Non-
vitamin K antagonist oral
anticoagulants (NOACs) are effective at preventing
stroke in patients with
atrial fibrillation (AF). However, little is known about the management of
bleeding in contemporary, clinical use of NOACs. We aimed to assess the frequency, management, and outcomes of major
bleeding in the setting of community use of NOACs. Using the Outcomes Registry for Better Informed Treatment of
Atrial Fibrillation II registry, we analyzed rates of International Society on
Thrombosis and Haemostasis major
bleeding and subsequent outcomes in patients treated with NOACs versus
warfarin. Outcomes of interest included acute and chronic
bleeding management, recurrent
bleeding, thromboembolic events, and death. In total, 344 patients with
atrial fibrillation experienced major
bleeding events over a median follow-up of 360 days follow-up: n = 273 on
NOAC (3.3 per 100 patient-years) and n = 71 on
warfarin (3.5 per 100 patient-years). Intracranial
bleeding was uncommon but similar (0.34 per 100 patient-years for
NOAC vs 0.44 for
warfarin, p = 0.5), as was gastrointestinal
bleeding (1.8 for
NOAC vs 1.3 for
warfarin, p = 0.1). Blood products and correction agents were less commonly used in
NOAC patients with major bleeds compared with
warfarin-treated patients (53% vs 76%, p = 0.0004 for blood products; 0% vs 1.5% for recombinant factor; p = 0.0499); no patients received pharmacologic
hemostatic agents (
aminocaproic acid,
tranexamic acid,
desmopressin,
aprotinin). Within 30 days, 23
NOAC-treated patients (8.4%) died versus 5 (7.0%) on
warfarin (p = 0.7). At follow-up, 126
NOAC-treated (46%) and 29
warfarin-treated patients (41%) were not receiving any anticoagulation. In conclusion, rates of major
bleeding are similar in
warfarin and
NOAC-treated patients in clinical practice. However,
NOAC-related bleeds require less blood product administration and rarely require factor replacement.