Antithrombotic therapy for patients with atrial fibrillation and stable coronary artery disease of 1-year and 3-year after percutaneous coronary intervention: a nationwide population-based study

Abstract

Abstract Background In a recent trial, rivaroxaban monotherapy was noninferior for efficacy and superior for safety to rivaroxaban plus single antiplatelet therapy, as antithrombotic therapy for patients with atrial fibrillation (AF) and stable coronary artery disease (CAD). However, there are limited data regarding the comparative effectiveness and safety of oral anticoagulant (OAC) monotherapy versus OAC plus single antiplatelet therapy (SAPT) in real-world practice, especially after the introduction of direct oral anticoagulants (DOAC). Purpose To compare the effectiveness, safety, and net clinical benefit of OAC monotherapy to OAC plus SAPT in patients with AF and stable CAD of 1-year and 3-year after percutaneous coronary intervention (PCI) in a contemporary real-world observational cohort. Methods Using the Korean nationwide claims database, we included AF patients who underwent PCI from January 1, 2009 to February 28, 2019. Considering dynamic changes of antithrombotic therapy according to the period after receiving PCI, the index antithrombotic treatment was independently defined at the different time after receiving PCI and we conducted two cohort: 1-year and 3-year after PCI. In each cohort, the baseline characteristics of OAC monotherapy and OAC plus SAPT groups were balanced using inverse probability of treatment weighting (IPTW) methods. To assess clinical outcomes, ischemic stroke, myocardial infarction, major bleeding, and composite clinical outcomes of each outcome were analyzed. Results In cohort with 1-year after PCI, 678 patients with OAC monotherapy and 3159 patients with OAC plus SAPT were included. In cohort with 3-year after PCI, 1038 patients with OAC monotherapy and 2128 patients with OAC plus SAPT were enrolled. The baseline characteristics were well-balanced after IPTW between the two groups in both cohorts. Among total population, about 45% of patients prescribed DOAC as OAC treatment. Among patients with 1-year after PCI, OAC monotherapy and OAC plus SAPT showed comparable results for ischemic stroke, myocardial infarction, major bleeding, and composite clinical outcomes (Figure). In cohort with 3-year after PCI, OAC monotherapy and OAC plus SAPT showed comparable results for ischemic stroke and myocardial infarction, but OAC monotherapy was associated with a lower risk of the composite clinical outcome (hazard ratio [HR] 0.762, 95% confidence interval [CI] 0.607–0.950), mainly driven by reduction of major bleeding risk (HR 0.762, 95% CI 0.607–0.950) compared to OAC plus SAPT (Figure). Conclusion OAC monotherapy might be, at least, comparable choice for patients with AF and stable CAD compared to OAC plus SAPT. In patients with stable CAD more than 3-years after index PCI, OAC monotherapy could be better therapeutic choice to achieve less major bleeding and positive net clinical benefit. Funding Acknowledgement Type of funding sources: None.