Department of Neurology, Danish Stroke Center, Aarhus University Hospital, Aarhus, Denmark.
Division of Neurointervention, Texas Stroke Institute, Dallas-Fort Worth.
JAMA Neurol. 2018 Apr 1;75(4):470-477. doi: 10.1001/jamaneurol.2017.4474.
Endovascular therapy (EVT) is the standard of care for select patients who had a stroke caused by a large vessel occlusion in the anterior circulation, but there is uncertainty regarding the optimal anesthetic approach during EVT. Observational studies suggest that general anesthesia (GA) is associated with worse outcomes compared with conscious sedation (CS).
To examine the effect of type of anesthesia during EVT on infarct growth and clinical outcome.
DESIGN, SETTING, AND PARTICIPANTS: The General or Local Anesthesia in Intra Arterial Therapy (GOLIATH) trial was a single-center prospective, randomized, open-label, blinded end-point evaluation that enrolled patients from March 12, 2015, to February 2, 2017. Although the trial screened 1501 patients, it included 128 consecutive patients with acute ischemic stroke caused by large vessel occlusions in the anterior circulation within 6 hours of onset; 1372 patients who did not fulfill inclusion criteria and 1 who did not provide consent were excluded. Primary analysis was unadjusted and according to the intention-to-treat principle.
Patients were randomized to either the GA group or the CS group (1:1 allocation) before EVT.
The primary end point was infarct growth between magnetic resonance imaging scans performed before EVT and 48 to 72 hours after EVT. The hypothesis formulated before data collection was that patients who were under CS would have less infarct growth.
Of 128 patients included in the trial, 65 were randomized to GA, and 63 were randomized to CS. For the entire cohort, the mean (SD) age was 71.4 (11.4) years, and 62 (48.4%) were women. Baseline demographic and clinical variables were balanced between the GA and CS treatment arms. The median National Institutes of Health Stroke Scale score was 18 (interquartile range [IQR], 14-21). Four patients (6.3%) in the CS group were converted to the GA group. Successful reperfusion was significantly higher in the GA arm than in the CS arm (76.9% vs 60.3%; P = .04). The difference in the volume of infarct growth among patients treated under GA or CS did not reach statistical significance (median [IQR] growth, 8.2 [2.2-38.6] mL vs 19.4 [2.4-79.0] mL; P = .10). There were better clinical outcomes in the GA group, with an odds ratio for a shift to a lower modified Rankin Scale score of 1.91 (95% CI, 1.03-3.56).
For patients who underwent thrombectomy for acute ischemic stroke caused by large vessel occlusions in the anterior circulation, GA did not result in worse tissue or clinical outcomes compared with CS.
clinicaltrials.gov Identifier: NCT02317237.
血管内治疗 (EVT) 是前循环大血管闭塞引起的中风患者的标准治疗方法，但在 EVT 过程中选择最佳麻醉方法仍存在不确定性。观察性研究表明，全身麻醉 (GA) 与意识镇静 (CS) 相比，结果较差。
检查 EVT 过程中麻醉类型对梗死生长和临床结果的影响。
设计、设置和参与者：General or Local Anesthesia in Intra Arterial Therapy (GOLIATH) 试验是一项单中心前瞻性、随机、开放标签、盲终点评估，于 2015 年 3 月 12 日至 2017 年 2 月 2 日期间纳入患者。虽然该试验筛查了 1501 名患者，但纳入了 128 名发病后 6 小时内因前循环大血管闭塞引起的急性缺血性中风患者；1372 名未符合纳入标准和 1 名未提供同意的患者被排除在外。主要分析为未调整和按意向治疗原则进行分析。
患者在 EVT 前随机分为 GA 组或 CS 组（1:1 分配）。
EVT 前磁共振成像扫描与 EVT 后 48 至 72 小时之间的梗死生长。在数据收集之前提出的假设是，接受 CS 的患者梗死生长会减少。
在纳入试验的 128 名患者中，65 名被随机分配至 GA 组，63 名被随机分配至 CS 组。对于整个队列，平均（SD）年龄为 71.4（11.4）岁，62 名（48.4%）为女性。基线人口统计学和临床变量在 GA 和 CS 治疗臂之间平衡。国立卫生研究院中风量表的中位数（IQR）为 18（14-21）。CS 组中有 4 名（6.3%）患者转为 GA 组。GA 组的再灌注成功率明显高于 CS 组（76.9%对 60.3%；P=0.04）。GA 或 CS 治疗患者的梗死生长量差异无统计学意义（中位数[IQR]生长量，8.2[2.2-38.6]mL 对 19.4[2.4-79.0]mL；P=0.10）。GA 组的临床结局更好，改良 Rankin 量表评分较低的优势比为 1.91（95%CI，1.03-3.56）。
对于接受急性前循环大血管闭塞性中风血栓切除术的患者，GA 不会导致比 CS 更差的组织或临床结局。
clinicaltrials.gov 标识符：NCT02317237。
