Rivaroxaban monotherapy non-inferior to combination therapy in AF and stable CAD patients

Data from the AFIRE study showed that oral anticoagulant monotherapy with rivaroxaban was superior to combination therapy with regard to both safety and efficacy. These findings support guideline recommendation of oral anticoagulant monotherapy for this population.

The Japanese AFIRE study researched whether rivaroxaban monotherapy is non-inferior to combination therapy (rivaroxaban + antiplatelet agent) in atrial fibrillation (AF) patients with stable coronary artery disease (CAD) who did not require percutaneous coronary intervention (PCI) or more than 1 year after PCI or coronary artery bypass grafting (CABG) [1]. A total of 2,236 patients were randomised to either rivaroxaban monotherapy or combination therapy (rivaroxaban + antiplatelet agent). The primary efficacy endpoint was stroke, systemic embolism, myocardial infarction, unstable angina requiring revascularisation, and all-cause mortality. The primary safety endpoint was major bleeding.

Results showed that the incidence rates per year of the primary endpoint in the modified intention-to-treat (ITT) population was 4.14% for those on monotherapy and 5.75% for those on combination therapy; this was a significant difference (HR 0.72; 95% CI 0.55-0.95; P<0.001 for non-inferiority). The incidence rate of major bleeding as seen in the safety population was significantly lower in those patients receiving monotherapy compared with those on combination therapy: 1.62% vs 2.76% per year (HR 0.59; 95% CI 0.39-0.89; P=0.0115). Furthermore, all-cause mortality was significantly lower for monotherapy patients than in combination therapy patients (1.85% vs 3.37%; HR 0.55; 95% CI 0.38-0.81). Adverse clinical events (i.e. the composite of all-cause death, myocardial infarction, stroke, and major bleeding) were lower in patients treated with monotherapy than for those on combination therapy: 3.90% vs 6.28% per year.

The study was terminated earlier than expected as a result of higher rates of all-cause mortality in the dual therapy arm (after median follow-up of 24.1 months). According to principal investigator Dr Satoshi Yasuda (National Cerebral and Cardiovascular Centre, Japan), these data support the guideline recommendation to use oral anticoagulant monotherapy and avoid antiplatelet therapy in AF with co-existing stable CAD. “However, this recommendation has yet to be supported by evidence from randomised controlled trials.”

1. Yasuda S. AFIRE - Rivaroxaban monotherapy versus combination therapy in patients with atrial fibrillation and stable coronary artery disease. FP Number 3175. ESC Congress 2019, 31 Aug-4 Sept, Paris, France.

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Posted on 10 October, 2019