Abstract：
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.).
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.).
摘要：
背景：在急性卒中和大范围不受限制的梗死患者中使用血栓切除术尚未得到很好的研究。
方法：我们指定，以1:1的比例，在症状发作后6.5小时内,磁共振成像或计算机断层扫描检测到前循环近端脑血管闭塞和大面积梗死(根据Alberta卒中计划早期计算机断层扫描评分≤5;值范围为0~10)的患者接受血管内血栓切除术并接受医疗护理(血栓切除术组)或单独接受医疗护理(对照组).主要结果是90天时改良Rankin量表的评分（评分范围从0到6，评分越高表示残疾越大）。主要的安全性结果是90天时的任何原因死亡，辅助安全性结局是有症状的脑出血.
结果：共333例患者被分配到血栓切除组（166例）或对照组（167例）；9例因同意退出或法律原因被排除在分析之外。该试验提前停止，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天时的中位改良Rankin量表评分在取栓组为4，在对照组为6（广义比值比，1.63；95%置信区间[CI]，1.29至2.06；P<0.001）。在90天时任何原因的死亡发生在血栓切除组的36.1％的患者和对照组的55.5％的患者中（调整后的相对风险，0.65；95%CI，0.50至0.84），有症状的脑出血患者的百分比为9.6％和5.7％，分别(调整后的相对风险，1.73；95%CI，0.78至4.68）。取栓组发生11例手术相关并发症。
结论：在急性卒中和大范围不受限制的梗死患者中，与单独的医疗相比,血栓切除术加医疗治疗可获得更好的功能结局和更低的死亡率,但可导致更高的症状性脑出血发生率.（由蒙彼利埃大学医院资助；LASTEClinicalTrials.gov编号，NCT03811769。).
方法：我们指定，以1:1的比例，在症状发作后6.5小时内,磁共振成像或计算机断层扫描检测到前循环近端脑血管闭塞和大面积梗死(根据Alberta卒中计划早期计算机断层扫描评分≤5;值范围为0~10)的患者接受血管内血栓切除术并接受医疗护理(血栓切除术组)或单独接受医疗护理(对照组).主要结果是90天时改良Rankin量表的评分（评分范围从0到6，评分越高表示残疾越大）。主要的安全性结果是90天时的任何原因死亡，辅助安全性结局是有症状的脑出血.
结果：共333例患者被分配到血栓切除组（166例）或对照组（167例）；9例因同意退出或法律原因被排除在分析之外。该试验提前停止，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天时的中位改良Rankin量表评分在取栓组为4，在对照组为6（广义比值比，1.63；95%置信区间[CI]，1.29至2.06；P<0.001）。在90天时任何原因的死亡发生在血栓切除组的36.1％的患者和对照组的55.5％的患者中（调整后的相对风险，0.65；95%CI，0.50至0.84），有症状的脑出血患者的百分比为9.6％和5.7％，分别(调整后的相对风险，1.73；95%CI，0.78至4.68）。取栓组发生11例手术相关并发症。
结论：在急性卒中和大范围不受限制的梗死患者中，与单独的医疗相比,血栓切除术加医疗治疗可获得更好的功能结局和更低的死亡率,但可导致更高的症状性脑出血发生率.（由蒙彼利埃大学医院资助；LASTEClinicalTrials.gov编号，NCT03811769。).
