Therapeutic Strategies Following Major, Clinically Relevant Nonmajor, and Nuisance Bleeding in Atrial Fibrillation: Findings From ORBIT‐AF

Abstract

BackgroundOral anticoagulation (OAC) reduces stroke risk in atrial fibrillation, but bleeding is a frequent side effect. The decision to discontinue or modify medication regimens in response to a bleeding event may differ according to bleeding site and severity.Methods and ResultsWe used data from a large, national outpatient registry, ORBIT‐AF (Outcomes Registry for Better Informed Treatment of Atrial Fibrillation; 2010–2011), to evaluate event characteristics and OAC management following the first bleeding event occurring during follow‐up. Bleeding events were classified into 3 categories: (1) International Society of Thrombosis and Hemostasis major bleeding, (2) clinically relevant nonmajor bleeding requiring medical attention, and (3) nuisance bleeding not requiring medical attention (eg, bruising, hemorrhoidal bleeding). Of 9743 patients enrolled in ORBIT‐AF with follow‐up data, 510 (3.23/100 subject‐years) experienced a major bleed, 615 (3.90/100 subject‐years), experienced a clinically relevant nonmajor bleed, and 1558 (9.87/100 subject‐years) experienced a nuisance bleed, among first bleeds over 2 years. Nearly one third of patients (31.6%) discontinued OAC therapy following a major bleeding event, 12.7% following a clinically relevant nonmajor bleed, and 4.5% following a nuisance bleed. Compared with those who experienced a clinically relevant nonmajor or nuisance bleed, patients who experienced a major bleed were more likely to be black and female and to have a history of heart failure and stroke. Those who discontinued were more likely to have central nervous system or gastrointestinal bleeding than those who persisted on OAC therapy.ConclusionsOverall, 1 in 3 patients who experienced a major bleed was no longer anticoagulated after the event. Those who discontinued OAC were more likely to have central nervous system or gastrointestinal bleeding than those who persisted on OAC.

Predicting Bleeding Events in Anticoagulated Patients With Atrial Fibrillation: A Comparison Between the HAS‐BLED and GARFIELD‐AF Bleeding Scores

“…Also, all bleeding events are associated with an impaired quality of life 28. Irrespective of type, patients experiencing a bleeding event are more likely to discontinue OAC treatment,29 which is associated with an increased risk for clinically significant events 30…”

Bleeding Risk Assessment in End-Stage Kidney Disease: Validation of Existing Risk Scores and Evaluation of a Machine Learning-Based Approach

“…23 24 25 Seven bleeding risk prediction scores potentially applicable to the HD setting were identified and evaluated. The HAS-BLED, 26 ATRIA, 27 ORBIT, 28 OBRI, 29 and mORBI 30 scores were calculated based on the variables collected at study inclusion for each patient as defined in their original development studies. For the HEMORR 2 HAGES risk score, two variables (i.e., “excessive fall risk” and “genetic factors”) could not be considered due to the lack of baseline information with respect to fall risk and CYP2C9 single nucleotide polymorphisms.…”

“…Of all scores, the HAS-BLED score (26) showed the highest discriminatory performance in the total population with a C-statistic of 0.59 (95%CI 0.53-0.66). C-statistics of the ATRIA (27), HEMORR 2 HAGES (39), ORBIT (28), OBRI (29), mOBRI (30), and Shireman et al (31) S3 and Figure S2.…”

Evaluation of definitions for oral anticoagulant-associated major bleeding: A population-based cohort study

“…Our findings demonstrate heterogeneity in clinical outcomes across bleeding definitions and thus call for definition revision with anchoring to clinically relevant outcomes for both patient and care providers. Perhaps a graded measure, such as the modified Rankins scale used in stroke research, could provide a potential solution [32]. In a points-based outcome measure, criteria with stronger association with death or OAC cessation, such as intracranial hemorrhage, would be weighted more heavily (i.e.…”