Welcome to the ESOC 2021 Virtual Conference Calendar

Group Name

The TRAIGE Collaborators

Beijing Tiantan Hospital
Liping Liu (PI), Zhonghua Yang, Miao Wen, Ximing Nie, Ying Tan, Yaozhi Chen, Dacheng Liu, Lina Zheng, Jingyi Liu, Jiahui Zhao

Tangshan People’s Hospital
Yan Wang (PI), Mingyang Sun, Wenjian Shi

Tangshan Gongren Hospital
Yibin Cao (PI), Zilong Rao, Yakun Wu, Fengqun Mu, Fengjie Kan, Haiying Wang, Xin Li, Nan Shi, Min Yuan, Yuling Yang, Lingyun Wu, Jingjing Li, Peng Sun, Hong Zhang, Jing Liu, Yueming Tian, Sujie Wang, Qian Li, Lili Chen, Pei Li, Jinghua Liu, Lijuan Liu

Beijing Luhe Hospital
Haomeng Zhu (PI), Huishan Du, Yan’na Tong, Nan Zhang, Fengli Che

Beijing Pinggu Hospital
Yunpeng Zhang (PI), Changbao Li, Yan Wang, Yuming Li, Jincheng Zhang, Jinju Yang

Liangxiang Hospital of Beijing Fangshan District
Lijin Yi (PI), Qingwei Meng, Wenqin Han, Lan Ma, Xinzhang Mu, Jing Yin, Ningning Qin

Kailuan General Hospital, Hebei
Ying Ma (PI), Nannan Zhang, Ya Ou, Lifu Zhou, Yujie Sun, Meng Zhao, Lili Zhang, Yesong Liu, Xiaodong Yuan

Beijing Huairou Hospital of University of Chinese Academy of Sciences
Fuying Yu (PI), Lijun Huang, Lixin Song, Jian Wang

Beijing Daxing District People’s Hospital
Fuming Shi (PI), Liping Dong

Beijing Haidian Hospital
Fengchun Yu (PI), Yongzhen Liu, Xiaomei Tang, Wei Liu, Ke Jia, Zhenghong Zhou, Qunyan Li, Hao Feng, Lei Liu, Fenghui Sun

Background And Aims

Studies show tranexamic acid can reduce the risk of death and early neurological deterioration after intracranial hemorrhage. We aimed to assess whether tranexamic acid reduces hematoma expansion and improves outcome in intracerebral hemorrhage patients susceptible to hemorrhage expansion.

Methods

We did a prospective, double-blind, randomized, placebo-controlled trial at 10 stroke centers in China. Acute supratentorial intracerebral hemorrhage patients were eligible if they had indication of hemorrhage expansion on admission imaging (e.g., spot sign, black hole sign, or blend sign), and were treatable within 8 hours of symptom onset. Patients were randomly assigned (1:1) to receive either tranexamic acid or a matching placebo. The primary outcome was intracerebral hematoma growth (>33% relative or >6 mL absolute) at 24 h. Clinical outcomes were assessed at 90 days.

Results

Of the 171 included patients, 124 (72.5%) were male, and the mean age was 55.9±11.6 years. 89 patients received tranexamic acid and 82 received placebo.36 (40.4%) patients in the tranexamic acid group and 34 (41.5%) patients in the placebo group had intracranial hemorrhage growth (odds ratio [OR] 0.96 [95% CI 0.52-1.77], p=0.89). Less proportion of death were observed in tranexamic acid treatment group than placebo group (8.1% vs 10.0%), but there were no significant differences in secondary outcomes including absolute intracranial hemorrhage growth, death, and dependency.

Conclusions

Among patients susceptible to hemorrhage expansion treated within 8 hours of stroke onset, tranexamic acid did not significantly prevent intracerebral hemorrhage growth. We found it was safe and caused less 90-day death.

Trial Registration Number

NCT02625948

Group Name

ANNEXA-4 Investigators

Background And Aims

Andexanet alfa is a modified recombinant inactive form of factor Xa (FXa) that reverses FXa inhibitors. ANNEXA-4 was a cohort registration study evaluating andexanet in patients with acute major bleeding. We present the final data.

Methods

We evaluated 477 patients with acute major bleeding within 18 hours of FXa inhibitor administration. Co-primary outcomes were percent change in anti–FXa activity from baseline to nadir during andexanet treatment and percentage of patients with excellent or good hemostatic efficacy 12 hours after andexanet treatment.

Results

Mean age was 78 years. Bleeding was predominantly intracranial (329 patients [69%]) or gastrointestinal (109 patients [23%]). In apixaban-treated patients (n=172), median anti–FXa activity decreased from 147 to 10 ng/mL (93% reduction; 95% CI, 94 -90%); in rivaroxaban-treated patients (n=130), it decreased from 214 to 11 ng/mL (94% reduction; 95% CI, 95-93%); in edoxaban-treated patients (n=28), median anti–FXa activity decreased from 121 to 24 ng/mL (71% reduction; 95% CI, 82- 65%); and in enoxaparin-treated patients (n=17), it decreased from 0.48 to 0.11 IU/mL (75% reduction; 95% CI, 79-67%). Excellent or good hemostasis occurred in 272 of 340 evaluable patients (80%, 95% CI 75-84%). Within 30 days, thrombotic events occurred in 50 patients (11%) and death in 81 patients (17%).

Conclusions

In acute major bleeding patients on FXa inhibitors, andexanet treatment reduced anti–FXa activity and resulted in good/excellent hemostasis in 80% of patients.

Trial Registration Number

NCT02329327

Group Name

DECOMPRESS2 Study Group

Background And Aims

Decompressive neurosurgery is recommended in patients with cerebral venous thrombosis (CVT) with large lesions and impending brain herniation. This recommendation is supported by a low level of evidence (retrospective, small sample size studies). We report the 12 months outcome of CVT patients treated by DN in a large multicenter prospective cohort.

Methods

We included consecutive CVT patients treated by decompressive neurosurgery at participating centres. Outcomes were evaluated at discharge, 6 and 12 months by the modified Rankin Scale (mRS) and by patient/caregiver opinion on the benefit of surgery.

Results

118 patients (80 women, median age 38 years) were included from 15 centers in Europe, Asia, and America. Decompressive neurosurgery (115 craniectomies, 37 hematoma evacuations) was performed on a median of 1 day after diagnosis. Before surgery, 68 (57.6%) patients were comatose. Pupillary reflexes were absent unilaterally in 27 (22.9%) and bilaterally in 9 (7.6%).

Twelve-month follow up data was available for 113 (95.8%) patients. Four (3.4%) patients had only 6 months follow up. Forty (33.9%) patients had died (28 during the acute phase), 42 (35.6%) were independent (mRS 0-2), while only 12 patients (10.2%) were severely dependent (mRS 4-5). Among the survivors, 78.9% of the patients and 87.1% of their caregivers had a positive opinion on decompressive neurosurgery.

Conclusions

Despite a severe clinical condition at baseline, two thirds of CVT patients were alive and more than one third were independent one year after decompressive surgery. Decompressive neurosurgery was judged as worthwhile by 4 out of 5 patients/caregivers.

Trial Registration Number

Not applicable

Group Name

On behalf of the MR ASAP Investigators

Background And Aims

A pooled analysis of randomised trials has suggested that administration of glyceryl trinitrate (GTN) via a transdermal patch in the first hours after stroke onset increases the chance of a favourable outcome, but this was not confirmed in a subsequent trial. We assessed the effect of transdermal GTN, started within 3 hours of symptom onset in the prehospital setting, on functional outcome at 90 days in patients with presumed acute stroke.

Methods

We performed a phase 3, multicentre, prospective, randomised, open-label, blinded end point (PROBE) trial in the Netherlands. Adults with presumed acute stroke within 3 hours of symptom onset, a face-arm-speech-time score of 2 or 3, and a systolic blood pressure ≥140 mmHg were randomised (1:1) to receive transdermal GTN (5 mg/day for 24 hours) plus standard care or to standard care alone. GTN was started in the prehospital setting and continued in the hospital. The trial used a deferred consent procedure. The primary outcome was functional outcome assessed with the modified Rankin Scale (mRS) at 90 days, analysed with ordinal logistic regression. Secondary outcomes included mortality and poor outcome (mRS score 3 to 6) at 90 days. Predefined subgroup analyses included stroke type and treatment with intravenous thrombolysis or endovascular thrombectomy. The target sample was 1400 patients. The trial is registered as ISRCTN99503308.

Results

In June 2021, the trial was terminated because of futility after the inclusion of 326 patients.

Conclusions

Final results will be presented at the Conference.

Trial Registration Number

ISRCTN99503308

Background And Aims

Effect of endovascular treatment (EVT) for acute ischemic stroke is time dependent and procedure should be initiated as fast as possible. Interventional expertise is scarce outside big cities, resulting in significant treatment delays and worse outcomes for stroke patients in remote areas. Using a helicopter to transfer a flying intervention team (FIT) to the primary stroke center (PSC) instead of transferring the patient to a comprehensive stroke center (CSC) has been shown to reduce time to treatment by 90 minutes. Aim of this study is to determine whether this new system of care is associated with improved functional outcome.

Methods

This is a prospective cohort study with random allocation of FIT service weeks. It includes consecutive patients from the TEMPiS-FIT registry with indication for EVT after arrival in PSC between 02-2018 and 01-2021. Patients were either treated by FIT in one of 15 participating PSC (available on 26 weeks/year) or transferred for EVT to CSC by emergency medical service. Primary outcome will be distribution of modified Rankin scale at 3 months. Secondary outcomes include clinical and safety outcomes during hospitalization and within 3 months after stroke onset.

Results

Data presentation will include baseline characteristics, procedural parameters and unadjusted and adjusted primary and secondary outcomes of stroke patients with FIT deployment vs. secondary transfer for EVT.

Conclusions

FIT is a novel system of care that reduces time to EVT significantly for eligible patients in underserved areas. Our results will show whether treatment by FIT is associated with improved functional outcome after 3 months.

Trial Registration Number

Not applicable

Group Name

on behalf of the MR CLEAN-MED investigators

Background And Aims

Many ischemic stroke patients do not recover despite fast and complete reperfusion after endovascular therapy (EVT). It is unknown whether periprocedural antithrombotic therapy improves clinical outcome. Our objective was to assess the effect of periprocedural acetylsalicylic acid (ASA), unfractionated heparin (UFH), both, or neither.

Methods

MR CLEAN-MED was a multicenter, prospective, randomized, open-label, blinded-endpoint trial with a 2x3 factorial design. Eligible patients had a clinical diagnosis of ischemic stroke and confirmed intracranial anterior circulation occlusion that could be treated intra-arterially within 6 hours of symptom onset. Patients were randomized for periprocedural intravenous treatment with ASA (300mg bolus) or no ASA, and for moderate-dose UFH (5000 IU bolus, and 1250 IU/hour for 6 hours), low-dose UFH (5000 IU bolus, and 500 IU/hour for 6 hours) or no UFH. The primary outcome was the modified Rankin Scale (mRS) score at 90 days. Safety endpoints included symptomatic intracranial hemorrhage (sICH) and death. We planned to enroll 1500 patients.

Results

After enrolling 132 patients, the Steering Committee decided to stop assigning moderate-dose UFH, because of an increased risk of sICH (adjusted OR 10.0, 95%CI 2.6-40.0). Enrolment in the other arms continued. After enrolling 629 patients, the Steering Committee decided to stop enrollment in the remaining arms, for reasons of safety rather than efficacy. Decisions were taken after obtaining advice from the Data Safety and Monitoring Board, which was based on the 2^nd interim analysis and 11^th safety analysis.

Conclusions

Follow-up will be completed by May 2021. Final results of the trial will be presented at the meeting.

Trial Registration Number

ISRCTN76741621

Group Name

SWIFT DIRECT investigators

Background And Aims

Whether pre-treatment with intravenous alteplase prior to mechanical thrombectomy (MT) in patients with large vessel occlusion is beneficial remains a matter of debate. Two Asian trials (DIRECT MT, DEVT) showed that direct MT is non-inferior to intravenous alteplase plus MT, whereas a European and Asian trial (MR CLEAN noIV, SKIP) failed to prove non-inferiority. SWIFT DIRECT aims to assess, whether direct MT in patients with proximal vessel occlusion in the anterior circulation is non-inferior to intravenous alteplase plus MT.

Methods

We conducted a trial at 44 academic tertiary care centers in Europe and North America to evaluate MT with or without intravenous alteplase in patients with acute ischaemic stroke. Patients with an occlusion of the internal carotid artery or the M1 segment of the middle cerebral artery and immediate access to MT were randomly assigned in a 1:1 ratio to undergo direct MT with a Solitaire device or intravenous alteplase plus MT, at a dose of 0.9 mg per kilogram of body weight, administered within 4.5 hours after symptom onset. Primary efficacy, defined as functional independence (mRS 0-2) at 90 days, was assessed for non-inferiority of the experimental arm to the standard arm using a one-sided type 1-error rate of 5% with a pre-specified non-inferiority margin of 12%.

Results

A total of 404 patients were randomly assigned either to the direct MT group (xy patients) or to the intravenous alteplase plus MT group (xy patients).

Current trial status (April 12, 2021): 373 / 404 patients randomised

Conclusions

To be determined

Trial Registration Number

ClinicalTrials.gov Identifier: NCT03192332

Group Name

on behalf of the Improving Reperfusion strategies in Ischemic Stroke (IRIS) working group investigators (DIRECT MT; MR CLEAN noIV; DEVT; SKIP; SAFE DIRECT; SWIFT DIRECT)

Background And Aims

Whether direct mechanical thrombectomy (MT) in acute ischaemic stroke patients with large vessel occlusion (LVO) is equally effective as intravenous thrombolysis (IVT) with alteplase followed by MT remains a matter of debate. Primary aim of this study was to test non-inferiority of direct mechanical thrombectomy using summary estimates of study-level aggregate data of all randomized controlled trials evaluating direct MT vs IVT followed by MT. Secondary aims included superiority testing of IVT followed by MT versus direct MT and presentation of relevant secondary outcomes.

Methods

We performed a PROSPERO registered, prespecified, systematic review of electronic databases (Web of Science, PubMed, Embase) and meta-analysis with data presentation adherent to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Random effects models were used to pool the study-level data. The primary outcome used for non-inferiority and superiority testing was good functional outcome at 90 days (mRS≤2). The non-inferiority margin was prespecified. Secondary outcomes included excellent functional outcome (mRS≤1), mortality, symptomatic intracranial haemorrhage (sICH), successful reperfusion (TICI≥2b) and procedure-related complications. Five RCTs comprising 2043 patients (xy dMT, yx bridging therapy) were included.

Results

To be determined

Conclusions

To be determined

Trial Registration Number

SWIFT DIRECT NCT03192332

MR CLEAN-NO IV ISRCTN80619088

SKIP UMIN000021488

DIRECT-MT NCT03469206

DEVT ChiCTR-IOR-17013568

Group Name

On behalf of the James Lind Alliance Priority Setting Partnership for Stroke Steering Group

Background And Aims

We currently do not have research priorities, as identified by people affected by stroke and healthcare workers. The Stroke Association (UK) led a Priority Setting Partnership (PSP) using the James Lind Alliance methodology. Here we announce the novel priorities for prevention, diagnosis, and acute care.

Methods

A Steering Group comprising of people affected by stroke and representatives from UK stroke healthcare professional bodies and charities developed the protocol. A first survey collected researchable questions from people affected by stroke and professionals. Unique unanswered questions were developed through de-duplicating, combining and checking against existing evidence. Questions were then categorised according to the stroke care pathway into prioritisation surveys. Workshops with professionals and people affected by stroke will develop the final research priorities.

Results

Almost 4000 questions were collected (41% from professionals; 46% people affected). 39 questions were included in the prevention, diagnosis, pre-hospital and hospital care prioritisation survey, which had 861 responses, resulting in 14 questions selected for the final workshop. The prioritised Top 10 questions will be presented. The process had good representation from professionals and people affected, however we had fewer responses from some Black and Asian ethnic communities.

Conclusions

The Top 10 priorities in stroke prevention, diagnosis, pre-hospital and hospital care will reflect the needs and priorities of professionals and people affected by stroke who will benefit from future stroke research. Stroke research is underfunded so it's vital additional funds are directed towards these priorities.

We acknowledge members of the Steering Group and all participants.

Trial Registration Number

Not applicable