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血管内治疗前静脉内使用阿替普酶治疗大核心梗死的急性大动脉闭塞:一项随机临床试验的亚组分析。

Intravenous alteplase before endovascular therapy for acute large vessel occlusion with large ischemic core: subanalysis of a randomized clinical trial.

机构信息

Department of Neurology, Japanese Red Cross Kumamoto Hospital, Kumamoto, Japan.

Department of Neurology, Kumamoto University, Kumamoto, Japan.

出版信息

J Neurointerv Surg. 2024 Oct 14;16(11):1094-1100. doi: 10.1136/jnis-2023-020846.

DOI:10.1136/jnis-2023-020846
PMID:37890987
Abstract

BACKGROUND

The efficacy of endovascular therapy (EVT) in patients with large ischemic core has been reported, but it remains unclear whether IV alteplase (IVT) has beneficial effects in addition to EVT in such patients. We evaluated the efficacy and safety of EVT with or without IVT.

METHODS

The RESCUE-Japan LIMIT was an open-label, prospective, multicenter, randomized clinical trial to evaluate the efficacy and safety of EVT in stroke patients with large ischemic core, defined as Alberta Stroke Program Early CT Score (ASPECTS) 3-5. This subanalysis evaluated the differences in the effects of EVT with medical care (EVT group) compared with medical care alone (No-EVT group) between those who received IVT (IVT stratum) and those who did not (No-IVT stratum) before EVT.

RESULTS

Among 202 enrolled patients, 147 (73%) did not receive IVT. In the No-IVT stratum, the modified Rankin Scale (mRS) score of 0-3 at 90 days was significantly higher in the EVT group than in the No-EVT group (31.1% vs 12.3%, OR 3.21 (95% CI 1.37 to 7.53)). In the IVT stratum, the mRS score of 0-3 was 30.8% in the EVT group and 13.8% in the No-EVT group (OR 2.78 (95% CI 0.72 to 10.7)) (interaction p=0.77). The incidence of symptomatic intracranial hemorrhage was not different between the two groups in the No-IVT stratum (OR 1.20 (95% CI 0.35 to 4.12)), but it was significantly higher in the EVT group than in the No-EVT group in the IVT stratum (11.5% vs 0%, p=0.03).

CONCLUSIONS

There was no difference in efficacy of EVT with or without IVT, while IVT before EVT might increase symptomatic intracranial hemorrhage in patients with large ischemic core.

TRIAL REGISTRATION INFORMATION

NCT03702413.

摘要

背景

血管内治疗(EVT)在大缺血核心患者中的疗效已被报道,但目前尚不清楚 IV 阿替普酶(IVT)是否除 EVT 之外对这些患者有益。我们评估了有或没有 IVT 的 EVT 的疗效和安全性。

方法

RESCUE-Japan LIMIT 是一项开放标签、前瞻性、多中心、随机临床试验,旨在评估大缺血核心卒中患者 EVT 的疗效和安全性,定义为 Alberta Stroke Program Early CT Score(ASPECTS)3-5。这项亚分析评估了接受 EVT 前接受 IVT(IVT 层)和未接受 IVT(无-IVT 层)的患者中 EVT 联合医疗护理(EVT 组)与单纯医疗护理(无-EVT 组)的疗效差异。

结果

在 202 名入组患者中,有 147 名(73%)未接受 IVT。在无-IVT 层,EVT 组 90 天改良 Rankin 量表(mRS)评分 0-3 分的比例明显高于无-EVT 组(31.1% vs 12.3%,OR 3.21(95%CI 1.37-7.53))。在 IVT 层,EVT 组 mRS 评分 0-3 分的比例为 30.8%,无-EVT 组为 13.8%(OR 2.78(95%CI 0.72-10.7))(交互 p=0.77)。无-IVT 层两组之间症状性颅内出血的发生率无差异(OR 1.20(95%CI 0.35-4.12)),但在 IVT 层 EVT 组明显高于无-EVT 组(11.5% vs 0%,p=0.03)。

结论

EVT 联合或不联合 IVT 的疗效无差异,而 EVT 前给予 IVT 可能会增加大缺血核心患者的症状性颅内出血。

试验注册信息

NCT03702413。

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