静脉溶栓患者远程缺血预处理的安全性和有效性：SERIC-IVT试验

Safety and Efficacy of Remote Ischemic Conditioning in Patients With Intravenous Thrombolysis: The SERIC-IVT Trial.

作者信息

Guo Zhen-Ni, Abuduxukuer Reziya, Zhang Peng, Qu Yang, Wang Li-Juan, Zhao Jun-Feng, Ju Dong-Sheng, Wang Jun-Min, Jin Hui-Min, Wang Wei-Wei, Teng Rui-Hong, Gao Jian-Hua, Yuan Zhi-Mei, Gao Hui-Fang, Jiang Yong-Fei, Li Zhi-Dan, He Ying, Jiang Li-Gang, Li Li, Hu Xue-Feng, Jiang Chun-Li, Wang Rui, Qi Ying-Bin, Xin Hong, Jia Yan, Yu Hong, Jin Hang, Chen Hui-Sheng, Wang Duo-Lao, Nguyen Thanh N, Yang Yi

机构信息

Stroke Center, Department of Neurology (Z.-N.G., R.A., P.Z., Y.Q., H.J., Y.Y.), The First Hospital of Jilin University, Changchun, China.

Neuroscience Research Center, Department of Neurology (Z.-N.G.), The First Hospital of Jilin University, Changchun, China.

出版信息

Stroke. 2025 Feb;56(2):335-343. doi: 10.1161/STROKEAHA.124.048509. Epub 2025 Jan 8.

DOI:10.1161/STROKEAHA.124.048509

PMID:39772709

Abstract

BACKGROUND

Approximately half of the patients with acute ischemic stroke who receive intravenous thrombolysis (IVT) do not achieve an excellent outcome. Remote ischemic conditioning (RIC) as a promising neuroprotective treatment may improve clinical outcomes in this population. This study aimed to assess the efficacy and safety of RIC in patients with IVT.

METHODS

This multicenter, participant-blinded, blinded end point, randomized controlled clinical trial included 558 patients with acute ischemic stroke who underwent IVT in 18 hospitals from August 2021 to May 2023. After IVT, patients were randomized 1:1 to the RIC (unilateral upper limb; cuff pressure, 200 mm Hg, twice daily for 7 days) or sham RIC groups (the same procedure; cuff pressure, 60 mm Hg). The primary efficacy outcome was an excellent functional outcome (modified Rankin Scale score, 0-1) at 90 days after IVT.

RESULTS

In total, 558 eligible patients were randomized, and 11 (2.0%) were excluded because they did not receive an RIC or sham RIC. Thus, 547 patients (RIC, n=274; sham RIC, n=273) were included in the modified intention-to-treat analysis, of whom 15 patients were lost to follow-up and 532 (95.3%) completed the trial. At 90 days, 62.7% of patients in the RIC group and 56.8% in the sham RIC group had an excellent functional outcome (unadjusted risk ratio, 1.10 [95% CI, 0.96-1.27]; =0.169). The proportion of patients with any adverse events was 11.2% in the RIC group and 8.1% in the sham RIC group, with no significant difference (=0.221).

CONCLUSIONS

RIC was safe in patients with acute ischemic stroke who received IVT. However, it did not significantly improve excellent functional outcome.

REGISTRATION

URL: https://www.clinicaltrials.gov; Unique identifier: NCT04980625.

摘要

背景

接受静脉溶栓治疗（IVT）的急性缺血性卒中患者中，约有一半未获得良好预后。远程缺血预处理（RIC）作为一种有前景的神经保护治疗方法，可能改善这部分患者的临床预后。本研究旨在评估RIC在接受IVT的患者中的疗效和安全性。

方法

这项多中心、参与者设盲、终点设盲的随机对照临床试验纳入了2021年8月至2023年5月期间在18家医院接受IVT的558例急性缺血性卒中患者。IVT后，患者按1:1随机分为RIC组（单侧上肢；袖带压力200 mmHg，每天两次，共7天）或假RIC组（相同操作；袖带压力60 mmHg）。主要疗效结局为IVT后90天时良好的功能结局（改良Rankin量表评分，0 - 1分）。

结果

总共558例符合条件的患者被随机分组，11例（2.0%）因未接受RIC或假RIC而被排除。因此，547例患者（RIC组，n = 274；假RIC组，n = 273）被纳入改良意向性分析，其中15例患者失访，532例（95.3%）完成试验。90天时，RIC组62.7%的患者和假RIC组56.8%的患者获得良好的功能结局（未调整风险比，1.10 [95% CI，0.96 - 1.27]；P = 0.169）。RIC组发生任何不良事件的患者比例为11.2%，假RIC组为8.1%，差异无统计学意义（P = 0.221）。