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Background Hypotension and blood pressure (BP) variability during endovascular therapy (EVT) for acute ischemic stroke (AIS) due to an anterior large vessel occlusion (LVO) is associated with worse outcomes. However, the optimal BP threshold during EVT is still unknown given the lack of randomized controlled evidence. We designed the DETERMINE trial to assess whether an individualized BP management during EVT could achieve better functional outcomes compared to a standard BP management. Methods The DETERMINE trial is a multicenter, prospective, randomized, controlled, open-label, blinded endpoint clinical trial (PROBE design). AIS patients with a proximal anterior LVO are randomly assigned, in a 1:1 ratio, to an experimental arm in which mean arterial pressure (MAP) is maintained within 10% of the first MAP measured before EVT, or a control arm in which systolic BP (SBP) is maintained within 140–180 mm Hg until reperfusion is achieved or artery closure in case of EVT failure. The primary outcome is the rate of favorable functional outcomes, defined by a modified Rankin Scale (mRS) between 0 and 2 at 90 days. Secondary outcomes include excellent outcome and ordinal analysis of the mRS at 90 days, early neurological improvement at 24 h (National Institutes of Health Stroke Scale), final infarct volume, symptomatic intracranial hemorrhage rates, and all-cause mortality at 90 days. Overall, 432 patients will be included. Discussion DETERMINE will assess the clinical relevance of an individualized BP management before reperfusion compared to the one size fits all approach currently recommended by international guidelines. Trial registration ClinicalTrials.gov , NCT04352296. Registered on 20th April 2020.

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.

Direct transfer to angiography suite (DTAS) for patients with suspected stroke primarily admitted to an endovascular-capable centre could accelerate in-hospital workflow and improve outcome. We aimed to assess the safety and efficacy of DTAS for patients with acute severe neurological deficit highly suggestive of ischaemic stroke due to a large vessel occlusion (ASND-LVO). We did an open-label, multicentre, randomised controlled trial in ten comprehensive stroke centres in France. We enrolled adult patients (age ≤85 years) with ASND-LVO (unilateral motor deficit with a score ≥5 plus a cortical symptom with a score ≥1 based on the National Institues of Health Stroke Scale) admitted within 5 h of symptom onset. Patients were randomly assigned (1:1) with a web-based system to DTAS or conventional pathway (ie, imaging followed by transfer to the angiography suite for endovascular treatment if eligible). The primary outcome was functional independence defined as a modified Rankin Scale score 0 to 2 at 90 days in the intention-to-treat population—ie, all randomly assigned patients in their originally assigned treatment groups, irrespective of diagnosis, imaging findings, or treatments received. Symptomatic intracranial haemorrhage and all-cause mortality at 90 days were the main safety outcomes. This study was registered on ClinicalTrials.gov (NCT03969511). Between July 9, 2020, and April 18, 2023, 115 patients were randomly assigned to the DTAS group (n=57) or the conventional group (n=58). An interim analysis was done on Sept 27, 2023. The trial steering committee permanently stopped the trial on Dec 1, 2023, for safety reasons after unmasking and analysis of the data. In the intention-to-treat analysis, the risk of symptomatic intracranial haemorrhage was increased in the DTAS group compared with the conventional group (five [15%] of 34 vs zero [0%] of 42; adjusted odds ratio [OR] 11·0 [95% CI 1·28–1406]). All-cause mortality did not differ significantly between groups (ten [18%] of 56 vs six [11%] of 53; adjusted OR 1·65 [95% CI 0·52–5·55]). Functional independence was reached in 20 [36%] of 56 participants in the DTAS group vs 22 [42%] of 53 in the conventional group (adjusted OR 0·73 [95% CI 0·32–1·69]). DTAS for patients with ASND-LVO was associated with an increased risk of symptomatic intracranial haemorrhage without evidence of a beneficial effect on functional outcome at 90 days. However, because the trial was stopped early for safety reasons, the small sample size limits the precision of the effect estimates on the primary outcome and all secondary and safety outcomes. Therefore, further clinical trials are required to firmly conclude on the safety and efficacy of DTAS for patients with suspected acute ischaemic stroke due to a large vessel occlusion. French Ministry of Health and Medtronic.

BackgroundStudies have suggested that collateral status modifies the effect of successful reperfusion on functional outcome after endovascular therapy (EVT). We aimed to assess the association between collateral status and EVT outcomes and to investigate whether collateral status modified the effect of successful reperfusion on EVT outcomes.MethodsWe used data from the ongoing, prospective, multicenter Endovascular Treatment in Ischemic Stroke (ETIS) Registry. Collaterals were graded according to the American Society of Interventional and Therapeutic Neuroradiology/Society of Interventional Radiology (ASITN/SIR) guidelines. Patients were divided into two groups based on angiographic collateral status: poor (grade 0–2) versus good (grade 3–4) collaterals.ResultsAmong 2020 patients included in the study, 959 (47%) had good collaterals. Good collaterals were associated with favorable outcome (90-day modified Rankin Scale (mRS) 0–2) (OR 1.5, 95% CI 1.19 to 1.88). Probability of good outcome decreased with increased time from onset to reperfusion in both good and poor collateral groups. Successful reperfusion was associated with higher odds of favorable outcome in good collaterals (OR 6.01, 95% CI 3.27 to 11.04) and poor collaterals (OR 5.65, 95% CI 3.32 to 9.63) with no significant interaction. Similarly, successful reperfusion was associated with higher odds of excellent outcome (90-day mRS 0–1) and lower odds of mortality in both groups with no significant interaction. The benefit of successful reperfusion decreased with time from onset in both groups, but the curve was steeper in the poor collateral group.ConclusionsCollateral status predicted functional outcome after EVT. However, collateral status on the pretreatment angiogram did not decrease the clinical benefit of successful reperfusion.

BackgroundEndovascular therapy (EVT) is effective and safe in patients with tandem occlusion. The benefit of intravenous thrombolysis (IVT) prior to EVT in acute tandem occlusion is debatable.ObjectiveTo compare EVT alone with EVT plus IVT in patients with acute ischemic stroke due to anterior circulation tandem occlusions.MethodsThis is an individual patient pooled analysis of the Thrombectomy In TANdem lesions (TITAN) and Endovascular Treatment in Ischemic Stroke (ETIS) Registries. Patients were divided into two groups based on prior IVT treatment: (1) IVT+ group, which included patients who received IVT prior to EVT, (2) IVT− group, which included patients who did not receive IVT prior to EVT. Propensity score (inverse probability of treatment weighting (IPTW)) was used to reduce baseline between-group differences. The primary outcome was favorable outcome—that is, modified Rankin Scale (mRS) score 0 to 2 at 90 days.ResultsOverall, 602 consecutive patients with an acute stroke with tandem occlusion were included (380 and 222 in the bridging therapy and EVT alone groups, respectively). Onset to imaging time was shorter in the IVT+ group (median 103 vs 140 min). In contrast, imaging to puncture time was longer in the IVT+ group (median 107 vs 91 min). In IPTW analysis, the IVT+ group had higher odds of favorable outcome, excellent outcome (90-day mRS score 0–1), and successful reperfusion (modified Thrombolysis in Cerebral Infarction score 2b/3 at the end of EVT). There was no difference in the risk of significant hemorrhagic complications between groups. In secondary analysis of patients treated with acute cervical internal carotid artery stenting, bridging therapy was associated with higher odds of favorable outcome and lower odds of mortality at 90 days.ConclusionsOur results suggest that bridging therapy in patients with acute ischemic stroke due to anterior tandem occlusion is safe and may improve functional outcome, even in the setting of acute cervical internal carotid artery stenting during EVT.

BackgroundThe best treatment for acute ischemic stroke (AIS) due to isolated cervical internal carotid artery occlusion (CICAO) (i.e., without associated occlusion of the circle of Willis) is still unknown. In this study, we aimed to describe EVT safety and clinical outcome in patients with CICAO.MethodsWe analyzed data of all consecutive patients, included in the Endovascular Treatment in Ischemic Stroke (ETIS) Registry between 2013 and 2020, who presented AIS and proven CICAO on angiogram and underwent EVT. We assessed carotid recanalization, procedural complications, National Institutes of Health Stroke Scale (NIHSS) at 24 h post-EVT, and 3-month favorable outcome (modified Rankin Scale, mRS ≤ 2 or equal to the pre-stroke value).ResultsForty-five patients were included (median age: 70 years; range: 62–82 years). The median NIHSS before EVT was 14 (9–21). Carotid stenting was performed in 23 (51%) patients. Carotid recanalization at procedure end and on control imaging was observed in 37 (82%) and 29 (70%) patients, respectively. At day 1 post-EVT, the NIHSS remained stable or decreased in 25 (60%) patients; 12 (29%) patients had early neurologic deterioration (NIHSS ≥ 4 points). The rate of procedural complications was 36%, including stent thrombosis (n = 7), intracranial embolism (n = 7), and symptomatic intracranial hemorrhage (n = 1). At 3 months, 18 (40%) patients had a favorable outcome, and 10 (22%) were dead.ConclusionOur study suggests that EVT in AIS patients with moderate/severe initial deficit due to CICAO led to high rate of recanalization at day 1, and a 40% rate of favorable outcome at 3 months. There was a high rate of procedural complication which is of concern. Randomized controlled trials assessing the superiority of EVT in patients with CICAO and severe deficits are needed.

BackgroundThe presence of a coincident intracranial aneurysm (CIA) on the target vessel of patients undergoing mechanical thrombectomy (MT) for acute ischemic stroke (AIS) poses challenges, as the benefits and risks of the procedure in this scenario remain unclear. This study aimed to evaluate the efficacy and safety of MT in AIS cases with a CIA on the target vessel.MethodsWe retrospectively analyzed data from 14 stroke centers in France and Switzerland between January 2015 and January 2023. We identified AIS cases with CIA on the target vessel treated with MT. The control population was constituted from the ETIS registry (Endovascular Treatment in Ischemic Stroke), including AIS patients treated with MT in the same centers during the same period, and were matched (1:4) on age (±1 year) and sex. The primary outcome was favorable functional status at 3 months, defined as a modified Rankin Scale (mRS) score ≤2 or equal to pre-stroke mRS.ResultsA total of 104 MT-treated patients with at least one CIA on the target vessel and 416 MT-treated patients without CIA were analyzed. Despite an aneurysm rupture occurring in 5.8% of cases, no significant differences were observed in favorable functional outcome at 3 months between the CIA and control groups (42.4% vs 41.0%; adjusted OR 1.20, 95% CI 0.72 to 1.97). Similarly, recanalization rates (modified Thrombolysis In Cerebral Infarction (mTICI) ≥2b at end of MT) did not differ significantly (90.0% vs 85.9%; adjusted OR 1.75, 95% CI 0.77 to 3.95).ConclusionMT is an effective option for AIS patients, even with CIA on the target vessel, but the risk of rupture underscores the need for procedural planning. Future studies should further explore size and location criteria to optimize patient selection and orientation.

BackgroundRescue intracranial stenting (RIS) can be used in refractory large vessel occlusion (LVO) after mechanical thrombectomy (MT). We aimed to assess the safety and efficacy of RIS versus a propensity matched sample of patients with persistent LVO.MethodsWe retrospectively analysed a multicenter retrospective pooled cohort of patients with anterior LVO (2015−2021) treated with MT, and identified patients with at least three passes and a modified Thrombolysis In Cerebral Infarction (mTICI) score of 0 to 2a. Propensity score matching was used to account for determinants of outcome in patients with or without RIS. The study outcomes included 3 months modified Rankin Scale (mRS) and symptomatic hemorrhagic transformation (HT).Results420 patients with a refractory anterior occlusion were included, of which 101 were treated with RIS (mean age 69 years). Favorable outcome (mRS 0–2) was more frequent in patients with a patent stent at day 1 (53% vs 6%, P<0.001), which was independently associated with an early dual antiplatelet regimen (P<0.05). In the propensity matched sample, patients treated with RIS versus without RIS had similar rates of favorable outcomes (36.8% vs 30.3%, P=0.606). Patients with RIS showed a favorable shift in the overall mRS distributions (common adjusted OR 0.74, 95% CI 0.60 to 0.91, P=0.006). Symptomatic HT was marginally more frequent in the RIS group (9% vs 3%, P=0.07), and there was no difference in 3-month mortality.ConclusionIn selected patients with a refractory intracranial occlusion despite at least three thrombectomy passes, RIS may be associated with an overall shift towards more favorable clinical outcome, and no significant increase in the odds of symptomatic HT or death.

BackgroundRetrospective studies suggest the superiority of first-line contact aspiration (CA) thrombectomy over stent-retriever (SR) in basilar artery occlusions (BAO). We aimed to investigate the impact of first-line mechanical thrombectomy per the occlusion level, considering differences in stroke etiology prevalence between proximal and distal BAO.MethodsA retrospective, multicentric analysis of the Endovascular Treatment in Ischemic Stroke Registry (ETIS) included consecutive BAO patients treated from January 2016 to May 2022. Patients were categorized into SR (±aspiration) and CA alone groups. Occlusion levels were determined through digital subtraction angiography. Favorable clinical outcome was defined as 90-day modified Rankin Scale (mRS) 0–3.ResultsA total of 380 patients were analyzed (251 CA alone, 129 SR±aspiration). Globally, first-line SR showed lower recanalization rates (89.1% vs 94.8%, OR=0.29, 95% CI 0.16 to 0.53; p<0.001) and worse clinical outcomes (mRS 0–3: 46.0% vs 52.2%, OR=0.62, 95% CI 0.44 to 0.87; p=0.006) compared with CA. In proximal occlusions, SR was significantly associated with poorer clinical outcomes (mRS 0–3: 20.9% vs 37.1%; OR=0.40, 95% CI 0.19 to 0.83; p=0.014) despite similar recanalization rates. Conversely, in distal occlusions there was no difference in clinical outcomes although recanalization rates were higher with CA (modified Thrombolysis in Cerebral Infarction score (mTICI 2b/3): 97.7% vs 91.7%; OR=0.17, 95% CI 0.05 to 0.66; p=0.01).ConclusionsIn our BAO population, CA demonstrated better angiographic outcomes in middle and distal occlusions and better clinical outcomes in proximal occlusions. This translated into better angiographic and clinical results in the global study population. Clinical results were particularly influenced by the negative impact of SR on 90-day mRS, independently of recanalization rates in proximal BAO.

BackgroundThe effect of multiple attempts on the outcome of endovascular treatment (EVT) of anterior circulation large ischemic core (LIC) stroke has not been fully explored.MethodsWe analyzed data from the Endovascular Treatment in Ischemic Stroke (ETIS) registry, a prospective, observational, multicenter study of acute ischemic stroke patients treated with EVT at 21 centers in France between January 1, 2015 and June 31, 2023. We included patients with proximal intracranial occlusion and LIC defined as Alberta Stroke Program Early CT Score (ASPECTS) of 0–5 up to 24 hours after last being seen well. We divided patients according to the number of passes with successful reperfusion (modified Thrombolysis In Cerebral Infarction (mTICI) ≥2b) into seven groups, according to the corresponding number of passes. We compared them to the group of patients with unsuccessful reperfusion.ResultsA total of 1235 patients with LIC constituted the study cohort. The rate of a modified Rankin Scale (mRS) score of 0 to 3 at 90 days was significantly higher for the one-pass successful recanalization category compared to no recanalization (48.1% vs 17.2%; adjusted OR (aOR) 7.99, 95% CI 4.30 to 14.8, P<0.001) and remained so even after six or more attempts (27.7% vs 17.2%; aOR 3.59, 95% CI 1.37 to 9.39, P=0.009). The rate of symptomatic intracranial hemorrhage was lower for successful recanalization up to two passes (11.1% vs 18.8%; aOR 0.36, 95% CI 0.18 to 0.69, P=0.002) without any significant differences for a higher number of passes.ConclusionIn anterior circulation LIC patients, successful reperfusion, even after six passes, is associated with favorable clinical outcomes with no increased hemorrhagic risk when compared to unsuccessful reperfusion.