Acronym: Rivaroxaban vs. Aspirin in Secondary Prevention of Stroke and Prevention of Systemic Embolism in Patients with Recent Embolic Stroke of Undetermined Source

Purpose: Researchers analyzed the efficacy of rivaroxaban (Xarelto, Janssen/Bayer) 15 mg daily vs. aspirin 100 mg daily for prevention of recurrent stroke in patients with embolic stroke of undetermined source

Format: Randomized, parallel-assignment, quadruple-making

Treatment Group: Daily rivaroxaban 15 mg

Control Group: Daily aspirin 100 mg

Number of Participants: 7,213

Centers: 454

Inclusion Criteria: Ischemic stroke that was not lacunar and not linked to extracranial vessel atherosclerosis

Primary Outcome(s):

  • First recurrent stroke or systemic embolism in a time-to-event analysis
  • Primary safety outcome: major bleeding at any site in the body

Follow-up: At the recommendation of the data and safety monitoring committee, the trial was terminated on Oct. 5, 2017, due to an excess risk for bleeding in patients assigned rivaroxaban and the lack of benefit for the reduction of stroke risk. Due to the termination, follow-up was conducted for a median of 11 months.

Summary: Recurrent stroke or systemic embolism occurred in 172 patients assigned rivaroxaban (5.1% annualized rate) vs. 160 assigned aspirin (4.8% annualized rate; HR = 1.07; 95% CI, 0.87-1.33). Ischemic stroke was seen in 158 patients in the rivaroxaban group (4.7% annualized rate) and 156 patients in the aspirin group (4.7% annualized rate; HR = 1.01; 95% CI, 0.81-1.26). More patients assigned rivaroxaban (n = 62; 1.8% annualized rate) had major bleeding compared with patients assigned aspirin (n = 23; 0.7% annualized rate; HR = 2.72; 95% CI, 1.68-4.39).

Original Publication:

Hart RG, et al. N Engl J Med. 2018;doi:10.1056/NEJMoa1802686.

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