Profiles and outcomes of patients treated with oral anticoagulants for atrial fibrillation who experience bleeding events requiring hospitalization in France.

Background: Patients with atrial fibrillation treated with oral anticoagulants are at risk of bleeding.

Aim: To describe oral anticoagulant-treated patients with atrial fibrillation who experience bleeding events requiring hospitalization, treatment patterns and outcomes following the bleeding event.

Methods: This was a retrospective cohort study using the French national health system claims database, analysing patients with atrial fibrillation newly treated with an oral anticoagulant, with at least one hospitalization for bleeding between 2014 and 2016, followed up to December 2019. Sites of bleeding, sociodemographic and clinical characteristics, treatment patterns before and after the first bleeding event, the number of bleeding events over follow-up, the time from index date to first bleed and the time from first bleed to death are described.

Results: Among 321,346 patients, 12,616 (3.9%) experienced at least one bleeding event (34.9% gastrointestinal). The median follow-up was 3.6 years from the index inclusion and 3.0 years from the first bleed. The mean age was 79.1 years, the mean Charlson Comorbidity Index score was 6.2 and 72% had modified HAS-BLED scores≤3. Before the first bleed, 9.2% of patients had switched from the index oral anticoagulant to another oral anticoagulant, and 6.6% had stopped oral anticoagulant treatment. After the first bleed, 43.6% remained treated with the same oral anticoagulant, 5.2% switched to another oral anticoagulant and 31.7% received no oral anticoagulant. Most patients experienced only one bleeding event; the median time from first bleed to death was 9.3 months.

Conclusions: These "real-life" data show that patients with atrial fibrillation who experience a bleeding event have a high co-morbidity score, but often a low modified HAS-BLED score. The data document treatment patterns before and after bleeding, and show that in patients treated with oral anticoagulants, bleeding is associated with a high subsequent risk of death.