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Patient with Stable CVD: Rivaroxaban, Aspirin or Both to Prevent Recurrent Events?

BACKGROUND AND PURPOSE:

  • Aspirin reduces risk of major CV events by 19% and CV death by 9% in those with CVD
    • 5 to 10% of patients will still have recurrent CV events
  • Eikelboom et al. (NEJM, 2017) assessed whether rivaroxaban, aspirin or both is most effective for secondary cardiovascular event prevention in those with stable atherosclerotic vascular disease

METHODS:

  • Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) trial
  • 602 centers in 33 countries
  • Double-blind randomized controlled (RCT) trial
  • Inclusion criteria: Coronary artery disease, peripheral arterial disease, or both
  • Participants were randomly assigned to 1 of 3 cohorts
    • Rivaroxaban (2.5 mg twice daily) plus aspirin (100 mg once daily)
    • Rivaroxaban (5 mg twice daily)
    • Aspirin (100 mg once daily)
  • Primary outcome
    • Composite of cardiovascular death, stroke, or myocardial infarction
  • The study was stopped short at 23 month follow-up, due to superiority of the rivaroxaban and aspirin group

RESULTS:

  • Comparing to aspirin-alone group, the rivaroxaban-plus-aspirin group had
    • Fewer patients (4.1% vs 5.4%) with adverse cardiovascular events (hazard ratio [HR] 0.76; 95% CI 0.66 to 0.86; P<0.001)
    • More major bleeding events occurred (3.1% vs 1.9% HR 1.70; 95% CI 1.40 to 2.05; P<0.001)
  • Most major bleeding was into the gastrointestinal tract
  • There was no significant difference in intracranial bleeding, fatal bleeding or bleeding into a critical organ
  • There were 313 deaths (3.4%) in the rivaroxaban-plus-aspirin group as compared with 378 (4.1%) in the aspirin-alone group ([HR] 0.82; 95% CI 0.71 to 0.96; P=0.01; threshold P value for significance, 0.0025)
  • When comparing rivaroxaban-alone group than in the aspirin-alone group, there was no significant difference in primary outcome but there were more major bleeding events

CONCLUSION:

  • Rivaroxaban-plus-aspirin had better cardiovascular outcomes compared to aspirin alone
  • Rivaroxaban alone did not impact outcomes and had more major bleeding events than aspirin alone

Learn More – Primary Sources:

Rivaroxaban with or without Aspirin in Stable Cardiovascular Disease