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接受直接口服抗凝剂治疗的急性缺血性中风患者的静脉溶栓治疗:一项系统评价和荟萃分析。

Intravenous thrombolysis for patients with acute ischemic stroke while receiving a direct oral anticoagulant: A systematic review and meta-analysis.

作者信息

Roberts Megan Z, Durham Spencer H, Pinner Nathan A, Starr Jessica A

机构信息

Auburn University Harrison College of Pharmacy, Univeristy of Alabama at Birmingham (UAB)-Huntsville Regional Medical Center, Huntsville, Alabama, USA.

Auburn University Harrison College of Pharmacy, Auburn, Alabama, USA.

出版信息

Pharmacotherapy. 2025 Feb;45(2):111-123. doi: 10.1002/phar.4644. Epub 2025 Jan 20.

Abstract

Recent guidelines for acute ischemic stroke (AIS) indicate administration of intravenous thrombolysis (IVT) in patients receiving direct oral anticoagulants (DOAC) is not firmly established and may be harmful unless certain potential parameters are met. This systematic review and meta-analysis explores safety outcomes and other clinical parameters from the growing number of publications describing patients taking a DOAC who experience an AIS that is treated acutely with IVT alone. Embase, International Pharmaceutical Abstracts, and PubMed were searched up to January 9, 2024 for studies including adult patients taking a DOAC who experienced an AIS treated with IVT and did not undergo endovascular therapy (EVT), regardless of the use of an anticoagulation reversal agent. Primary safety outcomes evaluated included symptomatic intracranial hemorrhage (sICH), any intracranial hemorrhage, and in-hospital mortality. A total of 873 patients from 78 studies, primarily case reports or case series of patients receiving dabigatran with or without idarucizumab reversal (n = 340), were included in the review. The rate of sICH during the index hospitalization was 3.3%. Seven high-quality studies with low risk of bias included outcomes for patients on DOAC and comparator groups of either patients not taking an oral anticoagulant (no OAC) or patients taking a vitamin K antagonist (VKA) with INR primarily <1.7 at the time of AIS. No significant difference was observed in the incidence of sICH among patients receiving DOAC vs. no OAC (odds ratio [OR] 0.8, 95% confidence interval [CI]: 0.48-1.33) or among patients receiving DOAC vs. VKA (OR 1.02, 95% CI 0.59-1.75). Similar findings of no difference were observed for other safety outcomes. Findings from this study suggest that utilization of IVT as sole recanalization therapy for AIS may be safe in patients taking a DOAC; however, further studies are needed to elucidate specific parameters that differentiate timepoints and variables to ensure safe, optimal treatment.

摘要

近期急性缺血性卒中(AIS)指南指出,对于正在接受直接口服抗凝剂(DOAC)治疗的患者,静脉溶栓(IVT)的应用尚未明确确立,并且可能有害,除非满足某些潜在参数。这项系统评价和荟萃分析探讨了越来越多描述服用DOAC且急性缺血性卒中仅接受IVT治疗患者的出版物中的安全性结果和其他临床参数。截至2024年1月9日,对Embase、《国际药学文摘》和PubMed进行了检索,以查找包括服用DOAC且经历急性缺血性卒中并接受IVT治疗且未接受血管内治疗(EVT)的成年患者的研究,无论是否使用抗凝逆转剂。评估的主要安全性结果包括症状性颅内出血(sICH)、任何颅内出血和住院死亡率。该评价纳入了来自78项研究的873例患者,主要是接受达比加群治疗且有或没有艾达凝血酶原复合物逆转治疗的病例报告或病例系列(n = 340)。索引住院期间sICH的发生率为3.3%。七项偏倚风险低的高质量研究纳入了服用DOAC患者以及未服用口服抗凝剂(无OAC)的对照患者组或急性缺血性卒中时国际标准化比值(INR)主要<1.7的服用维生素K拮抗剂(VKA)患者的结局。接受DOAC的患者与无OAC患者之间sICH的发生率无显著差异(优势比[OR] 0.8,95%置信区间[CI]:0.48 - 1.33),接受DOAC的患者与VKA患者之间也无显著差异(OR 1.02,95% CI 0.59 - 1.75)。其他安全性结果也观察到类似的无差异发现。本研究结果表明,对于服用DOAC的患者,将IVT作为AIS的唯一再通治疗方法可能是安全的;然而,需要进一步研究以阐明区分时间点和变量的具体参数,以确保安全、最佳的治疗。

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