2.1 Data sources and study population
ROCKTE AF was selected as a case of RCT evaluating the efficacy and safety of rivaroxaban versus warfarin in AF patients. XANTUS, a prospective observational study, was chosen to investigate whether the results of rivaroxaban obtained in ROCKET AF could translate into real-world clinical practice. Two other observational studies (Laliberte 2014 and Amin 2017) were used to assess the effectiveness and safety of rivaroxaban versus warfarin in routine care. Patient baseline characteristics of the four studies were collected, including age, gender, previous thromboembolic events (stroke, systemic embolism-SE), transient ischaemic attack-TIA, and myocardial infarction-MI), heart failure (HF), hypertension, diabetes mellitus (DM), CHADS2 risk of stroke, et al. The incidence rate of events, such as stroke/SE, major bleeding, intracranial hemorrhage (ICH), gastrointestinal (GI) bleeding, and MI, were extracted as events per 100 patient-years.