Asymptomatic Hemorrhagic Events and Functional Outcomes in Acute Stroke: A Secondary Analysis of the DIRECT-MI Randomized Clinical Trial.

IF 10.5 1区医学 Q1 MEDICINE, GENERAL & INTERNAL

JAMA Network Open Pub Date : 2025-03-03 DOI:10.1001/jamanetworkopen.2025.2411

Rundong Chen, Weilong Hua, Yilei Zhang, Yongxin Zhang, Hongjian Zhang, Yongwei Zhang, Jianmin Liu, Pengfei Yang, Xiaoxi Zhang, Lei Zhang

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引用次数: 0

Abstract

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.

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急性卒中的无症状出血事件和功能结局：DIRECT-MI随机临床试验的二次分析。

重要性：急性缺血性卒中血管内治疗（EVT）后无症状出血性梗死（HI）和蛛网膜下腔出血（SAH）通常被认为是低风险的，但它们对功能结局的长期影响尚不清楚。目的：确定无症状HI和SAH是否与EVT治疗的急性缺血性脑卒中患者90天功能恢复较差相关。设计、环境和参与者：这是对DIRECT-MT随机临床试验的二次分析，该试验比较了EVT前静脉溶栓和单独EVT。该多中心研究于2016年至2019年在中国三级医院进行，随访90天。无症状HI、SAH或无出血的试验患者纳入本分析，该分析于2024年12月进行。暴露：随访影像学发现无症状HI和SAH。主要结果和测量方法：主要结果是在90天评估的改良Rankin量表（mRS）得分。二次分析将mRS评分分为0 - 1、0 - 2和0 - 3三个阈值，分别代表极好、良好和有利的恢复。结果：共纳入490例患者(中位[IQR]年龄为70[60-76]岁；210例（42.9%），其中无症状HI和SAH组133例（27.1%），无出血组357例（72.9%）。倾向评分匹配后，与无出血组相比，无症状HI和SAH组90天mRS评分较差的比值比为2.59 (95% CI, 1.45-4.63；p = .001)。对于二元结果，在所有模型中，无症状的HI和SAH在mRS评分阈值为0到1和0到2时始终与较差的恢复相关。结论和相关性：在一项随机临床试验的二级分析中，无症状HI和SAH与接受EVT治疗的急性缺血性卒中患者90天功能预后较差相关。这些发现强调了对血栓切除术后无症状出血事件患者进行密切监测和量身定制管理策略的必要性。试验注册：ClinicalTrials.gov标识符：NCT03469206。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

JAMA Network Open Medicine-General Medicine

CiteScore

16.00

自引率

2.90%

发文量

2126

审稿时长

16 weeks

期刊介绍： JAMA Network Open, a member of the esteemed JAMA Network, stands as an international, peer-reviewed, open-access general medical journal.The publication is dedicated to disseminating research across various health disciplines and countries, encompassing clinical care, innovation in health care, health policy, and global health. JAMA Network Open caters to clinicians, investigators, and policymakers, providing a platform for valuable insights and advancements in the medical field. As part of the JAMA Network, a consortium of peer-reviewed general medical and specialty publications, JAMA Network Open contributes to the collective knowledge and understanding within the medical community.