Yoo Albert J, Soomro Jazba, Andersson Tommy, Saver Jeffrey L, Ribo Marc, Bozorgchami Hormozd, Dabus Guilherme, Liebeskind David S, Jadhav Ashutosh, Mattle Heinrich, Zaidat Osama O
Department of Neurointervention, Texas Stroke Institute, Fort Worth, TX, United States.
Neuroradiology, Karolinska University Hospital, Clinical Neuroscience Karolinska Institutet, Stockholm, Sweden.
Front Neurol. 2021 May 11;12:669934. doi: 10.3389/fneur.2021.669934. eCollection 2021.
End-of-procedure substantial reperfusion [modified Treatment in Cerebral Ischemia (mTICI) 2b-3], the leading endpoint for thrombectomy studies, has several limitations including a ceiling effect, with recent achieved rates of ~90%. We aimed to identify a more optimal definition of angiographic success along two dimensions: (1) the extent of tissue reperfusion, and (2) the speed of revascularization. Core-lab adjudicated TICI scores for the first three passes of EmboTrap and the final all-procedures result were analyzed in the ARISE II multicenter study. The clinical impact of extent of reperfusion and speed of reperfusion (first-pass vs. later-pass) were evaluated. Clinical outcomes included 90-day functional independence [modified Rankin Scale (mRS) 0-2], 90-day freedom-from-disability (mRS 0-1), and dramatic early improvement [24-h National Institutes of Health Stroke Scale (NIHSS) improvement ≥ 8 points]. Among 161 ARISE II subjects with ICA or MCA M1 occlusions, reperfusion results at procedure end showed substantial reperfusion in 149 (92.5%), excellent reperfusion in 121 (75.2%), and complete reperfusion in 79 (49.1%). Reperfusion rates on first pass were substantial in 81 (50.3%), excellent reperfusion in 62 (38.5%), and complete reperfusion in 44 (27.3%). First-pass excellent reperfusion (first-pass TICI 2c-3) had the greatest nominal predictive value for 90-day mRS 0-2 (sensitivity 58.5%, specificity 68.6%). There was a progressive worsening of outcomes with each additional pass required to achieve TICI 2c-3. First-pass excellent reperfusion (TICI 2c-3), reflecting rapid achievement of extensive reperfusion, is the technical revascularization endpoint that best predicted functional independence in this international multicenter trial and is an attractive candidate for a lead angiographic endpoint for future trials. http://www.clinicaltrials.gov, identifier NCT02488915.
手术结束时的实质性再灌注[改良脑缺血治疗（mTICI）2b - 3级]是取栓研究的主要终点，但存在包括天花板效应在内的若干局限性，近期达到的比率约为90%。我们旨在从两个维度确定血管造影成功的更优定义：（1）组织再灌注的程度，以及（2）血管再通的速度。在ARISE II多中心研究中，分析了核心实验室判定的EmboTrap前三次通过时的TICI评分以及最终所有手术的结果。评估了再灌注程度和再灌注速度（首次通过与后续通过）的临床影响。临床结局包括90天功能独立[改良Rankin量表（mRS）0 - 2级]、90天无残疾（mRS 0 - 1级）以及显著早期改善[24小时美国国立卫生研究院卒中量表（NIHSS）改善≥8分]。在161例患有颈内动脉或大脑中动脉M1段闭塞的ARISE II受试者中，手术结束时的再灌注结果显示，149例（92.5%）为实质性再灌注，121例（75.2%）为良好再灌注，79例（49.1%）为完全再灌注。首次通过时的再灌注率为：实质性再灌注81例（50.3%），良好再灌注62例（38.5%），完全再灌注44例（27.3%）。首次通过时的良好再灌注（首次通过TICI 2c - 3级）对90天mRS 0 - 2级具有最大的名义预测价值（敏感性58.5%，特异性68.6%）。为达到TICI 2c - 3级所需的每增加一次通过，结局都会逐渐恶化。首次通过时的良好再灌注（TICI 2c - 3级）反映了广泛再灌注的快速实现，是该国际多中心试验中最能预测功能独立的技术血管再通终点，也是未来试验主要血管造影终点的一个有吸引力的候选指标。http://www.clinicaltrials.gov，标识符NCT02488915。
