scholarly journals Direct transfer to angiosuite for patients with severe acute stroke treated with thrombectomy: the multicentre randomised controlled DIRECT ANGIO trial protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e040522
Author(s):  
Nolwenn Riou-Comte ◽  
François Zhu ◽  
Aboubaker Cherifi ◽  
Sébastien Richard ◽  
Lionel Nace ◽  
...  

IntroductionMechanical thrombectomy (MT) increases functional independence in patients with acute ischaemic stroke with anterior circulation large vessel occlusion (LVO), and the probability to achieve functional independence decreases by 20% for each 1-hour delay to reperfusion. Therefore, we aim to investigate whether direct angiosuite transfer (DAT) is superior to standard imaging/emergency department-based management in achieving 90-day functional independence in patients presenting with an acute severe neurological deficit likely due to LVO and requiring emergent treatment with MT.Methods and analysisDIRECT ANGIO (Effect of DIRECT transfer to ANGIOsuite on functional outcome in patient with severe acute stroke treated with thrombectomy: the randomised DIRECT ANGIO Trial) trial is an investigator-initiated, multicentre, prospective, randomised, open-label, blinded endpoint (PROBE) study. Eligibility requires a patient ≤75 years, pre-stroke modified Rankin Scale (mRS) 0–2, presenting an acute severe neurological deficit and admitted within 5 hours of symptoms onset in an endovascular-capable centre. A total of 208 patients are randomly allocated in a 1:1 ratio to DAT or standard management. The primary outcome is the rate of patients achieving a functional independence, assessed as mRS 0–2 at 90 days. Secondary endpoints include patients presenting confirmed LVO, patients eligible to intravenous thrombolysis alone, patients with intracerebral haemorrhage and stroke-mimics, intrahospital time metrics, early neurological improvement (reduction in National Institutes of Health Stroke Scale by ≥8 points or reaching 0–1 at 24 hours) and mRS overall distribution at 90 days and 12 months. Safety outcomes are death and intracerebral haemorrhage transformation. Medico-economics analyses include health-related quality of life and cost utility assessment.Ethics and disseminationThe DIRECT ANGIO trial was approved by the ethics committee of Ile de France 1. Study began in April 2020. Results will be published in an international peer-reviewed medical journal.Trial registration numberNCT03969511.

2017 ◽  
Vol 7 (1-2) ◽  
pp. 42-47 ◽  
Author(s):  
Andreia Carvalho ◽  
André Cunha ◽  
Tiago Gregório ◽  
Ludovina Paredes ◽  
Henrique Costa ◽  
...  

Background: Several reports refer to differences in stroke between females and males, namely in incidence and clinical outcome, but also in response to treatments. Driven by a recent analysis of the MR CLEAN trial, which showed a higher benefit from acute stroke endovascular treatment (EVT) in males, we intended to determine if clinical outcomes after EVT differ between sexes, in a real-world setting. Methods: We analyzed 145 consecutive patients submitted to EVT for anterior circulation large-vessel occlusion, between January 2015 and September 2016, and compared the outcomes between sexes. Results: Our population was represented by 81 (55.9%) females, with similar baseline characteristics (pre-stroke disability, baseline NIHSS, and ASPECTS), rate of previous intravenous thrombolysis, time from onset to recanalization, and rate of revascularization; with the exception that women were on average 4 years older and had more hypertension, and men in turn had more tandem occlusions and atherosclerotic etiology (all p < 0.05). Even after adjusting for these statistically significant variables and for intravenous thrombolysis (as some studies advocate a different response to this treatment between sexes), there were no differences in intracranial hemorrhage, functional independence (mRS ≤2 in 60.9% males vs. 66.7% in females, p = 0.48; adjusted p = 0.36), or mortality at 3 months. Conclusion: In a real-world setting, we found no sex differences in clinical and safety outcomes after acute stroke EVT. Our results support the idea that women are equally likely to achieve good outcomes as men after acute stroke EVT.


Author(s):  
Juha-Pekka Pienimäki ◽  
Jyrki Ollikainen ◽  
Niko Sillanpää ◽  
Sara Protto

Abstract Purpose Mechanical thrombectomy (MT) is the first-line treatment in acute stroke patients presenting with large vessel occlusion (LVO). The efficacy of intravenous thrombolysis (IVT) prior to MT is being contested. The objective of this study was to evaluate the efficacy of MT without IVT in patients with no contraindications to IVT presenting directly to a tertiary stroke center with acute anterior circulation LVO. Materials and Methods We collected the data of 106 acute stroke patients who underwent MT in a single high-volume stroke center. Patients with anterior circulation LVO eligible for IVT and directly admitted to our institution who subsequently underwent MT were included. We recorded baseline clinical, laboratory, procedural, and imaging variables and technical, imaging, and clinical outcomes. The effect of intravenous thrombolysis on 3-month clinical outcome (mRS) was analyzed with univariate tests and binary and ordinal logistic regression analysis. Results Fifty-eight out of the 106 patients received IVT + MT. These patients had 2.6-fold higher odds of poorer clinical outcome in mRS shift analysis (p = 0.01) compared to MT-only patients who had excellent 3-month clinical outcome (mRS 0–1) three times more often (p = 0.009). There were no significant differences between the groups in process times, mTICI, or number of hemorrhagic complications. A trend of less distal embolization and higher number of device passes was observed among the MT-only patients. Conclusions MT without prior IVT was associated with an improved overall three-month clinical outcome in acute anterior circulation LVO patients.


Stroke ◽  
2013 ◽  
Vol 44 (suppl_1) ◽  
Author(s):  
Pedro Cardona ◽  
Helena Quesada ◽  
Luis Cano ◽  
Lucia Aja ◽  
De Miquel MA. ◽  
...  

In our comprehensive stroke center we analyze correct selection criteria to use self-expandable retrievable intracranial stents for acute stroke treatment. The criteria for intervention were the onset of neurological symptoms, a National Institute of Health Stroke Scale Score (NIHSS) ≥9 at presentation, large vessel occlusion stroke demonstrated by angio-CT, and failure of intravenous thrombolysis or exclusion criteria to administrate it. METHODS: We performed an retrospective analysis of 512 consecutive patients with acute ischemic stroke candidates for thrombectomy, from April of 2010 to June of 2012, that met inclusion criteria for intervention. Experienced vascular neurologists selected 171 patients to undergoing endovascular therapy using retrievable stents (Solitaire,Trevo). Successful recanalization results were assessed by follow-up angiography immediately after the procedure (TIMI 2-3/TICI 2b-3 score), and good functional outcome was considered when ≤2 mRankin score (mRS) was achieved at 90 days. RESULTS: A total of 171 patients were treated, 87% with anterior circulation stroke. The mean age was 67.5 years (range 32-87); 58% men. The median NIHSS at presentation was 17 (range 6-26). Recanalization (TICI 2b-3) was achieved in 73% of patients. Symptomatic hemorrhage occurred in 8%. Ninety-day mortality was 19, 5% and good 90-day functional outcome (mRS ≤2) was achieved by 45%. Unsuccessful recanalization (TICI 0-2a) was a significant predictor of poor outcome (mRS≤2: 9%). When we analyzed these patients according to inclusion criteria of IMS trial, 101 patients who met strict criteria achieved good neurological outcome more frequently (51% versus 34%) and significant lower mortality rates (17% vs 28%) compared with the group of 70 patients with IMS exclusion criteria. CONCLUSIONS: Efficacy in recanalization, safety of thrombectomy and its consequent good clinical outcome is sufficiently established. It is important an experienced vascular neurologist to select possible candidates (proportion of evaluated/treated patients 3:1). Inclusion criteria for acute stroke trials do not always represent real population of stroke patients as well as their clinical results.


Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Christopher Blair ◽  
Cecilia Cappelen-Smith ◽  
Dennis Cordato ◽  
Leon Edwards ◽  
Amer Mitchelle ◽  
...  

Introduction: In patients with anterior circulation stroke with large vessel occlusion (LVO), recent data suggest that successful reperfusion (mTICI≥2b) after a single device pass results in more favourable functional outcomes in comparison to patients requiring multiple passes. It is unclear if this effect represents an epiphenomenon or a true independent effect. Methods: A prospectively maintained database of EVT was interrogated for patients presenting with anterior circulation LVO with onset to groin puncture times of ≤ 6 hours from January 2016 to March 2019. Three-month functional outcomes were compared between first-pass reperfusion and multiple-pass reperfusion patients using logistic regression. Results: A total of 169 patients were identified (mean age 71 yrs, 44% female, median NIHSS 17, intravenous thrombolysis (IVT) in 47%). Successful reperfusion (mTICI≥2b) was achieved with the first-pass (FP) in 80 patients (47%) and multiple-passes (MP) in 89 patients (53%). First pass patients had better outcomes when compared to MP patients (mRS 0-2 71% vs 31%, p < 0.001). No difference in functional outcomes was seen between FP patients who received IVT and those that did not (mRS 0-2 68% vs 75%, p = 0.459). Multiple-pass patients who received IVT achieved higher rates of functional independence than those who did not (mRS 0-2 40% vs 27%, p = 0.035). Conclusion: Intravenous thrombolysis may improve functional recovery in EVT patients requiring multiple-passes to achieve reperfusion. Prospective studies should be considered.


2021 ◽  
Vol 12 ◽  
Author(s):  
Zhao-Ji Chen ◽  
Xiao-Fang Li ◽  
Cheng-Yu Liang ◽  
Lei Cui ◽  
Li-Qing Yang ◽  
...  

Background: Whether bridging treatment combining intravenous thrombolysis (IVT) and endovascular thrombectomy (EVT) is superior to direct EVT alone for emergent large vessel occlusion (LVO) in the anterior circulation is unknown. A systematic review and a meta-analysis were performed to investigate and assess the effect and safety of bridging treatment vs. direct EVT in patients with LVO in the anterior circulation.Methods: PubMed, EMBASE, and the Cochrane library were searched to assess the effect and safety of bridging treatment and direct EVT in LVO. Functional independence, mortality, asymptomatic and symptomatic intracranial hemorrhage (aICH and sICH, respectively), and successful recanalization were evaluated. The risk ratio and the 95% CI were analyzed.Results: Among the eight studies included, there was no significant difference in the long-term functional independence (OR = 1.008, 95% CI = 0.845–1.204, P = 0.926), mortality (OR = 1.060, 95% CI = 0.840–1.336, P = 0.624), recanalization rate (OR = 1.015, 95% CI = 0.793–1.300, P = 0.905), and the incidence of sICH (OR = 1.320, 95% CI = 0.931–1.870, P = 0.119) between bridging therapy and direct EVT. After adjusting for confounding factors, bridging therapy showed a lower recanalization rate (effect size or ES = −0.377, 95% CI = −0.684 to −0.070, P = 0.016), but there was no significant difference in the long-term functional independence (ES = 0.057, 95% CI = −0.177 to 0.291, P = 0.634), mortality (ES = 0.693, 95% CI = −0.133 to 1.519, P = 0.100), and incidence of sICH (ES = −0.051, 95% CI = −0.687 to 0.585, P = 0.875) compared with direct EVT. Meanwhile, in the subgroup analysis of RCT, no significant difference was found in the long-term functional independence (OR = 0.927, 95% CI = 0.727–1.182, P = 0.539), recanalization rate (OR = 1.331, 95% CI = 0.948–1.867, P = 0.099), mortality (OR = 1.072, 95% CI = 0.776–1.481, P = 0.673), and sICH incidence (OR = 1.383, 95% CI = 0.806–2.374, P = 0.977) between patients receiving bridging therapy and those receiving direct DVT.Conclusion: For stroke patients with acute anterior circulation occlusion and who are eligible for intravenous thrombolysis, there is no significant difference in the clinical effect between direct EVT and bridging therapy, which needs to be verified by more randomized controlled trials.


2018 ◽  
Vol 60 (3) ◽  
pp. 308-314 ◽  
Author(s):  
Arturs Balodis ◽  
Maija Radzina ◽  
Evija Miglane ◽  
Anthony Rudd ◽  
Andrejs Millers ◽  
...  

Background Bridging treatment with intravenous thrombolysis (IVT) before endovascular thrombectomy (EVT) in acute ischemic stroke is applied under the assumption of benefits for patients with large vessel occlusion (LVO). However, the benefit of this additional step has not yet been proven. Purpose To compare procedural parameters (procedural time, number of attempts), complications, and clinical outcome in patients receiving EVT vs. patients with bridging treatment. Material and Methods In this prospective study all patients had acute anterior cerebral circulation occlusion and were treated with EVT. All patients were selected for treatment based on clinical criteria, multimodal computed tomography (CT) imaging. Eighty-four patients were treated with bridging IVT followed by EVT; 62 patients were treated with EVT only. Results Bridging therapy did not influence endovascular procedure time ( P = 0.71) or number of attempts needed ( P = 0.63). Bleeding from any site was more common in the bridging group (27, 32%) vs. the EVT group (12, 19%) ( P = 0.09). Functional independence modified Rankin Scale after 90 days was slightly higher in the bridging group (44%) vs. the EVT group (42%) ( P = 0.14). Mortality did not differ significantly at 90 days: 17% in the bridging group vs. 21% in EVT alone ( P = 0.57). Both treatment methods showed high recanalization rates: 94% in the bridging group and 89% for EVT alone. Conclusion Bridging treatment in LVO did not show benefits or elevated risks of complications in comparison to EVT only. The bridging group did not show significantly better neurological outcome or significant impact on procedural parameters vs. EVT alone.


2021 ◽  
Vol 12 ◽  
Author(s):  
Feifeng Liu ◽  
Hao Shen ◽  
Chen Chen ◽  
Huan Bao ◽  
Lian Zuo ◽  
...  

Purpose: To evaluate the safety and efficacy of mechanical thrombectomy (MT) for acute stroke due to large vessel occlusion (LVO), presenting with mild symptoms.Methods: A prospective cohort study of patients with mild ischemic stroke and LVO was conducted. Patients were divided into two groups: MT group or best medical management (MM) group. Propensity score matching (PSM) was conducted to reduce the confounding bias between the groups. The primary outcome was functional independence at 90 days. The safety outcome was symptomatic intracranial hemorrhage (sICH). Univariate and multivariate logistic regression analyses were used to identify the independent factors associated with outcomes.Results: Among the 105 included patients, 43 were in the MT group and 62 in the MM group. Forty-three pairs of patients were generated after PSM. There were no significant differences in sICH rates between two groups (p = 1.000). The MT group had a higher proportion of independent outcomes (83.7% MT vs. 67.4% MM; OR 2.483; 95% CI 0.886–6.959; p = 0.079) and excellent outcomes (76.7% MT vs. 51.2% MM; OR 3.150; 95% CI 1.247–7.954; p = 0.013) compared to the MM group, especially in patients with stroke of the anterior circulation (p &lt; 0.05). Multivariate logistic regression analysis showed that small infarct core volume (p = 0.015) and MT treatment (p = 0.013) were independently associated with excellent outcomes.Conclusions: Our results suggest that MT in stroke patients, presenting with mild symptoms, due to acute LVO in the anterior circulation may be associated with satisfactory clinical outcomes.Clinical Trial Registration:ClinicalTrials.gov, identifier: NCT04526756.


2019 ◽  
Vol 11 (1) ◽  
Author(s):  
Daria Antipova ◽  
Leila Eadie ◽  
Ashish Stephen Macaden ◽  
Philip Wilson

Abstract Introduction A number of pre-hospital clinical assessment tools have been developed to triage subjects with acute stroke due to large vessel occlusion (LVO) to a specialised endovascular centre, but their false negative rates remain high leading to inappropriate and costly emergency transfers. Transcranial ultrasonography may represent a valuable pre-hospital tool for selecting patients with LVO who could benefit from rapid transfer to a dedicated centre. Methods Diagnostic accuracy of transcranial ultrasonography in acute stroke was subjected to systematic review. Medline, Embase, PubMed, Scopus, and The Cochrane Library were searched. Published articles reporting diagnostic accuracy of transcranial ultrasonography in comparison to a reference imaging method were selected. Studies reporting estimates of diagnostic accuracy were included in the meta-analysis. Results Twenty-seven published articles were selected for the systematic review. Transcranial Doppler findings, such as absent or diminished blood flow signal in a major cerebral artery and asymmetry index ≥ 21% were shown to be suggestive of LVO. It demonstrated sensitivity ranging from 68 to 100% and specificity of 78–99% for detecting acute steno-occlusive lesions. Area under the receiver operating characteristics curve was 0.91. Transcranial ultrasonography can also detect haemorrhagic foci, however, its application is largely restricted by lesion location. Conclusions Transcranial ultrasonography might potentially be used for the selection of subjects with acute LVO, to help streamline patient care and allow direct transfer to specialised endovascular centres. It can also assist in detecting haemorrhagic lesions in some cases, however, its applicability here is largely restricted. Additional research should optimize the scanning technique. Further work is required to demonstrate whether this diagnostic approach, possibly combined with clinical assessment, could be used at the pre-hospital stage to justify direct transfer to a regional thrombectomy centre in suitable cases.


2021 ◽  
pp. 174749302110192
Author(s):  
Mahmoud H Mohammaden ◽  
Diogo C. Haussen ◽  
Leonardo Pisani ◽  
Alhamza Al-Bayati ◽  
Aaron Anderson ◽  
...  

Background Three randomized clinical trials have reported similar safety and efficacy for contact aspiration (CA) and Stent-retriever (SR) thrombectomy. Aim We aimed to determine whether the Combined Technique (SR+CA) was superior to SR alone as first-line thrombectomy strategy in a patient cohort where balloon-guide catheter was universally used. Methods A prospectively maintained mechanical thrombectomy database from January 2018-December 2019 was reviewed. Patients were included if they had anterior circulation proximal occlusion ischemic stroke (intracranial ICA or MCA-M1/M2 segments) and underwent SR alone thrombectomy or SR+CA as first-line therapy. The primary outcome was the first-pass effect (FPE) (mTICI2c-3). Secondary outcomes included modified FPE (mTICI2b-3), successful reperfusion (mTICI2b-3) prior to and after any rescue strategy, and 90-day functional independence (mRS ≤2). Safety outcomes included rate of parenchymal hematoma (PH) type-2 and 90-day mortality. Sensitivity analyses were performed after dividing the overall cohort according to first-line modality into two matched groups. Results A total of 420 patients were included in the analysis (mean age 64.4 years; median baseline NIHSS 16[11-21]). As compared to first-line SR alone, first-line SR+CA resulted in similar rates of FPE (53% vs. 51%,aOR 1.122, 95%CI[0.745-1.691],p=0.58), mFPE (63% vs. 60.4%,aOR1.250, 95%CI[0.782-2.00],p=0.35), final successful reperfusion (97.6% vs. 98%,p=0.75) and higher chances of successful reperfusion prior to any rescue strategy (81.8% vs. 72.5%,aOR 2.033, 95%CI[1.209-3.419],p=0.007). Functional outcome and safety measures were comparable between both groups. Likewise, the matched analysis (148 patient-pairs) demonstrated comparable results for all clinical and angiographic outcomes except for significantly higher rates of successful reperfusion prior to any rescue strategies with the first-line SR+CA treatment (81.8% vs. 73.6%,aOR 1.881, 95%CI[1.039-3.405],p=0.037). Conclusions Our findings reinforce the findings of ASTER-2 trial in that the first-line thrombectomy with a Combined Technique did not result in increased rates of first-pass reperfusion or better clinical outcomes. However, addition of contact aspiration after initial SR failure might be beneficial in achieving earlier reperfusion.


Author(s):  
Adnan Mujanovic ◽  
Christoph Kammer ◽  
Christoph C Kurmann ◽  
Lorenz Grunder ◽  
Morin Beyeler ◽  
...  

Introduction : The value of intravenous thrombolysis (IVT) in patients eligible for mechanical thrombectomy (MT) remains unclear. We hypothesized that pre‐treatment with and/or ongoing IVT may facilitate reperfusion of distal vessel occlusion after incomplete MT. We evaluated this potential association using follow‐up perfusion imaging. Methods : Retrospective observational analysis of our institution`s stroke registry included patients with incomplete reperfusion after MT, admitted between February 1, 2015 and December 8, 2020. Delayed reperfusion (DR) was defined as the absence of a persistent perfusion deficit on contrast‐enhanced perfusion imaging ⁓24h±12h after the intervention. The association between baseline parameters and the occurrence of DR was evaluated using a logistic regression analyses. To account for possible time‐dependent associations of IVT with DR, additional stratification sets were made based on different time windows between IVT start time and final angiography runs. Results : Among the 378 included patients (median age 73.5, 50.8% female), DR occurred in 226 (59.8%). Atrial fibrillation (aOR 2.53 [95% CI 1.34 ‐ 4.90]), eTICI score (aOR 3.79 [95% CI 2.71 ‐ 5.48] per TICI grade increase), and intervention‐to‐follow‐up time (aOR 1.08 [95% CI 1.04 ‐ 1.13] per hour delay) were associated with DR. Dichotomized IVT strata showed no association with DR (aOR 0.75 [95% CI 0.42 ‐ 1.33]), whereas shorter intervals between IVT start and end of the procedure showed a borderline significant association with DR (OR 2.24 [95% CI 0.98 ‐ 5.43, and OR 2.07 [95% 1.06 – 4.31], for 80 and 100 minutes respectively). Patients with DR had higher rates of functional independence (modified Rankin scale 0–2 at 90 days, DR: 63.3% vs PPD: 38.8%; p<0.01) and longer survival time (at 3 years, DR: 69.2% vs PPD: 45.8%; p = 0.001). Conclusions : There is weak evidence that IVT may favor DR after incomplete MT if the time interval between IVT administration and end of the procedure is short. In general, perfusion follow‐up imaging may constitute a suitable surrogate parameter for evaluating medical rescue strategies after incomplete MT, because a considerable proportion of patients do not experience DR, and there seems to be a close correlation with clinical outcomes.


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