Abstract Body (Do not enter title and authors here): Background: Despite guideline recommendations, randomized trial evidence on non-vitamin K antagonist oral anticoagulant (NOAC) monotherapy without antiplatelet agents in atrial fibrillation (AF) patients stabilized after drug-eluting stent (DES) implantation remains limited.
Methods: In this multicenter, randomized, open-label, noninferiority trial, we randomly assigned patients with AF who had undergone DES implantation at least 1 year earlier to receive either NOAC monotherapy or NOAC plus clopidogrel. The primary endpoint was net adverse clinical events, defined as a composite of all-cause death, myocardial infarction, stent thrombosis, stroke, systemic embolism, or major bleeding or clinically relevant nonmajor bleeding at 12 months, with a noninferiority margin of 3.0 percentage points. A sample size of 960 patients was calculated to provide 80% power to demonstrate noninferiority with a one-sided type I error rate of 2.5%, assuming an attrition rate of 18%.
Results: A total of 960 patients underwent randomization, with 482 assigned to the NOAC monotherapy group and 478 to the NOAC plus clopidogrel group. The mean age of the patients was 71.1 years, 21.4% were women, and the mean CHA₂DS₂-VASc score was 4.1. At 12 months, a primary endpoint had occurred in 9.6% of the patients in the NOAC monotherapy group and in 17.2% of those in the NOAC plus clopidogrel group (absolute difference, –7.6 percentage points [95.2% confidence interval, -11.9 to -3.3]; P<0.001 for noninferiority; hazard ratio, 0.54 [95.2% confidence interval, 0.37 to 0.77]; P<0.001 for superiority) (see Figure 1). Major bleeding or clinically relevant nonmajor bleeding occurred in 5.3% in the NOAC monotherapy group and in 13.3% in the NOAC plus clopidogrel group (hazard ratio, 0.38 [95% confidence interval, 0.24 to 0.60]). The incidence of major adverse cardiac and cerebrovascular events, comprising cardiovascular death, myocardial infarction, stent thrombosis, ischemic stroke, or systemic embolism, was similar between the two groups (hazard ratio, 0.84 [95% confidence interval, 0.43 to 1.63]) (see Figure 2).
Conclusions: In patients with AF and stable coronary artery disease beyond 1 year after DES implantation, NOAC monotherapy was both noninferior and superior to NOAC plus clopidogrel for the composite of all-cause death, myocardial infarction, stent thrombosis, stroke, systemic embolism, or major bleeding or clinically relevant nonmajor bleeding at 12 months.