Rivaroxaban With or Without Aspirin in Cardiovascular Disease

Study Questions:

Is low-dose rivaroxaban, with or without aspirin, more effective than aspirin alone for secondary cardiovascular prevention?


The COMPASS (Cardiovascular Outcomes for People Using Anticoagulation Strategies) investigators performed a double-blind randomized trial with three arms among 27,395 patients with stable atherosclerotic vascular disease. One arm received rivaroxaban 2.5 mg twice daily plus low-dose aspirin, the second arm received rivaroxaban 5 mg twice daily without aspirin, and the third arm received low-dose aspirin once a day. The primary outcome was a composite of cardiovascular death, stroke, or myocardial infarction. The study was stopped early for superiority in the rivaroxaban plus aspirin arm.


The composite primary endpoint occurred in 4.1% of patients treated with rivaroxaban plus aspirin versus 5.4% of patients in aspirin alone (hazard ratio [HR], 0.76; 95% confidence interval [CI], 0.66-0.86). Patients treated with rivaroxaban alone did not have a reduction in the primary composite endpoint versus patients treated with aspirin alone (4.9% vs. 5.4%; HR, 0.90; 95% CI, 0.79-1.03). Major bleeding occurred in 3.1% of patients in the rivaroxaban plus aspirin group versus 1.9% of patients in the aspirin alone group (HR, 1.70; 95% CI, 1.40-2.05). Mortality was reduced in the rivaroxaban plus aspirin versus aspirin alone group (3.4% vs. 4.1%; HR, 0.82; 95% CI, 0.71-0.96).


The authors concluded that among patients with stable atherosclerotic cardiovascular disease, treatment with rivaroxaban 2.5 mg twice daily plus low-dose aspirin was associated with better cardiovascular outcomes, but more major bleeding than treatment with low-dose aspirin alone.


For patients with stable cardiovascular disease (e.g., no recent acute coronary syndrome or stent requiring dual antiplatelet therapy, peripheral artery disease), use of very low-dose rivaroxaban in addition to standard-of-care aspirin is associated with fewer cardiovascular events, but more bleeding. Of note, benefit was greatest among patients ages <65 years and nonsignificant for patients ages ≥75 years. Whether bleeding risk is lower among these younger populations remains to be established. While the majority of patients in this study had coronary disease, benefit was also seen in patients with peripheral artery disease. However, rivaroxaban is currently not available in a 2.5 mg formulation in the United States.

Keywords: Anticoagulants, Aspirin, Atherosclerosis, Coronary Artery Disease, Hemorrhage, Myocardial Infarction, Peripheral Arterial Disease, Secondary Prevention, Stroke, Vascular Diseases, ESC Congress, ESC2017

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