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Choice of ANaesthesia for EndoVAScular treatment of acute ischaemic stroke at posterior circulation (CANVAS II): protocol for an exploratory randomised controlled study.

ABSTRACT: INTRODUCTION:Observational and interventional studies indicate that the type of anaesthesia may be associated with the postprocedural neurological function in patients with anterior circulation acute ischaemic stroke undergoing endovascular treatment. Patients with acute posterior circulation ischaemic stroke may experience different physiological changes and result in severe neurological outcome. However, the effect of the type of anaesthesia on postprocedure neurological function remained unclear in this population. METHODS AND ANALYSIS:This is an exploratory randomised controlled trial that will be carried out at Beijing Tiantan Hospital, Capital Medical University. Patients with acute posterior circulation ischaemic stroke and deemed suitable for emergency endovascular recanalisation will be recruited in this trial. Eighty-four patients will be randomised to receive either general anaesthesia or conscious sedation with 1:1 allocation ratio. The primary endpoint is the 90-day modified Rankin Scale. ETHICS AND DISSEMINATION:The study has been reviewed by and approved by Ethics Committee of Beijing Tiantan Hospital of Capital Medical University (KY2017-074-02). If the results are positive, the study will indicate whether the type of anaesthesia affects neurological outcome after endovascular treatment of posterior stroke. The findings of the study will be published in peer-reviewed journals and presented at national or international conferences. TRIAL REGISTRATION NUMBER:NCT03317535.

SUBMITTER: Liang F

PROVIDER: S-EPMC7398089 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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Choice of ANaesthesia for EndoVAScular treatment of acute ischaemic stroke at posterior circulation (CANVAS II): protocol for an exploratory randomised controlled study.

Liang Fa F Zhao Yan Y Yan Xiang X Wu Youxuan Y Li Xiuheng X Zhou Yang Y Jian Minyu M Li Shu S Miao Zhongrong Z Han Ruquan R Peng Yuming Y

BMJ open 20200731 7

<h4>Introduction</h4>Observational and interventional studies indicate that the type of anaesthesia may be associated with the postprocedural neurological function in patients with anterior circulation acute ischaemic stroke undergoing endovascular treatment. Patients with acute posterior circulation ischaemic stroke may experience different physiological changes and result in severe neurological outcome. However, the effect of the type of anaesthesia on postprocedure neurological function remai ...[more]

PMID: 32737091

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Project description:Background and purposeWe investigated the impact of stroke etiology on the endovascular treatment (EVT) procedure and clinical outcome of posterior circulation stroke (PCS) patients with EVT compared to anterior circulation stroke (ACS) patients.MethodsWe retrospectively analyzed ischemic stroke patients who underwent EVT between January 2012 and December 2020. Enrolled ACS and PCS patients were compared according to etiologies (intracranial arterial steno-occlusion [ICAS-O], artery-to-artery embolic occlusion [AT-O], and cardioembolic occlusion [CA-O]). EVT procedure and favorable clinical outcomes at 3 months (modified Rankin Scale 0-2) were compared between the ACS and PCS groups for each etiology.ResultsWe included 419 patients (ACS, 346; PCS, 73) including 88 ICAS-O (ACS, 67; PCS, 21), 66 AT-O (ACS, 50; PCS, 16), and 265 CA-O (ACS, 229; PCS, 36) patients in the study. The onset-to-recanalization time was longer in the PCS group than in the ACS group (median 628.0 minutes vs. 421.0 minutes, P=0.01). In CA-O patients, the door-to-puncture time was longer, whereas the puncture-to-recanalization time was shorter in the PCS group than in the ACS group. The proportions of successful recanalization and favorable clinical outcomes were similar between the ACS and PCS groups for all three etiologies. Low baseline National Institutes of Health Stroke Scale (NIHSS) scores and absence of intracerebral hemorrhage at follow-up imaging were associated with favorable clinical outcomes in both groups, whereas successful recanalization (odds ratio, 11.74; 95% confidence interval, 2.60 to 52.94; P=0.001) was only associated in the ACS group.ConclusionsThe proportions of successful recanalization and favorable clinical outcomes were similar among all three etiologies between PCS and ACS patients who underwent EVT. Initial baseline NIHSS score and absence of hemorrhagic transformation were related to favorable outcomes in the PCS and ACS groups, whereas successful recanalization was related to favorable outcomes only in the ACS group.

Project description:OBJECTIVE:The Pragmatic Ischaemic Thrombectomy Evaluation (PISTE) trial was a multicentre, randomised, controlled clinical trial comparing intravenous thrombolysis (IVT) alone with IVT and adjunctive intra-arterial mechanical thrombectomy (MT) in patients who had acute ischaemic stroke with large artery occlusive anterior circulation stroke confirmed on CT angiography (CTA). DESIGN:Eligible patients had IVT started within 4.5?hours of stroke symptom onset. Those randomised to additional MT underwent thrombectomy using any Conformité Européene (CE)-marked device, with target interval times for IVT start to arterial puncture of <90?min. The primary outcome was the proportion of patients achieving independence defined by a modified Rankin Scale (mRS) score of 0-2 at day 90. RESULTS:Ten UK centres enrolled 65 patients between April 2013 and April 2015. Median National Institutes of Health Stroke Scale score was 16 (IQR 13-21). Median stroke onset to IVT start was 120?min. In the intention-to-treat analysis, there was no significant difference in disability-free survival at day 90 with MT (absolute difference 11%, adjusted OR 2.12, 95% CI 0.65 to 6.94, p=0.20). Secondary analyses showed significantly greater likelihood of full neurological recovery (mRS 0-1) at day 90 (OR 7.6, 95% CI 1.6 to 37.2, p=0.010). In the per-protocol population (n=58), the primary and most secondary clinical outcomes significantly favoured MT (absolute difference in mRS 0-2 of 22% and adjusted OR 4.9, 95% CI 1.2 to 19.7, p=0.021). CONCLUSIONS:The trial did not find a significant difference between treatment groups for the primary end point. However, the effect size was consistent with published data and across primary and secondary end points. Proceeding as fast as possible to MT after CTA confirmation of large artery occlusion on a background of intravenous alteplase is safe, improves excellent clinical outcomes and, in the per-protocol population, improves disability-free survival. TRIAL REGISTRATION NUMBER:NCT01745692; Results.

Project description:ImportanceNo definitive conclusion can be made on the best choice of anesthesia for people with acute posterior circulation stroke during endovascular treatment. Only a few observational studies have focused on this topic in recent years, and they have differing conclusions.ObjectiveTo examine whether conscious sedation (CS) is a feasible alternative to general anesthesia (GA) during endovascular treatment in patients with acute posterior circulation stroke.Design, setting, and participantsA randomized parallel-group exploratory trial with blinded end point evaluation (Choice of Anesthesia for Endovascular Treatment of Acute Ischemic Stroke [CANVAS II]) enrolled adult patients from March 2018 to June 2021 at 2 comprehensive care hospitals in China. Patients with acute posterior circulation stroke were enrolled, randomized, and monitored for 3 months. Of 210 patients admitted with acute ischemic posterior circulation stroke, 93 were recruited and 87 were included in the intention-to-treat (ITT) analysis after exclusions, 43 were assigned to GA and 44 to CS. All analyses were unadjusted or adjusted with the ITT principle.InterventionsParticipants were randomly assigned to CS or GA in a 1:1 ratio.Main outcomes and measuresThe primary end point was functional independence at 90 days evaluated with the modified Rankin Scale (mRS).ResultsA total of 87 participants were included in the ITT study (mean [SD] age, 62 [12] years; 16 [18.4%] female and 71 [81.6%] male). Of these, 43 were in the GA group and 44 in the CS group. The overall baseline median (IQR) National Institute of Health Stroke Scale (NIHSS) score was 15 (12-17). In the CS group, 13 people (29.5%) were ultimately transferred to GA. The CS group had a higher incidence of functional independence; however, no significant difference was found between the 2 groups (48.8% vs 54.5%; risk ratio, 0.89; 95% CI, 0.58-1.38; adjusted odds ratio [OR], 0.91; 95% CI, 0.37-2.22). However, GA performed better in successful reperfusion (mTICI 2b-3) under ITT analysis (95.3% vs 77.3%; adjusted OR, 5.86; 95% CI, 1.16-29.53).Conclusion and relevanceThe findings in this study suggest that CS was not better than GA for the primary outcome of functional recovery and was perhaps worse for the secondary outcome of successful reperfusion.Trial registrationClinicalTrials.gov Identifier: NCT03317535.

Project description:Background and purposeWe aimed to assess the association of diabetes mellitus (DM) and admission hyperglycaemia (AH), respectively, and outcome in patients with acute ischaemic stroke with large vessel occlusion in the anterior circulation treated with endovascular therapy (EVT) in daily clinical practice.MethodsConsecutive EVT patients admitted to our stroke centre between February 2015 and April 2020 were included in this observational cohort study. Patients with versus without DM and with versus without AH (glucose ≥ 7.8 mmol/L) were compared.ResultsWe included 1020 patients (48.9% women, median age = 73.1 years); 282 (27.6%) had DM, and 226 (22.2%) had AH. Patients with versus without DM less often showed successful reperfusion (odds ratio [OR]adjusted = 0.61, p = 0.023) and worse 3-month functional outcome (modified Rankin Scale [mRS] = 0-2: 31.3% vs. 48%, ORadjusted = 0.59, p = 0.004; death: 38.9% vs. 24.1%, ORadjusted = 1.75, p = 0.002; mRS shift: padjusted < 0.0001; if moderate/good collaterals and mismatch, mRS = 0-2: ORadjusted = 0.52, p = 0.005; death: ORadjusted = 1.95, p = 0.005). If analysis was additionally adjusted for AH, only mRS shift was still significantly worse in patients with DM (padjusted = 0.012). Patients with versus without AH showed similar successful reperfusion rates and worse 3-month functional outcome (mRS = 0-2: 28.3% vs. 50.4%, ORadjusted = 0.52, p < 0.0001; death: 40.4% vs. 22.4%, ORadjusted = 1.80, p = 0.001; mRS shift: padjusted < 0.0001; if moderate/good collaterals and mismatch, mRS = 0-2: ORadjusted = 0.38, p < 0.0001; death: ORadjusted = 2.39, p < 0.0001). If analysis was additionally adjusted for DM, 3-month functional outcome remained significantly worse in patients with AH (mRS = 0-2: ORadjusted = 0.58, p = 0.004; death: ORadjusted = 1.57, p = 0.014; mRS shift: padjusted = 0.004). DM independently predicted recurrent/progressive in-hospital ischaemic stroke (OR = 1.71, p = 0.043) together with admission National Institutes of Health Stroke Scale score (OR = 0.95, p = 0.005), and AH independently predicted in-hospital symptomatic intracranial haemorrhage (OR = 2.21, p = 0.001). The association of admission continuous glucose levels and most outcome variables was (inversely) J-shaped.ConclusionsHyperglycaemia more than DM was associated with worse 3-month outcome in the patients studied, more likely so in the case of moderate/good collaterals and mismatch in admission imaging.

Project description:BackgroundMost disabling strokes are due to a blockage of a large artery in the brain by a blood clot. Prompt removal of the clot with intra-arterial thrombolytic drugs or mechanical devices, or both, can restore blood flow before major brain damage has occurred, leading to improved recovery. However, these so-called endovascular interventions can cause bleeding in the brain. This is a review of randomised controlled trials of endovascular thrombectomy or intra-arterial thrombolysis, or both, for acute ischaemic stroke.ObjectivesTo assess whether endovascular thrombectomy or intra-arterial interventions, or both, plus medical treatment are superior to medical treatment alone in people with acute ischaemic stroke.Search methodsWe searched the Trials Registers of the Cochrane Stroke Group and Cochrane Vascular Group (last searched 1 September 2020), CENTRAL (the Cochrane Library, 1 September 2020), MEDLINE (May 2010 to 1 September 2020), and Embase (May 2010 to 1 September 2020). We also searched trials registers, screened reference lists, and contacted researchers.Selection criteriaRandomised controlled trials (RCTs) of any endovascular intervention plus medical treatment compared with medical treatment alone in people with definite ischaemic stroke.Data collection and analysisTwo review authors (MBR and MJ) applied the inclusion criteria, extracted data, and assessed trial quality. Two review authors (MBR and HL) assessed risk of bias, and the certainty of the evidence using GRADE. We obtained both published and unpublished data if available. Our primary outcome was favourable functional outcome at the end of the scheduled follow-up period, defined as a modified Rankin Scale score of 0 to 2. Eighteen trials (i.e. all but one included trial) reported their outcome at 90 days. Secondary outcomes were death from all causes at in the acute phase and by the end of follow-up, symptomatic intracranial haemorrhage in the acute phase and by the end of follow-up, neurological status at the end of follow-up, and degree of recanalisation.Main resultsWe included 19 studies with a total of 3793 participants. The majority of participants had large artery occlusion in the anterior circulation, and were treated within six hours of symptom onset with endovascular thrombectomy. Treatment increased the chance of achieving a good functional outcome, defined as a modified Rankin Scale score of 0 to 2: risk ratio (RR) 1.50 (95% confidence interval (CI) 1.37 to 1.63; 3715 participants, 18 RCTs; high-certainty evidence). Treatment also reduced the risk of death at end of follow-up: RR 0.85 (95% CI 0.75 to 0.97; 3793 participants, 19 RCTs; high-certainty evidence) without increasing the risk of symptomatic intracranial haemorrhage in the acute phase: RR 1.46 (95% CI 0.91 to 2.36; 1559 participants, 6 RCTs; high-certainty evidence) or by end of follow-up: RR 1.05 (95% CI 0.72 to 1.52; 1752 participants, 10 RCTs; high-certainty evidence); however, the wide confidence intervals preclude any firm conclusion. Neurological recovery to National Institutes of Health Stroke Scale (NIHSS) score 0 to 1 and degree of recanalisation rates were better in the treatment group: RR 2.03 (95% CI 1.21 to 3.40; 334 participants, 3 RCTs; high-certainty evidence) and RR 3.11 (95% CI 2.18 to 4.42; 268 participants, 3 RCTs; high-certainty evidence), respectively.Authors' conclusionsIn individuals with acute ischaemic stroke due to large artery occlusion in the anterior circulation, endovascular thrombectomy can increase the chance of survival with a good functional outcome without increasing the risk of intracerebral haemorrhage or death.

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Choice of ANaesthesia for EndoVAScular treatment of acute ischaemic stroke at posterior circulation (CANVAS II): protocol for an exploratory randomised controlled study.

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Choice of ANaesthesia for EndoVAScular treatment of acute ischaemic stroke at posterior circulation (CANVAS II): protocol for an exploratory randomised controlled study.

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