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Background: The optimal long-term antithrombotic strategy in patients with atrial fibrillation (AF) and stable coronary artery disease (CAD) remains uncertain. Individual randomized controlled trials (RCTs) had variations in their reported results and were not powered for effectiveness outcomes.
Objectives: This study aimed to pool the results of RCTs comparing the effectiveness and safety of oral anticoagulation (OAC) monotherapy vs OAC plus single antiplatelet therapy (SAPT) in patients with AF and stable CAD.
Methods: We systematically searched PubMed, Embase, and ClinicalTrials.gov until September 09, 2024. The primary effectiveness outcome was a composite of myocardial infarction, ischemic stroke, systemic embolism, or death. The primary safety outcome was major bleeding. We obtained unpublished results from principal investigators of the included RCTs, as needed, to calculate pooled HRs and 95% CIs and to perform prespecified subgroup analyses.
Results: Among 690 screened records, 4 RCTs with 4,092 randomized patients were included (2 using edoxaban, 1 using rivaroxaban, and 1 using any oral anticoagulant; mean age 73.9 years, 20.1% women). The median follow-up durations ranged from 12 to 30 months (overall estimated weighted mean follow-up of 21.9 months). There were no statistically significant differences between OAC monotherapy vs OAC plus SAPT in the primary effectiveness outcome (7.3% vs 8.2%; HR: 0.90; 95% CI: 0.72-1.12), myocardial infarction (1.0% vs 0.7%; HR: 1.51; 95% CI: 0.75-3.04), ischemic stroke (1.9% vs 2.1%; HR: 0.89; 95% CI: 0.57-1.37), all-cause death (4.2% vs 5.3%; HR: 0.94; 95% CI: 0.49-1.80), or cardiovascular death (2.4% vs 3.0%; HR: 0.79; 95% CI: 0.54-1.15). OAC monotherapy was associated with a lower risk of major bleeding than OAC plus SAPT (3.3% vs 5.7%; HR: 0.59; 95% CI: 0.44-0.79). Subgroup analyses did not show significant interactions for effectiveness but suggested that the magnitude of bleeding reduction may be greater among men (Pinteraction = 0.03) and among patients with diabetes mellitus (Pinteraction = 0.04).
Conclusions: In patients with AF and stable CAD, OAC monotherapy, compared with OAC plus SAPT, was not associated with a statistically significant increased risk of ischemic events but resulted in a significantly reduced risk of bleeding.
