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Heart Disease - Clinical Brief

Dual Attack on AVD -- Rivaroxaban Plus Aspirin Better Than Aspirin Alone

In patients with stable atherosclerotic vascular disease, those assigned to rivaroxaban (2.5 mg twice daily) plus aspirin have better cardiovascular outcomes and more major bleeding events than those assigned to aspirin alone.

Author(s): Eikelboom JW, Connolly SJ, et al

Background: Among patients with an acute coronary syndrome, the risk of cardiovascular (CV) death (CVD), stroke, or myocardial infarction (MI) is lower with rivaroxaban (2.5 or 5.0 mg twice daily) than with placebo, with a higher risk of major bleeding.

Objective: To compare rivaroxaban plus aspirin and aspirin alone in preventing recurrent CV events in patients with stable atherosclerotic vascular disease (AVD).

Design: Double-blind, multicenter Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) trial.

Methods: 27,395 participants with stable AVD (mean age, 68.2 years; women, 22.0%) were randomized to rivaroxaban (2.5 mg twice daily) plus aspirin (100.0 mg once daily), rivaroxaban (5.0 mg twice daily), or aspirin (100.0 mg once daily). Primary outcome was a composite of CVD, stroke, or MI. The study was stopped for superiority of the rivaroxaban-plus-aspirin group after a mean follow-up of 23 months.

Results: Primary outcome occurred in 379 patients (4.1%) assigned to rivaroxaban plus aspirin, 448 (4.9%) assigned to rivaroxaban alone, and 496 (5.4%) assigned to aspirin alone. Comparing rivaroxaban plus aspirin with aspirin alone, the hazard ratio (HR) for the primary outcome was 0.76 (95% CI, 0.66 to 0.86; P <0.001). Comparing rivaroxaban (5.0 mg twice daily) alone with aspirin alone, HR was 0.90 (95% CI, 0.79 to 1.03; P =0.12). In the rivaroxaban-plus-aspirin group, 313 deaths (3.4%) were observed compared to 378 (4.1%) in the aspirin-alone group (HR, 0.82; 95% CI, 0.71 to 0.96; P =0.01). Major bleeding occurred in 288 patients (3.1%) in the rivaroxaban-plus-aspirin group compared to 170 patients (1.9%) in the aspirin-alone group (HR, 1.70; 95% CI, 1.40 to 2.05; P <0.001). Most of the excess major bleeding was in the gastrointestinal tract, with no significant difference in the rate of fatal, intracranial, or symptomatic bleeding into a critical organ. The risk of the composite net-clinical-benefit outcome of CVD, stroke, MI, fatal bleeding, or symptomatic bleeding into a critical organ was lower with rivaroxaban plus aspirin than with aspirin alone (431 patients [4.7%] vs 534 patients [5.9%]; HR, 0.80; 95% CI, 0.70 to 0.91; P <0.001).

Conclusions: In patients with stable AVD, the rate of a composite of CVD, stroke, or MI was 24.0% lower with rivaroxaban (2.5 mg twice daily) plus aspirin than with aspirin alone, the rate of major bleeding was higher by 70.0%, and the rate of the net-clinical-benefit outcome was lower by 20.0%. Rivaroxaban (5.0 mg twice daily) alone did not show better CV outcomes compared to aspirin alone but had more major bleeding events.

Reviewer's Comments: This study can potentially change clinical practice. Rivaroxaban plus aspirin had a benefit in reducing CV events in stable AVD patients by targeting both platelets and the coagulation pathway. Future studies need to compare dual-antiplatelet therapy with this combination in stable AVD patients. Also, the efficacy of this combination needs to be tested in various subgroups, for example, patients with heart failure.(Reviewer–Shuchita Gupta, MD).

Article Reviewed: Rivaroxaban With or Without Aspirin In Stable Cardiovascular Disease.

Eikelboom JW, Connolly SJ, et al: N Engl J Med; 2017;DOI: 10.1056/NEJMoa1709118 (August 27): epub ahead of print.

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