Evidence map›Paper›PMID 40152857›Full record

Trial reportJAMA network open2025

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

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

Erratum issued Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in JAMA network open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03469206 (Parallel Group, Randomized Clinical Trial of Direct Intra-arterial Thrombectomy Versus Intravenous Thrombolysis With Intra-arterial Thrombectomy for Patients With Large Vessel Occlusion of the Anterior Circulation), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03469206 nacompletednot on this map

Parallel Group, Randomized Clinical Trial of Direct Intra-arterial Thrombectomy Versus Intravenous Thrombolysis With Intra-arterial Thrombectomy for Patients With Large Vessel Occlusion of the Anterior Circulation

TypeinterventionalSponsorChanghai HospitalRan2018 to 2019Enrolled656ConditionsIschemic Stroke, Large Vessel Occlusion, Thrombectomy, ThrombosisArmsintra-arterial thrombectomy, Intravenous thrombolysis
3 · Its place in the literature

Who cites it

6 citing papers in PubMed.

  1. Article
  2. Article
  3. Article
  4. Article
  5. Error in Title.JAMA network open · 2025
    Article
  6. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors.

Rundong ChenSchool of Health Science and Engineering, University of Shanghai for Science and Technology, Shanghai, China.
Weilong HuaNeurovascular Center, Changhai Hospital, Naval Medical University, Shanghai, China.
Yilei ZhangNursing Department, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Yongxin ZhangNeurovascular Center, Changhai Hospital, Naval Medical University, Shanghai, China.
Hongjian ZhangOriental Pan-Vascular Devices Innovation College, University of Shanghai for Science and Technology, Shanghai, China.
Yongwei ZhangNeurovascular Center, Changhai Hospital, Naval Medical University, Shanghai, China.
Jianmin LiuSchool of Health Science and Engineering, University of Shanghai for Science and Technology, Shanghai, China.
Pengfei YangSchool of Health Science and Engineering, University of Shanghai for Science and Technology, Shanghai, China.
Xiaoxi ZhangNeurovascular Center, Changhai Hospital, Naval Medical University, Shanghai, China.
Lei ZhangNeurovascular Center, Changhai Hospital, Naval Medical University, Shanghai, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Endovascular ProceduresIschemic StrokeStrokeSubarachnoid HemorrhageAgedChinaFemaleHumansMaleMiddle AgedRecovery of FunctionThrombolytic TherapyTreatment Outcome

Identifiers

PMID40152857
PMCPMC11953756

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.