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

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

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

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