Balloon Angioplasty vs Medical Management for Intracranial Artery Stenosis: The BASIS Randomized Clinical Trial.

Importance: Previous randomized clinical trials did not demonstrate the superiority of endovascular stenting over aggressive medical management for patients with symptomatic intracranial atherosclerotic stenosis (sICAS). However, balloon angioplasty has not been investigated in a randomized clinical trial. Objective: To determine whether balloon angioplasty plus aggressive medical management is superior to aggressive medical management alone for patients with sICAS. Design, Setting, and Participants: A randomized, open-label, blinded end point clinical trial at 31 centers across China. Eligible patients aged 35 to 80 years with sICAS defined as recent transient ischemic attack (<90 days) or ischemic stroke (14-90 days) before enrollment attributed to a 70% to 99% atherosclerotic stenosis of a major intracranial artery receiving treatment with at least 1 antithrombotic drug and/or standard risk factor management were recruited between November 8, 2018, and April 2, 2022 (final follow-up: April 3, 2023). Interventions: Submaximal balloon angioplasty plus aggressive medical management (n = 249) or aggressive medical management alone (n = 252). Aggressive medical management included dual antiplatelet therapy for the first 90 days and risk factor control. Main Outcomes and Measures: The primary outcome was a composite of any stroke or death within 30 days after enrollment or after balloon angioplasty of the qualifying lesion or any ischemic stroke in the qualifying artery territory or revascularization of the qualifying artery after 30 days through 12 months after enrollment. Results: Among 512 randomized patients, 501 were confirmed eligible (mean age, 58.0 years; 158 [31.5%] women) and completed the trial. The incidence of the primary outcome was lower in the balloon angioplasty group than the medical management group (4.4% vs 13.5%; hazard ratio, 0.32 [95% CI, 0.16-0.63]; P < .001). The respective rates of any stroke or all-cause death within 30 days were 3.2% and 1.6%. Beyond 30 days through 1 year after enrollment, the rates of any ischemic stroke in the qualifying artery territory were 0.4% and 7.5%, respectively, and revascularization of the qualifying artery occurred in 1.2% and 8.3%, respectively. The rate of symptomatic intracranial hemorrhage in the balloon angioplasty and medical management groups was 1.2% and 0.4%, respectively. In the balloon angioplasty group, procedural complications occurred in 17.4% of patients and arterial dissection occurred in 14.5% of patients. Conclusions and Relevance: In patients with sICAS, balloon angioplasty plus aggressive medical management, compared with aggressive medical management alone, statistically significantly lowered the risk of a composite outcome of any stroke or death within 30 days or an ischemic stroke or revascularization of the qualifying artery after 30 days through 12 months. The findings suggest that balloon angioplasty plus aggressive medical management may be an effective treatment for sICAS, although the risk of stroke or death within 30 days of balloon angioplasty should be considered in clinical practice. Trial Registration: ClinicalTrials.gov Identifier: NCT03703635.

Basilar artery occlusion management: An international survey of gender influence on management.

BACKGROUND: The superiority of endovascular thrombectomy (EVT) over medical management was not established in two early basilar artery occlusion (BAO) randomized controlled trials. Despite this, many clinicians recommended EVT for acute BAO under certain circumstances. This paper aims to compare physicians' diagnostic and management strategies of BAO according to gender. METHODS: From January to March 2022 an international survey was conducted regarding management strategies in acute BAO. We compared responses between clinicians by identifying gender. Questions were designed to examine clinical and imaging parameters influencing management of patients with BAO. RESULTS: Among the 1245 respondents from 73 countries, 311 (25.0%) identified as female. This figure was 13.6% amongst interventionists. Geographically, female respondents were lowest in Asia (14.5%) and North America (23.9%). The proportion of respondents identifying as female was consistent regardless of their years of experience. Female respondents were more likely to choose time of onset as time of first estimated stroke like symptom (48.0% vs. 38.5%, p < .01), were less likely to favor thrombectomy in the V4 segment of vertebrobasilar artery occlusions (31.5% vs. 43.3%, p < .01), and were less likely to find it acceptable to enroll all patients who met trial criteria in the standard medical treatment arm of a clinical trial (41.2% vs. 47.0%, p = .01). Male respondents were more likely to agree that thrombolysis would not alter their decision on proceeding with EVT (93.7% vs. 88.3%, p < .01). CONCLUSIONS: Female clinicians appear to be significantly underrepresented in stroke medicine. This is most pronounced amongst interventionists and in Asia. Although male and female opinions were closely aligned on many aspects of BAO management, differences in opinion were observed in a number of significant areas which influence decision making.

Anaesthesia modality on endovascular therapy outcomes in patients with large infarcts: a post hoc analysis of the ANGEL-ASPECT trial.

OBJECTIVES: Endovascular therapy (EVT) now penetrates the once obscure realm of large infarct core volume acute ischaemic stroke (LICV-AIS). This research aimed to investigate the potential correlation between different anaesthetic approaches and post-EVT outcomes in LICV-AIS patients. METHODS: Between October 2020 and May 2022, the China ANGEL-Alberta Stroke Programme Early CT Score (ASPECT) trial studied patients with LICV-AIS, randomly assigning them to the best medical management (BMM) or BMM with EVT. This post hoc subgroup analysis categorised subjects receiving BMM with EVT into general anaesthesia (GA) and non-GA groups based on anaesthesia type. We applied multivariable logistic regression to evaluate the relationship between anaesthesia during EVT and patient functional outcomes, as measured by the modified Rankin scale (mRS), in addition to the occurrence of complications. Further adjustment for selection bias was achieved through propensity score matching (PSM). RESULTS: In total, 230 patients with LICV-AIS were enrolled (GA 84 vs Non-GA 146). No significant difference was observed between the two groups in terms of the proportion of patients who achieved an mRS score of 0-2 at 90 days (27.4% for the GA group vs 31.5% for the non-GA group, p=0.51). However, the GA group had significantly longer median surgical times (142 min vs 122 min, p=0.03). Furthermore, GA was associated with an increased risk of postoperative pneumonia (adjusted OR 2.03, 95% CI 1.04 to 3.98). The results of PSM analysis agreed with the results of the multivariate regression analysis. No significant difference in intracranial haemorrhage incidence or mortality rate was observed between the groups. CONCLUSION: This post hoc analysis of subgroups of the ANGEL-ASPECT trial suggested that there may be no significant association between the choice of anaesthesia and neurological outcomes in LICV-AIS patients. However, compared with non-GA, GA prolongs the duration of EVT and is associated with a greater postoperative pneumonia risk. TRIAL REGISTRATION NUMBER: NCT04551664.

Association of Mismatch Profiles and Clinical Outcome from Endovascular Therapy in Large Infarct: A Post-Hoc Analysis of the ANGEL-ASPECT Trial.

OBJECTIVES: We investigated whether patients with large infarct and the presence or absence of perfusion mismatch are associated with endovascular treatment benefit. METHODS: This is a post-hoc analysis of the Endovascular Therapy in Anterior Circulation Large Vessel Occlusion with a Large Infarct (ANGEL-ASPECT) randomized trial, which enrolled patients within 24 hours of onset with ASPECTS 3 to 5 or ASPECTS 0 to 2 with an infarct core 70 to 100 ml. Mismatch ratio was defined as time-to-maximum (Tmax) >6 s cerebral volume/ischemic core volume, and mismatch volume was defined as Tmax >6 s volume minus ischemic core volume. We divided patients into mismatch ratio ≥1.2 and mismatch volume ≥10 ml, and mismatch ratio ≥1.8 and mismatch volume ≥15 ml groups. The primary outcome was the 90-day modified Rankin Scale score ordinal distribution. Safety outcomes were symptomatic intracranial hemorrhage and 90-day mortality. RESULTS: There were 425 patients included. In both the mismatch ratio ≥1.2 and mismatch volume ≥10 ml (mismatch+, n = 395; mismatch-, n = 31) and mismatch ratio ≥1.8 and mismatch volume ≥15 ml groups (mismatch+, n = 346; mismatch-, n = 80), better 90-day modified Rankin Scale outcomes were found in the endovascular treatment group compared with the MM group (4 [2-5] vs 4 [3-5], common odds ratio [cOR], 1.9, 95% confidence interval [CI] 1.3-2.7, p = 0.001; 4 [2-5] vs 4 [3-5], cOR, 1.9, 95% CI 1.3-2.8, p = 0.001, respectively), but not in patients without mismatch ratio ≥1.2 and mismatch volume ≥10 ml (5 [3-6] vs 5 [4-6], cOR, 1.2, 95% CI 0.3-4.1, p = 0.83), and mismatch ratio ≥1.8 and mismatch volume ≥15 ml (4 [3-6] vs 5 [3-6], cOR, 1.2, 95% CI 0.6-2.7, p = 0.60). However, no interaction effect was found in both subgroups (p interaction >0.10). CONCLUSION: Endovascular treatment was more efficacious than MM in patients with mismatch profiles, but no treatment effect or interaction was noted in the no mismatch profile patients. However, the small sample size of patients with no mismatch may have underpowered our analysis. A pooled analysis of large core trials stratified by mismatch is warranted. ANN NEUROL 2024.

Cytomegalovirus pneumonia with intermittent pulmonary hemorrhage leading to asphyxia death: a case report and literature review.

Neonatal pulmonary hemorrhage is a late manifestation of various diseases. Premature delivery and low body weight are frequently observed as high-risk factors, characterized by acute onset, rapid progression, and high mortality rates. Pulmonary hemorrhage caused by cytomegalovirus infection in newborns with normal immune function is a rare occurrence. This case report focuses on a term neonate with normal birth weight who presented solely with nasal obstruction shortly after birth. However, 4 days after birth, the newborn experienced a sudden onset of blood gushing from both the mouth and nasal cavity. The patient was diagnosed with gastrointestinal bleeding, neonatal pneumonia and neonatal lung consolidation. And he was discharged after ten days of symptomatic treatment. However, upon returning home, the patient experienced a sudden onset of bleeding from the mouth and nose, leading to his untimely demise. Subsequent autopsy revealed the presence of pulmonary hemorrhage in newborn, which presented as interstitial pneumonia. The cause of pulmonary hemorrhage is cytomegalovirus infection. This case emphasizes the importance of pediatricians enhancing their skills in differentiating pulmonary hemorrhage, especially from cytomegalovirus pneumonia.

Impact of first pass effect in endovascular treatment of large core stroke: a post-hoc analysis of the ANGEL-ASPECT trial.

BACKGROUND: The first-pass effect (FPE) is linked to better safety and efficacy prognosis in patients with small- to- moderate sized ischemic infarctions. We evaluated the incidence, prognosis, and predictors of FPE in patients with large core infarctions (LCIs). METHODS: We conducted a post-hoc analysis of data from the Trial of Endovascular Therapy in Acute Anterior Circulation Large Vessel Occlusive Patients with a Large Infarct Core (ANGEL-ASPECT). The FPE was defined as a successful recanalization (expanded Thrombolysis in Cerebral Infarction (eTICI) 2 c/3, and eTICI 2b-3 as modified FPE (mFPE)) after one pass. The primary outcome was clinical functional independence, and the secondary outcomes were independent ambulation, assessed by the modified Rankin Scale (mRS) at 90 days. Safety outcomes included symptomatic intracranial hemorrhage (sICH) defined by the Heidelberg bleeding classification, any intracranial hemorrhage (ICH), and death within 90 days of stroke onset. RESULTS: Of the 226 patients in the study, FPE and mFPE were achieved in 33 (14.6%) and 82 (36.3%) patients, respectively. Patients with FPE exhibited shorter onset-to-puncture times (adjusted odds ratio [OR] 0.915; 95% confidence interval [CI]: 0.84 to 0.996), and patients with mFPE were older (OR 1.039; 95% CI: 1.005 to 1.075). mFPE was significantly associated with favorable outcomes (modified Rankin score [mRS] 0-2: OR 2.64; 95% CI: 1.37 to 5.07; mRS 0-3: OR 3.31; 95% CI: 1.73 to 6.33). FPE tended to improve outcomes (mRS 0-3: OR 2.24; 95% CI: 0.92 to 4.97; p=0.08). ICH rates (OR 0.60; 95% CI: 0.34 to 1.05; p=0.07) and 90-day deaths (OR 0.57; 95% CI: 0.30 to 1.09; p=0.09) tended to decrease in patients who achieved mFPE but not in patients who achieved FPE. CONCLUSIONS: In the ANGEL-ASPECT trial, patients who achieved mFPE had a higher rate of independent ambulation and functional independence, and the rates of any ICH and 90-day death tended to decrease.

Bailout intracranial angioplasty or stenting following thrombectomy for acute large vessel occlusion in China (ANGEL-REBOOT): a multicentre, open-label, blinded-endpoint, randomised controlled trial.

BACKGROUND: Unsuccessful recanalisation or reocclusion after thrombectomy is associated with poor outcomes in patients with large vessel occlusion (LVO) acute ischaemic stroke (LVO-AIS). Bailout angioplasty or stenting (BAOS) could represent a promising treatment for these patients. We conducted a randomised controlled trial with the aim to investigate the safety and efficacy of BAOS following thrombectomy in patients with LVO. METHODS: ANGEL-REBOOT was an investigator-initiated, multicentre, prospective, randomised, controlled, open-label, blinded-endpoint clinical trial conducted at 36 tertiary hospitals in 19 provinces in China. Participants with LVO-AIS 24 h after symptom onset were eligible if they had unsuccessful recanalisation (expanded Thrombolysis In Cerebral Infarction score of 0-2a) or risk of reocclusion (residual stenosis >70%) after thrombectomy. Eligible patients were randomly assigned by the minimisation method in a 1:1 ratio to undergo BAOS as the intervention treatment, or to receive standard therapy (continue or terminate the thrombectomy procedure) as a control group, both open-label. In both treatment groups, tirofiban could be recommended for use during and after the procedure. The primary outcome was the change in modified Rankin Scale score at 90 days, assessed in the intention-to-treat population. Safety outcomes were compared between groups. This trial was completed and registered at ClinicalTrials.gov (NCT05122286). FINDINGS: From Dec 19, 2021, to March 17, 2023, 706 patients were screened, and 348 were enrolled, with 176 assigned to the intervention group and 172 to the control group. No patients withdrew from the trial or were lost to follow-up for the primary outcome. The median age of patients was 63 years (IQR 55-69), 258 patients (74%) were male, and 90 patients (26%) were female; all participants were Chinese. After random allocation, tirofiban was administered either intra-arterially, intravenously, or both in 334 [96%] of 348 participants. No between-group differences were observed in the primary outcome (common odds ratio 0·86 [95% CI 0·59-1·24], p=0·41). Mortality was similar between the two groups (19 [11%] of 176 vs 17 [10%] of 172), but the intervention group showed a higher risk of symptomatic intracranial haemorrhage (eight [5%] of 175 vs one [1%] of 169), parenchymal haemorrhage type 2 (six [3%] of 175 vs none in the control group), and procedure-related arterial dissection (24 [14%] of 176 vs five [3%] of 172). INTERPRETATION: Among Chinese patients with unsuccessful recanalisation or who are at risk of reocclusion after thrombectomy, BAOS did not improve clinical outcome at 90 days, and incurred more complications compared with standard therapy. The off-label use of tirofiban might have affected our results and their generalisability, but our findings do not support the addition of BAOS for such patients with LVO-AIS. FUNDING: Beijing Natural Science Foundation, National Natural Science Foundation of China, National Key R&D Program Beijing Municipal Administration of Hospitals Incubating Program, Shanghai HeartCare Medical Technology, HeMo (China) Bioengineering, Sino Medical Sciences Technology.

Effectiveness and safety of bridging therapy and endovascular therapy in patients with large cerebral infarctions: from ANGEL-ASPECT.

BACKGROUND AND PURPOSE: The benefits of thrombolytic therapy before endovascular thrombectomy in cases of acute ischaemic stroke, with a large infarction volume, remain unclear. This analysis aims to evaluate the effectiveness and safety of bridging therapy and endovascular therapy among patients with large cerebral infarctions. METHODS: In this post-hoc analysis of the multicentre prospective study of ANGEL-ASPECT (Acute Anterior Circulation Large Vessel Occlusive Patients with a Large Infarct Core), participants were divided into two groups: an endovascular therapy group and a bridging therapy group. The primary outcome was the modified Rankin Scale (mRS) score at 90 days. The primary safety outcome was symptomatic intracranial haemorrhage. Ordinal logistic regression was performed to compare the primary endpoint between the two groups. Subgroup analyses were conducted to further explore potential risk factors associated with the outcomes. RESULTS: 122 patients were included, of whom 77 (63%) underwent endovascular therapy and 45 (37%) underwent bridging therapy. The median scores on mRS at 90 days of the bridging therapy group and the endovascular therapy group were 3 (2-5) and 4 (2-6), with no significant differences (common OR 1.36; 95% CI 0.71 to 2.61). Symptomatic intracranial haemorrhage was reported in three patients who were in the endovascular and bridging therapy groups (relative risk (RR) 1.71; 95% CI 0.36 to 8.12). The mortality between two groups did not differ (RR 0.75; 95% CI 0.37 to 1.54). CONCLUSIONS: Our study indicated that endovascular therapy alone might be a viable option for patients with large cerebral infarctions, displaying no noticeable disparity in outcomes compared with bridging therapy.

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].

Outcome Comparison of Endovascular Treatment for Acute Large Vessel Occlusion Due to Large Artery Atherosclerosis and Cardioembolism in the Chinese Population: Data from the ANGEL Registry.

Background and Purpose: Studies on outcome comparison after endovascular treatment (EVT) for large vessel occlusion (LVO) between large artery atherosclerosis (LAA) and cardioembolism (CE) in the Asian population are scarce. We aimed to compare the baseline characteristics and clinical outcomes after EVT for anterior circulation LVO with LAA and CE in the Chinese population. Methods: Patients were selected from the ANGEL registry and divided into LAA and CE groups. The primary outcome was the 90-day modified Rankin Scale (mRS) 0-2. The secondary outcomes were 90-day mRS distribution, 90-day mRS 0-1, 90-day mRS 0-3, and early neurological improvement. The safety outcomes included death, symptomatic intracranial hemorrhage, and any intracranial hemorrhage. We conducted logistic regression models with adjustments to compare the outcomes. Results: A total of 632 patients were included, of whom, 488 were in the LAA group and 144 were in the CE group. No significant difference in 90-day mRS 0-2 was observed between LAA and CE groups (55.7%vs.43.1%, odds ratio[OR] 1.19, 95% confidence interval(CI), 0.92-1.53, P=0.190). The LAA group exhibited a higher frequency of mRS 0-3 compared to the CE group (69.1% vs 32.6%, OR1.32, 95% CI 1.02-1.72, P=0.038). However, the incidence of death within 90 days did not significantly differ between the LAA and CE groups (10.9%vs.24.3%, OR0.91, 95% CI0.66-1.25, P=0.545), nor did the occurrences of symptomatic intracranial hemorrhage(SICH) (4.5%vs.9.7%,OR1.08, 95% CI 0.65-1.78, P=0.779) or intracranial hemorrhage(ICH) (21.9%vs.30.6%, OR 0.94, 95% CI0.71-1.25, P=0.680). Moreover, no significant disparities were detected in other outcomes between the two groups (All P>0.05). Conclusion: In the ANGEL registry, a higher prevalence of patients undergoing EVT for acute anterior circulation LVO with LAA was found than those with CE. However, our study revealed that the efficacy and safety of EVT remained consistent regardless of the stroke's etiology such as LAA or CE.

Outcomes of antiplatelet therapy before endovascular treatment of acute large vessel occlusion: Data from the ANGEL-ACT registry.

OBJECTIVES: To investigate whether single or dual antiplatelet therapy (SAPT or DAPT) within 24 hours before endovascular treatment (EVT) could improve the clinical outcomes of patients with large vessel occlusion (LVO). METHODS: Patients from the ANGEL-ACT registry were divided into antiplatelet therapy (APT) and non-APT groups. The APT group was divided into SAPT and DAPT groups. Outcome measurement included 90-day modified Rankin Scale (mRS) distribution, change in the NIHSS at 7 days or discharge, number of passes, modified first pass effect (mFPE), symptomatic intracranial hemorrhage (SICH), and mortality within 90 days. To compare the outcomes, we performed multivariable analyses by adjusting for the propensity score calculated by the logistic regression model. RESULTS: Of 1611 patients, 1349 were in the non-APT group, while 262 (16.3 %) were in the APT group (122 [46.6 %] received SAPT, 140 [53.4 %] received DAPT). APT, SAPT or DAPT were not associated with a shift to better outcomes (non-APT vs. APT, 3[0-5] vs. 3[0-5], common odds ratio [OR], 1.04, 95 %confidence interval [CI]:0.82-1.34, P = 0.734). DAPT was associated with mFPE (OR,2.05, 95 %CI:1.39-3.01, P<0.001), more NIHSS reduction at 7 days or discharge (ß, -2.13, 95 %CI: -4.02--0.24, P = 0.028), lower number of passes (ß, -0.40, 95 %CI: -0.68--0.12, P=0.006), and shorter procedure duration (ß, -12.4, 95 %CI: -23.74--1.05, P = 0.032) without increasing odds of successful recanalization, PH within 24 hours and mortality with 90 days . CONCLUSIONS: APT before MT for AIS due to LVO does not affect clinical outcome in 90 days despite a tendency to reduce MT procedure time and number of passes. APT before MT in LVO does not increase SICH or mortality rates.

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.

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.

Sex differences in outcomes of endovascular therapy for acute vertebrobasilar occlusion: data from ANGEL-ACT Registry.

BACKGROUND: Understanding sex disparities in stroke can identify gaps in clinical care. The objective of this study was to investigate whether sex differences could influence clinical outcomes of patients with acute vertebrobasilar artery occlusion (VBAO) who underwent endovascular therapy (EVT). METHODS: Patients were selected from the ANGEL-ACT Registry. The primary outcome was favorable functional outcome (90-day modified Rankin Scale [mRS] 0-3). Secondary outcomes included 90-day mRS distribution, excellent outcome (mRS 0-1), functional independence (mRS 0-2), early neurological improvement, recanalization, intracranial hemorrhage, and mortality within 90 days. The above outcomes were compared by two adjustment models, including (1) multivariable logistics analysis adjusting for all baseline and procedural variables with a P < 0.05; (2) adjusting for the propensity score. RESULTS: There were 347 acute VBAO patients treated with EVT included, of whom 72 (20.7%) were women and 275 (79.3%) were men. Women were older (72[63-76] vs. 62[53-69], P < 0.001) and had a higher rate of atrial fibrillation (31.9% vs. 8.7%, P < 0.001), lower rates of underlying intracranial atherosclerotic disease (30.6% vs. 51.3%, P = 0.007), and tandem occlusion (8.3% vs. 21.8%, P = 0.009) than men. The rate of favorable outcome (mRS 0-3) was similar between women and men (41.7% vs. 51.3%, adjusted odds ratio 1.56, 95%CI: 0.83-2.95, P = 0.171). There were no sex differences in other clinical outcomes (all P > 0.05). CONCLUSIONS: In the ANGEL-ACT registry, the percentage of men with acute VBAO undergoing EVT was approximately fourfold higher than that of women with acute VBAO undergoing EVT. Sex differences did not modify the outcomes of acute VBAO after EVT.

Chinese Stroke Association guidelines for clinical management of ischaemic cerebrovascular diseases: executive summary and 2023 update.

BACKGROUND: China is one of the countries with the highest burden of stroke. Implementing multidimensional management guidelines will help clinicians practise evidence-based care, improve patient outcomes and alleviate societal burdens. This update of the 2019 edition will provide the latest comprehensive recommendations for the diagnosis and treatment of ischaemic cerebrovascular diseases. METHODS: We conducted a comprehensive search on MEDLINE (via PubMed) up to 31 August 2023. The writing team established the recommendations through multiple rounds of online and offline discussions. Each recommendation was graded using the evidence grading algorithm developed by the Chinese Stroke Association (CSA). The draft was reviewed and finalised by the CSA Stroke Guidelines Writing Committee. RESULTS: This update included revisions of 15 existing recommendations and 136 new recommendations in the following areas of stroke care: emergency assessment and diagnosis of ischaemic cerebrovascular disease, acute-phase reperfusion therapy, evaluation of underlying mechanisms, antithrombotic therapy, prevention and treatment of complications, and risk factor management. CONCLUSIONS: This guideline updated the recommendations for the clinical management of ischaemic cerebrovascular disease from 2019.

Endovascular Therapy for Acute Stroke: New Evidence and Indications.

Endovascular therapy (EVT) has revolutionized the treatment of acute ischemic stroke. In the past few years, endovascular treatment indications have expanded to include patients being treated in the extended window, with large ischemic core infarction, basilar artery occlusion (BAO) thrombectomy, as demonstrated by several randomized clinical trials. Intravenous thrombolysis (IVT) bridging to mechanical thrombectomy has also been studied via several randomized clinical trials, with the overall results indicating that IVT should not be skipped in patients who are candidates for both IVT and EVT. Simplification of neuroimaging protocols in the extended window to permit non-contrast CT, CTA collaterals have also expanded access to mechanical thrombectomy, particularly in regions across the world where access to advanced imaging may not be available. Ongoing study of areas to develop include rescue stenting in patients with failed thrombectomy, medium vessel occlusion thrombectomy, and carotid tandem occlusions. In this narrative review, we summarize recent trials and key data in the treatment of patients with large ischemic core infarct, simplification of neuroimaging protocols for the treatment of patients presenting in the late window, bridging thrombolysis, and BAO EVT evidence. We also summarize areas of ongoing study including medium and distal vessel occlusion.

Incidence and predictors of futile recanalisation after endovascular therapy in acute vertebrobasilar artery occlusion patients: insight from the ANGEL-ACT registry.

OBJECTIVES: To identify the occurrence rate and predictors of futile recanalisation after endovascular therapy (EVT) for acute vertebrobasilar artery occlusion (VBAO). METHODS: Participants of the Endovascular Treatment Key Technique and Emergency Workflow Improvement of Acute Ischaemic Stroke (ANGEL-ACT) registry were selected for the analysis. Futile recanalisation was defined as patients did not achieve a 90-day good outcome (modified Rankin Scale ≤3) despite successful recanalisation (modified Treatment in Cerebral Ischaemia Scale ≥2b) after the procedure. Multivariable logistic regression analysis was conducted to find independent predictors of futile recanalisation in VBAO patients undergoing EVT. RESULTS: Three hundred and fifteen patients with VBAO who achieved successful recanalisation after EVT were included in current analysis, of whom, 155 (49.2%) suffered futile recanalisation, and 160 achieved effective recanalisation. After the multivariable analysis, we found admission National Institutes of Health Stroke Scale (NIHSS) ≥19 (OR 4.81, 95% CI 2.76 to 8.39, p<0.001), platelet-lymphocyte ratio (PLR) ≥162.2 (OR 1.93, 95% CI 1.14 to 3.27, p=0.001), onset-to-puncture time (OTP) ≥334 min (OR 2.15, 95% CI 1.25 to 3.68, p=0.005) and use of general anesthesia (GA) (OR 1.87, 95% CI 1.09 to 3.22, p=0.024) were associated with futile recanalisation. CONCLUSIONS: Futile recanalisation after EVT occurred 49.2% of VBAO patients in the ANGEL-ACT registry. NIHSS≥19, PLR≥162.2, OTP≥334 min and use of GA were independent predictors of futile recanalisation.

Endovascular Treatment for Acute Large Vessel Occlusion Due to Underlying Intracranial Atherosclerotic Disease.

Intracranial atherosclerotic disease (ICAD) is one of the most common causes of acute ischemic stroke worldwide. Patients with acute large vessel occlusion due to underlying ICAD (ICAD-LVO) often do not achieve successful recanalization when undergoing mechanical thrombectomy (MT) alone, requiring rescue treatment, including intra-arterial thrombolysis, balloon angioplasty, and stenting. Therefore, early detection of ICAD-LVO before the procedure is important to enable physicians to select the optimal treatment strategy for ICAD-LVO to improve clinical outcomes. Early diagnosis of ICAD-LVO is challenging in the absence of consensus diagnostic criteria on noninvasive imaging and early digital subtraction angiography. In this review, we summarize the clinical and diagnostic criteria, prediction of ICAD-LVO prior to the procedure, and EVT strategy of ICAD-LVO and provide recommendations according to the current literature.