Effect of In-Hospital Remote Ischemic Perconditioning on Brain Infarction Growth and Clinical Outcomes in Patients With Acute Ischemic Stroke

医学 冲程(发动机) 随机对照试验 梗塞 脑梗塞 磁共振成像 随机化 心脏病学 内科学 临床试验 麻醉 缺血 心肌梗塞 放射科 机械工程 工程类
作者
Fernando Pico,Bertrand Lapergue,Marc Ferrigno,Charlotte Rosso,Elena Meseguer,Marie‐Laure Chadenat,Frédéric Bourdain,Michaël Obadia,Catherine Hirel,Duc Long Duong,S. Deltour,Philippe Aegerter,Julien Labreuche,Amina Cattenoy,Didier Smadja,Hassan Hosseini,B. Guillon,Valérie Wolff,Yves Samson,Charlotte Cordonnier
出处
期刊:JAMA Neurology [American Medical Association]
卷期号:77 (6): 725-725 被引量:72
标识
DOI:10.1001/jamaneurol.2020.0326
摘要

Importance

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.

Objective

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).

Interventions

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.

Main Outcomes and Measures

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.

Results

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).

Conclusions and Relevance

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.

Trial Registration

ClinicalTrials.gov Identifier:NCT02189928
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