Key result
Rivaroxaban monotherapy reduced net adverse events vs combination therapy in patients with atrial fibrillation, CAD, and prior atherothrombosis (HR 0.50; 95% CI 0.34-0.74; P<0.001).
Why the study?
Patients with AF and stable CAD who have histories of atherothrombotic disease are at high risk for future ischemic events, but the efficacy and safety of rivaroxaban monotherapy in this population remained unclear.
Does rivaroxaban monotherapy reduce net adverse events compared to combination therapy in patients with atrial fibrillation, stable coronary artery disease, and prior atherothrombotic disease?
RCT (n=2,215)
Does rivaroxaban monotherapy reduce net adverse events compared to combination therapy in patients with atrial fibrillation, stable coronary artery disease, and prior atherothrombotic disease?
Hazard Ratio: 0.5 (95% CI 0.34–0.74)
p-value: p=<0.001
In patients with atrial fibrillation, stable coronary artery disease, and prior atherothrombotic disease, rivaroxaban monotherapy significantly reduces net adverse events and major bleeding compared to combination therapy with an antiplatelet agent.
Supports rivaroxaban monotherapy over combination therapy in this subgroup; extends randomized AF-CAD evidence to patients with prior atherothrombosis.
Background Among patients with atrial fibrillation and stable coronary artery disease, those with histories of atherothrombotic disease are at high‐risk for future ischemic events. This study investigated the efficacy and safety of rivaroxaban monotherapy in patients with atrial fibrillation, coronary artery disease, and histories of atherothrombotic disease. Methods and Results This was a post hoc subanalysis of the AFIRE (Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease) trial. Patients with non‐valvular atrial fibrillation and coronary artery disease were recruited and randomized to receive the rivaroxaban monotherapy or combination therapy with rivaroxaban plus antiplatelet drug. For the purpose of this sub‐study, participants were divided into 2 subgroups, including the atherothrombosis group (those with histories of myocardial infarction, stroke, and/or peripheral artery disease; n=1052, 47.5%) and non‐atherothrombosis group (n=1163, 52.5%). The efficacy end point included cardiovascular events or all‐cause death, while the safety end point was major bleeding. Net adverse events consisted of all‐cause death, myocardial infarction, stroke, or major bleeding. In the atherothrombosis group, rivaroxaban monotherapy was significantly associated with a lower risk of net adverse events when compared with combination therapy (hazard ratio [HR], 0.50; 95% CI, 0.34–0.74; P <0.001), with a decrease in both efficacy (HR, 0.68; 95% CI, 0.47–0.99; P =0.044) and safety (HR, 0.37; 95% CI, 0.19–0.71; P =0.003) end points. By contrast, there were no differences between treatment outcomes for the non‐atherothrombosis group. Conclusions Rivaroxaban monotherapy significantly reduced net adverse events as compared with combination therapy for patients with atrial fibrillation, coronary artery disease, and prior atherothrombotic disease. Registration URL: https://www.umin.ac.jp/ctr/ ; Unique identifier: UMIN000016612. URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02642419.
No takes yet. Share an insight, caveat, or question.
A 2021 study conducted an RCT in Atrial fibrillation and stable coronary artery disease (n=2,215). Rivaroxaban monotherapy vs. Combination therapy with rivaroxaban plus antiplatelet drug was evaluated on Net adverse events (all-cause death, myocardial infarction, stroke, or major bleeding) (HR 0.50, 95% CI 0.34-0.74, p=<0.001). Rivaroxaban monotherapy reduced net adverse events vs combination therapy in patients with atrial fibrillation, CAD, and prior atherothrombosis (HR 0.50; 95% CI 0.34-0.74; P<0.001).
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: