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Rivaroxaban for stroke prevention after embolic stroke of undetermined source

Hart, R. G. ; Sharma, M. ; Mundl, H. ; Kasner, S. E. ; Bangdiwala, S. I. ; Berkowitz, S. D. ; Swaminathan, B. ; Lavados, P. ; Wang, Y. and Davalos, A. , et al. (2018) In New England Journal of Medicine 378(23). p.2191-2201
Abstract

BACKGROUND Embolic strokes of undetermined source represent 20% of ischemic strokes and are associated with a high rate of recurrence. Anticoagulant treatment with rivaroxaban, an oral factor Xa inhibitor, may result in a lower risk of recurrent stroke than aspirin. METHODS We compared the efficacy and safety of rivaroxaban (at a daily dose of 15 mg) with aspirin (at a daily dose of 100 mg) for the prevention of recurrent stroke in patients with recent ischemic stroke that was presumed to be from cerebral embolism but without arterial stenosis, lacune, or an identified cardioembolic source.The primary efficacy outcome was the first recurrence of ischemic or hemorrhagic stroke or systemic embolism in a time-to-event analysis; the primary... (More)

BACKGROUND Embolic strokes of undetermined source represent 20% of ischemic strokes and are associated with a high rate of recurrence. Anticoagulant treatment with rivaroxaban, an oral factor Xa inhibitor, may result in a lower risk of recurrent stroke than aspirin. METHODS We compared the efficacy and safety of rivaroxaban (at a daily dose of 15 mg) with aspirin (at a daily dose of 100 mg) for the prevention of recurrent stroke in patients with recent ischemic stroke that was presumed to be from cerebral embolism but without arterial stenosis, lacune, or an identified cardioembolic source.The primary efficacy outcome was the first recurrence of ischemic or hemorrhagic stroke or systemic embolism in a time-to-event analysis; the primary safety outcome was the rate of major bleeding. RESULTS A total of 7213 participants were enrolled at 459 sites; 3609 patients were randomly assigned to receive rivaroxaban and 3604 to receive aspirin. Patients had been followed for a median of 11 months when the trial was terminated early because of a lack of benefit with regard to stroke risk and because of bleeding associated with rivaroxaban.The primary efficacy outcome occurred in 172 patients in the rivaroxaban group (annualized rate, 5.1%) and in 160 in the aspirin group (annualized rate, 4.8%) (hazard ratio, 1.07; 95% confidence interval [CI], 0.87 to 1.33; P = 0.52). Recurrent ischemic stroke occurred in 158 patients in the rivaroxaban group (annualized rate, 4.7%) and in 156 in the aspirin group (annualized rate, 4.7%). Major bleeding occurred in 62 patients in the rivaroxaban group (annualized rate, 1.8%) and in 23 in the aspirin group (annualized rate, 0.7%) (hazard ratio, 2.72; 95% CI, 1.68 to 4.39; P<0.001). CONCLUSIONS Rivaroxaban was not superior to aspirin with regard to the prevention of recurrent stroke after an initial embolic stroke of undetermined source and was associated with a higher risk of bleeding.

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organization
publishing date
type
Contribution to journal
publication status
published
subject
in
New England Journal of Medicine
volume
378
issue
23
pages
11 pages
publisher
Massachusetts Medical Society
external identifiers
  • pmid:29766772
  • scopus:85047954755
ISSN
0028-4793
DOI
10.1056/NEJMoa1802686
language
English
LU publication?
yes
id
34c9f043-3d1f-43cc-aab7-bdb147b5c79d
date added to LUP
2019-02-08 14:53:07
date last changed
2024-04-15 22:54:24
@article{34c9f043-3d1f-43cc-aab7-bdb147b5c79d,
  abstract     = {{<p>BACKGROUND Embolic strokes of undetermined source represent 20% of ischemic strokes and are associated with a high rate of recurrence. Anticoagulant treatment with rivaroxaban, an oral factor Xa inhibitor, may result in a lower risk of recurrent stroke than aspirin. METHODS We compared the efficacy and safety of rivaroxaban (at a daily dose of 15 mg) with aspirin (at a daily dose of 100 mg) for the prevention of recurrent stroke in patients with recent ischemic stroke that was presumed to be from cerebral embolism but without arterial stenosis, lacune, or an identified cardioembolic source.The primary efficacy outcome was the first recurrence of ischemic or hemorrhagic stroke or systemic embolism in a time-to-event analysis; the primary safety outcome was the rate of major bleeding. RESULTS A total of 7213 participants were enrolled at 459 sites; 3609 patients were randomly assigned to receive rivaroxaban and 3604 to receive aspirin. Patients had been followed for a median of 11 months when the trial was terminated early because of a lack of benefit with regard to stroke risk and because of bleeding associated with rivaroxaban.The primary efficacy outcome occurred in 172 patients in the rivaroxaban group (annualized rate, 5.1%) and in 160 in the aspirin group (annualized rate, 4.8%) (hazard ratio, 1.07; 95% confidence interval [CI], 0.87 to 1.33; P = 0.52). Recurrent ischemic stroke occurred in 158 patients in the rivaroxaban group (annualized rate, 4.7%) and in 156 in the aspirin group (annualized rate, 4.7%). Major bleeding occurred in 62 patients in the rivaroxaban group (annualized rate, 1.8%) and in 23 in the aspirin group (annualized rate, 0.7%) (hazard ratio, 2.72; 95% CI, 1.68 to 4.39; P&lt;0.001). CONCLUSIONS Rivaroxaban was not superior to aspirin with regard to the prevention of recurrent stroke after an initial embolic stroke of undetermined source and was associated with a higher risk of bleeding.</p>}},
  author       = {{Hart, R. G. and Sharma, M. and Mundl, H. and Kasner, S. E. and Bangdiwala, S. I. and Berkowitz, S. D. and Swaminathan, B. and Lavados, P. and Wang, Y. and Davalos, A. and Shamalov, N. and Mikulik, R. and Cunha, L. and Lindgren, A. and Arauz, A. and Lang, W. and Czlonkowska, A. and Eckstein, J. and Gagliardi, R. J. and Amarenco, P. and Ameriso, S. F. and Tatlisumak, T. and Veltkamp, R. and Hankey, G. J. and Toni, D. and Bereczki, D. and Uchiyama, S. and Ntaios, G. and Yoon, B. W. and Brouns, R. and Endres, M. and Muir, K. W. and Bornstein, N. and Ozturk, S. and O'Donnell, M. J. and De Vries Basson, M. M. and Pare, G. and Pater, C. and Kirsch, B. and Sheridan, P. and Peters, G. and Weitz, J. I. and Peacock, W. F. and Shoamanesh, A. and Benavente, O. R. and Joyner, C. and Themeles, E. and Connolly, S. J.}},
  issn         = {{0028-4793}},
  language     = {{eng}},
  month        = {{06}},
  number       = {{23}},
  pages        = {{2191--2201}},
  publisher    = {{Massachusetts Medical Society}},
  series       = {{New England Journal of Medicine}},
  title        = {{Rivaroxaban for stroke prevention after embolic stroke of undetermined source}},
  url          = {{http://dx.doi.org/10.1056/NEJMoa1802686}},
  doi          = {{10.1056/NEJMoa1802686}},
  volume       = {{378}},
  year         = {{2018}},
}