Department of Neurology, General Hospital of Northern Theater Command, No.83 Wenhua Road, Shenhe District, Shenyang, 110016, China.
Department of Neurology, General Hospital of Northern Theater Command, No.83 Wenhua Road, Shenhe District, Shenyang, 110016, China.
Neurotherapeutics. 2024 Sep;21(5):e00382. doi: 10.1016/j.neurot.2024.e00382. Epub 2024 Jun 8.
The ARAIS trial didn't demonstrate argatroban significantly improve functional outcome at 90 days in acute ischemic stroke. We conducted post hoc analysis of ARAIS to investigate whether baseline neurological deficit was associated with outcomes.
Patients without endovascular therapy who met screening criteria as protocol and completed argatroban treatment were enrolled and classified into two subgroups according to NIHSS score at admission. Primary outcome was excellent functional outcome at 90 days, defined as mRS score of 0 to 1. Early neurological deterioration (END), defined as an increase of ≥4 in the NIHSS score from baseline within 48 hours, was investigated as secondary outcome. Compared with alteplase alone, we investigated treatment effect of argatroban plus alteplase on outcomes in subgroups and interaction with subgroups.
A total of 675 patients from full analysis set were included: 390 were assigned into NIHSS score <10 subgroup and 285 into NIHSS score ≥10 subgroup. For primary outcome, there was similar treatment effect between argatroban plus alteplase and alteplase alone in NIHSS score ≥10 subgroup (adjusted RD, 5.8%; 95% CI, -6.0% to 17.5%; P = 0.33) and in NIHSS score <10 subgroup (adjusted RD, -1.4%; 95% CI, -9.9% to 7.1%; P = 0.75), and no significant interaction (P = 0.43). Occurrence of early neurological deterioration within 48 hours were significantly lower in NIHSS score ≥10 subgroup, compared with NIHSS score <10 subgroup (P = 0.006).
Among patients with NIHSS score ≥10, argatroban plus alteplase could safely reduce END within 48 hours.
ARAIS 试验并未表明在急性缺血性脑卒中 90 天时阿加曲班能显著改善功能结局。我们对 ARAIS 进行了事后分析，以调查基线神经功能缺损是否与结局相关。
符合筛选标准且完成阿加曲班治疗的未接受血管内治疗的患者被纳入研究，并根据入院时 NIHSS 评分将患者分为两组。主要结局为 90 天时的良好功能结局，定义为 mRS 评分 0 至 1 分。早期神经功能恶化（END）定义为基线后 48 小时内 NIHSS 评分增加≥4 分，作为次要结局进行研究。与单独使用阿替普酶相比，我们研究了阿加曲班联合阿替普酶在亚组中的治疗效果及其与亚组的交互作用。
共有 675 名患者来自全分析集：390 名患者被分配到 NIHSS 评分<10 亚组，285 名患者被分配到 NIHSS 评分≥10 亚组。对于主要结局，在 NIHSS 评分≥10 亚组中，阿加曲班联合阿替普酶与单独使用阿替普酶的治疗效果相似（调整后的 RD，5.8%；95%CI，-6.0%至 17.5%；P=0.33），在 NIHSS 评分<10 亚组中也相似（调整后的 RD，-1.4%；95%CI，-9.9%至 7.1%；P=0.75），且无显著交互作用（P=0.43）。与 NIHSS 评分<10 亚组相比，NIHSS 评分≥10 亚组在 48 小时内发生早期神经功能恶化的发生率显著较低（P=0.006）。
在 NIHSS 评分≥10 的患者中，阿加曲班联合阿替普酶可安全降低 48 小时内的 END 发生率。
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