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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.
Glossary
- AE=
- adverse event;
- aOR=
- adjusted odds ratio;
- AVERT=
- A Very Early Rehabilitation Trial;
- BP=
- blood pressure;
- CBF=
- cerebral blood flow;
- CI=
- confidence interval;
- IME=
- important medical event;
- IQR=
- interquartile range;
- NIHSS=
- NIH Stroke Scale;
- OR=
- odds ratio;
- rtPA=
- recombinant tissue plasminogen activator;
- SAE=
- serious adverse event;
- UC=
- usual stroke unit care;
- VEM=
- very early mobilization
Footnotes
Go to Neurology.org/N for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.
AVERT Trialists Collaboration Group coinvestigators are listed in the appendix 2 at the end of the article.
Coinvestigators are listed at http://links.lww.com/WNL/B261.
Patient page e1269
- Received October 15, 2019.
- Accepted in final form October 5, 2020.
- © 2020 American Academy of Neurology
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