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Sedation versus general anaesthesia in endovascular therapy for anterior circulation acute ischaemic stroke: the multicentre randomised controlled AMETIS trial study protocol.

ABSTRACT: INTRODUCTION:Endovascular thrombectomy is the standard of care for anterior circulation acute ischaemic stroke (AIS) secondary to emergent large vessel occlusion in patients who qualify. General anaesthesia (GA) or conscious sedation (CS) is usually required to ensure patient comfort and avoid agitation and movement during thrombectomy. However, the question of whether the use of GA or CS might influence functional outcome remains debated. Indeed, conflicting results exist between observational studies with better outcomes associated with CS and small monocentric randomised controlled trials favouring GA. Therefore, we aim to evaluate the effect of CS versus GA on functional outcome and periprocedural complications in endovascular mechanical thrombectomy for anterior circulation AIS. METHODS AND ANALYSIS:Anesthesia Management in Endovascular Therapy for Ischemic Stroke (AMETIS) trial is an investigator initiated, multicentre, prospective, randomised controlled, two-arm trial. AMETIS trial will randomise 270 patients with anterior circulation AIS in a 1:1 ratio, stratified by centre, National Institutes of Health Stroke Scale (?15?or >15) and association of intravenous thrombolysis or not to receive either CS or GA. The primary outcome is a composite of functional independence at 3 months and absence of perioperative complication occurring by day 7 after endovascular therapy for anterior circulation AIS. Functional independence is defined as a modified Rankin Scale score of 0-2 by day 90. Perioperative complications are defined as intervention-associated arterial perforation or dissection, pneumonia or myocardial infarction or cardiogenic acute pulmonary oedema or malignant stroke evolution occurring by day 7. ETHICS AND DISSEMINATION:The AMETIS trial was approved by an independent ethics committee. Study began in august 2017. Results will be published in an international peer-reviewed medical journal. TRIAL REGISTRATION NUMBER:NCT03229148.

SUBMITTER: Chabanne R

PROVIDER: S-EPMC6747652 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature

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Sedation versus general anaesthesia in endovascular therapy for anterior circulation acute ischaemic stroke: the multicentre randomised controlled AMETIS trial study protocol.

Chabanne Russell R Fernandez-Canal Charlotte C Degos Vincent V Lukaszewicz Anne-Claire AC Velly Lionel L Mrozek Segolene S Perrigault Pierre-François PF Molliex Serge S Tavernier Benoit B Dahyot-Fizelier Claire C Verdonk Franck F Caumon Elodie E Masgrau Aurélie A Begard Marc M Chabert Emmanuel E Ferrier Anna A Jaber Samir S Bazin Jean-Etienne JE Pereira Bruno B Futier Emmanuel E

BMJ open 20190913 9

<h4>Introduction</h4>Endovascular thrombectomy is the standard of care for anterior circulation acute ischaemic stroke (AIS) secondary to emergent large vessel occlusion in patients who qualify. General anaesthesia (GA) or conscious sedation (CS) is usually required to ensure patient comfort and avoid agitation and movement during thrombectomy. However, the question of whether the use of GA or CS might influence functional outcome remains debated. Indeed, conflicting results exist between observ ...[more]

PMID: 31519668

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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:The impact of reperfusion therapies on cognition has been poorly explored and little knowledge exists. We explored the influence of endovascular treatment (EVT) on cognitive outcome in patients with anterior circulation ischemic stroke. Patients presenting with ischemic stroke due to anterior large vessel occlusion who underwent intravenous thrombolysis (IVT) alone or EVT plus IVT were recruited. Cognitive abilities were evaluated at 6 months from stroke through a neuropsychological test battery. A total of 88 patients with a mean age of 66.3 ± 12.9 years were included, of which 38 treated with IVT alone and 50 with IVT plus EVT. Compared to patients treated with IVT alone, patients who received EVT plus IVT performed significantly better at the neuropsychological tests exploring executive functions, attention, abstract reasoning, visuospatial ability, visual and verbal and memory. At multivariable regression analysis, the EVT was independently associated with the 6-month cognitive performance after the adjustment for age, sex, admission National Institutes of Health Stroke Scale score, systolic blood pressure, glucose level, Alberta Stroke Program Early CT score, side of stroke, site of occlusion, and Back Depression Inventory score [Stroop Test Word Reading: adjβ = 13.99, 95% confidence interval (CI) 8.47-19.50, p < 0.001; Stroop Test Colour Naming: adjβ = 6.63, 95% CI 2.46-10.81, p = 0.002; Trail Making Test-A: adjβ = - 92.98, 95% CI - 153.76 to - 32.20, p = 0.003; Trail Making Test-B: adjβ = - 181.12, 95% CI - 266.09 to - 96.15; p < 0.001; Digit Span Test Forward: adjβ = 1.44, 95% CI 0.77-2.10, p < 0.001; Digit Span Test Backward: adjβ = 1.10, 95% CI 0.42-1.77, p = 0.002; Coloured Progressive Matrices: adjβ = 5.82, 95% CI 2.71-8.93, p < 0.001; Rey Complex Figure Test-Copy: adjβ = 6.02, 95% CI 2.74-9.30, p < 0.001; Rey Complex Figure Test-Immediate recall: adjβ = 6.00, 95% CI 2.34-9.66, p = 0.002; Rey Complex Figure Test-Delayed recall: adjβ = 5.73, 95% CI 1.95-9.51, p = 0.003; Rey Auditory Verbal Learning Test-Immediate recall: adjβ = 12.60, 95% CI 6.69-18.52, p < 0.001; Rey Auditory Verbal Learning Test-Delayed recall: adjβ = 1.85, 95% CI 0.24-3.45, p = 0.025]. Patients treated with EVT plus IVT had better cognitive performance than patients treated with IVT alone at 6 months from anterior circulation ischemic stroke.

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: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:BackgroundPatients who have severe narrowing at or near the origin of the internal carotid artery as a result of atherosclerosis have a high risk of ischaemic stroke ipsilateral to the arterial lesion. Previous trials have shown that carotid endarterectomy improves long-term outcomes, particularly when performed soon after a prior transient ischaemic attack or mild ischaemic stroke. However, complications may occur during or soon after surgery, the most serious of which is stroke, which can be fatal. It has been suggested that performing the operation under local anaesthesia, rather than general anaesthesia, may be safer. Therefore, a prospective, randomised trial of local versus general anaesthesia for carotid endarterectomy was proposed to determine whether type of anaesthesia influences peri-operative morbidity and mortality, quality of life and longer term outcome in terms of stroke-free survival.Methods/designA two-arm, parallel group, multicentre randomised controlled trial with a recruitment target of 5000 patients. For entry into the study, in the opinion of the responsible clinician, the patient requiring an endarterectomy must be suitable for either local or general anaesthesia, and have no clear indication for either type. All patients with symptomatic or asymptomatic internal carotid stenosis for whom open surgery is advised are eligible. There is no upper age limit. Exclusion criteria are: no informed consent; definite preference for local or general anaesthetic by the clinician or patient; patient unlikely to be able to co-operate with awake testing during local anaesthesia; patient requiring simultaneous bilateral carotid endarterectomy; carotid endarterectomy combined with another operation such as coronary bypass surgery; and, the patient has been randomised into the trial previously. Patients are randomised to local or general anaesthesia by the central trial office. The primary outcome is the proportion of patients alive, stroke free (including retinal infarction) and without myocardial infarction 30 days post-surgery. Secondary outcomes include the proportion of patients alive and stroke free at one year; health related quality of life at 30 days; surgical adverse events, re-operation and re-admission rates; the relative cost of the two methods of anaesthesia; length of stay and intensive and high dependency bed occupancy.Trial registrationCurrent Controlled Trials ISRCTN00525237.

Project description:BackgroundEndovascular thrombectomy (EVT) has been proven effective in anterior circulation stroke due to large vessel occlusion (LVO). However, translation from randomized clinical trials (RCTs) with highly selected patients to real-world requires confirmation, particularly to identify associations outside of strict selection criteria.AimsThis study aims to compare functional outcomes after EVT in real-world with those reported in RCTs, and to identify associations with functional outcome after EVT outside RCT-criteria.MethodsThis study analyzed longitudinal German real-world data from the Stroke Research Consortium in Northern Bavaria (STAMINA) cohort from January, 2015 to June, 2019. We conducted a trial emulation, comparing patients with anterior circulation stroke and LVO meeting selection criteria for RCTs investigating EVT (1) predominantly within 6 hours with those from HERMES meta-analysis, and (2) within 6-24 hours with those from AURORA meta-analysis. We (3) analyzed treatment effects of EVT and association with functional outcome in patients treated outside RCT criteria.ResultsOf 598 patients, 281 (47.0%) met RCT-criteria for treatment within 6 hours (hereinafter STAMINA-HERMES), 74 (12.4%) met RCT-criteria for treatment within 6-24 hours (STAMINA-AURORA), and 277 (46.3%) patients received EVT outside RCT-criteria. We observed no difference in rates of functional independence or mortality, comparing STAMINA-HERMES with HERMES meta-analysis (mRS 0-1: n=120/281 [43%] vs. 291/633 [46%], p=0.36; mortality: n=34/281 [12%] vs. 97/633 [15%], p=0.20), and STAMINA-AURORA with AURORA meta-analysis (mRS 0-1: n=26/74 [35%] vs. 122/266 [46%], p=0.10, mortality: n=10/74 [14%] vs. 45/266 [17%], p=0.48). Patients treated outside RCT-criteria had worse outcome (mRS 0-1: n=38/277 [14%], mortality: n=90/277 [32%], both p<0.001); possibly driven by pre-existing functional dependence (n=172/277 [62%]). Compared to matched controls, EVT outside of RCT-criteria was associated with lower mortality (absolute treatment effect: -14%, 95% Confidence Interval [CI] -23 to -5, p<0.01), but not with recovery to functional independence or premorbid functional status (treatment effect: 4%, CI -4 to 11, p=0.34), which was associated with lower NIHSS (Odds ratio [OR] 0.86, CI 0.80-0.92, p<0.001) and age (OR 0.95, CI 0.93-0.98, p=0.002).ConclusionsTranslation of EVT outcomes reported in RCTs into real-world is possible, however, almost half of patients did not meet trial criteria. Identification of patients who functionally benefit from frequently performed EVT outside RCT-criteria requires further investigation.Trial registrationClinicaltrials.gov, NCT04357899.

Dataset Information

Sedation versus general anaesthesia in endovascular therapy for anterior circulation acute ischaemic stroke: the multicentre randomised controlled AMETIS trial study protocol.

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Sedation versus general anaesthesia in endovascular therapy for anterior circulation acute ischaemic stroke: the multicentre randomised controlled AMETIS trial study protocol.

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