Rivaroxaban monotherapy reduces subsequent events risk in patients with AF and stable CAD: JAMA

Japan: A post hoc secondary analysis of the AFIRE randomized clinical trial results published in JAMA Cardiology showed that rivaroxaban monotherapy is associated with lower risks of total thrombotic and/or bleeding events than combination therapy in patients with AF and stable CAD. Tapered antithrombotic therapy with a sole anticoagulant should be considered in such patients.

Coronary artery disease (CAD) is one of the main risk factors for atrial fibrillation( AF). Optimal antithrombotic therapy has been sought in patients with atrial fibrillation (AF) complicated by coronary artery disease (CAD). Recently conducted AFIRE(Atrial Fibrillation and Ischemic Events With Rivaroxaban)trial demonstrated the efficiency of rivaroxaban monotherapy compared with standard combination therapy but it failed to capture the true burden of disease, such as multiple thromboembolism, bleeding events after thromboembolism, and thrombotic events after bleeding. Analysis of recurrent events may accurately represent the true burden of CAD with AF and help establish appropriate antithrombotic therapy for these patients.

Ryo Naito, Juntendo University Graduate School of Medicine, Japan, and colleagues conducted a study to compare the total number of thrombotic and/or bleeding events between rivaroxaban monotherapy and combined rivaroxaban and antiplatelet therapy in patients with AF and CAD.

The study enrolled 2215 patients (≥20 years) with AF and stable CAD who had undergone percutaneous coronary intervention (PCI) or coronary artery bypass grafting 1 or more years earlier or who had angiographically confirmed CAD not requiring revascularization.

Patients were equally randomized to either receive monotherapy with rivaroxaban (10 mg once daily for patients with a creatinine clearance of 15 to 49 mL/min or 15 mg once daily for patients with a creatinine clearance ≥50 mL/min) or combination therapy with rivaroxaban and an antiplatelet agent. The total incidences of thrombotic, bleeding, and fatal events were compared between the groups.

Cox regression analyses were used to estimate the risk of subsequent events in the 2 groups, with the status of thrombotic or bleeding events that had occurred by the time of death used as a time-dependent variable.

Data analysis showed that,

• The total event rates for the rivaroxaban monotherapy group and the combination-therapy group were 12.2% and 19.2% respectively, during a median follow-up of 24.1 months.

• The mortality rate was 3.7% in the monotherapy group and 6.6% in the combination therapy group.

• Rivaroxaban monotherapy was associated with a lower risk of total events compared with combination therapy. 

• The mortality risk after a bleeding event (monotherapy, 75%; combination therapy, 62.1%) was higher than that after a thrombotic event (monotherapy, 25%; combination therapy, 37.9%).

The authors concluded that rivaroxaban monotherapy is an independent factor associated with a 38% lower risk of total events, including both the first and subsequent events compared with combination therapy in patients with AF and stable CAD. The mortality risk after a bleeding event was higher than after a thrombotic event.

Clinicians should focus on bleeding as an eminent issue in societies that continue to age around the world and consider tapering antithrombotic agents in patients with AF after PCI to minimize their bleeding events, the authors suggested.

Reference:

Naito R, Miyauchi K, Yasuda S, et al. Rivaroxaban Monotherapy vs Combination Therapy With Antiplatelets on Total Thrombotic and Bleeding Events in Atrial Fibrillation With Stable Coronary Artery Disease: A Post Hoc Secondary Analysis of the AFIRE Trial. JAMA Cardiol. Published online June 15, 2022. doi:10.1001/jamacardio.2022.1561