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远程缺血预处理对接受血管内治疗患者的影响:RESIST试验事后分析研究

The Effect of Remote Ischemic Conditioning in Patients Treated with Endovascular Therapy: A RESIST Trial Post Hoc Study.

作者信息

Blauenfeldt Rolf Ankerlund, Hess David Charles, Gaist David, Modrau Boris, Valentin Jan Brink, Johnsen Søren Paaske, Hjort Niels, Behrndtz Anne Brink, Gude Martin Faurholdt, Zhao Wenbo, Jensen Jonas, Andersen Grethe, Simonsen Claus Ziegler

机构信息

Department of Neurology, Aarhus University Hospital, Palle Juul Jensens Boulevard 165, Entrance J 518, 8200, Aarhus N, Aarhus, Denmark.

Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.

出版信息

Transl Stroke Res. 2025 Sep 6. doi: 10.1007/s12975-025-01379-5.

Abstract

Remote ischemic conditioning (RIC) is a simple, non-invasive procedure that has been shown to be safe and feasible in multiple smaller clinical trials. Recent large randomized controlled trials have yielded mixed results regarding clinical effect. Patients with severe stroke may experience greater benefit from cerebroprotective interventions, highlighting the need for adjunctive therapies to enhance endovascular therapy (EVT) outcomes. This post hoc analysis of the RESIST trial evaluates the effect of RIC in the subgroup of patients who underwent EVT. Eligible patients were adults (≥ 18 years old), independent in activities of daily living, who had prehospital stroke symptoms with a duration of less than 4 h. They were randomized to RIC or sham. The primary analysis was performed using the entire range ("shift analysis") of the modified Rankin scale (mRS) at 90 days. A total of 737 patients had acute ischemic stroke, and 134 received EVT. The median (IQR) age was 74 (62, 82) years, median NIHSS was 16 (8, 20), and 52 (39%) were female. Median (IQR) overall adherence to RIC/sham was 81% (56, 96). Intravenous thrombolysis (IVT) was initiated in 76 out of the 134 (57%) EVT-treated patients. There was no significant effect of RIC on mRS in EVT-treated patients, OR (95% CI) 1.26 (0.68-2.32). When IVT was given in addition to EVT, RIC was associated with improved functional outcome at 90 days, adjusted OR 2.46 (1.05, 5.78), p = 0.038 but not without adjunctive IVT, aOR 0.57 (0.21-1.53). The effect of RIC was present only in patients achieving complete reperfusion (mTICI 3) following EVT and IVT (54 out of 134 patients). RIC treatment in addition to IVT and EVT was associated with significantly improved functional outcome at 90 days, observed only in patients who achieved complete reperfusion. These results should only serve as hypothesis-generating for future trials. ClinicalTrials.gov:NCT03481777.

摘要

远程缺血预处理(RIC)是一种简单的非侵入性程序,在多项规模较小的临床试验中已证明其安全可行。近期大型随机对照试验在临床疗效方面得出了喜忧参半的结果。重症中风患者可能从脑保护干预措施中获益更多,这凸显了需要辅助治疗来提高血管内治疗(EVT)的效果。这项对RESIST试验的事后分析评估了RIC在接受EVT治疗的患者亚组中的效果。符合条件的患者为成年人(≥18岁),日常生活活动独立,有院前中风症状且持续时间少于4小时。他们被随机分为RIC组或假手术组。主要分析采用90天时改良Rankin量表(mRS)的全范围(“移位分析”)。共有737例急性缺血性中风患者,其中134例接受了EVT治疗。年龄中位数(四分位间距)为74(62,82)岁,美国国立卫生研究院卒中量表(NIHSS)中位数为16(8,20),52例(39%)为女性。RIC/假手术组的总体依从性中位数(四分位间距)为81%(56,96)。134例接受EVT治疗的患者中有76例(57%)开始了静脉溶栓(IVT)。RIC对接受EVT治疗的患者的mRS没有显著影响,比值比(95%置信区间)为1.26(0.68 - 2.32)。当在EVT基础上联合使用IVT时,RIC与90天时功能结局改善相关,校正后的比值比为2.46(1.05,5.78),p = 0.038,但在没有辅助IVT的情况下则不然,校正后的比值比为0.57(0.21 - 1.53)。RIC的效果仅在接受EVT和IVT后实现完全再灌注(脑梗死溶栓分级[mTICI] 3级)的患者中存在(134例患者中有54例)。除IVT和EVT外进行RIC治疗与90天时功能结局显著改善相关,仅在实现完全再灌注的患者中观察到。这些结果仅应作为未来试验的假设生成。ClinicalTrials.gov:NCT03481777。

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