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消除对直接口服抗凝剂(DOAC)的疑虑:使用即时检验ClotPro检测法对比抗凝和非抗凝卒中患者功能转归的初步证据

Putting DOAC Doubts to Bed(Side): Preliminary Evidence of Comparable Functional Outcomes in Anticoagulated and Non-Anticoagulated Stroke Patients Using Point-of-Care ClotPro Testing.

作者信息

Seetge Jessica, Cséke Balázs, Karádi Zsófia Nozomi, Bosnyák Edit, Jozifek Eszter Johanna, Szapáry László

机构信息

Stroke Unit, Department of Neurology, University of Pécs, 7624 Pécs, Hungary.

Department of Emergency Medicine, University of Pécs, 7624 Pécs, Hungary.

出版信息

J Clin Med. 2025 Aug 4;14(15):5476. doi: 10.3390/jcm14155476.

Abstract

Direct oral anticoagulants (DOACs) are now the guideline-recommended alternative to vitamin K antagonists (VKAs) for long-term anticoagulation in patients with non-valvular atrial fibrillation. However, accurately assessing their impact on ischemic stroke outcomes remains challenging, primarily due to uncertainty regarding anticoagulation status at the time of hospital admission. This preliminary study addresses this gap by using point-of-care testing (POCT) to confirm DOAC activity at bedside, allowing for a more accurate comparison of 90-day functional outcomes between anticoagulated and non-anticoagulated stroke patients. We conducted a retrospective cohort study of 786 ischemic stroke patients admitted to the University of Pécs between February 2023 and February 2025. Active DOAC therapy was confirmed using the ClotPro viscoelastic testing platform, with ecarin Clotting Time (ECT) employed for thrombin inhibitors and Russell's Viper Venom (RVV) assays for factor Xa inhibitors. Patients were categorized as non-anticoagulated ( = 767) or DOAC-treated with confirmed activity ( = 19). Mahalanobis distance-based matching was applied to account for confounding variables including age, sex, pre-stroke modified Rankin Scale (mRS), and National Institutes of Health Stroke Scale (NIHSS) scores at admission and 72 h post-stroke. The primary outcome was the change in mRS from baseline to 90 days. Statistical analysis included ordinary least squares (OLS) regression and principal component analysis (PCA). After matching, 90-day functional outcomes were comparable between groups (mean mRS-shift: 2.00 in DOAC-treated vs. 1.78 in non-anticoagulated; = 0.745). OLS regression showed no significant association between DOAC status and recovery ( = 0.599). In contrast, NIHSS score at 72 h ( = 0.004) and age ( = 0.015) were significant predictors of outcome. PCA supported these findings, identifying stroke severity as the primary driver of outcome. This preliminary analysis suggests that ischemic stroke patients with confirmed active DOAC therapy at admission may achieve 90-day functional outcomes comparable to those of non-anticoagulated patients. The integration of bedside POCT enhances the reliability of anticoagulation assessment and underscores its clinical value for real-time management in acute stroke care. Larger prospective studies are needed to validate these findings and to further refine treatment strategies.

摘要

直接口服抗凝剂(DOACs)现已成为指南推荐的用于非瓣膜性心房颤动患者长期抗凝的维生素K拮抗剂(VKAs)替代药物。然而,准确评估它们对缺血性卒中结局的影响仍然具有挑战性,主要原因是入院时抗凝状态存在不确定性。这项初步研究通过使用即时检验(POCT)在床边确认DOAC活性来填补这一空白,从而能够更准确地比较抗凝和未抗凝卒中患者90天的功能结局。我们对2023年2月至2025年2月期间在佩奇大学住院的786例缺血性卒中患者进行了一项回顾性队列研究。使用ClotPro粘弹性检测平台确认DOAC的活性,用蛇静脉酶凝血时间(ECT)检测凝血酶抑制剂,用罗素蝰蛇毒(RVV)试验检测Xa因子抑制剂。患者被分为未抗凝组(n = 767)或经确认有活性的DOAC治疗组(n = 19)。应用基于马氏距离的匹配方法来考虑混杂变量,包括年龄、性别、卒中前改良Rankin量表(mRS)以及入院时和卒中后72小时的美国国立卫生研究院卒中量表(NIHSS)评分。主要结局是从基线到90天mRS的变化。统计分析包括普通最小二乘法(OLS)回归和主成分分析(PCA)。匹配后,两组间90天的功能结局具有可比性(DOAC治疗组的平均mRS变化:2.00,未抗凝组为1.78;p = 0.745)。OLS回归显示DOAC状态与恢复之间无显著关联(p = 0.599)。相比之下,72小时时的NIHSS评分(p = 0.004)和年龄(p = 0.015)是结局的显著预测因素。PCA支持了这些发现,确定卒中严重程度是结局的主要驱动因素。这项初步分析表明,入院时经确认有活性DOAC治疗的缺血性卒中患者90天的功能结局可能与未抗凝患者相当。床边POCT的整合提高了抗凝评估的可靠性,并强调了其在急性卒中护理实时管理中的临床价值。需要更大规模的前瞻性研究来验证这些发现并进一步完善治疗策略。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d935/12347577/59c02ede7b2a/jcm-14-05476-g001.jpg

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