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急性缺血性卒中中替奈普酶与阿替普酶静脉溶栓的急诊科工作流程时间:COVID-19大流行之前及期间的一项前瞻性队列研究

Emergency Department Workflow Times of Intravenous Thrombolysis with Tenecteplase versus Alteplase in Acute Ischemic Stroke: A Prospective Cohort Study before and during the COVID-19 Pandemic.

作者信息

Guzman Matias, Lavados Pablo M, Cavada Gabriel, Brunser Alejandro M, Olavarria Veronica V

机构信息

Unidad de Neurología Vascular, Servicio de Neurología, Departamento de Neurología y Psiquiatría, Clínica Alemana de Santiago, Vitacura, Chile,

Servicio de Neurología, Hospital Padre Hurtado, Servicio de Salud Metropolitano Sur Oriente, Santiago, Chile,

出版信息

Cerebrovasc Dis Extra. 2025;15(1):102-109. doi: 10.1159/000543900. Epub 2025 Feb 3.

DOI:10.1159/000543900
PMID:39899997
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11882161/
Abstract

INTRODUCTION

Tenecteplase (TNK) has demonstrated to be non-inferior to alteplase (ALT) for intravenous thrombolysis (IVT) in acute ischemic stroke (AIS). There are potential workflow benefits associated with TNK use, aiming to reduce patient length of stay in the emergency department. Our aim was to investigate whether the routine use of TNK during the COVID-19 pandemic influenced workflow times compared to historical use of ALT, while maintaining non-inferior clinical outcomes in a non-drip and ship scenario of a comprehensive stroke center.

METHODS

We included patients with AIS admitted from September 2019 to September 2022 and compared those treated with TNK during the COVID-19 pandemic to those treated with ALT in the period immediately before. We compared emergency department length of stay (EDLOS), door-to-needle time (DTN), door-to-groin puncture time (DTG), clinical and safety outcomes with adjusted general linear regression models.

RESULTS

110 patients treated with TNK and 111 with ALT were included in this study. Mean EDLOS was 251 (SD = 164) min for TNK users versus 240 (SD = 148) min for ALT (p = 0.62). Mean DTN was 43 (SD = 25) min for TNK versus 46 (SD = 27) min for ALT users (p = 0.39). Mean DTN under 60 min was achieved in 86 (78.2%) patients and in 85 (76.5%) patients of the TNK and ALT groups, respectively (p = 1.0). DTN under 45 min was achieved in 65.4% and 58.6% (p = 0.65) of the TNK and ALT groups, respectively. DTG time was 114 (SD = 43) min for TNK versus 111 (58 = SD) min in the ALT group (p = 0.88). DTG under 90 min was achieved in 32% of the TNK group and 35% of the ALT group (p = 0.69). There were no differences in any of the clinical or safety outcomes between groups at 90 days.

CONCLUSIONS

The adoption of TNK during COVID-19 pandemic did not result in a change in EDLOS, DTN, or DTG times when compared to ALT in this cohort. Safety and clinical outcomes were similar between groups. Probably a greater benefit could have been seen in a drip and ship thrombolysis setting. Further research is needed to assess the potential advantages of TNK in drip and ship scenarios of IVT.

INTRODUCTION

Tenecteplase (TNK) has demonstrated to be non-inferior to alteplase (ALT) for intravenous thrombolysis (IVT) in acute ischemic stroke (AIS). There are potential workflow benefits associated with TNK use, aiming to reduce patient length of stay in the emergency department. Our aim was to investigate whether the routine use of TNK during the COVID-19 pandemic influenced workflow times compared to historical use of ALT, while maintaining non-inferior clinical outcomes in a non-drip and ship scenario of a comprehensive stroke center.

METHODS

We included patients with AIS admitted from September 2019 to September 2022 and compared those treated with TNK during the COVID-19 pandemic to those treated with ALT in the period immediately before. We compared emergency department length of stay (EDLOS), door-to-needle time (DTN), door-to-groin puncture time (DTG), clinical and safety outcomes with adjusted general linear regression models.

RESULTS

110 patients treated with TNK and 111 with ALT were included in this study. Mean EDLOS was 251 (SD = 164) min for TNK users versus 240 (SD = 148) min for ALT (p = 0.62). Mean DTN was 43 (SD = 25) min for TNK versus 46 (SD = 27) min for ALT users (p = 0.39). Mean DTN under 60 min was achieved in 86 (78.2%) patients and in 85 (76.5%) patients of the TNK and ALT groups, respectively (p = 1.0). DTN under 45 min was achieved in 65.4% and 58.6% (p = 0.65) of the TNK and ALT groups, respectively. DTG time was 114 (SD = 43) min for TNK versus 111 (58 = SD) min in the ALT group (p = 0.88). DTG under 90 min was achieved in 32% of the TNK group and 35% of the ALT group (p = 0.69). There were no differences in any of the clinical or safety outcomes between groups at 90 days.

CONCLUSIONS

The adoption of TNK during COVID-19 pandemic did not result in a change in EDLOS, DTN, or DTG times when compared to ALT in this cohort. Safety and clinical outcomes were similar between groups. Probably a greater benefit could have been seen in a drip and ship thrombolysis setting. Further research is needed to assess the potential advantages of TNK in drip and ship scenarios of IVT.

摘要

引言

在急性缺血性卒中(AIS)的静脉溶栓(IVT)治疗中,替奈普酶(TNK)已被证明不劣于阿替普酶(ALT)。使用TNK可能会给工作流程带来潜在益处,目标是缩短患者在急诊科的停留时间。我们的目的是研究在2019冠状病毒病(COVID-19)大流行期间常规使用TNK与历史上使用ALT相比,是否会影响工作流程时间,同时在综合卒中中心的非“点滴转运”模式下保持非劣效的临床结局。

方法

我们纳入了2019年9月至2022年9月收治的AIS患者,并将在COVID-19大流行期间接受TNK治疗的患者与在此之前接受ALT治疗的患者进行比较。我们使用调整后的一般线性回归模型比较了急诊科停留时间(EDLOS)、门到针时间(DTN)、门到股动脉穿刺时间(DTG)、临床和安全性结局。

结果

本研究纳入了110例接受TNK治疗的患者和111例接受ALT治疗的患者。TNK使用者的平均EDLOS为251(标准差=164)分钟,而ALT使用者为240(标准差=148)分钟(p=0.62)。TNK使用者的平均DTN为43(标准差=25)分钟,而ALT使用者为46(标准差=27)分钟(p=0.39)。TNK组和ALT组分别有86例(78.2%)和85例(76.5%)患者实现了60分钟内的平均DTN(p=1.0)。TNK组和ALT组分别有65.4%和58.6%的患者实现了45分钟内的DTN(p=0.65)。TNK组的DTG时间为114(标准差=43)分钟,而ALT组为111(标准差=S58)分钟(p=0.88)。TNK组和ALT组分别有32%和35%的患者实现了90分钟内的DTG(p=0.69)。两组在90天时的任何临床或安全性结局均无差异。

结论

在本队列中,与ALT相比,在COVID-19大流行期间采用TNK并未导致EDLOS、DTN或DTG时间发生变化。两组的安全性和临床结局相似。在“点滴转运”溶栓模式下可能会看到更大的益处。需要进一步研究以评估TNK在IVT的“点滴转运”模式下的潜在优势。

引言

在急性缺血性卒中(AIS)的静脉溶栓(IVT)治疗中,替奈普酶(TNK)已被证明不劣于阿替普酶(ALT)。使用TNK可能会给工作流程带来潜在益处,目标是缩短患者在急诊科的停留时间。我们的目的是研究在2019冠状病毒病(COVID-19)大流行期间常规使用TNK与历史上使用ALT相比,是否会影响工作流程时间,同时在综合卒中中心的非“点滴转运”模式下保持非劣效的临床结局。

方法

我们纳入了2019年9月至2022年9月收治的AIS患者,并将在COVID-19大流行期间接受TNK治疗的患者与在此之前接受ALT治疗的患者进行比较。我们使用调整后的一般线性回归模型比较了急诊科停留时间(EDLOS)、门到针时间(DTN)、门到股动脉穿刺时间(DTG)、临床和安全性结局。

结果

本研究纳入了110例接受TNK治疗的患者和111例接受ALT治疗的患者。TNK使用者的平均EDLOS为251(标准差=164)分钟,而ALT使用者为240(标准差=148)分钟(p=0.62)。TNK使用者的平均DTN为43(标准差=25)分钟,而ALT使用者为46(标准差=27)分钟(p=0.39)。TNK组和ALT组分别有86例(78.2%)和85例(76.5%)患者实现了60分钟内的平均DTN(p=1.0)。TNK组和ALT组分别有65.4%和58.6%的患者实现了45分钟内的DTN(p=0.65)。TNK组的DTG时间为114(标准差=43)分钟,而ALT组为111(标准差=S58)分钟(p=0.88)。TNK组和ALT组分别有32%和35%的患者实现了90分钟内的DTG(p=0.69)。两组在90天时的任何临床或安全性结局均无差异。

结论

在本队列中,与ALT相比,在COVID-19大流行期间采用TNK并未导致EDLOS、DTN或DTG时间发生变化。两组的安全性和临床结局相似。在“点滴转运”溶栓模式下可能会看到更大的益处。需要进一步研究以评估TNK在IVT的“点滴转运”模式下的潜在优势。

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本文引用的文献

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Tenecteplase for Ischemic Stroke at 4.5 to 24 Hours without Thrombectomy.替奈普酶治疗发病 4.5 至 24 小时内的缺血性脑卒中且未进行取栓治疗。
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Tenecteplase versus alteplase for acute ischemic stroke: a systematic review and meta-analysis of randomized and non-randomized studies.替奈普酶与阿替普酶治疗急性缺血性脑卒中的比较:一项随机和非随机研究的系统评价和荟萃分析。
J Neurol. 2024 May;271(5):2309-2323. doi: 10.1007/s00415-024-12243-1. Epub 2024 Mar 4.
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Tenecteplase for Stroke at 4.5 to 24 Hours with Perfusion-Imaging Selection.发病 4.5 至 24 小时的脑卒中患者采用灌注成像选择使用替奈普酶溶栓治疗。
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Efficacy and safety outcomes of Tenecteplase versus Alteplase for thrombolysis of acute ischemic stroke: A meta-analysis of 9 randomized controlled trials.替奈普酶与阿替普酶溶栓治疗急性缺血性脑卒中的疗效和安全性:9 项随机对照试验的荟萃分析。
J Neurol Sci. 2024 Mar 15;458:122912. doi: 10.1016/j.jns.2024.122912. Epub 2024 Feb 3.
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Intravenous Tenecteplase for Acute Ischemic Stroke Within 4.5-24 Hours of Onset (ROSE-TNK): A Phase 2, Randomized, Multicenter Study.静脉注射替奈普酶治疗发病4.5 - 24小时内的急性缺血性卒中(ROSE-TNK):一项2期随机多中心研究
J Stroke. 2023 Sep;25(3):371-377. doi: 10.5853/jos.2023.00668. Epub 2023 Aug 24.
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