发病后 6 至 24 小时内进行取栓术治疗与缺损和梗死不匹配的脑卒中。

Thrombectomy 6 to 24 Hours after Stroke with a Mismatch between Deficit and Infarct.

机构信息

From the Marcus Stroke and Neuroscience Center, Grady Memorial Hospital, and the Department of Neurology, Emory University School of Medicine, Atlanta (R.G.N., D.C.H., M.R.F.); the Stroke Institute, Departments of Neurology (A.P.J., T.G.J.) and Neurosurgery (B.T.J.), University of Pittsburgh Medical Center, Pittsburgh, and Abington Health, Abington (Q.A.S.) - both in Pennsylvania; the Department of Neuroradiology, Hôpital Gui-de-Chauliac, Montpellier (A.B., V.C.), and the Department of Diagnostic and Therapeutic Neuroradiology (C.C.) and the Neuroimaging Center and Center for Clinical Investigations (J.-M.O.), University Hospital of Toulouse, Toulouse - both in France; OhioHealth Riverside Methodist Hospital, Columbus (R.F.B., N.A.V.), and University Hospitals of Cleveland, Cleveland (C.A.S., A.J.F.) - both in Ohio; Texas Stroke Institute, Dallas-Fort Worth (P.B., A.J.Y.), the Department of Neuroscience, Valley Baptist Medical Center, Harlingen (A.E.H., W.G.T.), and Berry Consultants, Austin (T.G., R.J.L.) - all in Texas; the Department of Neurology and Neurosurgery, University of Miami Miller School of Medicine-Jackson Memorial Hospital, Miami (D.R.Y., A.M.M.), Baptist Health, Jacksonville (R.A.H., A.A.), Memorial Regional Hospital, Hollywood (B.P.M.), and Florida Hospital, Orlando (F.R.H.) - all in Florida; the Stroke Unit, Hospital Vall d'Hebrón (M. Ribo, M. Rubiera), and Hospital Universitari de Bellvitge (P.C.), Barcelona, and the Department of Neuroscience, Hospital Germans Trias i Pujol, Universitat Autònoma de Barcelona, Badalona (M.M.) - all in Spain; the Department of Neurosurgery, State University of New York at Buffalo, Buffalo (E.I.L.); the Department of Interventional Neuroradiology, Royal Melbourne Hospital, Victoria (P.M.); the Departments of Neurology (M.C.) and Neurosurgery (D.K.L.), Rush University Medical Center, Chicago; California Pacific Medical Center (J.D.E.) and the Department of Neurology, University of California, San Francisco (W.S.S.), San Francisco, the Department of Neuroradiology, Kaiser Permanente (L.F.), and the Neurovascular Imaging Research Core, Department of Neurology and Comprehensive Stroke Center (D.S.L.), David Geffen School of Medicine, University of California, Los Angeles (UCLA) (D.S.L., J.L.S.), Los Angeles, Stryker Neurovascular, Fremont (R.S.), and Los Angeles County Harbor-UCLA Medical Center, Torrance (R.J.L.) - all in California; the Departments of Medical Imaging and Surgery (F.L.S., V.M.P.) and Neurology (V.M.P.), Toronto Western Hospital, University Health Network, University of Toronto, Toronto; the Department of Radiology, Erlanger Hospital at the University of Tennessee, Chattanooga (B.W.B.); the Department of Neurology, University of Kansas Medical Center, Kansas City (M.G.A.); and the Neuroscience Center, Capital Health Hospital, Trenton (E.V.), and the JFK Medical Center, Edison (J.F.K.) - both in New Jersey.

出版信息

N Engl J Med. 2018 Jan 4;378(1):11-21. doi: 10.1056/NEJMoa1706442. Epub 2017 Nov 11.

DOI:10.1056/NEJMoa1706442

PMID:29129157

Abstract

BACKGROUND

The effect of endovascular thrombectomy that is performed more than 6 hours after the onset of ischemic stroke is uncertain. Patients with a clinical deficit that is disproportionately severe relative to the infarct volume may benefit from late thrombectomy.

METHODS

We enrolled patients with occlusion of the intracranial internal carotid artery or proximal middle cerebral artery who had last been known to be well 6 to 24 hours earlier and who had a mismatch between the severity of the clinical deficit and the infarct volume, with mismatch criteria defined according to age (<80 years or ≥80 years). Patients were randomly assigned to thrombectomy plus standard care (the thrombectomy group) or to standard care alone (the control group). The coprimary end points were the mean score for disability on the utility-weighted modified Rankin scale (which ranges from 0 [death] to 10 [no symptoms or disability]) and the rate of functional independence (a score of 0, 1, or 2 on the modified Rankin scale, which ranges from 0 to 6, with higher scores indicating more severe disability) at 90 days.

RESULTS

A total of 206 patients were enrolled; 107 were assigned to the thrombectomy group and 99 to the control group. At 31 months, enrollment in the trial was stopped because of the results of a prespecified interim analysis. The mean score on the utility-weighted modified Rankin scale at 90 days was 5.5 in the thrombectomy group as compared with 3.4 in the control group (adjusted difference [Bayesian analysis], 2.0 points; 95% credible interval, 1.1 to 3.0; posterior probability of superiority, >0.999), and the rate of functional independence at 90 days was 49% in the thrombectomy group as compared with 13% in the control group (adjusted difference, 33 percentage points; 95% credible interval, 24 to 44; posterior probability of superiority, >0.999). The rate of symptomatic intracranial hemorrhage did not differ significantly between the two groups (6% in the thrombectomy group and 3% in the control group, P=0.50), nor did 90-day mortality (19% and 18%, respectively; P=1.00).

CONCLUSIONS

Among patients with acute stroke who had last been known to be well 6 to 24 hours earlier and who had a mismatch between clinical deficit and infarct, outcomes for disability at 90 days were better with thrombectomy plus standard care than with standard care alone. (Funded by Stryker Neurovascular; DAWN ClinicalTrials.gov number, NCT02142283 .).

摘要

背景

发病后 6 小时以上进行血管内血栓切除术的效果尚不确定。与梗死体积相比，临床缺损程度不成比例严重的患者可能会从晚期血栓切除术受益。

方法

我们招募了颅内颈内动脉或近端大脑中动脉闭塞的患者，这些患者在 6 至 24 小时前状态良好，并且存在临床缺损程度与梗死体积之间的不匹配，根据年龄（<80 岁或≥80 岁）定义不匹配标准。患者被随机分配至血栓切除术加标准治疗（血栓切除术组）或仅标准治疗（对照组）。主要终点是改良 Rankin 量表（范围为 0[死亡]至 10[无症状或残疾]）残疾的平均评分和 90 天的功能独立性率（改良 Rankin 量表评分 0、1 或 2，范围为 0 至 6，评分越高表示残疾越严重）。

结果

共纳入 206 例患者，107 例被分配至血栓切除术组，99 例被分配至对照组。31 个月时，由于预定的中期分析结果，试验的入组被停止。90 天时改良 Rankin 量表的效用加权平均评分在血栓切除术组为 5.5，而在对照组为 3.4（校正差异[贝叶斯分析]，2.0 分；95%可信区间，1.1 至 3.0；优势后验概率，>0.999），90 天时功能独立性率在血栓切除术组为 49%，而对照组为 13%（校正差异，33 个百分点；95%可信区间，24 至 44；优势后验概率，>0.999）。两组之间症状性颅内出血的发生率无显著差异（血栓切除术组为 6%，对照组为 3%，P=0.50），90 天死亡率也无差异（分别为 19%和 18%，P=1.00）。