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达比加群酯在非瓣膜性心房颤动合并首次急性缺血性脑卒中患者中的应用:来自 SITS 注册研究的回顾性观察研究。

Dabigatran initiation in patients with non-valvular AF and first acute ischaemic stroke: a retrospective observational study from the SITS registry.

机构信息

Department of Neurology, Hospital Universitario Virgen del Rocio and Instituto de Biomedicina de Sevilla, Seville, Spain.

Department of Neurology and Department of Clinical Neuroscience, Karolinska University Hospital and Karolinska Institutet, Stockholm, Sweden.

出版信息

BMJ Open. 2020 May 19;10(5):e037234. doi: 10.1136/bmjopen-2020-037234.

DOI:10.1136/bmjopen-2020-037234
PMID:32434935
原文链接:
https://pmc.ncbi.nlm.nih.gov/articles/PMC7247395/
Abstract

BACKGROUND AND OBJECTIVE

The optimal timing for initiation of dabigatran after acute ischaemic stroke (AIS) is not established. We aimed to evaluate initiation timing and clinical outcomes of dabigatran in AIS patients with non-valvular atrial fibrillation (NVAF).

DESIGN

Retrospective study based on prospectively collected data in SITS (Safe Implementation of Treatment in Stroke) Thrombolysis and Thrombectomy Registry from July 2014 to July 2018.

PARTICIPANTS

European NVAF patients (≥18 years) hospitalised after first-ever ischaemic stroke.

SETTING

A multinational, observational monitoring register.

INTERVENTION

Dabigatran initiation within 3 months after the ischaemic stroke.

PRIMARY AND SECONDARY OUTCOMES

The primary outcome was time from first-ever ischaemic stroke (index event) to dabigatran initiation. Additional outcomes included physicians' reasons for delaying dabigatran initiation beyond acute hospital discharge and outcomes within 3 months of index event.

METHODS

We identified patients with NVAF who received dabigatran within 3 months of the index event. We performed descriptive statistics for baseline and demographic data and clinical outcomes after dabigatran initiation.

RESULTS

In total, 1489 patients with NVAF received dabigatran after AIS treated with thrombolysis and/or thrombectomy. Of these, 1240 had available initiation time. At baseline, median age was 75 years; 53% of patients were women, 15% were receiving an oral anticoagulant, 29% acetylsalicylic acid and 4% clopidogrel. Most patients (82%) initiated dabigatran within 14 days after the index event. Patients initiating earlier had lower stroke severity from median NIHSS 8 (IQR 6-13) if initiated within 7 days to NIHSS 15 (9-19) if initiated between 28 days and 3 months. Most common reasons for delaying initiation were haemorrhagic transformation or intracranial haemorrhage, stroke severity and infarct size. Few thrombotic/haemorrhagic events occurred within 3 months after the index event (20 of 926 patients, 2.2% with the available data).

CONCLUSIONS

Our findings, together with previous observational studies, indicate that dabigatran initiated within the first days after an AIS is safe in patients treated with intravenous thrombolysis, endovascular thrombectomy or both.

TRIAL REGISTRATION NUMBER

SITS Thrombolysis and Thrombectomy Registry (NCT03258645).

摘要

背景与目的

急性缺血性脑卒中(AIS)后开始使用达比加群的最佳时机尚未确定。我们旨在评估非瓣膜性心房颤动(NVAF)的 AIS 患者使用达比加群的起始时间和临床结局。

设计

基于 2014 年 7 月至 2018 年 7 月期间前瞻性收集的 SITS(安全实施溶栓治疗和血栓切除术登记处)溶栓和血栓切除术登记处的数据进行的回顾性研究。

参与者

欧洲 NVAF 患者(≥18 岁),在首次缺血性中风后住院。

地点

多国家、观察性监测登记处。

干预措施

AIS 后 3 个月内开始使用达比加群。

主要和次要结局

主要结局为首次缺血性中风(指数事件)至达比加群起始的时间。其他结局包括医生延迟急性出院后开始使用达比加群的原因和指数事件后 3 个月内的结局。

方法

我们确定了在指数事件后 3 个月内接受达比加群治疗的 NVAF 患者。我们对基线和人口统计学数据以及达比加群起始后的临床结局进行了描述性统计。

结果

共有 1489 例 NVAF 患者在 AIS 接受溶栓和/或血栓切除术治疗后接受了达比加群治疗。其中,1240 例有起始时间可用。基线时,中位年龄为 75 岁;53%的患者为女性,15%正在服用口服抗凝药,29%服用乙酰水杨酸,4%服用氯吡格雷。大多数患者(82%)在指数事件后 14 天内开始使用达比加群。如果在 7 天内开始使用,则起始 NIHSS 为 8(IQR 6-13);如果在 28 天至 3 个月之间开始使用,则起始 NIHSS 为 15(9-19)。延迟起始的最常见原因是出血性转化或颅内出血、卒中严重程度和梗死灶大小。指数事件后 3 个月内发生的血栓/出血事件较少(926 例患者中有 20 例,有可用数据的患者中有 2.2%)。

结论

我们的研究结果与之前的观察性研究一起表明,在接受静脉溶栓、血管内血栓切除术或两者联合治疗的 AIS 患者中,在 AIS 发生后的最初几天内开始使用达比加群是安全的。

试验注册号

SITS 溶栓和血栓切除术登记处(NCT03258645)。

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