Cui Yu, Wang Er-Qiang, Wang Yi-Han, Chen Hui-Sheng
Department of Neurology, General Hospital of Northern Theater Command, Shenyang, China.
Department of Neurology, The Fuqing Hospital Affiliated of Fujian Medical University, Fuqing, China.
Front Neurol. 2025 Jun 25;16:1582513. doi: 10.3389/fneur.2025.1582513. eCollection 2025.
The Argatroban Plus Recombinant Tissue-Type Plasminogen Activator for AIS (ARAIS) trial failed to demonstrate the benefit of argatroban in patients diagnosed with acute ischemic stroke who were treated with intravenous alteplase. A analysis was conducted to investigate whether the time from onset to thrombolysis (OTT) affected the outcomes.
The included patients were classified into two subgroups according to OTT. The primary outcome was an excellent functional outcome at 90 days, defined as a modified Rankin Scale score of 0 or 1. The efficacy of argatroban plus alteplase was investigated in each subgroup compared with alteplase alone.
Overall, 696 patients were included: 452 were assigned to the OTT < 180 min subgroup, and 244 to the OTT ≥ 180 min subgroup. The treatment effect of argatroban plus alteplase was similar to that of alteplase alone in the OTT < 180 min subgroup (adjusted RD [95% CI] = 0.5% [-5.6 to 6.6%]) and OTT ≥ 180 min subgroup (adjusted RD [95% CI] = -1.3% [-9.8 to 7.1%]). No significant interaction between the treatment efficacy and OTT was found ( = 0.75).
The prespecified secondary analysis indicated that the efficacy of argatroban plus alteplase did not differ according to OTT in terms of achieving 90-day excellent functional outcomes compared with alteplase alone.
ClinicalTrials.gov, Identifier: NCT03740958.
阿加曲班联合重组组织型纤溶酶原激活剂治疗急性缺血性卒中（ARAIS）试验未能证明阿加曲班对接受静脉注射阿替普酶治疗的急性缺血性卒中患者有益。进行了一项分析以研究从发病到溶栓的时间（OTT）是否会影响治疗结果。
根据OTT将纳入的患者分为两个亚组。主要结局是90天时的良好功能结局，定义为改良Rankin量表评分为0或1。将阿加曲班加阿替普酶在每个亚组中的疗效与单独使用阿替普酶进行比较。
总体而言，共纳入696例患者：452例被分配到OTT＜180分钟亚组，244例被分配到OTT≥180分钟亚组。在OTT＜180分钟亚组（调整后的RD [95%CI] = 0.5% [-5.6至6.6%]）和OTT≥180分钟亚组（调整后的RD [95%CI] = -1.3% [-9.8至7.1%]）中，阿加曲班加阿替普酶的治疗效果与单独使用阿替普酶相似。未发现治疗效果与OTT之间存在显著交互作用（P = 0.75）。
预先设定的次要分析表明，与单独使用阿替普酶相比，在实现90天良好功能结局方面，阿加曲班加阿替普酶的疗效在不同OTT水平上并无差异。
ClinicalTrials.gov，标识符：NCT03740958。
