Dabigatran for prevention of stroke after embolic stroke of undetermined source

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 (2019)

Publication Type: Journal article

Publication year: 2019

Journal

Book Volume: 380

Pages Range: 1906-1917

Journal Issue: 20

DOI: 10.1056/NEJMoa1813959

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.

Authors with CRIS profile

Involved external institutions

Universitätsklinikum Essen Germany (DE) National Cerebral and Cardiovascular Center Japan (JP) Università degli studi "La Sapienza" Italy (IT) University of Miami United States (USA) (US) Duke University Medical Center United States (USA) (US) International University of Health and Welfare (IUHW) / 国際医療福祉大学 Japan (JP) Northwestern University United States (USA) (US) Hallym University Korea, Republic of (KR) Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS) Spain (ES) The University of Melbourne Australia (AU) Philipps-Universität Marburg Germany (DE) Boehringer Ingelheim Pharma GmbH & Co. KG Germany (DE) University Hospital Leuven (UZ) / Universitaire ziekenhuizen Leuven Belgium (BE) University of Lisbon / Universidade de Lisboa (ULisboa) Portugal (PT) Ruprecht-Karls-Universität Heidelberg Germany (DE) Johannes Wesling Klinikum Minden Germany (DE) University of California Los Angeles (UCLA) United States (USA) (US) City Clinical Hospital of Emergency Medical Care Russian Federation (RU) University of California San Francisco (UCSF) United States (USA) (US) Militärmedizinische Akademie S. M. Kirow Russian Federation (RU)

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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