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Updated: Jan 20, 2026
Robotic Ablation of Atrial Fibrillation
Published on: May 29, 2015
Antithrombotic Therapy for Atrial Fibrillation with Stable Coronary Disease
Satoshi Yasuda1, Koichi Kaikita1, Masaharu Akao1
1From the National Cerebral and Cardiovascular Center, Suita (S.Y., H.O.), the Department of Cardiology, Osaka Police Hospital, Osaka (A.H.), the Department of Cardiovascular Medicine, Graduate School of Medical Sciences, Kumamoto University (K. Kaikita), and the Department of General Medicine, Kumamoto University Hospital (K. Matsui), Kumamoto, the Department of Cardiology, National Hospital Organization Kyoto Medical Center, Kyoto (M.A.), the Department of Cardiovascular Medicine, Kitasato University School of Medicine, Sagamihara (J.A.), the Department of Cardiovascular Medicine, Kyushu University Hospital, Fukuoka (T.M.), the Division of Cardiovascular Medicine, Toho University Ohashi Medical Center (M.N.), the Department of Cardiology, Juntendo University School of Medicine (K. Miyauchi), and the Department of Cardiology, Tokyo Women's Medical University (N.H.), Tokyo, and the Cardiovascular Center, Yokohama City University Medical Center, Yokohama (K. Kimura) - all in Japan.
Insights
Rivaroxaban monotherapy is as effective as combination therapy for preventing major adverse events in patients with atrial fibrillation and stable coronary artery disease. This approach also significantly reduces the risk of major bleeding.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Limited randomized trial data exist for antithrombotic therapy in patients with atrial fibrillation and stable coronary artery disease.
- Existing guidelines often recommend dual therapy, but safety concerns persist.
Purpose of the Study:
- To evaluate the noninferiority and safety of rivaroxaban monotherapy compared to combination therapy in patients with atrial fibrillation and stable coronary artery disease.
Main Methods:
- A multicenter, open-label trial randomized 2236 patients with atrial fibrillation and stable coronary artery disease.
- Patients received either rivaroxaban monotherapy or rivaroxaban plus a single antiplatelet agent.
- Primary efficacy endpoint was a composite of major thrombotic events; primary safety endpoint was major bleeding.
Main Results:
- Rivaroxaban monotherapy was noninferior to combination therapy for efficacy (4.14% vs. 5.75% per patient-year; HR 0.72).
- Rivaroxaban monotherapy was superior to combination therapy for safety, demonstrating significantly lower rates of major bleeding (1.62% vs. 2.76% per patient-year; HR 0.59).
- The trial was stopped early due to increased mortality in the combination-therapy group.
Conclusions:
- Rivaroxaban monotherapy is a safe and effective alternative to combination therapy for patients with atrial fibrillation and stable coronary artery disease.
- This strategy offers improved safety without compromising efficacy.
- Findings support a shift towards simpler antithrombotic regimens in this patient population.
Background:
There are limited data from randomized trials evaluating the use of antithrombotic therapy in patients with atrial fibrillation and stable coronary artery disease.
Methods:
In a multicenter, open-label trial conducted in Japan, we randomly assigned 2236 patients with atrial fibrillation who had undergone percutaneous coronary intervention (PCI) or coronary-artery bypass grafting (CABG) more than 1 year earlier or who had angiographically confirmed coronary artery disease not requiring revascularization to receive monotherapy with rivaroxaban (a non-vitamin K antagonist oral anticoagulant) or combination therapy with rivaroxaban plus a single antiplatelet agent. The primary efficacy end point was a composite of stroke, systemic embolism, myocardial infarction, unstable angina requiring revascularization, or death from any cause; this end point was analyzed for noninferiority with a noninferiority margin of 1.46. The primary safety end point was major bleeding, according to the criteria of the International Society on Thrombosis and Hemostasis; this end point was analyzed for superiority.
Results:
The trial was stopped early because of increased mortality in the combination-therapy group. Rivaroxaban monotherapy was noninferior to combination therapy for the primary efficacy end point, with event rates of 4.14% and 5.75% per patient-year, respectively (hazard ratio, 0.72; 95% confidence interval [CI], 0.55 to 0.95; P<0.001 for noninferiority). Rivaroxaban monotherapy was superior to combination therapy for the primary safety end point, with event rates of 1.62% and 2.76% per patient-year, respectively (hazard ratio, 0.59; 95% CI, 0.39 to 0.89; P = 0.01 for superiority).
Conclusions:
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.).
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