OBJECTIVES : Atrial fibrillation (AF) can lead to blood clots, stroke, and other heart-related complications. To reduce the risk of stroke, treatment with NOACs is preferred over warfarin and is recommended for patients starting anticoagulant therapy. In clinical trials, differences in major bleeding and stroke/systemic embolic (SE) events in NOAC-treated patients across regions of the world have been documented. This systematic literature review summarizes reported bleeding and stroke NOAC outcomes in a real world setting in Asia and Europe.

METHODS : MEDLINE and EMBASE databases were searched for publications of real-world registries reporting bleeding and/or stroke outcomes in AF patients receiving NOACs through May 28, 2020. Studies were limited to full-text articles published in 2010 or later followed by targeted searching of conference abstracts for additional data on registries of interest.

RESULTS : 3 registries were identified reporting NOAC outcomes in Asian and European regions (XANTUS/XANAP, rivaroxaban; GLORIA-AF, dabigatran; ETNA AF, edoxaban). The XANTUS/XANAP reported incidence/100 patient-years outcomes in Western Europe, Canada, and Israel (n=5287) and East Asia (n=2233) were: major bleeding (2.3 and 1.5), non-major bleeding (17.9 and 11.1), stroke/non-CNS SE (1.0 and 1.8), and symptomatic thromboembolic event (2.0 and 2.5; includes stroke/non-CNS SE). In the GLORIA-AF registry, European (n=2682) and Asian (n=655) patients had incidences of major bleeding of 0.87 and 0.90 and stroke/SE of 0.70 and 0.90. ETNA AF patients without prior intracranial hemorrhage (ICH) in Europe (n=7636)/Korea or Taiwan (n=1674)/Japan (n=9809) experienced rates of major bleeding of 0.92/0.82/0.96 (including ICH of 0.26/0.32/0.26, major gastrointestinal bleeding of 0.28/0.13/0.43), clinically relevant non-major bleeding of 1.43/0.70/3.20, and ischemic stroke of 0.57/0.70/1.13.

CONCLUSIONS : Consistent with the NOAC clinical trials, these registries suggest regional differences in outcomes which may be associated with underlying patient characteristics and treatment patterns. However, real-world data on differences in NOAC outcomes between Asian and European patients are limited.