ABSTRACT: Background Little research has evaluated patient bleeding risk perceptions in comparison with calculated bleeding risk among oral anticoagulant users with atrial fibrillation. Our objective was to investigate underestimation of bleeding risk and to describe the characteristics and patient-reported outcomes associated with underestimation of bleeding risk. Methods and Results In the SAGE-AF (Systematic Assessment of Geriatric Elements in Atrial Fibrillation) study, a prospective cohort study of patients ≥65 years with atrial fibrillation, a CHA2DS2-VASc risk score ≥2 and who were on oral anticoagulant therapy, we compared patients' self-reported bleeding risk with their predicted bleeding risk from their HAS-BLED score. Among the 754 participants (mean age 74.8 years, 48.3% women), 68.0% underestimated their bleeding risk. Participants who were Asian or Pacific Islander, Black, Native American or Alaskan Native, Mixed Race or Hispanic (non-White) (adjusted OR [AOR], 0.45; 95% CI, 0.24-0.82) and women (AOR, 0.62; 95% CI, 0.40-0.95) had significantly lower odds of underestimating their bleeding risk than respective comparison groups. Participants with a history of bleeding (AOR, 3.07; 95% CI, 1.73-5.44) and prior hypertension (AOR, 4.33; 95% CI, 2.43-7.72), stroke (AOR, 5.18; 95% CI, 1.87-14.40), or renal disease (AOR, 5.05; 95% CI, 2.98-8.57) had significantly higher odds of underestimating their bleeding risk. Conclusions We found that more than two-thirds of patients with atrial fibrillation on oral anticoagulant therapy underestimated their bleeding risk and that participants with a history of bleeding and several comorbid conditions were more likely to underestimate their bleeding risk whereas non-Whites and women were less likely to underestimate their bleeding risk. Clinicians should ensure that patients prescribed oral anticoagulant therapy have a thorough understanding of bleeding risk.
