Prognostic Significance of Nuisance Bleeding in Anticoagulated Patients with Atrial Fibrillation
Background—Bleeding is commonly cited as a reason for stopping oral anticoagulants (OAC). Whether minor bleeding events ("nuisance bleeding", NB) in patients with atrial fibrillation (AF) on OAC are associated with OAC discontinuation, major bleeding and stroke/systemic embolism (SSE), is unknown.
Methods—Within the ORBIT-AF prospective, outpatient registry, we identified 6771 patients ≥18 years of age at 172 sites with AF and eligible followup visits. NB was ascertained from the medical record and was defined as minor bleeding that did not require medical attention (e.g. bruising, hemorrhoidal bleeding). We used multivariable pooled logistic regression modeling to evaluate the associations between NB and major bleeding and SSE in the 180 days after documentation of NB. Our unit of analysis was the patient visit, occurring at approximately 6 month intervals for a median of 1.5 years following enrollment. Changes in anticoagulation treatment satisfaction after NB were examined descriptively in a subset of patients.
Results—The median age of the overall population was 75.0 (IQR 67.0 - 81.0); 90.0% were white and 42.5% were female. Among 6771 patients (18,560 visits), n=1357 (20.0%) had documented NB, for an incidence rate of 14.8 events per 100 person-years. Over 96.4% of patients remained on OAC therapy after the NB event. Overall, 287 (4.3%) patients experienced major bleeding and 64 (0.96%) had a SSE event during follow-up. NB was not associated with a significant increased risk of major bleeding over 6 months models adjusting for the ATRIA bleeding score (OR 1.04; 95% CI 0.68-1.60; p=0.86). NB was also not associated with increased SSE risk over 6 months in or models adjusting for CHA2DS2-VASc risk score (OR 1.24; 95% CI 0.53-2.91; p=0.62).
Conclusions—Nuisance bleeding is common among AF patients on OAC. However, NB was not associated with a higher risk of major bleeding or SSE over the next 6 months, suggesting its occurrence should not lead to changes in anticoagulation treatment strategies in OAC-treated patients.
Clinical Trial Registration—URL: https://clinicaltrials.gov Unique Identifier: NCT01165710
- Received August 28, 2017.
- Revision received March 5, 2018.
- Accepted March 26, 2018.