中风后早期强化活动后14天内的致命和非致命事件
Fatal and Nonfatal Events Within 14 days After Early, Intensive Mobilization Poststroke.
作者信息
Bernhardt Julie, Borschmann Karen, Collier Janice M, Thrift Amanda G, Langhorne Peter, Middleton Sandy, Lindley Richard I, Dewey Helen M, Bath Philip, Said Catherine M, Churilov Leonid, Ellery Fiona, Bladin Christopher, Reid Christopher M, Frayne Judith H, Srikanth Velandai, Read Stephen J, Donnan Geoffrey A
机构信息
From Stroke Theme, Florey Institute of Neuroscience and Mental Health (J.B., K.B., J.M.C., H.M.D., F.E., C.B.), and Department of Medicine Austin Health (L.C.), University of Melbourne, Heidelberg; NHMRC Centre for Research Excellence in Stroke Rehabilitation and Brain Recovery (J.B., K.B., L.C., G.A.D.); Stroke and Ageing Research, Department of Medicine, School of Clinical Sciences at Monash Health (A.G.T.), Eastern Health Clinical School, Faculty of Medicine, Nursing and Health Sciences (H.M.D.), CCRE Therapeutics (C.M.R.), Faculty of Medicine, Nursing and Health Sciences (J.H.F.), and Peninsula Health & Peninsula Clinical School (V.S.), Monash University, Melbourne, Australia; Institute of Cardiovascular and Medical Sciences (P.L.), University of Glasgow, UK; Nursing Research Institute (S.M.), St Vincent's Health Australia, Sydney and Australian Catholic University, Darlinghurst; Westmead Clinical School (R.I.L.), University of Sydney, Australia;Stroke Trials Unit, Division of Clinical Neuroscience (P.B.), University of Nottingham; Stroke, Nottingham University Hospitals NHS Trust (P.B.), Nottingham, UK; Physiotherapy (C.M.S.), University of Melbourne, Parkville; Physiotherapy (C.M.S.), Western Health, St Albans; School of Sciences (L.C.), RMIT University, Melbourne; Eastern Health Clinical School (C.B.), Monash University, Box Hill; School of Public Health (C.M.R.), Curtin University, Perth; Alfred Hospital (J.H.F.), Melbourne; Faculty of Medicine (S.J.R.), The University of Queensland, Herston; and University of Melbourne (G.A.D.), Melbourne Brain Centre, Parkville, Australia.
出版信息
Neurology. 2021 Feb 22;96(8):e1156-e1166. doi: 10.1212/WNL.0000000000011106.
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, = 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.
目的
这项来自“超早期康复试验（AVERT）”的三级分析研究了14天时的致命和非致命严重不良事件（SAEs）。
方法
AVERT是一项前瞻性、平行组、评估者盲法、随机国际临床试验，比较了在卒中后<24小时开始的移动训练（称为超早期活动[VEM]）与常规护理（UC）。主要结局在3个月时评估。纳入发病24小时内的缺血性或出血性卒中患者。允许使用溶栓治疗。排除病前有严重残疾或合并症的患者。干预持续14天或至出院（若出院时间早于14天）。主要早期安全性结局是14天内的致命SAEs。次要结局是分为神经系统、与活动不能相关和其他类别的非致命SAEs。使用经基线卒中严重程度（美国国立卫生研究院卒中量表[NIHSS]评分）和年龄调整的二元逻辑回归评估死亡影响因素。
结果
共有2104名参与者被随机分为VEM组（n = 1054）或UC组（n = 1050），中位年龄72岁（四分位间距[IQR]63 - 80），NIHSS评分为7分（IQR 4 - 12）。到14天时,VEM组有48人死亡，UC组有32人死亡，经年龄和卒中严重程度调整后的优势比为1.76（95%置信区间1.06 - 2.92，P = 0.029）。卒中进展在VEM组更常见。探索性亚组分析显示脑出血和>80岁亚组死亡几率更高，但亚组间无显著的治疗交互作用。非致命SAEs方面未发现差异。
结论
虽然卒中后14天的总体病死率仅为3.8%，但与常规护理相比，经年龄和卒中严重程度调整后的死亡率在高剂量和强化训练时有所增加。卒中进展在VEM组更常见。
注册信息
澳大利亚新西兰临床试验注册中心，ACTRN12606000185561。
证据分级
本研究提供了I级证据，即超早期活动会增加卒中后14天的死亡率。
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