Rationale: Mechanical thrombectomy (MT), the standard of care for acute ischemic stroke 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 CT 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 CT or MRI) and anterior circulation LVO within 7 hours 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 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 USA. Methods and design: 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 acute ischemic stroke within 6.5 hours of last-seen-well (or negative 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, 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, rates of decompressive craniectomy, NIHSS score change, revascularization and infarct volume growth at 24 hours, 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 hours). 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
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.
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 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 hours 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 outcome(s). 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 hours, 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. NCT 03796468
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