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 ◽  
...  

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.

2020 ◽  
Vol 2020 ◽  
pp. 1-6
Author(s):  
Zhi-Xin Huang ◽  
Jianguo Lin ◽  
Cheng Zhang ◽  
Ying-Yi Dai ◽  
Songbin Lin ◽  
...  

Early neurologic deterioration (END) in the acute phase of ischemic stroke is a serious clinical event, which is closely related to poor prognosis. Therefore, it is important to identify presentation features that predict END and take relevant treatment measures, as they could help to prevent the deterioration of high-risk patients. The prospective intervention study was carried out from January 2018 to December 2019. We included consecutive patients hospitalized for acute ischemic stroke (AIS) within 6 hours of onset. Patients were randomly assigned (1 : 1) to recanalization therapy plus Huoxiang Zhengqi Pill (HXZQ) (intervention group) or standard recanalization therapy alone (control group). The primary outcome was the development of END according to predefined criteria within the first 1 week of stroke onset. Poisson regression was used to identify predictors for END. Of the 155 patients enrolled in the study (age, 63 ± 11 years; 28.4% female), 20 (12.9%) developed END. Univariate analysis showed that the use of HXZQ and Essen stroke risk score (ESRS) (low risk group) were protective factors for END, while advanced age was a risk factor for END. However, in multivariate analysis, only ESRS (OR, 0.232; 95%CI, 0.058–0.928; P=0.039) and the use of HXZQ (OR, 0.297; 95%CI, 0.096–0.917; P=0.035) were statistically significant. ESRS can be used as the prediction factor of END. HXZQ has small side effects and wide indication. It could be used in the treatment of AIS.


2018 ◽  
Vol 02 (03) ◽  
pp. 155-168
Author(s):  
Sharath Kumar G G ◽  
Chinmay Nagesh

AbstractTill recently, the mainstay of management of acute ischemic stroke (AIS) has been intravenous thrombolysis. However, response to treatment and outcomes in the presence of a large vessel occlusion (LVO) were largely suboptimal. Endovascular thrombectomy techniques with stentrievers and aspiration catheters have revolutionized stroke treatment significantly, improving outcomes in this once untreatable disease. The interventional radiologist must play an active role in the stroke team in streamlining imaging as well as endovascular management. The focus of this review article is on initial management and imaging. Initial measures consist of patient resuscitation, basic investigations and assessment of stroke severity using the National Institutes of Health Stroke Scale (NIHSS), all of which have therapeutic and prognostic implications to be considered by the neurointerventionist. Imaging must aim to be swift and efficient. Choice of a modality must be based on available infrastructure as well as clinical-radiologic factors such as the time since ictus or posterior circulation involvement. Computed tomography (CT) is the preferred modality for its speed, whereas magnetic resonance imaging (MRI) remains the gold standard problem solving technique for detection of stroke. Exclusion of hemorrhagic stroke and other stroke mimics is the first objective. Thereafter, imaging is targeted toward assessing the parenchyma and vasculature. Defining the core and penumbra is the most important goal of parenchymal imaging. The core may be defined by the presence of early ischemic changes on CT, CT angiographic source images, or diffusion restriction on MRI. The penumbra is approximated by collateral status or perfusion methods. The prime directive of vascular imaging, either CT or magnetic resonance angiography (MRA) is to establish the presence of an LVO. Once confirmed, the decision for thrombolysis and/or thrombectomy is based on clinical and imaging criteria, the most ideal being that of a moderately severe stroke with a small core and LVO on imaging.


2020 ◽  
Vol 13 (1) ◽  
pp. 4-7
Author(s):  
Okkes Kuybu ◽  
Vijayakumar Javalkar ◽  
Abdallah Amireh ◽  
Arshpreet Kaur ◽  
Roger E Kelley ◽  
...  

BackgroundThe effectiveness of mechanical thrombectomy (MT) was demonstrated in five landmark trials published in2015.Mechanical thrombectomy is now standard of care for acute ischemic stroke and has been growing in popularity after publication of landmark trials.ObjectiveTo analyze outcomes and trends of the use of MT and intravenous thrombolysis (IVT) in patients with acute ischemic stroke in US hospitals before and after publication of these trials.MethodsPatients discharged with a diagnosis of ischemic stroke between 2012 to 2017 were diagnosed using ICD codes from the National Inpatient Sample. Thereafter, patients given acute stroke treatment were identified using the corresponding procedure codes for IVT and MT. The primary clinical outcomes of in-hospital mortality and disability were then compared between two time periods: 2012–2014 (pre-landmark trials) and 2015–2017 (post-landmark trials). Binary logistic regression and Χ2 tests were used for statistical analysis.ResultsA total of 57 675 patients (median age 68.9 years (range 18-90), 50.1% female) were identified with acute procedures. Of these patients, 57.6% were from the post-landmark trials time period. Despite an increased number of cases, the rate of IVT decreased from 84.3% to 75.9% and the rate of IVT+MT decreased from 7.1% to 6.3%. After publication of the pivotal trials in 2015, the rates of MT increased from 8.7% to 17.8%. Significant reductions of in-hospital mortality (7.1% vs 8.7%, p<0.001) and disability (64% vs 66.2%, p<0.001) were noted.ConclusionThe analysis showed a significant increase in the proportion of patients receiving MT after 2015. This has translated into reduction of in-hospital mortality and improvement in disability.


2016 ◽  
Vol 5 (3-4) ◽  
pp. 174-178 ◽  
Author(s):  
Inger R. de Ridder ◽  
Puck S.S. Fransen ◽  
Debbie Beumer ◽  
Olvert A. Berkhemer ◽  
Lucie A. van den Berg ◽  
...  

Introduction: Stroke etiology and outcome after ischemic stroke differ between men and women. We examined if sex modifies the effect of intra-arterial treatment (IAT) in a randomized clinical trial of IAT for acute ischemic stroke in the Netherlands (MR CLEAN). Patients and Methods: The primary outcome was the score on the modified Rankin scale at 90 days. We tested for interaction between sex and treatment and estimated the treatment effect by sex with multiple ordinal logistic regression with adjustment for prognostic factors. Results: All 500 patients were included in the analysis; 292 (58.4%) were men. The treatment effect (adjusted common odds ratio) was 2.39 [95% confidence interval (CI) 1.55-3.68] in men and 0.99 (95% CI 0.60-1.66) in women (pinteraction = 0.016). In women, mortality was higher in the intervention group than in the control group (24 vs. 15%, p = 0.07). Serious adverse events occurred more often in women than in men undergoing intervention. There were no differences in neuro-imaging outcomes. Discussion and Conclusion: Contrary to other studies, we found a significant interaction between sex and treatment effect in the MR CLEAN trial. Pooled analyses of all published thrombectomy trials did not confirm this finding. In MR CLEAN, women seem to have a slightly more unfavorable profile, causing higher mortality and more serious adverse events, but insufficient to explain the absence of an overall effect. This suggests a play of chance and makes it clear that IAT should not be withheld in women.


2021 ◽  
pp. 0271678X2199298
Author(s):  
Chao Li ◽  
Chunyang Wang ◽  
Yi Zhang ◽  
Owais K Alsrouji ◽  
Alex B Chebl ◽  
...  

Treatment of patients with cerebral large vessel occlusion with thrombectomy and tissue plasminogen activator (tPA) leads to incomplete reperfusion. Using rat models of embolic and transient middle cerebral artery occlusion (eMCAO and tMCAO), we investigated the effect on stroke outcomes of small extracellular vesicles (sEVs) derived from rat cerebral endothelial cells (CEC-sEVs) in combination with tPA (CEC-sEVs/tPA) as a treatment of eMCAO and tMCAO in rat. The effect of sEVs derived from clots acquired from patients who had undergone mechanical thrombectomy on healthy human CEC permeability was also evaluated. CEC-sEVs/tPA administered 4 h after eMCAO reduced infarct volume by ∼36%, increased recanalization of the occluded MCA, enhanced cerebral blood flow (CBF), and reduced blood-brain barrier (BBB) leakage. Treatment with CEC-sEVs given upon reperfusion after 2 h tMCAO significantly reduced infarct volume by ∼43%, and neurological outcomes were improved in both CEC-sEVs treated models. CEC-sEVs/tPA reduced a network of microRNAs (miRs) and proteins that mediate thrombosis, coagulation, and inflammation. Patient-clot derived sEVs increased CEC permeability, which was reduced by CEC-sEVs. CEC-sEV mediated suppression of a network of pro-thrombotic, -coagulant, and -inflammatory miRs and proteins likely contribute to therapeutic effects. Thus, CEC-sEVs have a therapeutic effect on acute ischemic stroke by reducing neurovascular damage.


2018 ◽  
Vol 5 (1) ◽  
pp. 164
Author(s):  
Shiva Prasad Jagini ◽  
Suresh I.

Background: Stroke patients are at highest risk death in the first few weeks after the event, and between 20-50% die within first month depending on type, severity, age, co-morbidities and effectiveness of treatment of complications. Objective of this study was to clinical profile of patients with acute ischemic stroke receiving intravenous thrombolysis (rtPA-alteplase).Methods: Prospective Observational study of 26 cases of acute ischemic stroke receiving IV thrombolysis using rtPA-alteplase at Kovai Medical Centre Hospital, Coimbatore over a period of 1 year 9 months.Results: 21 cases had NIHSS score of range 10 to 22. The mean NIHSS score at admission is 13.5. 15 subjects (57.7%) had achieved primary outcome in this study. MRS Score of 0 to 2 is considered as favorable outcome. In this study 20 subjects (76.92 %) had favorable outcome at the end of 3 months.Conclusions: Majority of the patients receiving rtPA-alteplase had favorable outcome.


Stroke ◽  
2020 ◽  
Vol 51 (5) ◽  
pp. 1616-1619 ◽  
Author(s):  
James Beharry ◽  
Michael J. Waters ◽  
Roy Drew ◽  
John N. Fink ◽  
Duncan Wilson ◽  
...  

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.


2018 ◽  
Vol 10 (12) ◽  
pp. 1132-1136 ◽  
Author(s):  
Dylan N Wolman ◽  
Michael Iv ◽  
Max Wintermark ◽  
Gregory Zaharchuk ◽  
Michael P Marks ◽  
...  

Background and purposeAcute ischemic stroke (AIS) patients who benefit from endovascular treatment have a large vessel occlusion (LVO), small core infarction, and salvageable brain. We determined if diffusion-weighted imaging (DWI) and perfusion-weighted imaging (PWI) alone can correctly identify and localize anterior circulation LVO and accurately triage patients to endovascular thrombectomy (ET).Materials and methodsThis retrospective cohort study included patients undergoing MRI for the evaluation of AIS symptoms. DWI and PWI images alone were anonymized and scored for cerebral infarction, LVO presence and LVO location, DWI-PWI mismatch, and ET candidacy. Readers were blinded to clinical data. The primary outcome measure was accurate ET triage. Secondary outcomes were detection of LVO and LVO location.ResultsTwo hundred and nineteen patients were included. Seventy-three patients (33%) underwent endovascular AIS treatment. Readers correctly and concordantly triaged 70 of 73 patients (96%) to ET (κ=0.938; P=0.855) and correctly excluded 143 of 146 patients (98%; P=0.942). DWI and PWI alone had a 95.9% sensitivity and a 98.4% specificity for accurate endovascular triage. LVO were accurately localized to the ICA/M1 segment in 65 of 68 patients (96%; κ=0.922; P=0.817) and the M2 segment in 18 of 20 patients (90%; κ=0.830; P=0.529).ConclusionAIS patients with anterior circulation LVO are accurately identified using DWI and PWI alone, and LVO location may be correctly inferred from PWI. MRA omission may be considered to expedite AIS triage in hyperacute scenarios or may confidently supplant non-diagnostic or artifact-limited MRA.


2015 ◽  
Vol 5 (1) ◽  
pp. 31-40 ◽  
Author(s):  
Simone Rosa Poletto ◽  
Letícia Costa Rebello ◽  
Maria Júlia Monteiro Valença ◽  
Daniele Rossato ◽  
Andrea Garcia Almeida ◽  
...  

Background: The effect of early mobilization after acute stroke is still unclear, although some studies have suggested improvement in outcomes. We conducted a randomized, single-blind, controlled trial seeking to evaluate the feasibility, safety, and benefit of early mobilization for patients with acute ischemic stroke treated in a public teaching hospital in Southern Brazil. This report presents the feasibility and safety findings for the pilot phase of this trial. Methods: The primary outcomes were time to first mobilization, total duration of mobilization, complications during early mobilization, falls within 3 months, mortality within 3 months, and medical complications of immobility. We included adult patients with CT- or MRI-confirmed ischemic stroke within 48 h of symptom onset who were admitted from March to November 2012 to the acute vascular unit or general emergency unit of a large urban emergency department (ED) at the Hospital de Clínicas de Porto Alegre. The severity of the neurological deficit on admission was assessed by the National Institutes of Health Stroke Scale (NIHSS). The NIHSS and modified Rankin Scale (mRS, functional outcome) scores were assessed on day 14 or at discharge as well as at 3 months. Activities of daily living (ADL) were measured with the modified Barthel Index (mBI) at 3 months. Results: Thirty-seven patients (mean age 65 years, mean NIHSS score 11) were randomly allocated to an intervention group (IG) or a control group (CG). The IG received earlier (p = 0.001) and more frequent (p < 0.0001) mobilization than the CG. Of the 19 patients in the CG, only 5 (26%) underwent a physical therapy program during hospitalization. No complications (symptomatic hypotension or worsening of neurological symptoms) were observed in association with early mobilization. The rates of complications of immobility (pneumonia, pulmonary embolism, and deep vein thrombosis) and mortality were similar in the two groups. No statistically significant differences in functional independence, disability, or ADL (mBI ≥85) were observed between the groups at the 3-month follow-up. Conclusions: This pilot trial conducted at a public hospital in Brazil suggests that early mobilization after acute ischemic stroke is safe and feasible. Despite some challenges and limitations, early mobilization was successfully implemented, even in the setting of a large, complex ED, and without complications. Patients from the IG were mobilized much earlier than controls receiving the standard care provided in most Brazilian hospitals.


2015 ◽  
Vol 40 (5-6) ◽  
pp. 251-257 ◽  
Author(s):  
Andreas Ragoschke-Schumm ◽  
Umut Yilmaz ◽  
Panagiotis Kostopoulos ◽  
Martin Lesmeister ◽  
Matthias Manitz ◽  
...  

Background: For patients with acute ischemic stroke, intra-arterial treatment (IAT) is considered to be an effective strategy for removing the obstructing clot. Because outcome crucially depends on time to treatment (‘time-is-brain' concept), we assessed the effects of an intervention based on performing all the time-sensitive diagnostic and therapeutic procedures at a single location on the delay before intra-arterial stroke treatment. Methods: Consecutive acute stroke patients with large vessel occlusion who obtained IAT were evaluated before and after implementation (April 26, 2010) of an intervention focused on performing all the diagnostic and therapeutic measures at a single site (‘stroke room'). Result: After implementation of the intervention, the median intervals between admission and first angiography series were significantly shorter for 174 intervention patients (102 min, interquartile range (IQR) 85-120 min) than for 81 control patients (117 min, IQR 89-150 min; p < 0.05), as were the intervals between admission and clot removal or end of angiography (152 min, IQR 123-185 min vs. 190 min, IQR 163-227 min; p < 0.001). However, no significant differences in clinical outcome were observed. Conclusion: This study shows for the, to our knowledge, first time that for patients with acute ischemic stroke, stroke diagnosis and treatment at a single location (‘stroke room') saves crucial time until IAT.


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