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)
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 – 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
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Disclosure of Unlabeled Use
This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.
The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.
Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information
presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.
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