缺血性卒中快速血管内治疗评价的随机研究
Randomized Assessment of Rapid Endovascular Treatment of Ischemic Stroke
背景：接受阿替普酶治疗的颅内前循环近端血管闭塞患者，卒中发作90天内致死或致残的比例高达60-80%。本研究旨在评估在标准内科治疗的基础上，快速血管内治疗在具有脑小梗死核心、颅内近端大动脉闭塞、中度以上侧支循环代偿等特征的急性缺血性卒中患者治疗中的获益。
BACKGROUND Among patients with a proximal vessel occlusion in the anterior circulation, 60 to 80% of patients die within 90 days after stroke onset or do not regain functional independence despite alteplase treatment. We evaluated rapid endovascular treatment in addition to standard care in patients with acute ischemic stroke with a small infarct core, a proximal intracranial arterial occlusion, and moderate-to-good collateral circulation.
方法：本研究招募起病12小时内的颅内前循环近端血管闭塞患者入组，但是需排除计算机断层扫描（CT）和CT血管造影表现为梗死核心较大或侧支循环代偿不良者。全组患者被随机分配，分别给予标准内科治疗（对照组）或标准内科治疗联合血管内机械取栓治疗（干预组），并对工作流程中各个环节的用时与预定的目标时间进行比较。选择90天随访改良Rankin量表评分（分值在0分〔无症状〕至6分〔死亡〕之间）作为主要临床结局指标，采用比例优势模型计算普通比值比，用以衡量干预组改良Rankin量表评分低于对照组可能性的大小（偏移分析）。
METHODS We randomly assigned participants to receive standard care (control group) or standard care plus endovascular treatment with the use of available thrombectomy devices (intervention group). Patients with a proximal intracranial occlusion in the anterior circulation were included up to 12 hours after symptom onset. Patients with a large infarct core or poor collateral circulation on computed tomography (CT) and CT angiography were excluded. Workflow times were measured against predetermined targets. The primary outcome was the score on the modified Rankin scale (range, 0 [no symptoms] to 6 [death]) at 90 days. A proportional odds model was used to calculate the common odds ratio as a measure of the likelihood that the intervention would lead to lower scores on the modified Rankin scale than would control care (shift analysis).
结果：由于疗效的原因，本试验被提前终止。来自全球22家中心的316例患者被纳入研究，其中238例接受过静脉注射阿替普酶治疗（干预组120例，对照组118例）。在干预组中，从头部CT检查至实现首次再灌注的中位时间为84分钟。干预组患者预后功能独立（90天随访改良Rankin评分0-2分）的比例增高（干预组53.0% vs.对照组29.3%，P＜0.001），主要临床结局支持机械取栓治疗干预获益显著（普通比值比2.6，95%可信区间1.7-3.8，P＜0.001），而且干预组死亡率也降低（干预组10.4% vs.对照组19%，P＝0.04）。干预组患者症状性脑出血的发生率为3.6%，对照组为2.7%（P＝0.75）。
RESULTS The trial was stopped early because of efficacy. At 22 centers worldwide, 316 participants were enrolled, of whom 238 received intravenous alteplase (120 in the intervention group and 118 in the control group). In the intervention group, the median time from study CT of the head to first reperfusion was 84 minutes. The rate of functional independence (90-day modified Rankin score of 0 to 2) was increased with the intervention (53.0%, vs. 29.3% in the control group; P<0.001). The primary outcome favored the intervention (common odds ratio, 2.6; 95% confidence interval, 1.7 to 3.8; P<0.001), and the intervention was associated with reduced mortality (10.4%, vs. 19.0% in the control group; P=0.04). Symptomatic intracerebral hemorrhage occurred in 3.6% of participants in intervention group and 2.7% of participants in control group (P=0.75).
结论：对于表现为颅内近端血管闭塞、脑小梗死核心、中度以上侧支循环代偿等特征的急性缺血性卒中患者，快速血管内治疗有助于改善功能预后，并且使死亡率降低。（本研究由Covidien及其他机构共同资助，ESCAPE试验ClinicalTrials.gov注册号：NCT01778335。）
CONCLUSIONS Among patients with acute ischemic stroke with a proximal vessel occlusion, a small infarct core, and moderate-to-good collateral circulation, rapid endovascular treatment improved functional outcomes and reduced mortality. (Funded by Covidien and others; ESCAPE ClinicalTrials.gov number, NCT01778335.)
原文出处：Goyal M, Demchuk AM, Menon BK, et al. Randomized assessment of rapid endovascular treatment of ischemic stroke. N Engl J Med. 2015; 372(11): 1019-1030.
