scholarly journals A Prospective Multicenter Registry on Feasibility, Safety, and Outcome of Endovascular Recanalization in Childhood Stroke (Save ChildS Pro)

2021 ◽  
Vol 12 ◽  
Author(s):  
Peter B. Sporns ◽  
André Kemmling ◽  
Sarah Lee ◽  
Heather Fullerton ◽  
Wolfgang G. Kunz ◽  
...  
Keyword(s):  
Scale Score ◽  
Pediatric Patients ◽  
Arterial Occlusion ◽  
Intravenous Thrombolysis ◽  
Control Group ◽  
Arterial Ischemic Stroke ◽  
Vessel Occlusion ◽  
Clinical Trial Registration ◽  
Best Medical Treatment ◽  
The Impact

Rationale: Early evidence for the benefit of mechanical thrombectomy (MT) in pediatric patients with intracranial large vessel occlusion has been shown in previous retrospective cohorts. Higher-level evidence is needed to overcome the limitations of these studies such as the lack of a control group and the retrospective design. Randomized trials will very likely not be feasible, and several open questions remain, for example, the impact of arteriopathic etiologies or a possible lower age limit for MT. Save ChildS Pro therefore aims to demonstrate the safety and effectiveness of MT in pediatric patients compared to the best medical management and intravenous thrombolysis.Design: Save ChildS Pro is designed as a worldwide multicenter prospective registry comparing the safety and effectiveness of MT to the best medical care alone in the treatment of pediatric arterial ischemic stroke (AIS). It will include pediatric patients (<18 years) with symptomatic acute intracranial arterial occlusion who underwent either MT or best medical treatment including intravenous thrombolysis.Outcomes: The primary endpoint of Save ChildS Pro is the modified Rankin Scale score at 90 days post-stroke. Secondary endpoints will comprise the decrease of the Pediatric National Institutes of Health Stroke Scale score from admission to discharge and rate of complications.Discussion: Save ChildS Pro aims to provide high-level evidence for MT for pediatric patients with AIS, thereby improving functional outcome and quality of life and reducing the individual, societal, and economic burden of death and disability resulting from pediatric stroke.Clinical Trial Registration: Save ChildS Pro is registered at the German Clinical Trials Registry (DRKS; identifier: DRKS00018960).

scholarly journals Dabigatran Reversal Before Intravenous Tenecteplase in Acute Ischemic Stroke

Stroke ◽  
2020 ◽  
Vol 51 (5) ◽  
pp. 1616-1619 ◽  
Author(s):  
James Beharry ◽  
Michael J. Waters ◽  
Roy Drew ◽  
John N. Fink ◽  
Duncan Wilson ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Functional Outcome ◽  
Scale Score ◽  
Clinical Laboratory ◽  
Intravenous Thrombolysis ◽  
Interquartile Range ◽  
Large Vessel ◽  
Large Vessel Occlusion ◽  
Vessel Occlusion

Background and Purpose— Reversal of dabigatran before intravenous thrombolysis in patients with acute ischemic stroke has been well described using alteplase but experience with intravenous tenecteplase is limited. Tenecteplase seems at least noninferior to alteplase in patients with intracranial large vessel occlusion. We report on the experience of dabigatran reversal before tenecteplase thrombolysis for acute ischemic stroke. Methods— We included consecutive patients with ischemic stroke receiving dabigatran prestroke treated with intravenous tenecteplase after receiving idarucizumab. Patients were from 2 centers in New Zealand and Australia. We reported the clinical, laboratory, and radiological characteristics and their functional outcome. Results— We identified 13 patients receiving intravenous tenecteplase after dabigatran reversal. Nine (69%) were male, median age was 79 (interquartile range, 69–85) and median baseline National Institutes of Health Stroke Scale score was 6 (interquartile range, 4–21). Atrial fibrillation was the indication for dabigatran therapy in all patients. All patients had a prolonged thrombin clotting time (median, 80 seconds [interquartile range, 57–113]). Seven patients with large vessel occlusion were referred for endovascular thrombectomy, 2 of these patients (29%) had early recanalization with tenecteplase abrogating thrombectomy. No patients had parenchymal hemorrhage or symptomatic hemorrhagic transformation. Favorable functional outcome (modified Rankin Scale score, 0–2) occurred in 8 (62%) patients. Two deaths occurred from large territory infarction. Conclusions— Our experience suggests intravenous thrombolysis with tenecteplase following dabigatran reversal using idarucizumab may be safe in selected patients with acute ischemic stroke. Further studies are required to more precisely estimate the efficacy and risk of clinically significant hemorrhage.

Tenecteplase versus alteplase before endovascular thrombectomy (EXTEND-IA TNK): A multicenter, randomized, controlled study

2017 ◽  
Vol 13 (3) ◽  
pp. 328-334 ◽  
Author(s):  
Bruce CV Campbell ◽  
Peter J Mitchell ◽  
Leonid Churilov ◽  
Nawaf Yassi ◽  
Timothy J Kleinig ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Arterial Occlusion ◽  
Intravenous Thrombolysis ◽  
Stroke Onset ◽  
Large Vessel ◽  
Controlled Study ◽  
Modified Rankin Scale ◽  
Open Label ◽  
Vessel Occlusion ◽  
Symptomatic Intracerebral Hemorrhage

Background and hypothesis Intravenous thrombolysis with alteplase remains standard care prior to thrombectomy for eligible patients within 4.5 h of ischemic stroke onset. However, alteplase only succeeds in reperfusing large vessel arterial occlusion prior to thrombectomy in a minority of patients. We hypothesized that tenecteplase is non-inferior to alteplase in achieving reperfusion at initial angiogram, when administered within 4.5 h of ischemic stroke onset, in patients planned to undergo endovascular therapy. Study design EXTEND-IA TNK is an investigator-initiated, phase II, multicenter, prospective, randomized, open-label, blinded-endpoint non-inferiority study. Eligibility requires a diagnosis of ischemic stroke within 4.5 h of stroke onset, pre-stroke modified Rankin Scale≤3 (no upper age limit), large vessel occlusion (internal carotid, basilar, or middle cerebral artery) on multimodal computed tomography and absence of contraindications to intravenous thrombolysis. Patients are randomized to either IV alteplase (0.9 mg/kg, max 90 mg) or tenecteplase (0.25 mg/kg, max 25 mg) prior to thrombectomy. Study outcomes The primary outcome measure is reperfusion on the initial catheter angiogram, assessed as modified treatment in cerebral infarction 2 b/3 or the absence of retrievable thrombus. Secondary outcomes include modified Rankin Scale at day 90 and favorable clinical response (reduction in National Institutes of Health Stroke Scale by ≥8 points or reaching 0–1) at day 3. Safety outcomes are death and symptomatic intracerebral hemorrhage. Trial registration ClinicalTrials.gov NCT02388061

scholarly journals Impact of Reperfusion for Nonagenarians Treated by Mechanical Thrombectomy

Stroke ◽  
2019 ◽  
Vol 50 (11) ◽  
pp. 3164-3169 ◽  
Author(s):  
Eve Drouard-de Rousiers ◽  
Ludovic Lucas ◽  
Sébastien Richard ◽  
Arturo Consoli ◽  
Mikaël Mazighi ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Functional Outcome ◽  
Odds Ratio ◽  
Intravenous Thrombolysis ◽  
Modified Rankin Scale ◽  
Imaging Data ◽  
Vessel Occlusion ◽  
First Pass Effect ◽  
First Pass ◽  
The Impact

Background and Purpose— Nonagenarians represent a growing stroke population characterized by a higher frailty. Although endovascular therapy (ET) is a cornerstone of the management of acute ischemic stroke related to large vessel occlusion, the benefit of reperfusion among nonagenarians is poorly documented. We aimed to assess the impact of ET-related reperfusion on the functional outcome of reperfusion in this elderly population. Methods— A retrospective analysis of clinical and imaging data from all patients aged over 90 included in the ETIS (Endovascular Treatment in Ischemic Stroke) registry between October 2013 and April 2018 was performed. Association between post-ET reperfusion and favorable (modified Rankin Scale [0–2] or equal to prestroke value) and good (modified Rankin Scale [0–3] or equal to prestroke value) outcome were evaluated. Demographic and procedural predictors of functional outcome, including the first-pass effect, were evaluated. Results were adjusted for center, admission National Institutes of Health Stroke Scale, and use of intravenous thrombolysis. Results— Among the 124 nonagenarians treated with ET, those with successful reperfusion had the lowest 90-day modified Rankin Scale (odds ratio, 3.26; 95% CI, 1.04–10.25). Only patients with successful reperfusion after the first pass (n=53, 56.7%) had a reduced 90-day mortality (odds ratio, 0.15; 95% CI, 0.05–0.45) and an increased rate of good outcome (odds ratio, 4.55; 95% CI, 1.38–15.03). No increase in the rate of intracranial hemorrhage was observed among patients successfully reperfused. Conclusions— Successful reperfusion improves the functional outcome of nonagenarians who should not be excluded from ET. The first-pass effect should be considered in the procedural management of this frail population.

The effect of concomitant benzodiazepine use on neurocognition in stable, long-term patients with bipolar disorder

2020 ◽  
pp. 000486742096981
Author(s):  
Yolanda Cañada ◽  
Ana Sabater ◽  
Pilar Sierra ◽  
Vicent Balanzá-Martínez ◽  
Michael Berk ◽  
...  
Keyword(s):  
Bipolar Disorder ◽  
Scale Score ◽  
Processing Speed ◽  
Visual Memory ◽  
Rating Scale ◽  
Analysis Of Covariance ◽  
Control Group ◽  
Depressive Episodes ◽  
The Impact

Objective: Neurocognitive dysfunction is a common feature of bipolar disorder even in euthymia, and psychopharmacological treatment could have an effect on cognition. Long-term prescription of benzodiazepines in bipolar disorder is a common practice, and their effect on neurocognition has not been well studied in this population. The aim of this study was to evaluate the impact of concomitant benzodiazepine long-term use on neurocognitive function in stable euthymic bipolar disorder patients. Methods: Seventy-three euthymic bipolar disorder outpatients and 40 healthy individuals were assessed using a neurocognitive battery. Patients were classified in two groups according to the presence of benzodiazepines in their treatment: the benzodiazepine group ( n = 34) and the non- benzodiazepine group ( n = 39). Neurocognitive performance was compared between the groups using a multivariate analysis of covariance, considering age, number of depressive episodes, adjuvant antipsychotic drugs, Young Mania Rating Scale score and Hamilton Depression Rating Scale score as covariates. Results: Both bipolar disorder groups (benzodiazepine and non-benzodiazepine) showed an impairment in memory domains (Immediate Visual Memory [ p = 0.013], Working Memory [ p < 0.001], and Letter-Number Sequence [ p < 0.001] from the Wechsler Memory Scale-Revised-III) and slower processing speed functions (Stroop Colour [ p < 0.001]) relative to the control group. Nevertheless, the benzodiazepine group showed a greater impairment in executive functions (Conceptual Level Responses [ p = 0.024] from the Wisconsin Card Sorting Test and Frontal Assessment Battery [ p = 0.042]). Conclusion: Although memory and processing speed impairments were found in bipolar disorder, regardless of their benzodiazepine treatment, benzodiazepine users presented additional neurocognitive impairments in terms of executive functioning. These findings support restricted prescription of benzodiazepines in individuals with bipolar disorder.

Impact of pretreatment with intravenous thrombolysis on reperfusion status in acute strokes treated with mechanical thrombectomy

2019 ◽  
Vol 11 (11) ◽  
pp. 1073-1079 ◽  
Author(s):  
Nitin Goyal ◽  
Georgios Tsivgoulis ◽  
Abhi Pandhi ◽  
Konark Malhotra ◽  
Rashi Krishnan ◽  
...  
Keyword(s):  
Mechanical Thrombectomy ◽  
Tertiary Care ◽  
Intravenous Thrombolysis ◽  
High Volume ◽  
Functional Independence ◽  
Median Number ◽  
Vessel Occlusion ◽  
Multivariable Analyses ◽  
Stroke Center ◽  
The Impact

IntroductionWe sought to evaluate the impact of pretreatment with intravenous thrombolysis (IVT) on the rate and speed of successful reperfusion (SR) in patients with emergent large vessel occlusion (ELVO) treated with mechanical thrombectomy (MT) in a high-volume tertiary care stroke center.MethodsConsecutive patients with ELVO treated with MT were evaluated. Outcomes were compared between patients who underwent combined IVT and MT (IVT+MT) and those treated with direct MT (dMT). The elapsed time between groin puncture to beginning of reperfusion (GPTBRT) and the numbers of device passes required to achieve SR were also documented.ResultsA total of 287 and 132 patients were treated with IVT+MT and dMT, respectively. The IVT+MT group had higher SR (73.8% vs 62.9%; p=0.023) and 3-month functional independence (modified Rankin Scale score 0–2;51.6% vs 38.2%; p=0.008) rates. The median GPTBRT was shorter in the IVT+MT group (48 (IQR 33–70) vs 70 (IQR 44–98) min; p<0.001). Among patients who achieved SR (n=292), the median number of required device passes was lower in the IVT+MT subgroup (1 (IQR 1–1) vs 2 (IQR 1–2); p<0.001), while the rate of patients requiring ≤2 device passes was higher (98% vs 77%; p<0.001). IVT+MT was independently related to higher odds of SR (OR 1.64; 95% CI 1.03 to 2.61; p=0.036) and shorter GPTBRT (unstandardized linear regression coefficient −20.39; 95% CI −27.56 to –13.22; p<0.001) on multivariable analyses adjusting for potential confounders. Among patients with SR, IVT+MT was independently associated with a higher likelihood of ≤2 device passes (OR 14.63; 95% CI 4.46 to 48.00; p<0.001).ConclusionsIVT pretreatment appears to increase the rates of SR and shortens the duration of the endovascular procedure by requiring fewer device passes in patients with ELVO treated with MT.

scholarly journals A Single-Center Retrospective Study of the Impact of Thyroid Cancer on the Malignant Risk of Contralateral TI-RADS 3 and 4 Nodules

2021 ◽  
Vol 2021 ◽  
pp. 1-8
Author(s):  
Huan Liu ◽  
Jun Jin ◽  
Qiao Chen ◽  
Zhongmin Li
Keyword(s):  
Clinical Trial ◽  
Thyroid Cancer ◽  
Multivariate Logistic Regression Analysis ◽  
Control Group ◽  
Confounding Factors ◽  
Clinical Trial Registry ◽  
Clinical Trial Registration ◽  
The Difference ◽  
The Impact ◽  
Experimental Group

Background. The incidence of thyroid nodules increases in the general population. Similarly, we have also seen a dramatic increase in the number of thyroid surgeries. However, the mortality rate of thyroid cancer remained stable or even decreased. The purpose of our study was to investigate whether thyroid cancer affects the malignant risk of the contralateral TI-RADS 3 and 4 nodules. Methods. We conducted a retrospective cohort study in our institution for all thyroid procedures due to nodules from December 2018 to December 2019. All eligible patients were divided into the experimental group (bilateral nodules) and the control group (unilateral nodules) to assess whether the proportion of malignant nodules was different between the two groups. Multivariate logistic regression analysis was used to control potential confounding factors to investigate whether their differences were statistically significant. Results. A total of 330 patients underwent thyroid surgery, of whom 137 were eligible, including 84 in the experimental group and 53 in the control group. The proportion of malignant nodules was significantly different between the experimental group and the control group (29.8% versus 58.5%, unadjusted OR 0.30, 95% CI: 0.17–0.82, p = 0.001 ). However, after controlling for potential confounding factors, including age ( p = 0.004 ), gender ( p = 0.775 ), and TI-RADS classification ( p ≤ 0.001 ), we found that the difference was not significant (adjusted OR 1.08, 95% CI: 0.39–3.01, p = 0.886 ). Conclusion. There is no evidence that thyroid cancer affects the malignant risk of the contralateral TI-RADS 3 and 4 nodules. This study has been registered with the Chinese Clinical Trial Registry (clinical trial registration number: ChiCTR2000038611, registration time: September 26, 2020).

scholarly journals A Study Protocol for a Parallel-Designed Trial Evaluating the Impact of Plant-Based Diets in Comparison to Animal-Based Diets on Health Status and Prevention of Non-communicable Diseases—The Nutritional Evaluation (NuEva) Study

2021 ◽  
Vol 7 ◽  
Author(s):  
Christine Dawczynski
Keyword(s):  
Health Status ◽  
Nutrient Intake ◽  
Disease Risk ◽  
Disease Status ◽  
Activity Level ◽  
Control Group ◽  
Food Groups ◽  
Intervention Period ◽  
Clinical Trial Registration ◽  
The Impact

Background and Aims: Currently, there is a continuing upward trend for plant-based lifestyles in Germany and Europe. The implementation of vegetarian and vegan lifestyles is characterized by omitting defined food groups such as fish, meat, sausage (vegetarians), or dairy products and honey (vegans). This carries the risk of an undersupply of valuable nutrients. The NuEva study is designed to examine this hypothesis and to evaluate the impact of plant-based diets on health status and disease risk.Methods: The NuEva study is a parallel-designed trial with at least 55 participants for each diet (vegetarian, vegan, flexitarian [rare meat/sausage consumption, once or twice per week]), and participants who consume a traditional Western diet as the control group. In the screening period critical nutrients are identified for the studied diets by analysis of a broad spectrum of nutrients in the human samples (fatty acids, vitamins, minerals, trace elements, nutrient metabolites).Results: Based on the data from the screening period, defined menu plans, ensuring an adequate nutrient intake in accordance with the nutritional guidelines are prepared for each group. The plans are adapted and personalized to individual energy requirements based on the basal metabolic rate and physical activity level. The compliance with the NuEva concept and their impact on nutrient status and cardiovascular risk factors are validated during the intervention period of the NuEva study over 1 year. To investigate the impact of the studied diets on the microbiome, feces samples are collected at the beginning and after the 12 months intervention period (follow up: 12 months).Conclusion: The NuEva study is designed to investigate the impact of common diets on health and disease status, with focus on prevention of cardiovascular diseases. In addition, the effectiveness of the prepared nutritional coaching strategy, ensuring optimal nutrient intake in accordance with the guidelines, is validated during the intervention period of the NuEva study.Clinical Trial Registration: Registered under ClinicalTrials.gov Identifier no. NCT03582020.

Abstract WP439: Who Benefits From CT-Angiography Previous Intravenous Thrombolysis?

Stroke ◽  
2016 ◽  
Vol 47 (suppl_1) ◽  
Author(s):  
Pedro Cardona ◽  
Helena Quesada ◽  
Blanca Lara ◽  
Nuria Cayuela ◽  
Paloma Mora ◽  
...  
Keyword(s):  
Endovascular Treatment ◽  
Arterial Occlusion ◽  
Intravenous Thrombolysis ◽  
Artery Occlusion ◽  
Clinical Group ◽  
Large Artery ◽  
Characteristic Analysis ◽  
Vessel Occlusion ◽  
Significant Difference ◽  
Distal Migration

Background: Endovascular treatment (EVT) is an effective treatment in strokes with persistent large artery occlusion despite previous intravenous thrombolisis (IVT) as rescue treatment. Performing computer tomography angiography (CTA) before IVT could allow early activation of neurointerventional teams; however routine CTA could delay unnecessary door-to-needle time of IVT and may be infeasible. Methods: We reviewed stroke code activations between May 2011 and June 2015 in our comprehensive stroke center and divided into groups based on NIHSS and patency of arterial occlusion according to non-enhanced CT on admission (dense artery sign or dot sign) and baseline CTA. We assessed patients treated with IVT and selected to EVT according to results in CTA post-IVT. We analyze percentage of recanalization or migration of thrombus after IVT alone and variables associated to successful treatment. Results: Of 2856 stroke codes registered during the study period 1810 were diagnosis of ischemic strokes. We treated 520 patients with IVT, 202 had a radiological evidence of large artery occlusion (55%M1, 32% M2, 5%TICA, 5%ICA, 3% basilar). Thirty-two percent of patients showed changes in CTA carried out after IVT(17% successfully recanalized, 15% distal migration of thrombus) so they were not selected to endovascular treatment. There were significant difference between M1 and M2 occlusion regarding changes in CTA after IVT (23% vs 70%; p<0.001). In multivariate logistic regression a baseline score NIH<10 was associated with higher percentage of recanalization with rtPA despite signs of large vessel occlusion (78% vs 32%; p:0.001). In receiver operating characteristic analysis higher baseline NIH was associated with persistent occlusion after IVT (area under curve=0.79;95% CI, 0.6-0.9; P:0.001) with optima threshold of 10 ( Sensivity 84%, Specificity 74%). Conclusions: We consider defer CTA angiography until after IVT in stroke code patients with moderate clinical impairment (NIH<10) or M2-segment occlusion, because they achieve a high percentage of arterial recanalization. CTA previous IVT could be unnecessary, provide unreliable information and delay IVT in that clinical group but could be useful to plan EVT in patients with higher NIH scores.

Abstract 1122‐000157: Safety and Effectiveness of MT for Primary Isolated Distal Vessel Occlusions: A Retrospective Comparative Study

2021 ◽  
Vol 1 (S1) ◽  
Author(s):  
Ossama Y Mansour ◽  
Mahmoud Elhorany ◽  
Nader A Sourour ◽  
Frédéric Clarençon
Keyword(s):  
Medical Treatment ◽  
Mechanical Thrombectomy ◽  
Secondary Analysis ◽  
Intravenous Thrombolysis ◽  
Vessel Occlusion ◽  
Best Medical Treatment ◽  
Significant Difference ◽  
Retrospective Comparative Study ◽  
Distal Vessel ◽  
Historic Cohort

Introduction : Distal vessel occlusions represent about 25–40% of acute ischemic stroke (AIS), either as primary occlusion or secondary occlusion complicating mechanical thrombectomy (MT) for large vessel occlusion. Our aim was to evaluate safety and effectiveness of MT associated with the best medical treatment (BMT) in the management of AIS patients with distal vessel occlusion in comparison with the BMT alone. Methods : Retrospective analysis was conducted on AIS patients treated by MT+BMT for primary distal vessel occlusion between 2015 and 2020, and were compared with a historic cohort managed by BMT alone between 2006 and 2015 selected based on the same inclusion criteria. A secondary analysis was conducted using propensity score matching (PSM) including the following: NIHSS, age and treatment with intravenous thrombolysis (IVT) as covariates. Results : Of 650 patients screened, 44 patients with distal vessel occlusions treated by MT+BMT were selected and compared with 36 patients who received BMT alone. After PSM, 28 patients in each group were matched without significant difference. Good clinical outcome defined as mRS≤2 was achieved by 53.6% of the MT+BMT group and 57% of the BMT group (OR, 0.87; 95%CI, 0.3–2.4; P = 1.00). The mortality rate was comparable in both groups (7% vs 10.7% in MT+BMT and BMT patients, respectively; OR = 0.64; 95%CI, 0.1‐4; P = 1.00). Symptomatic intracranial haemorrhage (ICH) was seen in only one patient treated by MT+BMT (3.6%). Conclusions : Mechanical thrombectomy seems to be comparable with the best medical treatment regarding the effectiveness and safety in the management of patients with distal vessel occlusions.

Abstract TP29: Endovascular Thrombectomy and Medical Therapy Versus Medical Therapy Alone in Acute Stroke (EASI): a Randomized Care Trial

Stroke ◽  
2016 ◽  
Vol 47 (suppl_1) ◽  
Author(s):  
Naim N Khoury ◽  
Tim E Darsaut ◽  
Jimmy Ghostine ◽  
Yan Deschaintre ◽  
Nicole Daneault ◽  
...  
Keyword(s):  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Medical Therapy ◽  
Standard Care ◽  
Primary Outcome ◽  
Intervention Group ◽  
Intravenous Thrombolysis ◽  
Control Group ◽  
Vessel Occlusion ◽  
Stroke Treatment

Background: Until recently, clinical benefits of endovascular stroke treatment remained unproven. Care trials can be used to simultaneously offer yet-to-be validated interventions and verify treatment outcomes. Our aim was to implement care trial methodology for patients with severe acute ischemic stroke. Methods: The study was offered to all patients considered for endovascular management of acute ischemic stroke in one Canadian hospital. Inclusion criteria were broad: onset of symptoms ≤ 5h or at any time in the presence of clinical-imaging mismatch; suspected anterior or posterior circulation large vessel occlusion; patients eligible or ineligible for intravenous thrombolysis. Exclusion criteria were few: established infarction or hemorrhagic transformation of the target symptomatic territory; poor 3-month prognosis from comorbidities. The primary outcome was mRS ≤ 2 at three months. Patients were randomly allocated to standard care (control) or standard care plus endovascular treatment (intervention group). Analyses were by intention-to-treat. (Identifier NCT02157532) Findings: Seventy-seven patients were recruited in 19 months (March 2013 - October 2014) at a single center. Randomized allocation was interrupted when other trials showed the benefits of endovascular therapy. At three months, 20 of 40 patients (50·0 %; 95% C.I.: 35%-65%) in the intervention group had reached the primary outcome, compared to 14 of 37 patients (37·8%; 95% C.I.: 24%-54%) in the control group arm (P=0·36). Eleven patients in the intervention arm died within 3 months compared to 9 patients in the standard care arm. Interpretation: EASI met all the characteristics of a care trial: inclusion of all eligible patients, no extra risk, no extra test, no extra cost, simple case report forms filled by care personnel, normal follow-up, involvement of all regular practitioners, and flexible care. The trial was prematurely interrupted, but this approach offers a promising means to manage clinical dilemmas and guide uncertain practices in the care of patients. Funding: There was no funding source for this study.

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