Arrhythmias & electrophysiologyMeta-analysis
Incidence and Predictors of Extracranial Bleeding on Oral Anticoagulants for Stroke Prevention in Patients With Atrial Fibrillation: A COMBINE-AF Analysis
- Pooled analysis of 5 randomised trials (COMBINE-AF)
- patient-level pooled analysis
Authors' conclusion
Extracranial clinically relevant bleeding is common among patients with AF treated with OACs and may more accurately reflect the overall burden of bleeding than major bleeding alone. Our models explained about two-thirds of the average population attributable risk, suggesting that additional unmeasured or unknown factors contribute to bleeding risk.
Study context
- Population
- Patients with atrial fibrillation (AF) receiving oral anticoagulant (OACs) (DOAC or warfarin) in 5 pivotal randomised trials
- Participants
- 73,737 patients · 5 RCTs
- Outcome
- Extracranial clinically relevant bleeding (first extracranial major or clinically relevant nonmajor bleeding, ISTH criteria)
Pooled result
As reported in the abstract
Patients with clinically relevant extracranial bleeding
10 634
Cumulative incidence
26% (95% CI, 18%-35%)
Rate
7.6 per 100 person-years
Further pooled results
Major bleeding
- Major bleeds
- 3188
- Cumulative incidence
- 7% (95% CI, 6%-7%)
- Rate
- 2.1 per 100 person-years
Clinically relevant nonmajor bleeding
- Clinically relevant nonmajor bleeds
- 7446
- Cumulative incidence
- 19% (95% CI, 12%-28%)
- Rate
- 5.2 per 100 person-years
Gastrointestinal share of bleeds
- Of clinically relevant bleeds
- 26%
- Of major bleeds
- 49%
- Of clinically relevant nonmajor bleeds
- 15%
Population attributable bleeding risk explained by baseline covariates
- Population attributable risk accounted for
- 66% to 69%
- Risk factors consistent across bleeding severity categories
Original publication
Summarised from the published abstract; every number is checked against it