Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
Neurological Research and Practice
Published in: Neurological Research and Practice 1/2022

Open Access 01-12-2022 | Subdural Hematoma | Research article

Intracranial bleeding under vitamin K antagonists or direct oral anticoagulants: results of the RADOA registry

Authors: Waltraud Pfeilschifter, Edelgard Lindhoff-Last, Ali Alhashim, Barbara Zydek, Simone Lindau, Stavros Konstantinides, Oliver Grottke, Ulrike Nowak-Göttl, Christian von Heymann, Ingvild Birschmann, Jan Beyer-Westendorf, Patrick Meybohm, Andreas Greinacher, Eva Herrmann, the RADOA-Registry Investigators (Reversal Agent use in patients treated with Direct Oral Anticoagulants or vitamin K antagonists Registry)

Published in: Neurological Research and Practice | Issue 1/2022

Login to get access

Abstract

Background and purpose

The use of direct oral anticoagulants (DOAC) has increased sharply and DOAC are the oral anticoagulant therapy (OAT) of choice for the majority of patients with newly-diagnosed atrial fibrillation. Intracranial hemorrhage is the most severe adverse event of OAT. Systematic data on the course of intracranial hemorrhage under DOAC compared to vitamin K antagonists (VKA) are warranted to enable shared decision making in AF patients needing OAT.

Methods

This is a secondary analysis of the patients with intracranial bleedings from the prospective multicenter emergency department-based RADOA registry, which collected data on patients admitted with major bleeding while taking VKA or DOAC. The primary endpoint was in-hospital mortality until day 30. We evaluated hematoma volume and short-term clinical outcomes in relation to the extent of active OAT according to coagulation parameters and OAT plasma levels measured by UPLC-MS/MS.

Results

Of 193 patients with major bleeding, 109 (56.5%) had intracranial hemorrhage [52.3% intracerebral (ICH), 33.9% subdural (SDH), 11.0% subarachnoidal (SAH)]. 64 (58.7%) were on VKA and 45 (41.2%) were on DOAC. On admission, we could confirm active anticoagulation in 97.7% of VKA-treated patients based on either INR > 1.3 or phenprocoumon levels and in 75.8% of DOAC-treated patients based on DOAC levels. Patients suffering an intracranial hemorrhage under VKA showed significantly larger hematoma volumes and a higher in-hospital mortality. Especially in intracerebral hemorrhage, we observed a higher initial severity and numerically greater proportion of early changes towards palliative therapy under VKA, which coincided with a numerically higher case fatality.

Conclusions

We show significantly smaller hematoma volumes for ICH and SDH under DOAC in comparison to VKA and a significantly lower 30-day in-hospital mortality rate of DOAC-ICH, even before the introduction of specific antidotes. These data strongly support the use of DOAC whenever possible in patients requiring OAT.
Trial Registration: http://​www.​clinicaltrials.​gov; Unique identifier: NCT01722786.
Literature
1.
Pan, K. L., Singer, D. E., Ovbiagele, B., Wu, Y. L., Ahmed, M. A., & Lee, M. (2017). Effects of non-vitamin K antagonist oral anticoagulants versus warfarin in patients with atrial fibrillation and valvular heart disease: a systematic review and meta-analysis. Journal of the American Heart Association, 6, e005835.CrossRefPubMedPubMedCentral
2.
Hart, R. G., Diener, H. C., Yang, S., Connolly, S. J., Wallentin, L., Reilly, P. A., Ezekowitz, M. D., & Yusuf, S. (2012). Intracranial hemorrhage in atrial fibrillation patients during anticoagulation with warfarin or dabigatran: the RE-LY trial. Stroke, 43, 1511–1517.CrossRefPubMed
3.
Hankey, G. J., Stevens, S. R., Piccini, J. P., Lokhnygina, Y., Mahaffey, K. W., Halperin, J. L., Patel, M. R., Breithardt, G., Singer, D. E., Becker, R. C., et al. (2014). ROCKET AF Steering Committee and Investigators. Stroke. Intracranial hemorrhage among patients with atrial fibrillation anticoagulated with warfarin or rivaroxaban: the rivaroxaban once daily, oral, direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation. Stroke, 45, 1304–12.CrossRefPubMed
4.
López-López, J. A., Sterne, J. A. C., Thom, H. H. Z., Higgins, J. P. T., Hingorani, A. D., Okoli, G. N., Davies, P. A., Bodalia, P. N., Bryden, P. A., Welton, N. J., et al. (2017). Oral anticoagulants for prevention of stroke in atrial fibrillation: systematic review, network meta-analysis, and cost effectiveness analysis. BMJ, 359, j5058.CrossRefPubMedPubMedCentral
5.
Wilson, D., Seiffge, D. J., Traenka, C., Basir, G., Purrucker, J. C., Rizos, T., Sobowale, O. A., Sallinen, H., Yeh, S. J., Wu, T. Y., et al. (2017). And the CROMIS-2 collaborators. Outcome of intracerebral hemorrhage associated with different oral anticoagulants. Neurology, 88, 1693–1700.CrossRefPubMedPubMedCentral
6.
Kurogi, R., Nishimura, K., Nakai, M., Kada, A., Kamitani, S., Nakagawara, J., Toyoda, K., Ogasawara, K., Ono, J., Shiokawa, Y., et al. (2018). J-ASPECT study collaborators. Neurology, 90, e1143–e1149.CrossRefPubMedPubMedCentral
7.
Seiffge, D. J., Goeldlin, M. B., Tatlisumak, T., Lyrer, P., Fischer, U., Engelter, S. T., & Werring, D. J. (2019). Meta-analysis of haematoma volume, haematoma expansion and mortality in intracerebral haemorrhage associated with oral anticoagulant use. Journal of Neurology, 266, 3126–3135.CrossRefPubMedPubMedCentral
8.
Tsivgoulis, G., Lioutas, V. A., Varelas, P., Katsanos, A. H., Goyal, N., Mikulik, R., Barlinn, K., Krogias, C., Sharma, V. K., Vadikolias, K., et al. (2017). Direct oral anticoagulant– vs vitamin K antagonist–related nontraumatic intracerebral hemorrhage. Neurology, 89, 1142–1151.CrossRefPubMed
9.
Gerner, S. T., Kuramatsu, J. B., Sembill, J. A., Sprügel, M. I., Hagen, M., Knappe, R. U., Endres, M., Haeusler, K. G., Sobesky, J., Schurig, J., et al. (2019). Characteristics in non-vitamin K antagonist oral anticoagulant-related intracerebral hemorrhage. Stroke, 50, 1392–1402.CrossRefPubMed
10.
Beynon, C., Brenner, S., Younsi, A., Rizos, T., Neumann, J. O., Pfaff, J., & Unterberg, A. W. (2019). Management of patients with acute subdural hemorrhage during treatment with direct oral anticoagulants. Neurocritical Care, 30, 322–333.CrossRefPubMed
11.
Won, S. Y., Dubinski, D., Bruder, M., Cattani, A., Seifert, V., & Konczalla, J. (2017). Acute subdural hematoma in patients on oral anticoagulant therapy: Management and outcome. Neurosurgical Focus, 43, E12.CrossRefPubMed
12.
Lindhoff-Last, E. (2017). Direct oral anticoagulants (DOAC)—Management of emergency situations. Hämostaseologie, 37, 257–266.CrossRefPubMed
13.
Lindhoff-Last, E., Herrmann, E., Lindau, S., Konstantinides, S., Grottke, O., Nowak-Goettl, U., Lucks, J., Zydek, B., Heymann, C. V., Birschmann, I., et al. (2020). Severe Hemorrhage associated with oral anticoagulants. Deutsches Ärzteblatt International, 117, 312–319.PubMedPubMedCentral
14.
Kothari, R. U., Brott, T., Broderick, J. P., Barsan, W. G., Sauerbeck, L. R., Zuccarello, M., & Khoury, J. (1996). The ABCs of measuring intracerebral hemorrhage volumes. Stroke, 27, 1304–1305.CrossRefPubMed
15.
Won, S. Y., Zagorcic, A., Dubinski, D., Quick-Weller, J., Herrmann, E., Seifert, V., & Konczalla, J. (2018). Excellent accuracy of ABC/2 volume formula compared to computer-assisted volumetric analysis of subdural hematomas. PLoS ONE, 13(6), e0199809.CrossRefPubMedPubMedCentral
Metadata
Title
Intracranial bleeding under vitamin K antagonists or direct oral anticoagulants: results of the RADOA registry
Authors
Waltraud Pfeilschifter
Edelgard Lindhoff-Last
Ali Alhashim
Barbara Zydek
Simone Lindau
Stavros Konstantinides
Oliver Grottke
Ulrike Nowak-Göttl
Christian von Heymann
Ingvild Birschmann
Jan Beyer-Westendorf
Patrick Meybohm
Andreas Greinacher
Eva Herrmann
the RADOA-Registry Investigators (Reversal Agent use in patients treated with Direct Oral Anticoagulants or vitamin K antagonists Registry)
Publication date
01-12-2022
Publisher
BioMed Central
Published in
Neurological Research and Practice / Issue 1/2022
Electronic ISSN: 2524-3489
DOI
https://doi.org/10.1186/s42466-022-00183-y

Other articles of this Issue 1/2022

Neurological Research and Practice 1/2022 Go to the issue

Research article

Characterization of advanced Parkinson’s disease in Germany: results of the non-interventional OBSERVE-PD study

Research article

Antithrombotic treatment and outcome after endovascular treatment and acute carotid artery stenting in stroke patients with atrial fibrillation

Research article

Long-term efficacy with deep brain stimulation of the globus pallidus internus in cervical dystonia: a retrospective monocentric study

Letter to the editor

Polyradiculitis and encephalomyelitis in the same patient following a SARS-CoV-2 vaccination

Research article

Essen transition model for neuromuscular diseases

Research article

A mobile battery-powered brain perfusion ultrasound (BPU) device designed for prehospital stroke diagnosis: correlation to perfusion MRI in healthy volunteers