Dabigatran for prevention of stroke after embolic stroke of undetermined source

Journal article


Publication Details

Author(s): Diener HC, Sacco RL, Donald Easton J, Granger CB, Bernstein RA, Uchiyama S, Kreuzer J, Cronin L, Cotton D, Grauer C, Brueckmann M, Chernyatina M, Donnan G, Ferro JM, Grond M, Kallmünzer B, Krupinski J, Lee BC, Lemmens R, Masjuan J, Odinak M, Saver JL, Schellinger PD, Toni D, Toyoda K
Journal: New England Journal of Medicine
Publication year: 2019
Volume: 380
Journal issue: 20
Pages range: 1906-1917
ISSN: 0028-4793


Abstract

BACKGROUND Cryptogenic strokes constitute 20 to 30% of ischemic strokes, and most cryptogenic strokes are considered to be embolic and of undetermined source. An earlier randomized trial showed that rivaroxaban is no more effective than aspirin in preventing recurrent stroke after a presumed embolic stroke from an undetermined source. Whether dabigatran would be effective in preventing recurrent strokes after this type of stroke was unclear. METHODS We conducted a multicenter, randomized, double-blind trial of dabigatran at a dose of 150 mg or 110 mg twice daily as compared with aspirin at a dose of 100 mg once daily in patients who had had an embolic stroke of undetermined source. The primary outcome was recurrent stroke. The primary safety outcome was major bleeding. RESULTS A total of 5390 patients were enrolled at 564 sites and were randomly assigned to receive dabigatran (2695 patients) or aspirin (2695 patients). During a median follow-up of 19 months, recurrent strokes occurred in 177 patients (6.6%) in the dabigatran group (4.1% per year) and in 207 patients (7.7%) in the aspirin group (4.8% per year) (hazard ratio, 0.85; 95% confidence interval [CI], 0.69 to 1.03; P=0.10). Ischemic strokes occurred in 172 patients (4.0% per year) and 203 patients (4.7% per year), respectively (hazard ratio, 0.84; 95% CI, 0.68 to 1.03). Major bleeding occurred in 77 patients (1.7% per year) in the dabigatran group and in 64 patients (1.4% per year) in the aspirin group (hazard ratio, 1.19; 95% CI, 0.85 to 1.66). Clinically relevant nonmajor bleeding occurred in 70 patients (1.6% per year) and 41 patients (0.9% per year), respectively. CONCLUSIONS In patients with a recent history of embolic stroke of undetermined source, dabigatran was not superior to aspirin in preventing recurrent stroke. The incidence of major bleeding was not greater in the dabigatran group than in the aspirin group, but there were more clinically relevant nonmajor bleeding events in the dabigatran group.


FAU Authors / FAU Editors

Kallmünzer, Bernd PD Dr.
Neurologische Klinik


External institutions with authors

Boehringer Ingelheim Pharma GmbH & Co. KG
City Clinical Hospital of Emergency Medical Care
Duke University Medical Center
Hallym University
Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS)
International University of Health and Welfare (IUHW) / 国際医療福祉大学
Johannes Wesling Klinikum Minden
Militärmedizinische Akademie S. M. Kirow
National Cerebral and Cardiovascular Center
Northwestern University
Philipps-Universität Marburg
Ruprecht-Karls-Universität Heidelberg
The University of Melbourne
Università degli studi "La Sapienza"
Universitätsklinikum Essen
University Hospital Leuven (UZ) / Universitaire ziekenhuizen Leuven
University of California Los Angeles (UCLA)
University of California San Francisco (UCSF)
University of Lisbon / Universidade de Lisboa (ULisboa)
University of Miami


How to cite

APA:
Diener, H.C., Sacco, R.L., Donald Easton, J., Granger, C.B., Bernstein, R.A., Uchiyama, S.,... Toyoda, K. (2019). Dabigatran for prevention of stroke after embolic stroke of undetermined source. New England Journal of Medicine, 380(20), 1906-1917. https://dx.doi.org/10.1056/NEJMoa1813959

MLA:
Diener, Hans Christoph, et al. "Dabigatran for prevention of stroke after embolic stroke of undetermined source." New England Journal of Medicine 380.20 (2019): 1906-1917.

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Last updated on 2019-03-06 at 11:23