Search

BACKGROUND: The superiority of balloon angioplasty plus aggressive medical management (AMM) to AMM alone for symptomatic intracranial artery stenosis (sICAS) on efficacy and safety profiles still lacks evidence from randomised controlled trials (RCTs). AIM: To demonstrate the design of an RCT on balloon angioplasty plus AMM for sICAS. DESIGN: Balloon Angioplasty for Symptomatic Intracranial Artery Stenosis (BASIS) trial is a multicentre, prospective, randomised, open-label, blinded end-point trial to investigate whether balloon angioplasty plus AMM could improve clinical outcome compared with AMM alone in patients with sICAS. Patients eligible in BASIS were 35-80 years old, with a recent transient ischaemic attack within the past 90 days or ischaemic stroke between 14 days and 90 days prior to enrolment due to severe atherosclerotic stenosis (70%-99%) of a major intracranial artery. The eligible patients were randomly assigned to receive balloon angioplasty plus AMM or AMM alone at a 1:1 ratio. Both groups will receive identical AMM, including standard dual antiplatelet therapy for 90 days followed by long-term single antiplatelet therapy, intensive risk factor management and life-style modification. All participants will be followed up for 3 years. STUDY OUTCOMES: Stroke or death in the next 30 days after enrolment or after balloon angioplasty procedure of the qualifying lesion during follow-up, or any ischaemic stroke or revascularisation from the qualifying artery after 30 days but before 12 months of enrolment, is the primary outcome. DISCUSSION: BASIS trail is the first RCT to compare the efficacy and safety of balloon angioplasty plus AMM to AMM alone in sICAS patients, which may provide an alternative perspective for treating sICAS. TRIAL REGISTRATION NUMBER: NCT03703635; https://www. CLINICALTRIALS: gov.

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

BackgroundMost trials comparing endovascular treatment (EVT) alone versus intravenous thrombolysis with alteplase (IVT) + EVT in directly admitted patients with a stroke are non-inferiority trials. However, the margin based on the level of uncertainty regarding non-inferiority of the experimental treatment that clinicians are willing to accept to incorporate EVT alone into clinical practice remains unknown.ObjectiveTo characterize what experienced stroke clinicians would consider an acceptable level of uncertainty for hypothetical decisions on whether to administer IVT or not before EVT in patients admitted directly to EVT-capable centers.MethodsA web-based, structured survey was distributed to a cross-section of 600 academic neurologists/neurointerventionalists. For this purpose, a response framework for a hypothetical trial comparing IVT+EVT (standard of care) with EVT alone (experimental arm) was designed. In this trial, a similar proportion of patients in each arm achieved functional independence at 90 days. Invited physicians were asked at what level of certainty they would feel comfortable skipping IVT in clinical practice, considering these hypothetical trial results.ResultsThere were 180 respondents (response rate: 30%) and 165 with complete answers. The median chosen acceptable uncertainty suggesting reasonable comparability between both treatments was an absolute difference in the rate of day 90 functional independence of 3% (mode 5%, IQR 1-5%), with higher chosen margins observed in interventionalists (aOR 2.20, 95% CI 1.06 to 4.67).ConclusionPhysicians would generally feel comfortable skipping IVT before EVT at different certainty thresholds. Most physicians would treat with EVT alone if randomized trial data suggested that the number of patients achieving functional independence at 90 days was similar between the two groups, and one could be sufficiently sure that no more than 3 out of 100 patients would not achieve functional independence at 90 days due to skipping IVT.

In acute ischemic stroke patients with large vessel occlusion, the characteristics of the occluding thrombus on neuroimaging may be associated with recanalization after endovascular thrombectomy (EVT); however, the relationship between magnetic susceptibility of thrombus and clinical outcome remains unclear. We utilized quantitative susceptibility mapping (QSM) MRI to assess the magnetic susceptibility of thrombus in acute ischemic stroke patients undergoing EVT, and to evaluate its relationship with recanalization and functional outcomes. Patients with documented intracranial artery occlusion were consecutively recruited from one research center of the RESCUE-RE study (a registration study for Critical Care of Acute Ischemic Stroke After Recanalization). All the recruited patients underwent a 3D multi-echo MRI scan on a 3.0 T scanner for both susceptibility-weighted imaging (SWI) and QSM quantification of the thrombus. Among 61 patients included in the analyses, 51 (75.0 %) patients achieved thrombolysis in cerebral infarction (TICI) 2b/3 and 22 (36.1 %) patients had favorable functional outcomes. Successful recanalization was significantly associated with a higher thrombus magnetic susceptibility mean value (0.27 ± 0.09 vs 0.20 ± 0.09 ppm, p = 0.020) and lower coefficient of variation (0.42 ± 0.12 vs 0.52 ± 0.19, p = 0.024). ROC curve analysis showed the optimal cutoff value for thrombus susceptibility for predicting good clinical outcomes was 0.25 ppm (sensitivity 86.4 %, specificity 69.2 %). In multivariable logistic regression analyses, increased thrombus magnetic susceptibility was independently and significantly associated with good functional outcomes (adjusted odds ratio 15.11 [95 % confidence interval 2.64-86.46], p = 0.002). This study demonstrated that the increased thrombus magnetic susceptibility is associated with successful recanalization and favorable functional outcomes for intracranial artery occluded stroke patients.

BackgroundThe effect of choice of anesthesia on clinical outcome for endovascular treatment (EVT) in patients with acute ischemic stroke (AIS) remains unclear.MethodsWe conducted a pilot trial of 43 patients with acute anterior circulation ischemic stroke having EVT. Patients were randomly allocated to receive general anesthesia or conscious sedation. We documented the rate of recruitment and rate of conversion from conscious sedation to general anesthesia. In addition, we recorded the change in National Institute of Health stroke scale (NIHSS) on day 7, the rate of successful reperfusion and measured neurological function by certified researchers using modified Rankin Score (mRS 0 to 2) at 90 days.ResultsThe recruitment rate was 31.4% and majority of patients were excluded because of delay in hospital presentation and posterior circulation stroke. The rate of conversion from conscious sedation to general anesthesia was 18.2%. This was primarily related to excessive sedation and uncontrolled movement. Change in NIHSS score, rate of successful reperfusion and functional recovery were similar between groups.ConclusionsIt was feasible to randomize AIS patients receiving either general anesthesia or conscious sedation for EVT.

Background: The benefits of heparization during mechanical thrombectomy (MT) with newer generation thrombectomy devices, and if it is counterbalanced by the increased risk of intracranial hemorrhage (ICH) remain unknown. Methods: We included eligible patients who underwent MT from the ANGEL registry study (2015-2017) in China. Subjects in the current analysis were dichotomized into two groups according to whether adequate heparinization during MT was performed. In the heparinization group, unfractionated heparin was infused at 50-100 IU/Kg at first and additional 1,000 IU at intervals of an hour during the operation. Safety outcomes (symptomatic intracerebral hemorrhage [sICH], ICH and distal embolization) and efficacy outcomes (artery recanalization and functional outcomes at 3-month follow-up) were compared between groups. Results: We included 619 patients from the entire cohort of 917 patients. The average age of them was 63.9 ± 13.7 years, 269 (43.5%) were treated with heparinization during MT. Heparinization during MT didnt significantly influence recanalization rates, total ICH and long-term mortality (adjusted p > 0.05 for all). But sICH and distal embolization occurred more frequently (9.3 vs. 5.1%, adjusted p = 0.02; 7.1 vs. 3.1%, adjusted p = 0.04, respectively), while functional independence appeared less likely (39.8 vs. 47.4%, adjusted p = 0.01) in heparinization group than that in non-heparinization group. Multivariable logistic regression analyses showed that heparinization during MT was an independent predictor for sICH (Odds ratio 2.36 [1.19-4.67], p = 0.01) in addition to cardio-embolism stroke and posterior circulation stroke (PCS), and an independent predictor for poor outcome (Odds ratio 1.79 [1.23-2.59], p < 0.01) besides age, bridging intravenous thrombolysis, admission NIHSS, drinking and PCS. Conclusion: Heparinization during MT may be associated with increased risk of safety outcomes over sICH and distal embolization, as well as efficacy outcomes over long-term poor outcome. Further randomized controlled trials are needed.

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;96:729–738 [ABSTRACT FROM AUTHOR]

Purpose: To identify and compare the predictors of failure of early neurological improvement (fENI)after successful EVT for anterior circulation large vessel occlusion (ACLVO) and posterior circulation LVO (PCLVO). Methods: Subjects were selected from the ANGEL-ACT registry. fENI was defined as unchanged or worsened in National Institutes of Health Stroke Scale score (NIHSS) between admission and 24 h after EVT. Predictors of fENI after successful EVT (mTICI 2b-3) were determined via center-adjusted analyses. Univariable and multivariable comparisons between ACLVO and PCLVO were performed. Results: A total of 1447 patients, 1128 were with ACLVO, and 319 were with PCLVO. Among the patients with ACLVO, there were 409 patients (36.3%) with fENI and 719 patients (63.7%) with ENI. We observed that pre-stroke mRS scale score of 2 (odd ratio[OR] 95% confidence interval[CI], 6.93[1.99–24.10], P = 0.002), initial NIHSS score (OR per point[95%CI], 0.97[0.95–0.99], P = 0.012), diabetes (OR[95%CI], 1.56[1.08–2.25], P = 0.017), previous ICH (OR[95%CI] 9.21[1.76–48.15], P = 0.008), local anesthesia (OR[95%CI] 1.63[1.10–2.42], P = 0.014), onset-to-puncture time (OR[95%CI], 1.001[1.000–1.001], P = 0.009), symptomatic ICH (OR[95%CI] 3.90[2.27–6.69], P < 0.001), and continued use of tirofiban within 2 h after EVT (OR[95%CI], 0.69[0.51–0.93], P = 0.014) were independent predictors of fENI of ACLVO after EVT. Among the patients with PCLVO, there were 112 patients (35.1%) with fENI and 207 patients (64.9%) with ENI. In contrast, admission SBP (OR[95%CI], 0.98[0.97–0.99], P = 0.012), and vascular dissection within 2 h after EVT (OR[95%CI], 7.23[1.33–39.13], P = 0.022) were independent predictors of fENI of PCLVO after EVT. Conclusion: In selected patients, successful EVT can lead to similar outcomes in PCLVO and ACLVO. Some predictors of fENI in both anterior circulation and posterior circulation were identified in our study, which should be highly considered in the clinical practice in LVO patients undergoing EVT. [ABSTRACT FROM AUTHOR]

In 2015, several clinical trials demonstrated the efficacy of endovascular reperfusion therapies (EVT) in stroke patients with large vessel occlusion, which had changed stroke treatment guidelines and clinical practice all over the world. However, despite substantial recanalization, about half of the patients obtain a poor functional outcome at 3 months after endovascular treatment. The difference between the high recanalization rate of cerebral vessels and the low recovery rate of good clinical function has become a pain for neurointerventionalists! Alberta stroke program early CT score (ASPECTS), direct arrival, previous thrombolysis, time from onset to recanalization < 6 h, and recanalization status, etc. are certainly the reasons for this outcome. But we may have overlooked an important issue, that recanalization of blood vessels does not mean reperfusion of tissues. The phenomenon of poor tissue perfusion after recanalization is called no-reflow phenomenon (NRP). Coronary NRP has become an important predictor of clinical prognosis for acute coronary occlusion after percutaneous coronary intervention (PCI). In the past nearly half century, interventional cardiologists have done a lot of researches on the pathogenesis, diagnosis and treatment of NRP, which effectively improve the clinical efficacy of coronary PCI. When neurointerventionalists are actively carrying out endovascular treatment for acute ischemic stroke, should they actively pay more attention to NRP?