N Engl J Med:血栓切除术治疗不受限制的大面积梗死卒中的试验
本文由小咖机器人翻译整理
期刊来源:N Engl J Med
原文链接:https://doi.org/10.1056/NEJMoa2314063
摘要内容如下:
背景
血栓切除术在急性卒中和不受限制的大面积梗死患者中的应用尚未得到很好的研究。
方法
我们以1:1的比例将前循环近端脑血管闭塞和大面积梗死(根据阿尔伯塔省卒中计划早期计算机断层扫描评分≤5;在症状发作后6.5小时内在磁共振成像或计算机断层扫描上检测到(数值范围为0至10),接受血管内血栓切除术并接受医疗护理(血栓切除术组)或仅接受医疗护理(对照组)。主要转归是90天时的改良Rankin量表评分(评分范围为0至6,评分越高表示残疾程度越大)。主要安全性转归为90天时任何原因导致的死亡,辅助安全性转归为症状性脑出血。
结果
总共333名患者被分配到血栓切除组(166名患者)或对照组(167名患者);9人因撤回同意或法律原因被排除在分析之外。该试验被提前终止,因为类似试验的结果有利于血栓切除术。大约35%的患者接受了溶栓治疗。90天时血栓切除组的改良Rankin量表评分中位数为4,对照组为6(总优势比为1.63;95%置信区间[CI],1.29至2.06;P<0.001)。在血栓切除组和对照组中,90天内任何原因导致的死亡率分别为36.1%和55.5%(调整后的相对危险度为0.65;95%CI为0.50至0.84),症状性脑出血患者的百分比分别为9.6%和5.7%(调整后的相对风险为1.73;95%置信区间,0.78至4.68)。血栓切除组发生11例手术相关并发症。
结论
在患有急性卒中和不受限制的大面积梗死的患者中,血栓切除术加内科治疗比单纯内科治疗导致更好的功能结果和更低的死亡率,但导致更高的症状性脑内出血发生率。(由蒙彼利埃大学医院资助;LASTE ClinicalTrials.gov编号,NCT03811769。)
英文原文如下:
Abstracts
BACKGROUND The use of thrombectomy in patients with acute stroke and a large infarct of unrestricted size has not been well studied.
METHODS We assigned, in a 1:1 ratio, patients with proximal cerebral vessel occlusion in the anterior circulation and a large infarct (as defined by an Alberta Stroke Program Early Computed Tomographic Score of ≤5; values range from 0 to 10) detected on magnetic resonance imaging or computed tomography within 6.5 hours after symptom onset to undergo endovascular thrombectomy and receive medical care (thrombectomy group) or to receive medical care alone (control group). The primary outcome was the score on the modified Rankin scale at 90 days (scores range from 0 to 6, with higher scores indicating greater disability). The primary safety outcome was death from any cause at 90 days, and an ancillary safety outcome was symptomatic intracerebral hemorrhage.
RESULTS A total of 333 patients were assigned to either the thrombectomy group (166 patients) or the control group (167 patients); 9 were excluded from the analysis because of consent withdrawal or legal reasons. The trial was stopped early because results of similar trials favored thrombectomy. Approximately 35% of the patients received thrombolysis therapy. The median modified Rankin scale score at 90 days was 4 in the thrombectomy group and 6 in the control group (generalized odds ratio, 1.63; 95% confidence interval [CI], 1.29 to 2.06; P<0.001). Death from any cause at 90 days occurred in 36.1% of the patients in the thrombectomy group and in 55.5% of those in the control group (adjusted relative risk, 0.65; 95% CI, 0.50 to 0.84), and the percentage of patients with symptomatic intracerebral hemorrhage was 9.6% and 5.7%, respectively (adjusted relative risk, 1.73; 95% CI, 0.78 to 4.68). Eleven procedure-related complications occurred in the thrombectomy group.
CONCLUSIONS In patients with acute stroke and a large infarct of unrestricted size, thrombectomy plus medical care resulted in better functional outcomes and lower mortality than medical care alone but led to a higher incidence of symptomatic intracerebral hemorrhage. (Funded by Montpellier University Hospital; LASTE ClinicalTrials.gov number, NCT03811769.).
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