Compared with aspirin monotherapy, twice daily 2.5 mg rivaroxaban plus aspirin resulted in better cardiovascular outcomes, but more major bleeding events in patients with stable atherosclerotic vascular disease, according to the results from a double-blind trial published in the New England Journal of Medicine. The trial results were presented at the European Society of Cardiology’s 2017 Congress held from August 26-30 in Barcelona, Spain.1,2
In the COMPASS trial (ClinicalTrials.gov identifier: NCT01776424), researchers randomly assigned 27,395 patients with stable atherosclerotic vascular disease to 1 of 3 groups: twice daily rivaroxaban (5 mg), once daily aspirin (100 mg), or rivaroxaban (2.5 mg) twice daily plus once daily aspirin (100 mg). Primary outcome for this study was the composite of cardiovascular death, myocardial infarction, or stroke.
In the rivaroxaban plus aspirin combination group, fewer patients experienced the primary outcome compared with aspirin monotherapy (4.1% vs 5.4%; hazard ratio [HR], 0.76; 95% CI, 0.66-0.86; P <.001; z=4.126). Combination therapy resulted in more major bleeding events than aspirin alone (3.1% vs 1.9%; HR, 1.70; 95% CI, 1.40-2.05; P <.001). Major bleeding events also occurred more frequently in the rivaroxaban-alone group. No significant differences were observed between the 2 groups in terms of intracranial or fatal bleeding.
In additional, mortality was significantly higher in the aspirin monotherapy group compared with rivaroxaban-aspirin dual therapy (4.1% vs 3.4%; HR, 0.82; 95% CI, 0.71 to 0.96; P =.01). After a mean follow-up period of 23 months, the trial was stopped due to superiority of the rivaroxaban plus aspirin combination group.
Despite greater events of major bleeding, the investigators concluded that dual therapy with twice-daily rivaroxaban 2.5 mg plus aspirin results in better cardiovascular outcomes in secondary cardiovascular prevention.
- Eikelboom JW, Connolly SJ, Bosch J, et al. Rivaroxaban with or without aspirin in stable cardiovascular disease. European Society of Cardiology Congress 2017; August 26-30, 2017; Barcelona, Spain.
- Eikelboom JW, Connolly SJ, Bosch J, et al. Rivaroxaban with or without aspirin in stable cardiovascular disease [published online August 27, 2017]. N Engl J Med. doi:10.1056/NEJMoa1709118