Relationship Between Endovascular Therapy and Functional Outcome by Follow-up Infarct Volume in Patients With Acute Ischemic Stroke

1 AMC - Academic Medical Center - Academisch Medisch Centrum [Amsterdam]
2 University of Twente
3 Altair Development
4 Erasmus University Rotterdam
5 UTC - University of Tennessee [Chattanooga]
6 Hospital Sant Joan de Déu [Barcelona]
7 Yonsei University
8 Vall d'Hebron University Hospital [Barcelona]
9 King Abdulaziz University
10 UC - University of California
11 McGill University = Université McGill [Montréal, Canada]
12 UAB - Universitat Autònoma de Barcelona
13 Frankfurt University of Applied Sciences
14 CIC-IT - Centre d'Investigation Clinique - Innovation Technologique [Nancy]
15 IADI - Imagerie Adaptative Diagnostique et Interventionnelle
16 UCL - University College of London [London]
17 Texas Stroke Institute
18 University of Melbourne
19 Centre Hospitalier Sainte Anne [Paris]
20 CHRU Besançon - Centre Hospitalier Régional Universitaire de Besançon
21 CIC-EC - Centre d'investigation clinique - Epidémiologie clinique [Nancy]
22 Rush University Medical Center [Chicago]
23 IDIBELL - Institut d'Investigació Biomèdica de Bellvitge = Bellvitge Biomedical Research Institute
24 Erasmus MC - Erasmus University Medical Center [Rotterdam]
25 KFU - King Faisal University
26 St George’s University Hospitals
27 Stanford Stroke Center
28 Hôpital universitaire Robert Debré [Reims]
29 Emory University School of Medicine
30 University of Calgary
31 University of Glasgow
32 Newcastle University [Newcastle]
33 CARIM - Cardiovascular Research Institute Maastricht
34 PITT - University of Pittsburgh
35 Département de neuroradiologie diagnostique et thérapeutique [CHRU Nancy]
Scott Brown
  • Function : Author
Ji-Hoe Heo
  • Function : Author

Abstract

Importance: The positive treatment effect of endovascular therapy (EVT) is assumed to be caused by the preservation of brain tissue. It remains unclear to what extent the treatment-related reduction in follow-up infarct volume (FIV) explains the improved functional outcome after EVT in patients with acute ischemic stroke. Objective: To study whether FIV mediates the relationship between EVT and functional outcome in patients with acute ischemic stroke. Design, setting, and participants: Patient data from 7 randomized multicenter trials were pooled. These trials were conducted between December 2010 and April 2015 and included 1764 patients randomly assigned to receive either EVT or standard care (control). Follow-up infarct volume was assessed on computed tomography or magnetic resonance imaging after stroke onset. Mediation analysis was performed to examine the potential causal chain in which FIV may mediate the relationship between EVT and functional outcome. A total of 1690 patients met the inclusion criteria. Twenty-five additional patients were excluded, resulting in a total of 1665 patients, including 821 (49.3%) in the EVT group and 844 (50.7%) in the control group. Data were analyzed from January to June 2017. Main outcome and measure: The 90-day functional outcome via the modified Rankin Scale (mRS). Results: Among 1665 patients, the median (interquartile range [IQR]) age was 68 (57-76) years, and 781 (46.9%) were female. The median (IQR) time to FIV measurement was 30 (24-237) hours. The median (IQR) FIV was 41 (14-120) mL. Patients in the EVT group had significantly smaller FIVs compared with patients in the control group (median [IQR] FIV, 33 [11-99] vs 51 [18-134] mL; P = .007) and lower mRS scores at 90 days (median [IQR] score, 3 [1-4] vs 4 [2-5]). Follow-up infarct volume was a predictor of functional outcome (adjusted common odds ratio, 0.46; 95% CI, 0.39-0.54; P < .001). Follow-up infarct volume partially mediated the relationship between treatment type with mRS score, as EVT was still significantly associated with functional outcome after adjustment for FIV (adjusted common odds ratio, 2.22; 95% CI, 1.52-3.21; P < .001). Treatment-reduced FIV explained 12% (95% CI, 1-19) of the relationship between EVT and functional outcome. Conclusions and relevance: In this analysis, follow-up infarct volume predicted functional outcome; however, a reduced infarct volume after treatment with EVT only explained 12% of the treatment benefit. Follow-up infarct volume as measured on computed tomography and magnetic resonance imaging is not a valid proxy for estimating treatment effect in phase II and III trials of acute ischemic stroke.
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Dates and versions

hal-03225408 , version 1 (20-05-2021)

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Anna M M Boers, Ivo G H Jansen, Scott Brown, Hester F Lingsma, Ludo F M Beenen, et al.. Mediation of the Relationship Between Endovascular Therapy and Functional Outcome by Follow-up Infarct Volume in Patients With Acute Ischemic Stroke. JAMA neurology, 2019, 76 (2), pp.194-202. ⟨10.1001/jamaneurol.2018.3661⟩. ⟨hal-03225408⟩
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