Edoxaban monotherapy reduced primary outcome events by 58% (6.3% vs 16.5%; HR 0.42; P<.001) and major bleeding by 65% compared to dual therapy in AF patients post-PCI.
Does edoxaban monotherapy reduce adverse clinical events compared to dual antithrombotic therapy in patients with atrial fibrillation and a history of PCI?
In patients with atrial fibrillation and prior PCI, edoxaban monotherapy significantly reduces the composite of ischemic and bleeding events compared to dual antithrombotic therapy, driven by a reduction in bleeding without an increase in ischemic events.
Absolute Event Rate: 0% vs 0%
Abstract Background The EPIC-CAD (Edoxaban versus Edoxaban with Antiplatelet Agent in Patients with Atrial Fibrillation and Chronic Stable Coronary Artery Disease) trial demonstrated the superior clinical benefit of edoxaban monotherapy compared with dual antithrombotic therapy (edoxaban plus a single antiplatelet agent) in patients with atrial fibrillation (AF) and stable coronary artery disease. However, debate remains regarding the optimal long-term antithrombotic therapy in AF patients with coronary stenting in terms of thrombotic risk management. Purpose This study aimed to compare the efficacy and safety of edoxaban monotherapy versus dual antithrombotic therapy in AF patients with a history of percutaneous coronary intervention (PCI), with particular focus on their elevated thrombotic risk profile. Methods This prespecified main subgroup analysis compared monotherapy versus daul antithrombotic therapy in patients with previous PCI from the EPIC-CAD trial. The primary outcome was a composite of all-cause mortality, myocardial infarction, stroke, systemic embolism, unplanned urgent revascularization, and bleeding events (major or clinically relevant nonmajor) over entire study period. Additionally, we employed win ratio methodology to analyze hierarchical outcomes with prioritization of ischemic risk. Results Of 1040 patients in EPIC-CAD trial, 626 (60.2%) patients who underwent PCI at least 6 months before randomization were included in the analysis. At 12 months, monotherapy (n=308) was significantly associated with a lower risk of the primary-outcome events compared with dual antithrombotic therapy (6.3% vs. 16.5%; hazard ratioHR: 0.42; 95% confidence interval CI: 0.26 to 0.68; P.001), while the cumulative incidence of major ischemic events was not significantly different (0.7% vs 1.4%; HR: 1.05; 95% CI: 0.26 to 4.20, P=0.95). The difference in the occurrence of the primary-outcome events were primarily driven by the major bleeding or clinically relevant nonmajor bleeding (4.7% vs 14.2%; HR: 0.35; 95% CI: 0.20 to 0.61, P.001). In addition, edoxaban monotherapy was associated with wins in 16.0% of pairs, compared with 6.2% in the dual antithrombotic therapy group, resulting in a win ratio of 2.57 (95% CI: 1.55-4.25; P.001). Conclusion In AF patients with PCI, the comparative clinical benefit of edoxaban monotherapy compared with dual antithrombotic therapy was consistent with those in the EPIC-CAD trial.Time-to-event curves Win ratio diagram
Wee et al. (Sat,) reported a other. Edoxaban monotherapy reduced primary outcome events by 58% (6.3% vs 16.5%; HR 0.42; P<.001) and major bleeding by 65% compared to dual therapy in AF patients post-PCI.