Department of Neurology and Stroke Center, Versailles Mignot Hospital, Versailles, France.
University of Versailles Saint-Quentin-en-Yvelines and Paris-Saclay University, Saint-Aubin, France.
JAMA Neurol. 2020 Jun 1;77(6):725-734. doi: 10.1001/jamaneurol.2020.0326.
Treatment with remote ischemic perconditioning has been reported to reduce brain infarction volume in animal models of stroke. Whether this neuroprotective effect was observed in patients with acute ischemic stroke remains unknown.
To determine whether treatment with remote ischemic perconditioning administered to the leg of patients with acute ischemic stroke can reduce brain infarction volume growth.
DESIGN, SETTING, AND PARTICIPANTS: This proof-of-concept multicenter prospective randomized open-label with blinded end point clinical trial was performed from January 12, 2015, to May 2, 2018. Patients were recruited from 11 stroke centers in France. Of the 188 patients who received magnetic resonance imaging within 6 hours of symptom onset and were confirmed to have carotid ischemic stroke, 93 were randomized to receive treatment with lower-limb remote ischemic perconditioning in addition to standard care (the intervention group), and 95 were randomized to receive standard care alone (the control group).
Randomization on a 1:1 ratio to receive treatment with remote ischemic perconditioning (4 cycles of 5-minute inflations and 5-minute deflations to the thigh to 110 mm Hg above systolic blood pressure) in addition to standard care or standard care alone.
The change in brain infarction volume growth between baseline and 24 hours, measured by a diffusion-weighted sequence of magnetic resonance imaging scans of the brain.
A total of 188 patients (mean [SD] age, 67.2 [15.7] years; 98 men [52.1%]) were included in this intention-to-treat analysis. At hospital admission, the median National Institutes of Health Stroke Scale score was 10 (interquartile range [IQR], 6-16) and the median brain infarction volume was 11.4 cm3 (IQR, 3.6-35.8 cm3); 164 patients (87.2%) received intravenous thrombolysis, and 64 patients (34.0%) underwent mechanical thrombectomy. The median increase in brain infarction growth was 0.30 cm3 (IQR, 0.11-0.48 cm3) in the intervention group and 0.37 cm3 (IQR, 0.19-0.55 cm3) in the control group (mean between-group difference on loge-transformed change, -0.07; 95% CI, -0.33 to 0.18; P = .57). An excellent outcome (defined as a score of 0-1 on the 90-day modified Rankin Scale or a score equal to the prestroke modified Rankin Scale score) was observed in 46 of 90 patients (51.1%) in the intervention group and 37 of 91 patients (40.7%) in the control group (P = .12). No significant differences in 90-day mortality were observed between the intervention and control groups (14 of 90 patients; Kaplan-Meier estimate, 15.8% vs 10 of 91 patients; Kaplan-Meier estimate, 10.4%, respectively; P = .45) or with symptomatic intracerebral hemorrhage (4 of 88 patients [4.5%] in both groups; P = .97).
In this study, treatment with remote ischemic perconditioning, during or after reperfusion therapies, had no significant effect on brain infarction volume growth at 24 hours after symptom onset.
ClinicalTrials.gov Identifier: NCT02189928.
有研究报道，远程缺血预处理治疗可减少中风动物模型的脑梗死体积。这种神经保护作用是否在急性缺血性中风患者中得到证实尚不清楚。
确定在急性缺血性中风患者中，腿部进行远程缺血预处理治疗是否能减少脑梗死体积的增长。
设计、地点和参与者：这是一项概念验证性多中心前瞻性随机开放标签临床试验，于 2015 年 1 月 12 日至 2018 年 5 月 2 日进行。患者从法国 11 个中风中心招募。188 名患者在症状发作后 6 小时内接受磁共振成像检查，并经证实患有颈动脉缺血性中风，其中 93 名随机接受下肢远程缺血预处理治疗加标准护理（干预组），95 名随机接受单独标准护理（对照组）。
随机分为 1:1 比例，接受远程缺血预处理治疗（4 个周期，每次 5 分钟充气和 5 分钟放气，使大腿血压达到收缩压以上 110mmHg）加标准护理或单独标准护理。
基线和 24 小时之间脑梗死体积生长变化，通过脑部磁共振弥散加权序列扫描测量。
共有 188 名患者（平均[标准差]年龄 67.2[15.7]岁；98 名男性[52.1%]）纳入本意向治疗分析。入院时，美国国立卫生研究院中风量表中位数为 10 分（四分位距[IQR]，6-16），脑梗死体积中位数为 11.4cm3（IQR，3.6-35.8cm3）；164 名患者（87.2%）接受了静脉溶栓治疗，64 名患者（34.0%）接受了机械血栓切除术。干预组脑梗死生长中位数增加 0.30cm3（IQR，0.11-0.48cm3），对照组增加 0.37cm3（IQR，0.19-0.55cm3）（对数变换后变化的平均组间差异，-0.07；95%CI，-0.33 至 0.18；P=0.57）。干预组 90 天改良 Rankin 量表评分为 0-1 的患者为 46 例（51.1%），对照组为 37 例（40.7%）（P=0.12）；两组 90 天死亡率无显著差异（干预组 90 例患者中有 14 例[15.8%]，对照组 91 例患者中有 10 例[10.4%]；P=0.45），也与症状性颅内出血无显著差异（两组各有 4 例患者[4.5%]；P=0.97）。
在这项研究中，在症状发作后 24 小时，与再灌注治疗同时或之后进行远程缺血预处理治疗，对脑梗死体积的增长没有显著影响。
ClinicalTrials.gov 标识符：NCT02189928。
