WSO December 2023 – Issue 3 - 1169

1184366
WSO
International Journal of StrokeGrosse et al.
Research
Early or late initiation of dabigatran
versus vitamin-K-antagonists in
acute ischemic stroke or TIA:
The PRODAST study
International Journal of Stroke
2023, Vol. 18(10) 1169 -1177
© 2023 World Stroke Organization
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DOI: 10.1177/17474930231184366
journals.sagepub.com/home/wso
https://doi.org/10.1177/17474930231184366
Gerrit M Grosse1,2 , Anika Hüsing1, Andreas Stang1,3, Nils Kuklik1,
Marcus Brinkmann1,4, Darius Nabavi5, Paul Sparenberg6,
Karin Weissenborn2 , Klaus Gröschel7 , Georg Royl8,
Sven Poli9,10 , Dominik Michalski11, Christoph C Eschenfelder12
,
Christian Weimar1,13 and Hans-Christoph Diener1 , on behalf
of the PRODAST Investigators
Abstract
Background: The optimal timing of initiating or resuming anticoagulation after acute ischemic stroke (AIS) or transient
ischemic attack (TIA) in patients with atrial fibrillation (AF) is debated. Dabigatran, a non-vitamin K oral anticoagulant
(NOAC), has shown superiority against vitamin K antagonists (VKA) regarding hemorrhagic complications.
Aims: In this registry study, we investigated the initiation of dabigatran in the early phase after AIS or TIA.
Methods: PRODAST (Prospective Record of the Use of Dabigatran in Patients with Acute Stroke or TIA) is a prospective,
multicenter, observational, post-authorization safety study. We recruited 10,039 patients at 86 German stroke
units between July 2015 and November 2020. A total of 3,312 patients were treated with dabigatran or VKA and were
eligible for the analysis that investigates risks for major hemorrhagic events within 3 months after early (⩽ 7 days) or
late (> 7 days) initiation of dabigatran or VKA initiated at any time. Further endpoints were recurrent stroke, ischemic
stroke, TIA, systemic embolism, myocardial infarction, death, and a composite endpoint of stroke, systemic embolism,
life-threatening bleeding and death.
Results: Major bleeding event rates per 10,000 treatment days ranged from 1.9 for late administered dabigatran to 4.9
for VKA. Early or late initiation of dabigatran was associated with a lower hazard for major hemorrhages as compared
to VKA use. The difference was pronounced for intracranial hemorrhages with an adjusted hazard ratio (HR) of 0.47
1 Department of Neuroepidemiology, Institute for Medical Informatics, Biometry and Epidemiology, Faculty of Medicine, University of DuisburgEssen,
Essen, Germany
2Department of Neurology, Hannover Medical School, Hannover, Germany
3Department of Epidemiology, School of Public Health, Boston University, Boston, MA, USA
4Center for Clinical Trials Essen, University Hospital Essen, Essen, Germany
5Department of Neurology, Vivantes Klinikum Neukölln, Berlin, Germany
6Department of Neurology, BG Klinikum Unfallkrankenhaus Berlin, Berlin, Germany
7Department of Neurology, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany
8Department of Neurology, University of Lübeck, Lübeck, Germany
9Department of Neurology and Stroke, University of Tübingen, Tübingen, Germany
10Hertie Institute for Clinical Brain Research, University of Tübingen, Tübingen, Germany
11Department of Neurology, University of Leipzig, Leipzig, Germany
12Human Pharma Germany, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany
13BDH-Klinik Elzach, Elzach, Germany
*Members of the PRODAST Investigators are listed in Supplementary material.
Corresponding author:
Hans-Christoph Diener, Department of Neuroepidemiology, Institute for Medical Informatics, Biometry and Epidemiology, Faculty of Medicine,
University of Duisburg-Essen, Hufelandstrasse 55, Essen 45147, Germany.
Email: hans.diener@uk-essen.de; hans.diener@uni-duisburg-essen.de
International Journal of Stroke, 18(10)
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WSO December 2023 – Issue 3

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