Rivaroxaban curbs MACE, major bleeding risks in AF patients with CAD, regardless of age

Monotherapy with rivaroxaban in patients with atrial fibrillation (AF) and stable coronary artery disease (CAD) appears to protect against the risks of major adverse cardiovascular event (MACE) and major bleeding, with the benefit observed across the broad range of age, according to a post hoc analysis of the open-label AFIRE* trial.

AFIRE included 2,215 patients (mean age 74.3 years, 79.1 percent male) with AF and stable CAD who had undergone percutaneous coronary intervention or coronary artery bypass grafting at least 1 year earlier or who had angiographically confirmed CAD that did not require revascularization. These patients were grouped according to age: <70 years, 70–74 years, 75–79 years, and ≥80 years.

The patients had been randomly assigned to receive rivaroxaban alone or in combination with an antiplatelet. The primary efficacy endpoint of MACE was defined as a composite of stroke, systemic embolism, myocardial infarction, unstable angina requiring revascularization, or death from any cause. Major bleeding was the primary safety endpoint.

The incidence rate of MACE with rivaroxaban monotherapy vs rivaroxaban plus antiplatelet therapy was 3.2 percent vs 4.3 percent per patient-year in the <70-year age group (hazard ratio, 0.74, 95 percent confidence interval [CI], 0.40–1.37), 3.2 percent vs 2.8 percent per patient-year in the 70–74-year age group (HR, 1.16, 95 percent CI, 0.55–2.45), 3.8 percent vs 5.3 percent per patient-year in the 75–79-year age group (HR, 0.72, 95 percent CI, 0.41–1.26), and 6.2 percent vs 10.3 percent in the ≥80-year age group (HR, 0.61, 95 percent CI, 0.40–0.93; p=0.51 for interaction).

Major bleeding occurred in 0.5 percent of patients with rivaroxaban monotherapy vs 2.3 percent with rivaroxaban plus antiplatelet therapy in the <70-year age group (HR, 0.23, 95 percent CI, 0.06–0.79), 2.2 percent vs 2.4 percent in the 70–74-year age group (HR, 0.91, 95 percent CI, 0.39–2.15), 1.1 percent vs 2.1 percent in the 75–79-year age group (HR, 0.52, 95 percent CI, 0.19–1.42), and 2.9 percent vs 4.3 percent in the ≥80-year age group (HR, 0.67, 95 percent CI, 0.35–1.27; p=0.33 for interaction).

*Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease