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

<b>Background/Objectives:</b> 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. <b>Methods:</b> 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<sup>®</sup> 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 (<i>n</i> = 767) or DOAC-treated with confirmed activity (<i>n</i> = 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). <b>Results:</b> After matching, 90-day functional outcomes were comparable between groups (mean mRS-shift: 2.00 in DOAC-treated vs. 1.78 in non-anticoagulated; <i>p</i> = 0.745). OLS regression showed no significant association between DOAC status and recovery (<i>p</i> = 0.599). In contrast, NIHSS score at 72 h (<i>p</i> = 0.004) and age (<i>p</i> = 0.015) were significant predictors of outcome. PCA supported these findings, identifying stroke severity as the primary driver of outcome. <b>Conclusions:</b> 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.

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Journal
Journal of Clinical Medicine
Published
2025-08-04
DOI
https://doi.org/10.3390/jcm14155476
Primary Topic
Atrial Fibrillation Management and Outcomes
Type
article
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0.00

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article

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

Zsófia Nozomi Karádi, Edit Bosnyák, Eszter Johanna Jozifek, Balázs Cséke et al.
Journal of Clinical Medicine
Atrial Fibrillation Management and Outcomes
article

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

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

Abstract

<b>Background/Objectives:</b> 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. <b>Methods:</b> 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<sup>®</sup> 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 (<i>n</i> = 767) or DOAC-treated with confirmed activity (<i>n</i> = 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). <b>Results:</b> After matching, 90-day functional outcomes were comparable between groups (mean mRS-shift: 2.00 in DOAC-treated vs. 1.78 in non-anticoagulated; <i>p</i> = 0.745). OLS regression showed no significant association between DOAC status and recovery (<i>p</i> = 0.599). In contrast, NIHSS score at 72 h (<i>p</i> = 0.004) and age (<i>p</i> = 0.015) were significant predictors of outcome. PCA supported these findings, identifying stroke severity as the primary driver of outcome. <b>Conclusions:</b> 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.

Journal of Clinical MedicineVol. 14(15)
University of Pecs (HU)
Egészségügyi Tudományos Tanács, Pécsi Tudományegyetem, Medical Research Council
Good health and well-being
Openalex Percentile: Top 69%
Atrial Fibrillation Management and Outcomes
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