Rivaroxaban, Aspirin, or Both in Stable Coronary Disease

August 27, 2017

Rivaroxaban, Aspirin, or Both in Stable Coronary Disease

  1. Joel M. Gore, MD

The combination of rivaroxaban plus aspirin was shown to improve outcome, even when bleeding was factored in.

  1. Joel M. Gore, MD

Aspirin remains the mainstay of secondary prevention for coronary artery disease; vitamin K antagonists are superior when added to aspirin or used alone for patients with acute myocardial infarction (MI), but excess bleeding has limited their use. In the manufacturer-sponsored, double-blind COMPASS trial, investigators enrolled 27,395 patients (mean age, 68; 22% women) with stable coronary artery disease to the direct-acting oral anticoagulant rivaroxaban (2.5 mg twice a day) plus aspirin (100 mg daily), rivaroxaban (5 mg twice a day), or aspirin (100 mg daily). The primary outcome was cardiovascular death, stroke, or MI.

The study was stopped after 23 months of follow-up because of a significant advantage in efficacy for rivaroxaban plus aspirin. The primary outcome occurred in 4.1% of patients who received rivaroxaban plus aspirin, 4.9% who received rivaroxaban alone, and 5.4% who received aspirin alone. When bleeding events (3.1%, 2.8%, and 1.9%, respectively) were included in the analysis, the net clinical benefit remained significantly greater with rivaroxaban plus aspirin than with aspirin alone; rivaroxaban alone did not have a significant advantage over aspirin alone. Results were consistent across predefined subgroups including age, sex, geographic region, and race or ethnicity.

Comment

For patients with stable coronary artery disease, it appears that rivaroxaban plus aspirin improves cardiovascular outcomes at 2 years. Many patients who might benefit from this combination are already taking aspirin and other medications, and their ability to add another twice-daily drug to their regimen long-term may bear on how readily rivaroxaban plus aspirin is adopted in clinical practice. The current recommendation for patients with atherosclerotic disease is to remain on aspirin for life; it's unclear whether patients would need to remain on rivaroxaban plus aspirin for life as well. Furthermore, the additional cost of rivaroxaban is not insignificant.

Editor Disclosures at Time of Publication

  • Disclosures for Joel M. Gore, MD at time of publication Grant / Research support NIH–National Heart, Lung, and Blood Institute

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