- In patients with atrial fibrillation (Afib) and stable coronary artery disease (CAD), rivaroxabanmonotherapy was non-inferior to combination therapy with rivaroxaban plus antiplatelet therapy for the composite of cardiovascular events or death from any cause and was superior with respect to major bleeding.
Why this matters
- Limited data exist from randomised trials evaluating the use of antithrombotic therapy in patients with Afib and stable CAD.
- Atrial fibrillation and Ischemic Events with Rivaroxaban in Patients with Stable Coronary Artery Disease (AFIRE) trial included 2236 patients with Afib and stable CAD who were randomly assigned to receive rivaroxabanmonotherapy or rivaroxaban plus a single antiplatelet therapy.
- Primary endpoints:
- efficacy: composite of stroke, systemic embolism, myocardial infarction, unstable angina requiring revascularisation, or death from any cause.
- safety: major bleeding.
- Trial was stopped early because of increased mortality in the combination therapy group.
- Funding: The Japan Cardiovascular Research Foundation.
- Rivaroxabanmonotherapy was non-inferior to combination therapy for primary efficacy endpoint (event rates: 4.14% vs 5.75% per patient-year; HR, 0.72; 95% CI, 0.55-0.95; P<.001 for non-inferiority>
- Rivaroxabanmonotherapy was superior to combination therapy in lowering major bleeding event (1.62% vs 2.76% per patient-year; HR, 0.59; 95% CI, 0.39-0.89; P=.01 for superiority).
- Rivaroxabanmonotherapyvsrivaroxaban plus single antiplatelet therapy was associated with lower risk for:
- all-cause mortality (HR, 0.55; 95% CI, 0.38-0.81) and
- cardiovascular (HR, 0.59; 95% CI, 0.36-0.96) and non-cardiovascular (HR, 0.49; 95% CI, 0.27-0.92) death.
- Risk of bias.
- Rates of withdrawal of consent and loss of patients to follow-up were higher.