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Dabigatran for Prevention of Stroke after Embolic Stroke of Undetermined Source.

Publication ,  Journal Article
Diener, H-C; Sacco, RL; Easton, JD; Granger, CB; Bernstein, RA; Uchiyama, S; Kreuzer, J; Cronin, L; Cotton, D; Grauer, C; Brueckmann, M ...
Published in: N Engl J Med
May 16, 2019

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. (Funded by Boehringer Ingelheim; RE-SPECT ESUS ClinicalTrials.gov number, NCT02239120.).

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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

May 16, 2019

Volume

380

Issue

20

Start / End Page

1906 / 1917

Location

United States

Related Subject Headings

  • Stroke
  • Secondary Prevention
  • Recurrence
  • Platelet Aggregation Inhibitors
  • Middle Aged
  • Male
  • Kaplan-Meier Estimate
  • Intracranial Embolism
  • Incidence
  • Humans
 

Citation

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Diener, H.-C., Sacco, R. L., Easton, J. D., Granger, C. B., Bernstein, R. A., Uchiyama, S., … RE-SPECT ESUS Steering Committee and Investigators, . (2019). Dabigatran for Prevention of Stroke after Embolic Stroke of Undetermined Source. N Engl J Med, 380(20), 1906–1917. https://doi.org/10.1056/NEJMoa1813959
Diener, Hans-Christoph, Ralph L. Sacco, J Donald Easton, Christopher B. Granger, Richard A. Bernstein, Shinichiro Uchiyama, Jörg Kreuzer, et al. “Dabigatran for Prevention of Stroke after Embolic Stroke of Undetermined Source.N Engl J Med 380, no. 20 (May 16, 2019): 1906–17. https://doi.org/10.1056/NEJMoa1813959.
Diener H-C, Sacco RL, Easton JD, Granger CB, Bernstein RA, Uchiyama S, et al. Dabigatran for Prevention of Stroke after Embolic Stroke of Undetermined Source. N Engl J Med. 2019 May 16;380(20):1906–17.
Diener, Hans-Christoph, et al. “Dabigatran for Prevention of Stroke after Embolic Stroke of Undetermined Source.N Engl J Med, vol. 380, no. 20, May 2019, pp. 1906–17. Pubmed, doi:10.1056/NEJMoa1813959.
Diener H-C, Sacco RL, Easton JD, 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 B-C, Lemmens R, Masjuan J, Odinak M, Saver JL, Schellinger PD, Toni D, Toyoda K, RE-SPECT ESUS Steering Committee and Investigators. Dabigatran for Prevention of Stroke after Embolic Stroke of Undetermined Source. N Engl J Med. 2019 May 16;380(20):1906–1917.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

May 16, 2019

Volume

380

Issue

20

Start / End Page

1906 / 1917

Location

United States

Related Subject Headings

  • Stroke
  • Secondary Prevention
  • Recurrence
  • Platelet Aggregation Inhibitors
  • Middle Aged
  • Male
  • Kaplan-Meier Estimate
  • Intracranial Embolism
  • Incidence
  • Humans