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.