What question did this study set out to answer?

To compare the efficacy and safety of rivaroxaban monotherapy against combination antithrombotic therapy in patients with atrial fibrillation and stable coronary artery disease.

September 2, 2019New England Journal of MedicineOpen Access

Antithrombotic Therapy for Atrial Fibrillation with Stable Coronary Disease

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Why the study?

Does rivaroxaban monotherapy improve efficacy and safety compared to combination therapy in patients with atrial fibrillation and stable coronary artery disease?

Key Points

To compare the efficacy and safety of rivaroxaban monotherapy against combination antithrombotic therapy in patients with atrial fibrillation and stable coronary artery disease.
Randomized trial conducted under the AFIRE study protocol (UMIN Clinical Trials Registry: UMIN000016612; ClinicalTrials.gov: NCT02642419), funded by the Japan Cardiovascular Research Foundation.
Evaluated patients with atrial fibrillation and stable coronary artery disease assigned to receive either rivaroxaban monotherapy or combination antithrombotic therapy.
Rivaroxaban monotherapy demonstrated noninferior efficacy compared to combination antithrombotic therapy for cardiovascular outcomes (numerical effect sizes not reported in abstract).
Rivaroxaban monotherapy demonstrated statistical superiority for safety over combination therapy, reducing bleeding events (numerical effect sizes not reported in abstract).

Structured PICO

Does rivaroxaban monotherapy improve efficacy and safety compared to combination therapy in patients with atrial fibrillation and stable coronary artery disease?

Population

Patients with atrial fibrillation and stable coronary artery disease

Intervention

Rivaroxaban monotherapy

Comparator

Combination therapy

In patients with atrial fibrillation and stable coronary artery disease, rivaroxaban monotherapy provides noninferior efficacy and superior safety compared to combination therapy.

Implication

May support rivaroxaban monotherapy to reduce bleeding in AF with stable CAD; challenges prior consensus favoring combination therapy.

Abstract

As antithrombotic therapy, rivaroxaban monotherapy was noninferior to combination therapy for efficacy and superior for safety in patients with atrial fibrillation and stable coronary artery disease. (Funded by the Japan Cardiovascular Research Foundation; AFIRE UMIN Clinical Trials Registry number, UMIN000016612; and ClinicalTrials.gov number, NCT02642419.).