Endovascular therapy in acute ischaemic stroke with large infarction with matched or mismatched clinical-radiological severities: a post-hoc analysis of the ANGEL-ASPECT trial.

Background: Endovascular therapy (EVT) was demonstrated effective in acute large vessel occlusion (LVO) with large infarction. Revealing subgroups of patients who would or would not benefit from EVT will further inform patient selection for EVT. Methods: This post-hoc analysis of the ANGEL-ASPECT trial, a randomised controlled trial of 456 adult patients with acute anterior-circulation LVO and large infarction, defined by ASPECTS 3-5 or infarct core volume 70-100 mL, enrolled from 46 centres across China, between October 2, 2020 and May 18, 2022. Patients were randomly assigned (1:1) to receiving EVT and medical management or medical management alone. One patient withdrew consent, 455 patients were included in this post-hoc analysis and categorised into 4 subgroups by lower or higher NIHSS (< or ≥16) and smaller or larger infarct core (< or ≥70 mL). Those with lower NIHSS & smaller core, and higher NIHSS & larger core were considered clinical-radiological matched subgroups; otherwise clinical-radiological mismatched subgroups. Primary outcome was 90-day modified Rankin Scale (mRS). ANGEL-ASPECT is registered with ClinicalTrials.gov, NCT04551664. Findings: Overall, 139 (30.5%) patients had lower NIHSS & smaller core, 106 (23.3%) higher NIHSS & larger core, 130 (28.6%) higher NIHSS & smaller core, and 80 (17.6%) lower NIHSS & larger core. There was significant ordinal shift in the 90-day mRS toward a better outcome with EVT in clinical-radiological matched subgroups: lower NIHSS & smaller core (generalised OR, 1.76; 95% CI, 1.18-2.62; p = 0.01) and higher NIHSS & larger core (1.64; 1.06-2.54; 0.01); but not in the two clinical-radiological mismatched subgroups. Interpretation: Our findings suggested that in patients with anterior-circulation LVO and large infarction, EVT was associated with improved 90-day functional outcomes in those with matched clinical and radiological severities, but not in those with mismatched clinical and radiological severities. Simultaneous consideration of stroke severity and infarct core volume may inform patient selection for EVT. Funding: Unrestricted grants from industry [Covidien Healthcare International Trading (Shanghai), Johnson & Johnson MedTech, Genesis MedTech (Shanghai), and Shanghai HeartCare Medical Technology].

Unsuccessful Recanalization versus Medical Management of Patients with Large Ischemic Core : Analysis of the ANGEL-ASPECT Randomized Trial.

PURPOSE: The outcomes of patients with large ischemic core who fail to recanalize with endovascular therapy (EVT) compared to medical management (MM) are uncertain. The objective was to evaluate the clinical and safety outcomes of patients who underwent EVT in patients with large ischemic core and unsuccessful recanalization. METHODS: This was a post hoc analysis of the ANGEL-ASPECT randomized trial. Unsuccessful recanalization was defined as patients who underwent EVT with eTICI 0-2a. The primary endpoint was 90-day very poor outcome (mRS 5-6). Multivariable logistic regression was conducted controlling for ASPECTS, occlusion location, intravenous thrombolysis, and time to treatment. RESULTS: Of 455 patients 225 were treated with MM. Of 230 treated with EVT, 43 (19%) patients had unsuccessful recanalization. There was no difference in 90-day very poor outcomes (39.5% vs. 40%, aOR 0.93, 95% confidence interval, CI 0.47-1.85, p = 0.95), sICH (7.0% vs. 2.7%, aOR 2.81, 95% CI 0.6-13.29, p = 0.19), or mortality (30% vs. 20%, aOR 1.65, 95% CI 0.89-3.06, p = 0.11) between the unsuccessful EVT and MM groups, respectively. There were higher rates of ICH (55.8% vs. 17.3%, p < 0.001), infarct core volume growth (142.7 ml vs. 90.5 ml, ß = 47.77, 95% CI 20.97-74.57 ml, p < 0.001), and decompressive craniectomy (18.6% vs. 3.6%, p < 0.001) in the unsuccessful EVT versus MM groups. CONCLUSION: In a randomized trial of patients with large ischemic core undergoing EVT with unsuccessful recanalization, there was no difference in very poor outcomes, sICH or death versus medically managed patients. In the unsuccessful EVT group, there were higher rates of any ICH, volume of infarct core growth, and decompressive craniectomy.

The impact of intraarterial, intravenous, and combined tirofiban on endovascular treatment for acute intracranial atherosclerotic occlusion.

Background and purpose: Adjunctive tirofiban administration in patients undergoing endovascular treatment (EVT) for acute large vessel occlusion (LVO) has been investigated in several studies. However, the findings are conflict. This study aimed to compare the effect of different administration pathways of tirofiban on patients undergoing EVT for acute LVO with intracranial atherosclerotic disease (ICAD). Methods: Patients were selected from the ANGEL-ACT Registry (Endovascular Treatment Key Technique and Emergency Workflow Improvement of Acute Ischemic Stroke: A Prospective Multicenter Registry Study) and divided into four groups: intra-arterial (IA), intravenous (IV), and intra-arterial plus intravenous (IA+IV) and non-tirofiban. The primary outcome was 90-day ordinal modified Rankin Scale (mRS) score, and the secondary outcomes included the rates of mRS 0-1, 0-2, and 0-3 at 90-day, successful recanalization. The safety outcomes were symptomatic intracranial hemorrhage (sICH) and other safety endpoints. The multivariable logistic regression models adjusting for potential baseline confounders were performed to compare the outcomes. A propensity score matching (PSM) with a 1:1:1:1 ratio was conducted among four groups, and the outcomes were then compared in the post-matched population. Results: A total of 502 patients were included, 80 of which were in the IA-tirofiban group, 73 in IV-tirofiban, 181 in (IA+IV)-tirofiban group, and 168 in the non-tirofiban group. The median (IQR) 90-day mRS score in the four groups of IA, IV, IA+IV, and non-tirofiban was, respectively 3(0-5) vs. 1(0-4) vs. 1(0-4) vs. 3(0-5). The adjusted common odds ratio (OR) for 90-day ordinal modified Rankin Scale distribution with IA-tirofiban vs. non-tirofiban was 0.77 (95% CI, 0.45-1.30, P = 0.330), with IV-tirofiban vs. non-tirofiban was 1.36 (95% CI, 0.78-2.36, P = 0.276), and with (IA+IV)-tirofiban vs. non-tirofiban was 1.03 (95% CI, 0.64-1.64, P = 0.912). The adjusted OR for mRS 0-1 and mRS 0-2 at 90-day with IA-tirofiban vs. non-tirofiban was, respectively 0.51 (95% CI, 0.27-0.98, P = 0.042) and 0.50 (95% CI, 0.26-0.94, P = 0.033). The other outcomes of each group were similar with non-tirofiban group, all P was >0.05. After PSM, the common odds ratio (OR) for 90-day ordinal modified Rankin Scale distribution with IA-tirofiban vs. non-tirofiban was 0.41 (95% CI, 0.18-0.94, P = 0.036), and the OR for mRS 0-1 and mRS 0-2 at 90-day with IA-tirofiban vs. non-tirofiban was, respectively 0.28 (95% CI, 0.11-0.74, P = 0.011) and 0.25 (95% CI, 0.09-0.67, P = 0.006). Conclusions: Intra-arterial administration of tirofiban was associated with worse outcome than non-tirofiban, which suggested that intra-arterial tirofiban had a harmful effect on patients undergoing EVT for ICAD-LVO. Clinical trial registration: http://www.clinicaltrials.gov, Unique identifier: NCT03370939.

Environmental factors affecting the risk of generalization for ocular-onset myasthenia gravis: a nationwide cohort study.

BACKGROUND: The environmental effects on the prognosis of ocular myasthenia gravis (OMG) remain largely unexplored. AIM: To investigate the association between specific environmental factors and the generalization of OMG. DESIGN: The cohort study was conducted in China based on a nationwide multicenter database. METHODS: Adult patients with OMG at onset, who were followed up for at least 2 years until May 2022, were included. We collected data on demographic and clinical factors, as well as environmental factors, including latitude, socioeconomic status (per capita disposable income [PDI] at provincial level and education) and smoking. The study outcome was the time to the development of generalized myasthenia gravis (GMG). Cox models were employed to examine the association between environmental exposures and generalization. Restricted cubic spline was used to model the association of latitude with generalization risk. RESULTS: A total of 1396 participants were included. During a median follow-up of 5.15 (interquartile range [IQR] 3.37-9.03) years, 735 patients developed GMG within a median of 5.69 (IQR 1.10-15.66) years. Latitude of 20-50°N showed a U-shaped relation with generalization risk, with the lowest risk at around 30°N; both higher and lower latitudes were associated with the increased risk (P for non-linearity <0.001). Living in areas with lower PDI had 1.28-2.11 times higher risk of generalization. No significant association was observed with education or smoking. CONCLUSIONS: Latitude and provincial-level PDI were associated with the generalization of OMG in China. Further studies are warranted to validate our findings and investigate their potential applications in clinical practice and health policy.

Alberta Stroke Program Early Computed Tomography Score, Infarct Core Volume, and Endovascular Therapy Outcomes in Patients With Large Infarct: A Secondary Analysis of the ANGEL-ASPECT Trial.

Importance: Endovascular therapy (EVT) demonstrated better outcomes compared with medical management in recent randomized clinical trials (RCTs) of patients with large infarct. Objective: To compare outcomes of EVT vs medical management across different strata of the Alberta Stroke Program Early Computed Tomography Score (ASPECTS) and infarct core volume in patients with large infarct. Design, Setting, and Participants: This prespecified secondary analysis of subgroups of the Endovascular Therapy in Acute Anterior Circulation Large Vessel Occlusive Patients With a Large Infarct Core (ANGEL-ASPECT) RCT included patients from 46 stroke centers across China between October 2, 2020, and May 18, 2022. Participants were enrolled within 24 hours of symptom onset and had ASPECTS of 3 to 5 or 0 to 2 and infarct core volume of 70 to 100 mL. Patients were divided into 3 groups: ASPECTS of 3 to 5 with infarct core volume less than 70 mL, ASPECTS of 3 to 5 with infarct core volume of 70 mL or greater, and ASPECTS of 0 to 2. Interventions: Endovascular therapy or medical management. Main Outcomes and Measures: The primary outcome was the ordinal 90-day modified Rankin Scale (mRS) score. Results: There were 455 patients in the trial; median age was 68 years (IQR, 60-73 years), and 279 (61.3%) were male. The treatment effect did not vary significantly across the 3 baseline imaging subgroups (P = .95 for interaction). The generalized odds ratio for the shift in the 90-day mRS distribution toward better outcomes with EVT vs medical management was 1.40 (95% CI, 1.06-1.85; P = .01) in patients with ASPECTS of 3 to 5 and infarct core volume less than 70 mL, 1.22 (95% CI, 0.81-1.83; P = .23) in patients with ASPECTS of 3 to 5 and infarct core volume of 70 mL or greater, and 1.59 (95% CI, 0.89-2.86; P = .09) in patients with ASPECTS of 0 to 2. Conclusions and Relevance: In this study, no significant interaction was found between baseline imaging status and the benefit of EVT compared with medical management in patients with large infarct core volume. However, estimates within subgroups were underpowered. A pooled analysis of large core trials stratified by ASPECTS and infarct core volume strata is warranted. Trial Registration: ClinicalTrials.gov Identifier: NCT04551664.

Early monitoring of intravenous thrombolysis in acute ischaemic stroke using wearable intelligent vital sign devices: protocol for a prospective, multicentre, observational registry cohort study.

INTRODUCTION: Continuous monitoring of vital signs during and after ischaemic stroke was recommended by the 'Guidelines for the Early Management of Patients with Acute Ischaemic Stroke: 2019 Update to the 2018 Guidelines for the Early Management of Acute Ischaemic Stroke'. Vital sign data can be associated with disease conditions and prognosis, while there is limited evidence regarding continuous monitoring of vital signs during and after acute ischaemic stroke. The wearable intelligent vital sign monitoring device is small and lightweight and constantly monitors the health status during daily activities. However, wearable intelligent vital sign monitoring devices have not been widely used in clinical practice so far. Therefore, we will investigate the effectiveness and safety of wearable intelligent vital sign monitoring devices in early in-hospital management and monitoring programmes for patients with acute ischaemic stroke. This paper presents the study protocol. METHODS AND DESIGN: This study is a prospective, multicentre, observational registry study starting from 20 March 2023 to 20 March 2025. A total of 5740 patients with acute ischaemic stroke from 10 Chinese hospitals are planned to be enrolled. Continuous vital sign data, demographics, medical history, medication history, treatments, laboratory tests, imaging scans and follow-up data will be collected. Follow-up time points were 30 days after discharge, 30 days after intravenous thrombolysis, 3 months after intravenous thrombolysis and 12 months after intravenous thrombolysis (until March 2026). The primary outcome included the evaluation of the modified Rankin Scale at 3 months, as well as the assessment of the rate of symptomatic and asymptomatic intracranial haemorrhage throughout the hospitalisation period. ETHICS AND DISSEMINATION: This study has been approved by the Medical Ethics Committee of Xuanwu Hospital, Capital Medical University ([2022] 203). We plan to disseminate the research findings through publication in peer-reviewed scientific journals and presentations at international conferences. TRIAL REGISTRATION NUMBER: ChiCTR2300069512.

Cost-effectiveness of endovascular therapy for acute ischemic stroke with large infarct in China.

BACKGROUND: Endovascular therapy administered within 24 hours has been shown to improve outcomes for patients with acute ischemic stroke with large infarction, but the data on its cost-effectiveness are limited. OBJECTIVE: To evaluate the cost-effectiveness of endovascular therapy for acute ischemic stroke with large infarction in China, the largest low- and middle-income country. METHODS: A short-term decision tree model and a long-term Markov model were used to analyze the cost-effectiveness of endovascular therapy for patients with acute ischemic stroke with large infarction. Outcomes, transition probability, and cost data were obtained from a recent clinical trial and published literature. The benefit of endovascular therapy was assessed by the cost per quality-adjusted life-years (QALYs) gained in the short and long term. Deterministic one-way and probabilistic sensitivity analyses were performed to assess the robustness of the results. RESULTS: Compared with medical management alone, endovascular therapy for acute ischemic stroke with large infarction was found to be cost-effective from the fourth year onward and during a lifetime. In the long term, endovascular therapy yielded a lifetime gain of 1.33 QALYs at an additional cost of ¥73 900 (US$ 11 400), resulting in an incremental cost of ¥55 500 (US$ 8530) per QALY gained. Probabilistic sensitivity analysis showed that endovascular therapy was cost-effective in 99.5% of the simulation runs at a willingness-to-pay threshold of ¥243 000 (3 × gross domestic product per capita of China in 2021) per QALY gained. CONCLUSIONS: Endovascular therapy for acute ischemic stroke with large infarction could be cost-effective in China.

Does MRI add value in selecting patients for thrombectomy beyond the 6 h window? A matched-control analysis.

Background: Controversy exists regarding the need of advanced imaging for patient selection in the extended window. Aims: To analyze the effect of initial imaging modalities on clinical outcomes of patients underwent MT in the extended window. Methods: This was a retrospective analysis of a prospective registry, the Endovascular Treatment Key Technique and Emergency Workflow Improvement of Acute Ischemic Stroke (ANGEL-ACT) registry which was conducted at 111 hospitals between November 2017 and March 2019 in China. Primary study cohort and Guideline like cohort were identified, in each cohort, two imaging modalities for patient selection in 6 to 24 h window were defined: (1) NCCT ± CTA, (2) MRI. Guideline-like cohort were further screened based on key features of the DAWN and DEFUSE 3 trials. The primary outcome was 90 day mRS. The safety outcomes were sICH, any ICH and 90-day mortality. Results: After adjusting for covariates, there were no significant differences in 90 day mRS or any safety outcomes between two imaging modalities groups in both cohorts. All outcome measures of mixed-effects logistic regression model were consistent with propensity score matching model. Conclusion: Our results indicate that patients presented with anterior large vessel occlusion in the extended time window can potentially benefit from MT even in the absence of MRI selection. This conclusion needs to be verified by the prospective randomized clinical trials.

First-pass effect of mechanical thrombectomy for anterior circulation large vessel occlusion: incidence, predictors, and clinical impact. Insight from the ANGEL-ACT registry.

OBJECTIVE: The objective of this study was to investigate the incidence and predictors of first-pass effect (FPE) and to compare the clinical outcomes among FPE, multiple-pass effect, and incomplete reperfusion (ICR) in acute anterior circulation large vessel occlusion. METHODS: Patients from the ANGEL-ACT (Endovascular Treatment Key Technique and Emergency Workflow Improvement of Acute Ischemic Stroke) registry were included. FPE was defined as complete reperfusion after a single pass of the thrombectomy device without rescue treatment. MPE was defined as complete reperfusion after ≥ 2 passes of the thrombectomy device. ICR was defined as a modified Thrombolysis in Cerebral Infarction score of 2b independent of the number of passes. Multivariable analyses were used to determine predictors of FPE and to compare the following outcomes: functional independence, mortality within 90 days, intraprocedural complications, and intracranial hemorrhage (ICH) among FPE, MPE, and ICR. RESULTS: There were 1139 patients, of whom 307 (27.0%) achieved FPE. FPE was related to occlusion location (M1 vs internal carotid artery [ICA], adjusted OR [aOR] 1.57, 95% CI 1.15-2.15, p = 0.004; M2/anterior cerebral artery vs ICA, aOR 2.06, 95% CI 1.32-3.22, p = 0.002) and negatively associated with underlying intracranial atherosclerosis disease (ICAD) (aOR 0.33, 95% CI 0.23-0.49, p < 0.001). Patients with FPE had a higher rate of functional independence (52.7% of FPE patients vs 45.6% of MPE patients and 37.1% of ICR patients, p = 0.002; MPE vs FPE, aOR 0.69, 95% CI 0.51-0.95, p = 0.023; ICR vs FPE, aOR 0.45, 95% CI 0.31-0.66, p < 0.001), lower rate of intraprocedural complications (4.2% vs 18.1% and 21.2%, p < 0.001; MPE vs FPE, aOR 6.23, 95% CI 3.36-11.54, p < 0.001; ICR vs FPE, aOR 7.70, 95% CI 3.97-14.94, p < 0.001), and lower rate of ICH within 24 hours (18.3% vs 27.9% and 26.9%, p = 0.009; MPE vs FPE, aOR 1.97, 95% CI 1.35-2.86, p < 0.001; ICR vs FPE, aOR 2.03, 95% CI 1.30-3.16, p = 0.002) than those with MPE and ICR. CONCLUSIONS: FPE was achieved at a rate of 27.0% and associated with functional independence, decreased intraprocedural complications, and ICH. Non-ICA occlusion and underlying ICAD were predictors of FPE.

Trial of Endovascular Therapy for Acute Ischemic Stroke with Large Infarct.

BACKGROUND: The role of endovascular therapy for acute stroke with a large infarction has not been extensively studied in differing populations. METHODS: We conducted a multicenter, prospective, open-label, randomized trial in China involving patients with acute large-vessel occlusion in the anterior circulation and an Alberta Stroke Program Early Computed Tomography Score of 3 to 5 (range, 0 to 10, with lower values indicating larger infarction) or an infarct-core volume of 70 to 100 ml. Patients were randomly assigned in a 1:1 ratio within 24 hours from the time they were last known to be well to undergo endovascular therapy and receive medical management or to receive medical management alone. The primary outcome was the score on the modified Rankin scale at 90 days (scores range from 0 to 6, with higher scores indicating greater disability), and the primary objective was to determine whether a shift in the distribution of the scores on the modified Rankin scale at 90 days had occurred between the two groups. Secondary outcomes included scores of 0 to 2 and 0 to 3 on the modified Rankin scale. The primary safety outcome was symptomatic intracranial hemorrhage within 48 hours after randomization. RESULTS: A total of 456 patients were enrolled; 231 were assigned to the endovascular-therapy group and 225 to the medical-management group. Approximately 28% of the patients in both groups received intravenous thrombolysis. The trial was stopped early owing to the efficacy of endovascular therapy after the second interim analysis. At 90 days, a shift in the distribution of scores on the modified Rankin scale toward better outcomes was observed in favor of endovascular therapy over medical management alone (generalized odds ratio, 1.37; 95% confidence interval, 1.11 to 1.69; P = 0.004). Symptomatic intracranial hemorrhage occurred in 14 of 230 patients (6.1%) in the endovascular-therapy group and in 6 of 225 patients (2.7%) in the medical-management group; any intracranial hemorrhage occurred in 113 (49.1%) and 39 (17.3%), respectively. Results for the secondary outcomes generally supported those of the primary analysis. CONCLUSIONS: In a trial conducted in China, patients with large cerebral infarctions had better outcomes with endovascular therapy administered within 24 hours than with medical management alone but had more intracranial hemorrhages. (Funded by Covidien Healthcare International Trading [Shanghai] and others; ANGEL-ASPECT ClinicalTrials.gov number, NCT04551664.).

Sex-Related Differences in Outcomes of Endovascular Treatment for Anterior Circulation Large Vessel Occlusion.

BACKGROUND: Sex disparities in acute large vessel occlusion (LVO) following endovascular treatment (EVT) have been recently reported. However, there is uncertainty about the effect of sex differences on functional outcomes after EVT, particularly in an Asian population. The present study aimed to compare the clinical and safety outcomes between men and women with anterior circulation LVO treated with EVT. METHODS: We analyzed data from the ANGEL-ACT (Endovascular Treatment Key Technique and Emergency Work Flow Improvement of Acute Ischemic Stroke: a Prospective Multicenter Registry Study) Registry, which was conducted at 111 hospitals from 26 provinces in China between November 2017 and March 2019. Men and women with anterior circulation LVO treated with EVT were matched using propensity scores. After a 1:1 propensity score matching, we compared the clinical outcomes including 90-day ordinal modified Rankin Scale distribution (primary outcome), procedure duration, successful reperfusion, symptomatic intracranial hemorrhage, and mortality. Furthermore, we explored sex modification on the primary outcome in subgroup analysis. RESULTS: Of 1321 patients, 483 (36.6%) were women and 838 (63.4%) were men. The mean age for women and men were 68 and 62 years old, respectively. Among 578 patients identified after matching, there were no sex differences (men versus women) in 90-day ordinal modified Rankin Scale distribution (median [interquartile range], 4 [1-5] versus 3 [1-5], P=0.464), successful reperfusion (86.5% versus 91.0%, P=0.089), symptomatic intracranial hemorrhage (6.5% versus 7.9%, P=0.512), and mortality within 90 days (17.7% versus 17.0%, P=0.826). However, men had a longer median procedure duration than women (86 [52-128] versus 72 [48-110] minutes, ß=14.51, [95% CI, 4.19-24.84]; P=0.006). Subgroup analysis showed that in patients with National Institutes of Health Stroke Scale score <15, women tended to have a better outcome than men, whereas there was no gender effect in those with National Institutes of Health Stroke Scale score ≥15 (P for interaction=0.032). CONCLUSIONS: Overall, this matched-control study from the ANGEL-ACT study showed similar clinical outcomes between men and women with anterior circulation LVO treated with EVT. However, in the subgroup of patients presenting with lower stroke severity (ie, National Institutes of Health Stroke Scale score <15), women tended to have a better outcome than men highlighting a potential sex disparity for further investigation. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT03370939.

Mechanical thrombectomy with combined stent retriever and contact aspiration versus stent retriever alone for acute large vessel occlusion: data from ANGEL-ACT registry.

BACKGROUND AND PURPOSE: An analysis of the ASTER 2 trial revealed similar final recanalisation levels and clinical outcomes in acute large vessel occlusion (LVO) stroke between stent retrieval (SR) alone as a first-line mechanical thrombectomy (MT) technique (SR alone first-line) and concomitant use of contact aspiration (CA) plus SR as a first-line MT technique (SR+CA first-line). The purpose of the present study was to compare the safety and efficacy of SR+CA first-line with those of SR alone first-line for patients with LVO in China. METHODS: We conducted the present study by using the data from the ANGEL-ACT registry. We divided the selected patients into SR+CA first-line and SR alone first-line groups. We performed logistic regression and generalised linear models with adjustments to compare the angiographic and clinical outcomes, including successful/complete recanalisation after the first technique alone and all procedures, first-pass successful/complete recanalisation, number of passes, 90-day modified Rankin Scale, procedure duration, rescue treatment and intracranial haemorrhage within 24 hours. RESULTS: Of the 1233 enrolled patients, 1069 (86.7%) received SR alone first-line, and 164 (13.3%) received SR+CA first-line. SR+CA first-line was associated with more thrombectomy passes (3 (2-4) vs 2 (1-2); ß=1.77, 95% CI=1.55 to 1.99, p<0.001), and longer procedure duration (86 (60-129) min vs 80 (50-122) min; ß=10.76, 95% CI=1.08 to 20.43, p=0.029) than SR alone first-line group. Other outcomes were comparable (all p>0.05) between the two groups. CONCLUSIONS: Patients undergoing SR+CA first-line had more thrombectomy passes and longer procedure duration than patients undergoing SR alone first-line. Additionally, we suggested that SR+CA first-line was not superior to SR alone first-line in final recanalisation level, first-pass recanalisation level and 90-day clinical outcomes in the Chinese population.

Incidence, predictors, and impact on outcome of underlying intracranial atherosclerotic disease in acute vertebrobasilar artery occlusion undergoing endovascular therapy: Data from ANGEL-ACT registry.

BACKGROUND AND PURPOSE: Intracranial atherosclerotic disease (ICAD) is a common etiology of acute vertebrobasilar artery occlusion (VBAO) in Asia, which complicated endovascular treatment (EVT). We aimed to investigate the incidence, impacts, and predictors of ICAD in VBAO. METHODS: Subjects were selected from the Endovascular Treatment Key Technique and Emergency Work Flow Improvement of Acute Ischemic Stroke registry and divided into two groups based on whether underlying ICAD existed. Underlying ICAD was determined when the following situations arise in the occlusion site during EVT: (1) fixed stenosis degree >70% or (2) stenosis >50% with distal blood flow impairment or evidence of repeated reocclusion. Multivariable regression models were used to investigate the effect of underlying ICAD on outcomes measured by modified Rankin Scale (mRS) score at 90 days and to identify baseline characteristics associated with underlying ICAD. RESULTS: Among the 315 patients enrolled, 171 (54.3%) had underlying ICAD. Favorable functional outcomes (mRS 0-3) occurred in 79 of 163 patients (48.5%) with ICAD and 69 of 137 patients (50.4%) without ICAD (p = 0.743). Outcomes were similar between the two groups and remained similar after adjusting for the confounders. History of hypertension and elevated admission neutrophil to lymphocyte ratio were strong predictors of underlying ICAD, whereas history of atrial fibrillation and distal basilar artery occlusion were negative predictors. CONCLUSIONS: In our study, underlying ICAD was recognized in approximately half of the VBAO patients, leading to comparable outcomes after more complex EVT strategies. Some baseline characteristics were identified to be predictors for underlying ICAD, which were helpful to guide the EVT strategies before the procedure.

Delayed neurological improvement after endovascular treatment for acute large vessel occlusion: data from ANGEL-ACT registry.

BACKGROUND: A subgroup of patients with acute large vessel occlusion (ALVO) may experience delayed neurological improvement (DNI) after endovascular treatment (EVT). Our study aimed to investigate the incidence and independent predictors of DNI in patients with ALVO after EVT. METHODS: We selected subjects from ANGEL-ACT Registry. The definition of DNI is patients with ALVO who did not experience early neurological improvement (ENI) despite complete recanalization after EVT. These patients achieved a 90-day favorable outcome assessed by a modified Rankin Scale (mRS) score. We defined ENI as a ≥ 4-point decrease in the National Institutes of Health Stroke Scale (NIHSS) between baseline and 24 h or NIHSS of 0 or 1 at 24 h, with complete recanalization after EVT. We performed logistic regression analyses to determine the independent predictors of DNI. RESULTS: Among the 1056 enrolled patients, 406 (38.4%) did not experience ENI. 106 (26.1%) patients without ENI achieved DNI. On Multivariate analysis, lower admission NIHSS score (odds ratio [OR] = 1.17,95% confidence interval [CI]: 1.11-1.23, P < 0.001), underlying ICAD (OR = 2.03, 95% CI: 1.07-3.85, P = 0.029) and absence of general anesthesia (OR = 2.13, 95% CI: 1.24-3.64, P = 0.006) were independent predictors of DNI. CONCLUSION: DNI occurred in 26.1% of patients with ALVO who did not experience ENI after EVT. Our study identified several independent predictors of DNI that should be highly considered in daily clinical practice to improve ALVO management.

Predictors of poor outcome after endovascular treatment for acute vertebrobasilar occlusion: data from ANGEL-ACT registry.

PURPOSE: Acute vertebrobasilar artery occlusion (VBAO) is a catastrophic disease for patients. There is evidence that the eventual patient outcome depends on patient-specific and procedural factors. This study aimed to identify the incidence and independent predictors of the 90-day poor outcome in VBAO after endovascular treatment (EVT). METHODS: Subjects were selected from the ANGEL-ACT registry. The 90-day poor outcome was defined as a 90-day modified Rankin Scale (mRS) of 4 to 6. Logistic regression analyses were performed to determine the independent predictors of the 90-day poor outcome. RESULTS: Of the 347 enrolled patients with acute VBAO undergoing EVT, 176 (50.7%) experienced the 90-day poor outcome. Multivariate logistic regression indicated that only the use of general anesthesia (GA) (odds ratio [OR] = 2.04; 95% confidence interval [CI], 1.23-3.37; P = 0.006) and heparin during the procedure (OR =1.74; 95% CI, 1.06-2.86; P = 0.028), admission National Institute of Health Stroke Scale (NIHSS) ≥ 26 (OR=3.96; 95% CI, 2.37-6.61; P < 0.001), and time from onset to puncture (OTP) ≥ 395 min (OR=1.91; 95% CI, 1.14-3.20; P = 0.014) and procedure duration ≥ 102 min (OR = 1.70; 95% CI, 1.04-2.79; P = 0.036) were independent predictors of the 90-day poor outcome after EVT. Furthermore, admission NIHSS (OR > 36 vs. ≤ 11 = 9.01, P for trend < 0.001), OTP (OR > 441min vs. ≤ 210 min = 2.71, P for trend = 0.023), and procedure duration (OR > 145 min vs. ≤ 59 min = 2.77, P for trend = 0.031) were significantly associated with increasing risk of the 90-day poor outcome. CONCLUSIONS: Poor outcome after EVT at 90 days occurred in 50.7% of acute VBAO patients from the ANGEL-ACT registry. Our study found several predictors of the 90-day poor outcome which should be highly considered in daily practice to improve acute VBAO management. CLINICAL TRIAL REGISTRATION : http://www. CLINICALTRIALS: gov . Unique identifier: NCT03370939.

Predictors of parenchymal hemorrhage after endovascular treatment in acute ischemic stroke: data from ANGEL-ACT Registry.

BACKGROUND: Parenchymal hemorrhage (PH) is a troublesome complication after endovascular treatment (EVT). OBJECTIVE: To investigate the incidence, independent predictors, and clinical impact of PH after EVT in patients with acute ischemic stroke (AIS) due to anterior circulation large vessel occlusion (LVO). METHODS: Subjects were selected from the ANGEL-ACT Registry. PH was diagnosed according to the European Collaborative Acute Stroke Study classification. Logistic regression analyses were performed to determine the independent predictors of PH, as well as the association between PH and 90-day functional outcome assessed by modified Rankin Scale (mRS) score. RESULTS: Of the 1227 enrolled patients, 147 (12.0%) were diagnosed with PH within 12-36 hours after EVT. On multivariable analysis, low admission Alberta Stroke Program Early CT score (ASPECTS)(adjusted OR (aOR)=1.13, 95% CI 1.02 to 1.26, p=0.020), serum glucose >7 mmol/L (aOR=1.82, 95% CI 1.16 to 2.84, p=0.009), and neutrophil-to-lymphocyte ratio (NLR; aOR=1.05, 95% CI 1.02 to 1.09, p=0.005) were associated with a high risk of PH, while underlying intracranial atherosclerotic stenosis (ICAS; aOR=0.42, 95% CI 0.22 to 0.81, p=0.009) and intracranial angioplasty/stenting (aOR=0.37, 95% CI 0.15 to 0.93, p=0.035) were associated with a low risk of PH. Furthermore, patients with PH were associated with a shift towards to worse functional outcome (mRS score 4 vs 3, adjusted common OR (acOR)=2.27, 95% CI 1.53 to 3.38, p<0.001). CONCLUSIONS: In Chinese patients with AIS caused by anterior circulation LVO, the risk of PH was positively associated with low admission ASPECTS, serum glucose >7 mmol/L, and NLR, but negatively related to underlying ICAS and intracranial angioplasty/stenting. TRIAL REGISTRATION NUMBER: NCT03370939.

Endovascular therapy in acute anterior circulation large vessel occlusive patients with a large infarct core (ANGEL-ASPECT): protocol of a multicentre randomised trial.

BACKGROUND: The benefit of stroke thrombectomy for large infarct core still lacks robust randomised controlled studies. AIM: To demonstrate the design of a clinical trial on endovascular therapy for acute anterior circulation large vessel occlusion (LVO) patients with large infarct core volume. DESIGN: ANGEL-ASPECT is a multicentre, prospective, randomised, open-label, blinded End-point trial to evaluate whether best medical management (BMM) combined with endovascular therapy improves neurological functional outcomes as compared with BMM alone in acute LVO patients with Alberta Stroke Program Early CT Score (ASPECTS) of 3-5 on non-contrast CT or infarct core volume range of 70-100 mL (defined as rCBF <30% on CT perfusion or ADC <620 on MRI) up to 24 hours from symptom onset or last seen well. STUDY OUTCOMES: The primary efficacy outcome is 90 (±7) days modified Rankin Scale. Symptomatic intracranial haemorrhage within 48 hours from randomisation is the primary safety outcome. DISCUSSION: The ANGEL-ASPECT trial will screen patients with large infarct core (ASPECTS 3-5 or 70-100 mL) through image evaluation criteria within 24 hours and explore the efficacy and safety of endovascular therapy compared with BMM.

Endovascular treatment for acute ischaemic stroke due to medium vessel occlusion: data from ANGEL-ACT registry.

OBJECTIVES: To investigate the safety and efficacy of endovascular treatment (EVT) for acute medium vessel occlusion (MeVO) in the anterior circulation and to explore the independent predictors of the 90-day good outcome for such patients. METHODS: Data from ANGEL-ACT Registry were analysed in our study. The outcomes, such as the modified Rankin Scale (mRS) at 90 days, successful recanalisation rate and symptomatic intracranial haemorrhage (SICH) rate, were compared between MeVO and acute large vessel occlusions (LVO). Then, the independent predictors of the good outcome at 90 days in MeVO patients were determined by the logistic regression analyses. RESULTS: We included 1032 subjects in the analysis, of which, 147 were MeVO and 885 were LVO. mRS at 90 days distribution (3 (0-4) vs 3 (0-5), common odds ratio (OR) =1.00, 95% confidence interval (CI) 0.73 to 1.38, p=0.994), SICH rate (4.8% vs 8.9%; OR=0.59, 95% CI 0.26 to 1.34, p=0.205) and successful recanalisation rate (89.8% vs 89.7%; OR=1.00 95% CI 0.51 to 1.93, p=0.992) were similar between the MeVO and LVO groups after adjusting for the confounders. We identified that baseline neutrophil-to-lymphocyte ratio ≤4.1 (OR=2.13, 95% CI 1.14 to 3.99, p=0.019), baseline National Institutes of Health Stroke Scale ≤14 (OR=1.96, 95% CI 1.02 to 3.80, p=0.045) and mechanical thrombectomy passes ≤1 (OR=2.16, 95% CI 1.14 to 4.11, p=0.021) were independent predictors of the 90-day good outcome in MeVO patients undergoing EVT. CONCLUSIONS: Patients with MeVO achieved similar 90-day mRS, SICH rate and successful recanalisation rate after EVT compared with patients with LVO. Several independent predictors of 90-day good outcome in MeVO patients undergoing EVT were determined, which should be highly considered in MeVO stroke management.

Predictors of symptomatic intracranial hemorrhage after endovascular treatment for acute large vessel occlusion: data from ANGEL-ACT registry.

Symptomatic intracranial hemorrhage (SICH) is a catastrophic complication of endovascular treatment (EVT) for large vessel occlusion (LVO). We aimed to investigate the incidence and predictors of SICH after EVT. Patients were selected from the ANGEL-ACT registry. We diagnosed SICH according to the Heidelberg Bleeding Classification. Logistic regression analyses were performed to determine the independent predictors of SICH. Of the 1283 patients, SICH was observed in 116 patients (9.0%). On multivariable analysis, admission National Institutes of Health Stroke Scale (NIHSS) > 12 (odds ratio [OR] = 1.86, 95% confidence interval [CI]: 1.11-3.11, P = 0.018), admission Alberta Stroke Program Early CT Score (ASPECTS) < 6 (OR = 2.98, 95%CI: 1.68-5.29, P < 0.001), general anesthesia (OR = 1.81, 95%CI: 1.20-2.71, P = 0.004), prior intravenous thrombolysis (OR = 1.58, 95%CI: 1.04-2.40, P = 0.031), number of mechanical thrombectomy passes > 2 (OR = 1.68, 95%CI: 1.10-2.57, P = 0.016), and procedure duration > 96 min (OR = 1.82, 95%CI: 1.20-2.77, P = 0.005) were associated with high risk of SICH, whereas SICH was negatively associated with underlying intracranial atherosclerotic disease (OR = 0.45, 95%CI: 0.26-0.79, P = 0.021). The incidence of SICH after EVT for anterior LVO was 9.0% in ANGEL-ACT registry. Our study identified some predictors, which may assist doctors in identifying LVO patients with a high risk of SICH and making the optimal peri-procedural management strategies for such patients.