Time to angiographic reperfusion and clinical outcome after acute ischaemic stroke: an analysis of data from the Interventional Management of Stroke (IMS III) phase 3 trial.

Time to angiographic reperfusion and clinical outcome after acute ischaemic stroke: an analysis of data from the Interventional Management of Stroke (IMS III) phase 3 trial.
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DOI:
10.1016/s1474-4422(14)70066-3
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发表时间:
2014-06
期刊:
The Lancet. Neurology
影响因子:
--
通讯作者:
IMS III Trialists
IMS III Trialists
中科院分区:
其他
文献类型:
--
作者:
Khatri P;Yeatts SD;Mazighi M;Broderick JP;Liebeskind DS;Demchuk AM;Amarenco P;Carrozzella J;Spilker J;Foster LD;Goyal M;Hill MD;Palesch YY;Jauch EC;Haley EC;Vagal A;Tomsick TA;IMS III Trialists

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IMS III试验未证明血管内方法与单独IV rt-PA相比在卒中发作3小时内入组的中度或重度缺血性卒中(NIHSS≥8)中的临床获益。无法挽救的组织的晚期再灌注可能是一种解释,如先前的探索性研究所示,显示再灌注时间与良好的临床结局之间存在相关性。我们试图在大规模IMS III试验中验证这种关系,并考虑其对未来血管内试验的影响。该分析包括前循环近端动脉闭塞的血管内队列,在血管内手术期间(症状发作后7小时内)实现血管造影再灌注(TICI 2-3)。使用逻辑回归来模拟良好的临床结局(90天改良兰金0-2)作为再灌注时间的函数,并考虑预先指定的变量进行调整。在240例近端血管闭塞中,182例(76%)实现了血管造影再灌注(TICI 2-3)。平均再灌注时间为325分钟(范围180-418分钟)。较长的再灌注时间与良好临床结局的可能性降低相关(每延迟30分钟的RR [95%CI]:未校正的0.85 [0.77 - 0.94];校正的0.88 [0.80 - 0.98])。我们证实,血管造影再灌注时间的延迟导致良好临床结局的可能性降低。实现快速再灌注可能是未来急性血管内试验成功的关键。资金来源:NIH/NINDS(研究申办方)、Genentech Inc.(研究药物-动脉内t-PA)、EKOS Corp.(器械)、Concentric Inc.(器械),Cordis Neurovascular,Inc.(器械)和勃林格殷格翰(欧洲研究者会议支持)。
The IMS III Trial did not demonstrate clinical benefit of the endovascular approach compared to IV rt-PA alone for moderate or severe ischemic strokes (NIHSS≥8) enrolled within three hours of stroke onset. Late reperfusion of tissue that is no longer salvageable may be one explanation, as suggested by prior exploratory studies showing an association between time to reperfusion and good clinical outcome. We sought to validate this relationship in the large-scale IMS III trial, and consider its implications for future endovascular trials. The analysis consisted of the endovascular cohort with proximal arterial occlusions in the anterior circulation that achieved angiographic reperfusion (TICI 2–3) during the endovascular procedure (within 7 hours from the onset of symptoms). Logistic regression was used to model good clinical outcome (90-day modified Rankin 0–2) as a function of the time to reperfusion, and prespecified variables were considered for adjustment. Among 240 proximal vessel occlusions, angiographic reperfusion (TICI 2–3) was achieved in 182 (76%). Mean time to reperfusion was 325 minutes (range 180–418 minutes). Longer time for reperfusion was associated with a decreased likelihood of good clinical outcome (RR [95% CI] for every 30 minute delay: unadjusted 0·85 [0·77–0·94]; adjusted 0·88 [0·80–0·98]). We confirm that delay in time to angiographic reperfusion leads to a decreased likelihood of good clinical outcome. Achieving rapid reperfusion may be critical for the successes of future acute endovascular trials. FUNDING: NIH/NINDS (study sponsor), Genentech Inc. (study drug - intra-arterial t-PA), EKOS Corp. (device), Concentric Inc. (device), Cordis Neurovascular, Inc. (device), and Boehringer Ingelheim (European Investigator Meeting support).