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Comment
. 2021 Feb 22;96(8):e1156-e1166.
doi: 10.1212/WNL.0000000000011106.

Fatal and Nonfatal Events Within 14 days After Early, Intensive Mobilization Poststroke

Julie Bernhardt  1 , Karen Borschmann  2 , Janice M Collier  2 , Amanda G Thrift  2 , Peter Langhorne  2 , Sandy Middleton  2 , Richard I Lindley  2 , Helen M Dewey  2 , Philip Bath  2 , Catherine M Said  2 , Leonid Churilov  2 , Fiona Ellery  2 , Christopher Bladin  2 , Christopher M Reid  2 , Judith H Frayne  2 , Velandai Srikanth  2 , Stephen J Read  2 , Geoffrey A Donnan  2 ; AVERT Trialists Collaboration Group
Collaborators, Affiliations
Comment

Fatal and Nonfatal Events Within 14 days After Early, Intensive Mobilization Poststroke

Julie Bernhardt et al. Neurology. .

Abstract

Objective: This tertiary analysis from A Very Early Rehabilitation Trial (AVERT) examined fatal and nonfatal serious adverse events (SAEs) at 14 days.

Method: AVERT was a prospective, parallel group, assessor blinded, randomized international clinical trial comparing mobility training commenced <24 hours poststroke, termed very early mobilization (VEM), to usual care (UC). Primary outcome was assessed at 3 months. Patients with ischemic or hemorrhagic stroke within 24 hours of onset were included. Treatment with thrombolytics was allowed. Patients with severe premorbid disability or comorbidities were excluded. Interventions continued for 14 days or hospital discharge if less. The primary early safety outcome was fatal SAEs within 14 days. Secondary outcomes were nonfatal SAEs classified as neurologic, immobility-related, and other. Mortality influences were assessed using binary logistic regression adjusted for baseline stroke severity (NIH Stroke Scale [NIHSS] score) and age.

Results: A total of 2,104 participants were randomized to VEM (n = 1,054) or UC (n = 1,050) with a median age of 72 years (interquartile range [IQR] 63-80) and NIHSS 7 (IQR 4-12). By 14 days, 48 had died in VEM, 32 in UC, age and stroke severity adjusted odds ratio of 1.76 (95% confidence interval 1.06-2.92, p = 0.029). Stroke progression was more common in VEM. Exploratory subgroup analyses showed higher odds of death in intracerebral hemorrhage and >80 years subgroups, but there was no significant treatment by subgroup interaction. No difference in nonfatal SAEs was found.

Conclusion: While the overall case fatality at 14 days poststroke was only 3.8%, mortality adjusted for age and stroke severity was increased with high dose and intensive training compared to usual care. Stroke progression was more common in VEM.

Registration: Australian New Zealand Clinical Trials Registry, ACTRN12606000185561.

Classification of evidence: This study provides Class I evidence that very early mobilization increases mortality at 14 days poststroke.

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Figures

Figure 1
Figure 1. Participant Progress Through Trial to 14 Days
Primary reason for not receiving mobilization within 14 days: very early mobilization (VEM), n = 12; serious adverse event (SAE) and death outcome, n = 9; alive at 14 days: discharged home from hospital ≤24 hours, n = 1; SAE then transfer to intensive care unit ≤24 hours, n = 1; lost to follow-up: withdrawal, n = 1. Usual care (UC), n = 14: SAE and death outcome, n = 10; alive at 14 days: SAE, n = 2; palliated, n = 1; transferred to another ward, n = 1.
Figure 2
Figure 2. Forest Plot: Subgroup Analysis for Death at 14 Days
Total number of deaths at 14 days, n = 80 (very early mobilization [VEM] 48, usual care [UC] 32). Missing data: unknown status at day 14, n = 6. Subgroup interactions were not significant. CI = confidence interval; OR = odds ratio; rtPA = recombinant tissue plasminogen activator.
See this image and copyright information in PMC

Comment on

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