By Matthew E. Fink, MD

Louis and Gertrude Feil Professor and Chair, Department of Neurology, Associate Dean for Clinical Affairs, NYP/Weill Cornell Medical College

Dr. Fink reports no financial relationships relevant to this field of study.

SOURCE: Yasuda S, Kaikita K, Akao M, et al. Antithrombotic therapy for atrial fibrillation with stable coronary disease. N Engl J Med 2019;381:1103-1113.

Optimal antithrombotic therapy for stroke prevention in patients with atrial fibrillation continues to evolve. Subcategories may require different types of therapy.

This Japanese study was performed as a multicenter, open-label trial. The authors enrolled 2,236 patients with atrial fibrillation who underwent percutaneous coronary intervention or bypass grafting more than a year earlier and who were stable. Subjects were randomized to receive monotherapy with rivaroxaban alone or combination therapy with rivaroxaban plus a single antiplatelet agent. The primary endpoint was a composite of stroke, systemic embolism, myocardial infarction, unstable angina, or death from any cause, and it was analyzed for noninferiority. The primary safety endpoint was major bleeding. This trial ended early because of increased mortality in the combination therapy group of rivaroxaban plus an antiplatelet agent. Monotherapy with rivaroxaban was noninferior to combination therapy for the primary efficacy endpoint, with event rates of 4.14% and 5.75% per patient year, respectively.

Regarding the safety endpoint, rivaroxaban was superior, with event rates of 1.62% and 2.76% per patient year, respectively, for a hazard ratio of 0.59 (P = 0.01). Because this study was performed only in Japan, caution should be taken before generalizing these findings to other countries with different ethnicities.