Purroy Francisco, Arqué Gloria, Jiménez-Fàbrega Xavier, Subirats Teresa, Ropero José Ramon, Vicente-Pascual Mikel, Cardona Pere, Gómez-Choco Manuel, Pagola Jorge, Abilleira Sònia, Rovira Àlex, Cirer-Sastre Rafel, Mauri-Capdevila Gerard
Stroke Unit, Department of Neurology, Hospital Universitari Arnau de Vilanova de Lleida, Neurology, Lleida, Spain.
Universitat de Lleida - UdL, Lleida, Spain.
EClinicalMedicine. 2025 Apr 25;83:103208. doi: 10.1016/j.eclinm.2025.103208. eCollection 2025 May.
Acute ischaemic stroke (IS) remains one of the leading causes of morbidity and mortality worldwide. Remote ischaemic perconditioning (RIperC) is a neuroprotective treatment with promising preclinical results, acting through humoral and neural mechanisms. This trial aimed to evaluate the clinical benefits of prehospital-initiated RIperC in acute IS patients.
REMOTE-CAT was a multicentre, randomised, double-blind, sham-controlled trial across four Catalonian stroke centres. Patients over 18 years with stroke symptoms under 8 h, a pre-stroke modified Rankin Scale (mRS) score <3, and motor deficits (RACE motor score ≥1) were randomised 1:1 to active RIperC or sham. RIperC was applied via an automated cuff on the unaffected arm in five 5-min inflation-deflation cycles. Investigators and participants were blinded to treatment. The primary outcome was the proportion of patients with a favourable outcome (mRS <3) at 90 days. The intention-to-treat analysis included all patients receiving at least one inflation-deflation cycle and had a final diagnosis of ischaemic stroke or transient ischaemic attack (ClinicalTrials.gov: NCT03375762).
Between August 2019 and December 2023, 350 patients were screened, with 200 randomised. After 78 exclusions (29 haemorrhagic strokes, 41 stroke mimics, and 8 patients with mRS >3), 122 patients were included in the primary analysis (RIperC group, n = 57; sham group, n = 65). The RIperC group had a higher proportion of mRS <3 at 90 days (64.9%) than the sham group (47.3%), though not statistically significant in the unadjusted analysis (OR 2.03 [95% CI 0.98-4.21], p = 0.057 However, statistical significance was achieved in the post-hoc analysis adjusted for age, baseline status (determined by pre-stroke mRS score), and initial stroke severity (measured by baseline RACE score by paramedics) (OR 2.94 [95% CI 1.21-7.16], p = 0.017). No serious adverse events were observed.
Despite the small sample size, our findings suggest that prehospital application of RIPerC is safe and may confer clinical benefit, as indicated in the post hoc adjusted analysis. However, larger, adequately powered trials are required to validate these results, and to determine potential differential effects across underrepresented patient subgroups.
Institute of Health Carlos III (ISCIII) of the Spanish Ministry of Health and Government of Catalonia-Agència de Gestió d'Ajuts Universitaris i de Recerca (AGAUR).
急性缺血性卒中（IS）仍然是全球发病和死亡的主要原因之一。远程缺血预处理（RIperC）是一种具有前景的临床前研究结果的神经保护治疗方法，通过体液和神经机制发挥作用。本试验旨在评估院前启动的RIperC对急性IS患者的临床益处。
REMOTE-CAT是一项在四个加泰罗尼亚卒中中心进行的多中心、随机、双盲、假对照试验。年龄超过18岁、卒中症状出现时间在8小时以内、卒中前改良Rankin量表（mRS）评分<3且存在运动功能缺损（RACE运动评分≥1）的患者按1:1随机分为RIperC治疗组或假治疗组。通过在未受影响的手臂上使用自动袖带进行五个5分钟的充气-放气循环来实施RIperC。研究者和参与者对治疗分组不知情。主要结局是90天时预后良好（mRS<3）的患者比例。意向性分析纳入了所有接受至少一个充气-放气循环且最终诊断为缺血性卒中或短暂性脑缺血发作的患者（ClinicalTrials.gov：NCT03375762）。
在2019年8月至2023年12月期间，共筛选了350例患者，其中200例被随机分组。在排除78例患者（29例出血性卒中、41例疑似卒中以及8例mRS>3的患者）后，122例患者纳入主要分析（RIperC组，n = 57；假治疗组，n = 65）。RIperC组在90天时mRS<3的患者比例（64.9%）高于假治疗组（47.3%），尽管在未校正分析中无统计学意义（优势比2.03 [95%置信区间0.98 - 4.21]，p = 0.057）。然而，在根据年龄、基线状态（由卒中前mRS评分确定）和初始卒中严重程度（由急救人员的基线RACE评分测量）进行校正的事后分析中达到了统计学意义（优势比2.94 [95%置信区间1.21 - 7.16]，p = 0.017）。未观察到严重不良事件。
尽管样本量较小，但我们的研究结果表明，如事后校正分析所示，院前应用RIperC是安全的，可能带来临床益处。然而，需要更大规模、有足够统计学效力的试验来验证这些结果，并确定在代表性不足的患者亚组中的潜在差异效应。
西班牙卫生部卡洛斯三世卫生研究所（ISCIII）以及加泰罗尼亚政府大学与研究资助管理局（AGAUR）。
