An emulated target trial analysis based on Medicare data suggested non-inferiority of Dabigatran versus Rivaroxaban.

ABSTRACT

OBJECTIVES: Rivaroxaban and Dabigatran were the first two non-vitamin K antagonist oral anticoagulants (NOACs) for preventing stroke among non-valvular Atrial Fibrillation patients. This article aimed to evaluate the relative efficacy and safety of Rivaroxaban versus Dabigatran. STUDY DESIGN AND SETTING: An emulated target trial analysis was conducted based on Medicare, in which we constructed three "randomized clinical trials" with well-defined inclusion/exclusion criteria, treatment regimens, and analysis procedures. We analyzed the individual trials, examined temporal variations, and generated unified results via pooled analysis. RESULTS: With a two-year data collection window (2012-2013), 70,129 subjects were enrolled in the three emulated trials, with 36,269 and 34,089 in the Rivaroxaban and Dabigatran arms, respectively. Dabigatran (the reference group for hazard ratio - HR) was superior regarding time to any primary event (including ischemic stroke, other thromboembolic events, major bleeding, and death; HR 1.232, P-value 0.0025), major bleeding (HR 1.187, P-value <0.0001), and mortality (HR 1.488, P-value <0.0001). Differences regarding stroke and other thromboembolic events were not significant. CONCLUSION: Dabigatran was found as superior for the Medicare patients with multiple chronic conditions. Temporal variations, which had been largely neglected in the literature, were observed. This study may provide new insight into treating AF with NOACs.