European Stroke Journal最新文献

Introduction: Data on safety of endovascular therapy (EVT) in the very elderly are scarce. Using data from a large prospective EVT registry, we aimed at providing better evidence for EVT decision-making in patients aged 90 years and older.

Patients and methods: In this multicentre observational study from the EVA-TRISP collaboration outcomes were compared between patients aged ⩾90 years with those aged <90 years using multivariate logistic regression analysis and reporting odds ratios and 95% confidence intervals. Outcomes were occurrence of poor functional outcome in survivors (modified Rankin Scale (mRS) 3-5 if pre-stroke mRS 0-2 and mRS higher than pre-stroke mRS if pre-stroke mRS 3-5), mortality at 3 months after stroke, unsuccessful recanalization (mTICI 0-2a) and symptomatic intracranial hemorrhage (sICH, defined by ECASS-II-/III-criteria).

Results: Of 13,306 eligible patients, 892 were ⩾90 years old (6.7%). The very elderly had a higher median National Institutes of Health Stroke Scale (NIHSS) on admission (16 vs 14) and were more likely to have a pre-stroke mRS of 3-5 (38.0% vs 8.7%). The odds of poor functional outcome (ORadjusted 2.35 (95%-CI 1.87-2.97); 61.6% vs 38.7%), death (ORadjusted 3.04 (95%-CI 2.60-3.55); 53.9% vs 21.3%) and unsuccessful recanalization (ORadjusted 1.34 (95%-CI 1.14-1.57); 32.4% vs 27.2%) were higher in patients aged ⩾90 years. The odds of sICH did not differ (ORadjusted 0.92 (95%-CI 0.66-1.28); 5.1% vs 5.0%).

Discussion and conclusion: EVT-treated stroke patients ⩾90 years had higher odds of poor functional outcome, mortality and unsuccessful recanalization than younger patients. However, the probability of sICH after EVT was not increased. The decision in favor of or against EVT in the very elderly should not be based on age alone.

Introduction: Cardiac CT is increasingly used to screen for cardioembolism in stroke patients. We assessed the frequency and management of non-cardiac incidental findings on prospective ECG-gated cardiac CT in patients with a suspected stroke.

Patients and methods: This was a post-hoc analysis of the Mind the Heart study, a prospective single-centre cohort study including consecutive adult patients with acute ischaemic stroke (AIS), transient ischaemic attack (TIA), or a stroke mimic who underwent cardiac CT as part of an acute stroke imaging protocol. Endpoints were pre-defined non-cardiac incidental findings that were detected on cardiac CT: pulmonary embolism (PE), potential malignant lesions, pulmonary consolidations or ground-glass densities, bone fractures, lymphadenopathy, focal liver lesions, and ascending aortic or pulmonary artery dilatation. Change of management was defined as additional treatment or follow-up.

Results: We included 654 patients (57% men, median age 71 [IQR 59-80] years) of whom 451 (69%) had AIS, 48 had TIA (7%), and 155 had a stroke mimic (24%). Overall, 58 non-cardiac incidental findings were found in 55 (8%; 95%CI, 6-11) patients. The most frequent incidental findings were consolidations or ground-glass densities (n = 17, 3%), liver cysts or non-specific hypodensities (n = 14, 2%), pulmonary nodules or masses (n = 9, 1%), and PEs (n = 8, 1%). Incidental findings led to a change of management in 17/55 (31%) patients of whom 13/55 (24%) had additional follow-up and 9/55 (16%) received treatment (anticoagulation n = 8, chemotherapy n = 1).

Discussion & conclusion: Non-cardiac incidental findings were observed on cardiac CT in 8% of patients with a suspected stroke. These findings changed management in 31% of these patients.

Introduction: Predicting the occurrence of late seizures after intracerebral haemorrhage may help in making clinical decisions about treatment. Currently, the CAVE score is the best performing risk score. We aimed to design a different, pragmatic risk prediction score and compared it to the CAVE score.

Patients and methods: The South Limburg (Netherlands) intracerebral haemorrhage registry, consisting of patients with a primary intracerebral haemorrhage in 2004-2009, was used for the derivation cohort. We made a prediction model using Cox proportional hazard analyses; comparisons between models were made with the c-statistic. We validated our model externally in three independent cohorts.

Results: Our derivation cohort consisted of 781 patients, of whom 78 (10%) developed late seizures. We found the following independent predictors for late seizures: any neurosurgical procedure, age < 65 years, lobar haemorrhage, and early seizures (occurring within the first week). These formed our new prediction score (LEAN score), which had an optimism-corrected c-statistic of 0.80 (95%-confidence interval 0.78-0.86). The LEAN score predicts late seizure risk as 0.7%, 1.6%, 8.8%, 22.0%, 29.8%, 43.5%, 100% for the increasing score groups respectively. External validation showed comparable optimism-corrected c-statistics for both the LEAN score and the CAVE score.

Conclusion: The newly developed LEAN score consists of easily available clinical variables and performs equally to the CAVE score. Additionally, the high risk of late seizures in patients with the maximum LEAN score might make a diagnosis of epilepsy possible according to international guidelines despite these patients only had early seizures.

Introduction: The predictive value of CT markers of intracerebral haemorrhage (ICH) expansion is time-dependent, but data in the ultra-early period (<2 h from onset) are limited. We aimed to describe the frequency of these CT markers, their association with haematoma volume, haematoma expansion (HE) and functional outcome at 90-days. We also investigated the effect of tranexamic acid on HE in the presence of these markers.

Patients and methods: We performed a pooled analysis of individual patient data from the STOP-AUST and STOP-MSU placebo-controlled randomised trials of tranexamic acid, including ICH patients scanned within 2 h of symptom onset. Logistic regression was used to assess the association between CT markers and HE or 90-days functional outcomes (poor outcome defined as mRS3-6).

Results: Among 246 patients, the swirl sign (74.3%) was the most frequent CT marker and the blend sign least frequent (7.3%). All markers were associated with increased baseline haematoma volume, and excluding the black hole sign, all were more common in patients with 24-h HE. The blend and spot signs were associated with 24-h HE and heterogenous density, swirl sign, hypodensity and island sign were associated with poor 90-day function outcomes in univariate logistic regression. However, the area under the receiver-operating-characteristic curve was similar for all markers and indicated low discriminative ability (Chi-squared test p = 0.81). A potential benefit of tranexamic acid in HE reduction was observed in patients with the spot sign (interaction p = 0.01).

Conclusions: The discriminative utility of CT markers of HE in the early timeframe appears insufficient. There may be an effect of tranexamic acid in spot sign positive patients <2 h from onset.

Introduction: Non-inferiority trials in acute ischemic stroke (AIS) are crucial to improve access to high-quality care. Population shifts must be accounted for when estimating non-inferiority margins, eg, changes in population characteristics (trial vs historical data); however, existing methods have practical and statistical limitations. We propose a pragmatic conceptual approach and fully pre-specifiable procedure for calibrating non-inferiority margins that account for population shifts in observed trial populations.

Patients and methods: Our approach splits trial and historical data into subgroups based on relevant effect-modifying covariates. Trial data from TASTE, which investigated the effect (mRS score 0-1 at day 90) of tenecteplase vs alteplase, were compared to historical data from the Stroke Thrombolysis Trialists' Collaboration (STTC) meta-analysis (alteplase vs control). We reweighted the STTC treatment effect to match the shifted AIS population in TASTE before deriving the calibrated non-inferiority margin.

Results: For both datasets, subgroups were based on onset-to-treatment time and baseline NIHSS values. The reweighted risk difference for alteplase vs control was 11.70% (95% CI, 6.67-16.73); the conservative treatment-effect estimate was 6.67%, corresponding to a risk difference of 3.33% (50% reduction). Hence, the calibrated margin for comparing alternative interventions to alteplase was set at -3.33%, consistent with the European Stroke Organisation's clinically recommended margin (-3.0%).

Conclusion: Our conceptual approach to estimate calibrated non-inferiority margins is a simple and pragmatic alternative to existing methods to account for population shifts in stroke trials. The supporting procedure has already been applied.

Introduction: In patients with intracerebral haemorrhage (ICH), perihaematomal oedema (PHO) is considered a marker of secondary injury and is associated with worse functional outcomes. Minimally invasive surgery (MIS) has been suggested to reduce PHO when performed within 72 h of symptom onset. However, the effect of early surgery on PHO formation remains unclear. We aimed to determine the effect of MIS within 8 h of ICH onset on PHO formation.

Patients and methods: We included patients with spontaneous, supratentorial ICH ≥10 mL undergoing MIS within 8 h from the DIST-pilot study and compared them to patients receiving standard care from a cohort study. ICH and PHO volumes at baseline and 24(±12) h were manually segmented. The primary outcome was absolute PHO (aPHO) volume at 24 h. Secondary outcomes included aPHO growth between baseline, and 24 h and oedema extension distance (OED).

Results: We included 34 patients (median age 61 years, 68% male) undergoing MIS and 16 patients (median age 65 years, 69% male) receiving standard medical care. At baseline, median ICH, aPHO and OED volume were similar between groups. Median aPHO volume at 24 h was similar between groups (median difference -3.0 mL, 95% CI, -19.4 to 9.8, P =.67), while median aPHO growth was smaller in the MIS-group (median difference -6.8 mL, 95% CI, -18.67 to 0.33, P =.002). Median OED was greater in the MIS-group (median difference 0.18 cm, 95% CI, 0.05-0.40, P =.002).

Conclusion: Absolute PHO growth in the first 24 h after ICH was less pronounced after early MIS than after standard care, suggesting that early MIS may ameliorate secondary injury after ICH.

Rationale: Intra-arterial fibrinolytics may be used for distal remaining vessel occlusions after incomplete mechanical thrombectomy (MT). However, their efficacy in improving reperfusion in this specific clinical scenario is unclear. While better reperfusion may lead to improved clinical outcomes, additional fibrinolytics could also increase the risk of hemorrhagic complications.

Aim: To assess the safety and reperfusion efficacy of intra-arterial tenecteplase (TNK) compared to no further interventional treatment in patients with incomplete reperfusion and mechanically non-amendable residual occlusions after MT.

Methods and design: This is an international, multicenter, randomized (1:1) controlled, two-arm, open, assessor-blinded, surrogate endpoint trial. The interventional arm receives 3 mg (not weight-adjusted) intra-arterial TNK, administered as close as possible to the residual occlusion. The control arm receives no further interventional treatment.

Sample size: TECNO will randomize 156 participants 1:1 to 3 mg intra-arterial tenecteplase or no further interventional treatment. This sample size is based on anticipated absolute improvements in early and late reperfusion with intra-arterial TNK of 25% and 30%, respectively.

Outcomes: The two co-primary imaging outcomes are early and late reperfusion. Early reperfusion is defined as an extended Thrombolysis in Cerebral Infarction (eTICI) score ⩾ 2a for residual occlusions on angiography 25 min after randomization. Late reperfusion is defined as the absence of a wedge-shaped perfusion delay on delay-sensitive perfusion maps assessed on 24 h ± 6 h perfusion imaging. Standard secondary clinical outcomes will be assessed at 24 h and 90 ± 15 days.

Discussion: The TECNO trial will provide evidence on the safety and reperfusion efficacy of locally administered intra-arterial TNK in patients with residual occlusions following MT.

Introduction: Neutral results from trials assessing mechanical thrombectomy (MT) for medium/distal vessel occlusions (MDVO) suggest the need for better selection criteria in these patients. Tortuous vascular anatomies may negatively influence MT efficacy and safety.

Patients and methods: Consecutive patients with middle cerebral artery (MCA)-MDVO (M2/M3) who underwent MT at our center between January 2017 and September 2024 were included. Baseline CTAs were semi-automatically analyzed using an in-house vascular analysis framework. The internal carotid artery (ICA) tortuosity index (TI) and anatomical features of the MCA were extracted. Logistic regression adjusted for intravenous thrombolysis administration and onset-to-puncture time evaluated associations of anatomical features with treatment efficacy and safety endpoints. Primary endpoints were complete recanalization (final eTICI 2c/3) and symptomatic intracranial hemorrhage (sICH).

Results: 213 patients (81 years IQR 72-87, 51.2% female) were included. MCA bending length (aOR 0.48 [95%CI 0.27-0.86], p = 0.013), MCA-TI (aOR 0.77 [0.60-0.98], p = 0.032) and ICA-TI (aOR 0.59 [0.36-0.96], p = 0.034) were associated with lower probability of complete recanalization. ICA-TI (aOR 0.51 [0.31-0.84], p = 0.008) and mean MCA diameter (aOR 0.34 [0.13-0.90], p = 0.030) correlated with decreased odds of first-pass recanalization. Large mean MCA diameter was associated with lower likelihood of excellent functional outcome (aOR 0.30 [0.09-0.96], p = 0.042). Regarding safety endpoints, larger diameter at occlusion was associated with sICH (aOR 4.04 [1.03-15.87], p = 0.046), while MCA bending length (aOR 2.47 [1.24-4.92], p = 0.010) was linked to subarachnoid hemorrhage.

Discussion: Automatic evaluation of anatomical vascular features may predict safety and efficacy of MT in stroke patients with MCA-MDVO. The value of these features as inclusion criteria for future MCA-MDVO clinical trials should be explored.

Conclusion: Intracranial vascular tortuosity is associated to poor thrombectomy outcomes in patients with MDVO.

Introduction: Whether sex influence the clinical pathway of stroke, has been debated. In this study, we want to compare and add knowledge to presentation of symptoms and time to treatment of cerebral infarction in men and women.

Patients and methods: Data on 38,489 patients with cerebral infarction from 2018 to 2022 were obtained from the Norwegian Stroke Registry (NHR). The analyses were stratified by sex and age groups.

Results: Overall, there was a substantial sex parity for both focal neurological deficits and time to treatment. However, women were less likely to be awake at admission (RR 0.96, CI 0.95-0.97). A higher proportion of women presented with FAST symptoms (RR 1.06, CI 1.04-1.07), and women presented more often with arm paresis (RR 1.11, CI 1.08-1.14), facial paresis (RR 1.08, CI 1.05-1.11), aphasia (RR 1.17, CI 1.13-1.21), leg paresis (RR 1.18, CI 1.15-1.21) and neglect (RR 1.24, CI 1.18-1.31). Men presented more often with ataxia (RR 0.85, CI 0.81-0.89) and double vision (RR 0.72, CI 0.64-0.81). At admission, women had significantly higher National Institutes of Health Stroke Scale (NIHSS) score compared to men (average 5.60 vs 4.66), and significantly longer time from symptom onset to notification of Emergency Medical Communication Center (EMCC; average 298 vs 282 min).

Discussion and conclusion: Our findings indicate a large degree of sex equality in terms of symptoms and time to treatment for Norwegian patients with cerebral infarction. Further research exploring possible sex disparity in stroke treatment, is warranted.