急性卒中的无症状出血事件与功能转归：DIRECT-MI随机临床试验的二次分析
Asymptomatic Hemorrhagic Events and Functional Outcomes in Acute Stroke: A Secondary Analysis of the DIRECT-MI Randomized Clinical Trial.
作者信息
Chen Rundong, Hua Weilong, Zhang Yilei, Zhang Yongxin, Zhang Hongjian, Zhang Yongwei, Liu Jianmin, Yang Pengfei, Zhang Xiaoxi, Zhang Lei
机构信息
School of Health Science and Engineering, University of Shanghai for Science and Technology, Shanghai, China.
Neurovascular Center, Changhai Hospital, Naval Medical University, Shanghai, China.
出版信息
JAMA Netw Open. 2025 Mar 3;8(3):e252411. doi: 10.1001/jamanetworkopen.2025.2411.
IMPORTANCE
Asymptomatic hemorrhagic infarction (HI) and subarachnoid hemorrhage (SAH) after endovascular treatment (EVT) for acute ischemic stroke are commonly considered low risk, but their long-term impact on functional outcomes is unclear.
OBJECTIVE
To determine whether asymptomatic HI and SAH are associated with worse 90-day functional recovery in patients with acute ischemic stroke treated with EVT.
DESIGN, SETTING, AND PARTICIPANTS: This is a secondary analysis of the DIRECT-MT randomized clinical trial, which compared intravenous thrombolysis prior to EVT with EVT alone. The multicenter study was conducted at tertiary hospitals in China between 2016 and 2019 with 90-day follow-up. Trial patients with asymptomatic HI, SAH, or no hemorrhage were included in the present analysis, which was performed in December 2024.
EXPOSURE
Asymptomatic HI and SAH detected on follow-up imaging.
MAIN OUTCOMES AND MEASURES
The primary outcome was the score on the modified Rankin scale (mRS) assessed at 90 days. Secondary analyses categorized mRS scores into thresholds of 0 to 1, 0 to 2, and 0 to 3, representing excellent, good, and favorable recovery, respectively.
RESULTS
A total of 490 patients were included (median [IQR] age, 70 [60-76] years; 210 [42.9%] female), with 133 (27.1%) in the asymptomatic HI and SAH group and 357 (72.9%) in the no hemorrhage group. After propensity score matching, the odds ratio of having a worse mRS scores at 90 days in the asymptomatic HI and SAH group compared with the no hemorrhage group was 2.59 (95% CI, 1.45-4.63; P = .001). For binary outcomes, asymptomatic HI and SAH were consistently associated with worse recovery across mRS score thresholds of 0 to 1 and 0 to 2 in all models.
CONCLUSIONS AND RELEVANCE
In this secondary analysis of a randomized clinical trial, asymptomatic HI and SAH were associated with worse 90-day functional outcomes in patients with acute ischemic stroke treated with EVT. These findings emphasize the need for close monitoring and tailored management strategies in patients with asymptomatic hemorrhagic events following thrombectomy.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT03469206.
重要性
急性缺血性卒中血管内治疗（EVT）后无症状性出血性梗死（HI）和蛛网膜下腔出血（SAH）通常被认为风险较低，但其对功能结局的长期影响尚不清楚。
目的
确定无症状性HI和SAH是否与接受EVT治疗的急性缺血性卒中患者90天功能恢复较差有关。
设计、设置和参与者：这是对DIRECT-MT随机临床试验的二次分析，该试验比较了EVT前静脉溶栓与单纯EVT。这项多中心研究于2016年至2019年在中国三级医院进行，随访90天。本分析纳入了无症状性HI、SAH或无出血的试验患者，分析于2024年12月进行。
暴露因素
随访影像学检查发现的无症状性HI和SAH。
主要结局和测量指标
主要结局是90天时评估的改良Rankin量表（mRS）评分。二次分析将mRS评分分为0至1、0至2和0至3的阈值，分别代表优秀、良好和有利的恢复。
结果
共纳入490例患者（年龄中位数[四分位间距]，70[60-76]岁；210例[42.9%]为女性），无症状性HI和SAH组133例（27.1%），无出血组357例（72.9%）。倾向评分匹配后，无症状性HI和SAH组90天时mRS评分较差的比值比为2.59（95%CI，1.45-4.63；P = .001）。对于二分结局，在所有模型中，无症状性HI和SAH在mRS评分阈值0至1和0至2时均与较差的恢复一致相关。
结论和相关性
在这项随机临床试验的二次分析中，无症状性HI和SAH与接受EVT治疗的急性缺血性卒中患者90天功能结局较差有关。这些发现强调了对血栓切除术后无症状性出血事件患者进行密切监测和制定个性化管理策略的必要性。
试验注册
ClinicalTrials.gov标识符：NCT03469206。
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