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

BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e027561 ◽  
Author(s):  
Russell Chabanne ◽  
Charlotte Fernandez-Canal ◽  
Vincent Degos ◽  
Anne-Claire Lukaszewicz ◽  
Lionel Velly ◽  
...  

IntroductionEndovascular 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 analysisAnesthesia 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 disseminationThe 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 numberNCT03229148.

2019 ◽  
Vol 32 (4) ◽  
pp. 303-308 ◽  
Author(s):  
Yasuhiro Kawabata ◽  
Norio Nakajima ◽  
Hidenori Miyake ◽  
Shunichi Fukuda ◽  
Tetsuya Tsukahara

Purpose: Endovascular therapy for emergent large vessel occlusion has been established as the standard approach for acute ischaemic stroke. However, the effectiveness and safety of endovascular therapy in the very elderly population has not been proved. Objective: To determine the safety and effectiveness of endovascular therapy in octogenarians and nonagenarians. Methods: We retrospectively reviewed all patients who underwent endovascular therapy at two stroke centres between April 2012 and July 2018. Functional outcome was assessed using the modified Rankin scale at 90 days after stroke or at discharge. A favourable outcome was defined as a modified Rankin scale score of 0–2 or not worsening of the modified Rankin scale score before stroke. Outcome was compared between younger patients (aged 46–79 years, n = 40) and octogenarians and nonagenarians (aged 80–97 years, n = 19). Results: Octogenarian and nonagenarian patients had pre-stroke functional deficit (modified Rankin scale score >1) more frequently than younger patients (57.9% vs. 20.0%, respectively, P = 0.0059). No difference was observed between very elderly and younger patients in the rate of successful reperfusion (89.5% vs. 67.5%, respectively, P = 0.11), favourable functional outcome (47.4% vs. 45.0%, respectively, P = 1.00) and mortality (21.1% vs. 27.5%, respectively, P = 1.00). On multiple regression analysis, successful reperfusion, concomitant use of intravenous thrombolysis, and out-of-hospital onset were independent predictors of favourable outcome ( P = 0.0003, 0.015 and 0.028, respectively). Conclusions: Successful reperfusion, concomitant use of intravenous thrombolysis, and out-of-hospital onset were clinical predictors of favourable outcome. However, we did not observe an age-dependent effect of clinical outcome after endovascular therapy.


2015 ◽  
Vol 21 (6) ◽  
pp. 684-690 ◽  
Author(s):  
Reuben Grech ◽  
Mark Schembri ◽  
John Thornton

Purpose To date only a few studies have compared the effectiveness and functional outcomes of stent retrievers versus intravenous thrombolysis in acute ischaemic stoke. Our aim was to identify and collate all the available data and to assess for statistical differences in patient outcomes between the two treatments. Materials and methods We performed a systematic review and meta-analysis of studies with a randomised controlled design which utilised stentrievers and intravenous thrombolysis in acute ischaemic stroke. Results Five randomised controlled studies published in 2015 were identified. Second-generation thrombectomy devices constituted at least 80% of thrombectomy devices in the included studies, namely MR CLEAN, ESCAPE, EXTEND-IA, SWIFT PRIME and REVASCAT. No significant heterogeneity was seen in the included studies and the five trials were therefore included in the meta-analysis. A total of 46.10% of patients treated with stentrievers achieved an independent functional outcome (mRS < 2) at 90 days compared with 26.46% of those treated with intravenous thrombolysis with an odds ratio of 2.40 ( p < 0.001). The weighted recanalisation mean in the thrombectomy arms was 76.02%. A lower mortality rate was observed with stentrievers compared to intravenous thrombolysis (15.33% vs 18.74%; OR 0.81, p = 0.15). Stentrievers were also associated with a lower risk of symptomatic intracranial haemorrhage (7.86% vs 8.64%; OR 1.02, p = 0.93). The differences in the secondary/safety outcomes were not statistically significant. Conclusion Stentrievers can achieve a high rate of recanalisation and functional independence in acute ischaemic stroke and have a relatively good safety profile. Our meta-analysis demonstrates a clear benefit of an intra-arterial mechanical approach vs standard treatment.


BMJ Open ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. e045559
Author(s):  
Xuelei Zhang ◽  
Anxin Wang ◽  
Jing Yu Zhang ◽  
Baixue Jia ◽  
Xiaochuan Huo ◽  
...  

IntroductionAs a neuroprotective medication, butylphthalide (NBP) may help protect against cerebral ischaemic injury. However, evidence on whether NBP influences the outcomes of patients who had acute ischaemic stroke who are receiving revascularisation treatment is limited. This study aims to evaluate whether additional NBP therapy can improve the functional outcome of patients who receive intravenous recombinant tissue plasminogen activator and/or endovascular treatment (EVT).Methods and analysisThe study will be a randomised, double-blind, placebo-controlled, multiple-centre, parallel group trial. The sample size is estimated at 1200 patients. Eligible patients will be randomised at a 1:1 ratio to receive either NBP or placebo daily for 90 days, which will include 14 days of injections and 76 days of capsules. The first use of NBP/placebo will be started within 6 hours of onset of ischaemic stroke. The primary outcome is the functional outcome as assessed by the 90-day modified Rankin Scale, adjusted for baseline scores on the National Institutes of Health Stroke Scale. The primary safety outcome is the percentage of serious adverse events during the 90 days of treatment. This trial will determine whether NBP medication benefits patients who had acute ischaemic stroke who receive intravenous thrombolysis or EVT.Ethics and disseminationThe protocol was written according to the general ethical guidelines of the Declaration of Helsinki and approved by the Institutional Review Board/Ethics Committee of Beijing Tiantan Hospital, Capital Medical University with approval number KY 2018-003-02. Ethics committees of all participating sites have approved the study . Results of the study will be published in peer-reviewed scientific journals and shared in scientific presentations.Trial registration numberNCT03539445.


BMJ Open ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. e044917
Author(s):  
Tao Xu ◽  
You Wang ◽  
Jinxian Yuan ◽  
Yangmei Chen ◽  
Haiyan Luo

ObjectiveContrast extravasation (CE) after endovascular therapy (EVT) is commonly present in acute ischaemic stroke (AIS) patients. Substantial uncertainties remain about the relationship between CE and the outcomes of EVT in patients with AIS. Therefore, we aimed to evaluate this association.DesignA systematic review and meta-analysis of published studies were performed.Data sourceWe systematically searched the Medline and Embase databases for relevant clinical studies. The last literature search in databases was performed in June 2020.Eligibility criteria for study selectionWe included studies exploring the associations between CE and the outcomes of EVT in patients with AIS undergoing EVT.Data extraction and synthesisTwo reviewers extracted relevant information and data from each article independently. We pooled ORs with CIs using a random-effects meta-analysis to calculate the associations between CE and outcomes of EVT. The magnitude of heterogeneity between estimates was quantified with the I2 statistic with 95% CIs.ResultsFifteen observational studies that enrolled 1897 patients were included. Patients with CE had higher risks of poor functional outcome at discharge (2.38, 95% CI 1.45 to 3.89 p=0.001; n=545) and poor functional outcome at 90 days (OR 2.16, 95% CI 1.20 to 3.90; n=1194). We found no association between CE and in-hospital mortality (OR 0.95, 95% CI 0.27 to 3.30; n=376) or 90-day mortality (OR 1.38, 95% CI 0.81 to 2.36; n=697) after EVT. Moreover, CE was associated with higher risks of post-EVT intracranial haemorrhage (ICH) (OR 6.68, 95% CI 3.51 to 12.70; n=1721) and symptomatic ICH (OR 3.26, 95% CI 1.97 to 5.40; n=1092).ConclusionsThis systematic review and meta-analysis indicates that in patients with AIS undergoing EVT, CE is associated with higher risks of unfavourable functional outcomes and ICH. Thus, we should pay more attention to CE in patients with AIS undergoing EVT.


2021 ◽  

Objectives: To describe the clinical and epidemiological characteristics of patients with basilar artery occlusion (BAO) treated with mechanical thrombectomy (MT) in Aragón, and to compare its anaesthetic management, technical effectivity, security, and prognosis with those of anterior circulation. Methods: 322 patients from the prospective registry of mechanical thrombectomies from Aragon were assessed: 29 with BAO and 293 with an anterior circulation large vessel occlusion. Baseline characteristics, procedural, clinical and safety outcomes variables were compared. Results: Out of 29 patients with BAO that underwent endovascular therapy (62.1% men; average age 69.8 ± 14.05 years) 18 (62.1%) received endovascular therapy (EVT) alone and 11 (37.9%) EVT plus intravenous thrombolysis. Atherothrombotic stroke was the most common etiology (41%). The BAO group had longer Door-to-groin (160 vs 141 min; P = 0.043) and Onset-to-reperfusion times (340 vs 297 min; P = 0.005), and higher use of general anaesthesia (60.7% vs 14.7%; P < 0.01). No statistically significant difference was found for Procedure time (60 vs 50 min; P = 0.231) nor the rate of successful recanalization (72.4% vs 82.7%; P = 0.171). Functional independence at 90 days was significantly worse in the BAO group (17.9% vs 38.2%; P < 0.01). Conclusions: Patients with basilar artery occlusion had higher morbimortality despite similar angiographic results. Mechanical thrombectomy for BAOs is a safe and effective procedure in selected patients. A consensus about the effect of anaesthesia has yet to be reached, for BAO general anaesthesia remains the most frequently used technique.


Stroke ◽  
2016 ◽  
Vol 47 (suppl_1) ◽  
Author(s):  
Natalia Perez de la Ossa ◽  
Srikant Rangaraju ◽  
Tudor Jovin ◽  
Anoni Dávalos ◽  

Introduction: Various scales have been developed to predict long-term clinical outcome after endovascular therapy (EVT) in stroke patients. The objective of this study was to validate and compare five well-validated scales in terms of predictive accuracy for functional independence in a recent endovascular stroke trial (REVASCAT). Hypothesis: We hypothesize that predictive scales (PRE, THRIVE, HIAT2, SPAN-100, FAR) have good-excellent (AUC>0.7) predictive accuracy for good functional outcome and can predict the beneficial effect of EVT demonstrated in randomized clinical trials. Methods: REVASCAT (Randomized Trial of Revascularization with Solitaire-FR Device versus Best Medical Therapy in the Treatment of Acute Stroke Due to Anterior Circulation Large Vessel Occlusion Presenting within Eight Hours of Symptom Onset) enrolled 206 patients who were randomized to receive EVT or best medical treatment. Five scores (PRE-score, THRIVE, HIAT2, SPAN-100 and FAR-score) were retrospectively calculated on patients who received EVT. Receiver-operator characteristics (ROC) for good outcome (mRS 0-2 at 90 days) for each scale were compared. Using the highest predictive scales, the proportion of patients with good outcome by the score categorized in quartiles was analyzed. Results: 103 patients received EVT in the REVASCAT trial (mean age 65.7, median NIHSS 17). Baseline NIHSS, baseline CT-ASPECTS, age and atrial fibrillation, but not previous iv tPA or DM, were associated with good outcome in multivariable analysis. AUC for good outcome was ≥0.70 for FAR (0.74) and PRE (0.70) scores while SPAN-100 (0.67), HIAT2 (0.65) and THRIVE (0.64) had lower AUCs although differences were not statistically significant. The higher the score on the PRE and FAR scores, the lower the proportion of patients with good outcome (PRE-score: 1QT 44.4%, 2QT 24.4%, 3QT 22.2%, 4 QT 8.9%; FAR-score: 1QT 57.8%, 2QT 22.2%, 3QT 6.7%, 4QT 3.3%). Benefit of EVT accordingly to the score on the different scales will be also presented. Conclusions: Of the 5 stroke scales, FAR and PRE had better predictive accuracy for functional independence after EVT. These tools may facilitate decision making for EVT in anterior circulation large vessel occlusion stroke.


2019 ◽  
Vol 96 (1141) ◽  
pp. 680-685
Author(s):  
Xi Chen ◽  
Yu Shen ◽  
Chengfang Huang ◽  
Yu Geng ◽  
Yunxian Yu

ObjectivesThe aim of this study was to evaluate the effect of alteplase in intravenous thrombolysis of acute ischaemic stroke (AIS) regarding the different time windows of treatment (<3 hours, 3–4.5 hours, >4.5 hours).MethodsA systematic literature search was conducted from PubMed, Cochrane Library and Embase. 12 clinical randomised controlled trials with 3402 patients with AIS met the inclusion criteria. The primary, secondary and tertiary outcomes were modified Rankin Scale (mRS) scores 0–1, mortality at 90th day after treatment and symptomatic intracerebral haemorrhage within 36 hours, respectively. Network meta-analysis and conventional meta-analysis were carried out for calculating odds ratio (OR), the surface under cumulative ranking curve (SUCRA) and the probabilities of being the best.ResultsFor mRS, alteplase regardless of time delay was significantly more effective than placebo (OR 1.33–2.17). However, alteplase used within 3 hours after AIS occurrence (SUCRA=98.3%) was significantly more effective (OR=1.64) than that at 3–4.5 hours (SUCRA=43%) and showed the trend of priority (OR=1.47) compared with that beyond 4.5 hours (SUCRA=58%). For the mortality, compared with placebo (SUCRA=64.7%), alteplase within 3 hours was similar to that of 3–4.5 hours whereas alteplase beyond 4.5 hours (SUCRA=7.3%) showed the trend of significantly increasing 85% mortality. For the tertiary outcome, alteplase within 3 hours (SUCRA=19.0%) was comparable with placebo (SUCRA=99.9%) whereas alteplase beyond 3 hours significantly increased (OR 5.89–6.67) the symptomatic intracerebral haemorrhage.ConclusionsAlteplase within 3 hours should be recommended as the best treatment delay for its best efficacy among all the intervention and equivalent safety compared with placebo. Alteplase beyond 3 hours was less effective compared with that within 3 hours and increased the risk of mortality on 3 months as well as symptomatic intracerebral haemorrhage at 36 hours. More head-to-head clinical trials are needed to confirm those findings.


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