Department of Neurology and the Stroke Center, Georgetown University, Washington, DC 20007, USA.
N Engl J Med. 2013 Mar 7;368(10):914-23. doi: 10.1056/NEJMoa1212793. Epub 2013 Feb 8.
Whether brain imaging can identify patients who are most likely to benefit from therapies for acute ischemic stroke and whether endovascular thrombectomy improves clinical outcomes in such patients remains unclear.
In this study, we randomly assigned patients within 8 hours after the onset of large-vessel, anterior-circulation strokes to undergo mechanical embolectomy (Merci Retriever or Penumbra System) or receive standard care. All patients underwent pretreatment computed tomography or magnetic resonance imaging of the brain. Randomization was stratified according to whether the patient had a favorable penumbral pattern (substantial salvageable tissue and small infarct core) or a nonpenumbral pattern (large core or small or absent penumbra). We assessed outcomes using the 90-day modified Rankin scale, ranging from 0 (no symptoms) to 6 (dead).
Among 118 eligible patients, the mean age was 65.5 years, the mean time to enrollment was 5.5 hours, and 58% had a favorable penumbral pattern. Revascularization in the embolectomy group was achieved in 67% of the patients. Ninety-day mortality was 21%, and the rate of symptomatic intracranial hemorrhage was 4%; neither rate differed across groups. Among all patients, mean scores on the modified Rankin scale did not differ between embolectomy and standard care (3.9 vs. 3.9, P=0.99). Embolectomy was not superior to standard care in patients with either a favorable penumbral pattern (mean score, 3.9 vs. 3.4; P=0.23) or a nonpenumbral pattern (mean score, 4.0 vs. 4.4; P=0.32). In the primary analysis of scores on the 90-day modified Rankin scale, there was no interaction between the pretreatment imaging pattern and treatment assignment (P=0.14).
A favorable penumbral pattern on neuroimaging did not identify patients who would differentially benefit from endovascular therapy for acute ischemic stroke, nor was embolectomy shown to be superior to standard care. (Funded by the National Institute of Neurological Disorders and Stroke; MR RESCUE ClinicalTrials.gov number, NCT00389467.).
脑部成像是否能够识别出最有可能从急性缺血性脑卒中治疗中获益的患者，以及血管内血栓切除术是否能改善此类患者的临床转归，目前仍不清楚。
在这项研究中，我们将发病 8 小时内的大血管前循环脑卒中患者随机分为机械取栓组（Merci 取栓器或 Penumbra 系统）或接受标准治疗。所有患者均接受脑 CT 或 MRI 平扫。根据患者是否存在可挽救组织较多且梗死核心较小的缺血半暗带（有利半暗带）或梗死核心较大或半暗带较小或不存在（无利半暗带），进行分层随机分组。采用 90 天改良 Rankin 量表评估结局，0 分为无症状，6 分为死亡。
在 118 例符合条件的患者中，平均年龄为 65.5 岁，平均入组时间为 5.5 小时，58%存在有利半暗带。取栓组有 67%的患者实现血管再通。90 天死亡率为 21%，症状性颅内出血发生率为 4%；两组间无差异。所有患者中，改良 Rankin 量表评分在取栓组与标准治疗组间无差异（3.9 分比 3.9 分，P=0.99）。在有利半暗带（平均评分 3.9 分比 3.4 分，P=0.23）或无利半暗带（平均评分 4.0 分比 4.4 分，P=0.32）患者中，取栓治疗均不比标准治疗更优。在主要的 90 天改良 Rankin 量表评分分析中，影像学预处理模式与治疗分组之间无交互作用（P=0.14）。
神经影像学上有利半暗带模式不能识别出可能从急性缺血性脑卒中血管内治疗中获益不同的患者，也不能证明取栓治疗优于标准治疗。（由美国国立神经病学与卒中研究所资助；MR RESCUE 临床试验.gov 编号，NCT00389467。）
