Patient concern regarding bleeding side effects from oral anticoagulation therapy for atrial fibrillation: an analysis from the multicentre KiCS-AF registry

Aims: The purpose of this study is to utilize patient-reported outcomes to determine the percentage of patients concerned about mild to moderate bleeding side effects of anticoagulants. Methods and results: We consecutively enrolled 3312 newly diagnosed or referred patients for atrial fibrillation (AF) management from 11 sites within the Keio interhospital Cardiovascular Studies-Atrial Fibrillation registry between September 2012 and May 2018. Of these patients, 2636 (79.5%) were taking oral anticoagulants at enrollment. Using the Atrial Fibrillation Effect on Quality-of-life questionnaire (AFEQT), the patients who responded '1: not at all bothered' or '2: hardly bothered' on the seven-point scale regarding bleeding side effects were classified as the 'no OAC concern' group while those responding '3: a little bothered' to '7: extremely bothered' were classified as the 'OAC concern' group. On baseline analysis, 29.3% (n = 772) were 'concerned' about bleeding side effects. The proportion of women and patients with AF-related symptoms was higher in the oral anticoagulant (OAC) concern vs. no OAC concern group (36.9% vs. 29.8%, P < 0.0004 and 66.2% vs. 56.7%, P < 0.0001, respectively). The CHADS2 scores ≥ 2 were comparable between groups. Of the 430 patients in the 1-year follow-up analysis, the proportion of the continued OAC concern group (1 year from enrollment) was 41.6%. The dabigatran, rivaroxaban, and apixaban usage rates were comparable between the two groups in baseline and 1-year follow-up analysis. Conclusion: Approximately one-third of all patients with AF on anticoagulant therapy were concerned regarding bleeding from short- and long-term anticoagulant use.