Trial of Thrombectomy for Stroke with a Large Infarct of Unrestricted Size.

BACKGROUND: The use of thrombectomy in patients with acute stroke and a large infarct of unrestricted size has not been well studied. METHODS: We assigned, in a 1:1 ratio, patients with proximal cerebral vessel occlusion in the anterior circulation and a large infarct (as defined by an Alberta Stroke Program Early Computed Tomographic Score of ≤5; values range from 0 to 10) detected on magnetic resonance imaging or computed tomography within 6.5 hours after symptom onset to undergo endovascular thrombectomy and receive medical care (thrombectomy group) or to receive medical care alone (control group). The primary outcome was the score on the modified Rankin scale at 90 days (scores range from 0 to 6, with higher scores indicating greater disability). The primary safety outcome was death from any cause at 90 days, and an ancillary safety outcome was symptomatic intracerebral hemorrhage. RESULTS: A total of 333 patients were assigned to either the thrombectomy group (166 patients) or the control group (167 patients); 9 were excluded from the analysis because of consent withdrawal or legal reasons. The trial was stopped early because results of similar trials favored thrombectomy. Approximately 35% of the patients received thrombolysis therapy. The median modified Rankin scale score at 90 days was 4 in the thrombectomy group and 6 in the control group (generalized odds ratio, 1.63; 95% confidence interval [CI], 1.29 to 2.06; P<0.001). Death from any cause at 90 days occurred in 36.1% of the patients in the thrombectomy group and in 55.5% of those in the control group (adjusted relative risk, 0.65; 95% CI, 0.50 to 0.84), and the percentage of patients with symptomatic intracerebral hemorrhage was 9.6% and 5.7%, respectively (adjusted relative risk, 1.73; 95% CI, 0.78 to 4.68). Eleven procedure-related complications occurred in the thrombectomy group. CONCLUSIONS: In patients with acute stroke and a large infarct of unrestricted size, thrombectomy plus medical care resulted in better functional outcomes and lower mortality than medical care alone but led to a higher incidence of symptomatic intracerebral hemorrhage. (Funded by Montpellier University Hospital; LASTE ClinicalTrials.gov number, NCT03811769.).

Evaluation of acute mechanical revascularization in large stroke (ASPECTS ⩽5) and large vessel occlusion within 7 h of last-seen-well: The LASTE multicenter, randomized, clinical trial protocol.

RATIONALE: Mechanical thrombectomy (MT), the standard of care for acute ischemic stroke (AIS) secondary to large vessel occlusion (LVO), is generally not offered to patients with large baseline infarct (core). Recent studies demonstrated MT benefit in patients with anterior circulation stroke and large core (i.e. Alberta Stroke Program Early Computed Tomography Score, ASPECTS 3-5). However, its benefit in patients with the largest core (ASPECTS 0-2) remains unproven. AIM: To compare the efficacy and safety of MT plus best medical treatment (BMT) and of BMT alone in patients with ASPECTS 0-5 (baseline computed tomography (CT) or magnetic resonance imaging (MRI)) and anterior circulation LVO within 7 h of last-seen-well. SAMPLE SIZE ESTIMATE: To detect with a two-sided test at 5% significance level (80% power) a common odds ratio of 1.65 for 1-point reduction in the 90-day modified Rankin Scale (mRS) score in the MT + BMT arm versus BMT arm and to anticipate 10% of patients with missing primary endpoint, 450 patients are planned to be included by 36 centers in France, Spain, and the United States. METHODS AND DESIGN: LArge Stroke Therapy Evaluation (LASTE) is an international, multicenter, Prospectively Randomized into two parallel (1:1) arms, Open-label, with Blinded Endpoint (PROBE design) trial. Eligibility criteria are diagnosis of AIS within 6.5 h of last-seen-well (or negative fluid-attenuated inversion recovery (FLAIR) if unknown stroke onset time), ASPECTS 0-5 (ASPECTS 4-5 for ⩾80-year-old patients), and LVO in the anterior circulation (intracranial internal carotid artery (ICA) and M1 or M1-M2 segment of the middle cerebral artery (MCA)). STUDY OUTCOMES: The primary endpoint is the day-90 mRS score distribution (shift analysis) with mRS categories 5 and 6 coalesced into one category. Secondary endpoints include day-180 mRS score, rates of 90-day and 180-day mRS score = 0-2 and 0-3, rate of decompressive craniectomy, the National Institutes of Health Stroke Scale (NIHSS) score change, revascularization and infarct volume growth at 24 h, and quality of life at day 90 and 180. Safety outcomes (90-day all-cause mortality, procedural complications, symptomatic intracerebral hemorrhage, and early NIHSS score worsening) are recorded. A dynamic balanced randomization (1:1) is used to distribute eligible patients into the experimental arm and control arm, by incorporating the center and these pre-specified factors: baseline ASPECTS (0-3 vs 4-5), age (⩽70 vs >70 years), baseline NIHSS (<20 vs ⩾20), intravenous thrombolysis (no vs yes), admission mode (Drip-and-Ship vs Mothership), occlusion site (intracranial ICA vs MCA-M1 or M1-M2), intravenous fibrinolysis (no vs yes), and last-seen-well to randomization time (0-4.5 vs >4.5-6.5 h). DISCUSSION: The LASTE trial will determine MT efficacy and safety in patients with ASPECTS 0-5 and LVO in the anterior circulation. TRIAL REGISTRATION: LASTE Trial NCT03811769.

Evaluation of acute mechanical revascularization in minor stroke (NIHSS score ⩽ 5) and large vessel occlusion: The MOSTE multicenter, randomized, clinical trial protocol.

RATIONALE: Mechanical thrombectomy (MT) has become the standard of care for patients with acute ischemic stroke secondary to large vessel occlusion (LVO) of the anterior circulation. Conversely, its benefit in patients with National Institutes of Health Stroke Scale (NIHSS) score ⩽ 5 is unproven. AIM: To demonstrate the superiority of immediate MT plus best medical treatment (BMT) compared to BMT (with secondary MT in case of deterioration) for increasing the rate of modified Rankin Scale (mRS) score ⩽ 1 at 90 days after minor stroke (NIHSS score ⩽ 5) and anterior circulation LVO. SAMPLE SIZE ESTIMATES: To detect an absolute increase of 10% (80% power) in the 90-day mRS score = 0-1 rate in the MT + BMT group, by assuming an mRS score = 0-1 rate of 60% in the BMT group and by considering two interim efficacy/futility analyses (after study completion by 274 and 548 patients), 824 patients must be included by 36 centers in France, Spain, and the USA. METHODS AND DESIGN: MOSTE is an international, multicenter, prospectively randomized into two parallel (1:1) arms, open-label, with blinded endpoint trial. Eligibility criteria are diagnosis of acute ischemic stroke within 23 h of last-seen-well, NIHSS score ⩽ 5, and LVO in the anterior circulation (intracranial internal carotid artery, M1 or M1-M2 segment of the middle cerebral artery). STUDY OUTCOMES: The primary endpoint is the rate of excellent outcome at day 90 (mRS score = 0-1). Secondary endpoints include the rates of 90-day mRS score = 0-2 and score = 0, NIHSS score change, secondary MT, revascularization and infarct volume growth at 24 h, and quality of life and cognitive function at day 90. Safety outcomes (90-day all-cause mortality, procedural complications, symptomatic intracerebral hemorrhage, and rapid NIHSS score worsening) are recorded. DISCUSSION: The MOSTE trial will determine MT efficacy and safety in patients with minor stroke and LVO in the anterior circulation. TRIAL REGISTRATION: MOSTE Trial. NCT03796468.

Safety and outcomes of endovascular treatment in patients with very severe acute ischemic stroke.

BACKGROUND: Patients with anterior circulation ischemic strokes due to large vessel occlusion (AIS-LVO) and very severe neurological deficits (National Institutes of Health Stroke Scale (NIHSS) score > 25) were under-represented in clinical trials on endovascular treatment (EVT). We aimed to evaluate safety and outcomes of EVT in patients with very severe vs. severe (NIHSS score 15-25) neurological deficits. METHODS: We included consecutive patients undergoing EVT for AIS-LVO between January 2015 and December 2019 at Lille University Hospital. We compared rates of parenchymal hemorrhage (PH), symptomatic intracranial hemorrhage (SICH), procedural complications, and 90-day mortality between patients with very severe vs. severe neurological deficit using univariable and multivariable logistic regression analyses. Functional outcome (90-days modified Rankin Scale) was compared between groups using ordinal logistic regression analysis. RESULTS: Among 1484 patients treated with EVT, 108 (7%) had pre-treatment NIHSS scores > 25, 873 (59%) with NIHSS scores 15-25 and 503 (34%) with NIHSS scores < 15. Rates of PH, SICH, successful recanalization, and procedural complications were similar in patients with NIHSS scores > 25 and NIHSS 15-25. Patients with NIHSS > 25 had a lower likelihood of improved functional outcome (adjcommon OR 0.31[95% CI 0.21-0.47]) and higher odds of mortality at 90 days (adjOR 2.3 [95% CI 1.5-3.7]) compared to patients with NIHSS 15-25. Successful recanalization was associated with better functional outcome (adjcommon OR 3.8 [95% CI 1.4-10.4]), and lower odds of mortality (adjOR 0.3 [95% CI 0.1-0.9]) in patients with very severe stroke. The therapeutic effect of recanalization on functional outcome and mortality was similar in both groups. CONCLUSIONS: In patients with very severe neurological deficit, EVT was safe and successful recanalization was strongly associated with better functional outcome at 90 days.

Compliant balloon angioplasty for the treatment of internal carotid artery dissection.

This report describes the innovative management of a severe haemodynamic stroke related to an occlusive extracranial internal carotid artery dissection. Intravenous thrombolysis combined with endovascular treatment were undertaken on the basis of a total mismatch profile (National Institutes of Health stroke scale (NIHSS) score of 27 and infarct volume on diffusion-weighted imaging of 0 mL). Balloon angioplasty using a long and compliant balloon microcatheter allowed complete recovery of the intracranial blood flow. The patient showed dramatic clinical improvement (day 1, NIHSS 5) and favourable functional outcome (day 90, modified Rankin scale score 2). Day 90 follow-up brain magnetic resonance imaging revealed no ischaemic change and magnetic resonance angiography assessed the patency of the internal carotid artery.

Real-World Thrombectomy Using the Sofia Catheter.

OBJECTIVE: To study the safety and performance of real-world thrombectomy using the SOFIA Catheter in our comprehensive stroke center. METHODS: We conducted a cohort study from a prospective clinical registry of consecutive stroke patients treated by mechanical thrombectomy between March 2016 and September 2017. Baseline clinical and imaging characteristics, recanalization rates, complications, and clinical outcomes were analyzed. RESULTS: Among the 140 patients included, 54 were treated using aspiration first, 64 were treated using aspiration and stent-retriever straightaway, and 22 were treated with SOFIA as a rescue device. Successful recanalization (Modified Thrombolysis In Cerebral Infarction score 2b/3) was achieved in 82.1% patients and good outcomes in 34.3%. Symptomatic intracranial hemorrhage occurred in 7.1% and mortality in 25%. CONCLUSIONS: In our single-center experience, thrombectomy using the SOFIA as an intermediate or aspiration catheter provided high recanalization rates under everyday conditions.

Traumatic Meniscus and Cruciate Ligament Tears in Young Patients: A Comparison of 3T Versus 1.5T MRI.

OBJECTIVE: To compare diagnosis value of 1.5T and 3T MRI in the detection of traumatic knee injuries in young patients by reference to arthroscopy. MATERIALS AND METHODS: One hundred patients were prospectively included. All patients randomly underwent standardized knee 1.5T or 3T MRI with subsequent knee arthroscopy. Meniscus and cruciate ligaments tears were blindly assessed by two independent musculoskeletal radiologists. RESULTS: Comparison of 1.5T and 3T MRI groups in the diagnosis of medial and lateral meniscal tears showed significantly higher sensitivity (p = 0.015) of 1.5T MRI in the diagnosis of lateral meniscal tears. Sensitivity and specificity for complete ACL tears were 100 percent [35/35] and 100 percent [23/23] at 1.5T MRI (p = < 0.0001) versus 95.5 percent [21/22] and 100 percent [16/16] at 3T MRI (p = < 0.0001).Only three complete PCL tears were observed in this study. Sensitivity and specificity for all complete CL tears were 100 percent [37/37]; 100 percent [77/77] for 1.5T MRI (p < 0.0001); and 95.7 percent [22/23] and 100 percent [59/59] for 3-T MRI (p < 0.0001). Diagnosis value of 1.5T and 3T MRI was equal for ACL and PCL complete tears. CONCLUSION: Diagnosis value of 1.5T was similar to 3T MRI for medial meniscal and cruciate ligament tears of the knee in symptomatic patients and higher for lateral meniscal tears.