Arrhythmias & electrophysiology

Bleeding risk using non-steroidal anti-inflammatory drugs in anticoagulated patients with atrial fibrillation: a nationwide cohort study

Eur Heart J Qual Care Clin OutcomesPublished nationwide cohort study

Authors' conclusion

NSAID use was associated with a nearly two-fold increase in hospital-diagnosed bleeding among patients with AF receiving oral anticoagulation. The risk appeared highest with edoxaban, followed by apixaban and rivaroxaban, and lowest with dabigatran and warfarin. The risk was not restricted to the gastrointestinal tract.

Study context

Population
Patients with first-time diagnosed atrial fibrillation (AF) who initiated oral anticoagulation during 2012–22
Participants
114,119 patients
Exposure
NSAID use vs non-use
Outcome
Hospital-diagnosed bleeding events per 100 person-years

Main finding

As reported in the abstract

Number needed to harm (patients treated for 1 year)
43

Observational data: associations, not effects.

Further findings

OutcomeaHR (95% CI)
Hospital-diagnosed bleeding by siteNSAID use vs non-use · bleeding overall · Time-dependent multivariate cause-specific Cox regression1.81 (1.59–2.06)
Hospital-diagnosed bleeding by siteNSAID use vs non-use · gastrointestinal bleeding · Time-dependent multivariate cause-specific Cox regression2.30 (1.92–2.76)
Hospital-diagnosed bleeding by siteNSAID use vs non-use · thoracic/respiratory tract bleeding · Time-dependent multivariate cause-specific Cox regression1.59 (1.13–2.24)
Hospital-diagnosed bleeding by siteNSAID use vs non-use · urinary tract bleeding · Time-dependent multivariate cause-specific Cox regression1.48 (1.17–1.88)
Hospital-diagnosed bleeding by siteNSAID use vs non-use · anaemia caused by bleeding · Time-dependent multivariate cause-specific Cox regression3.50 (2.33–5.26)
Bleeding by anticoagulantNSAID use vs non-use · rivaroxaban2.05 (1.64–2.57)
Bleeding by anticoagulantNSAID use vs non-use · apixaban2.15 (1.70–2.72)
Bleeding by anticoagulantNSAID use vs non-use · dabigatran1.40 (0.92–2.13)
Bleeding by anticoagulantNSAID use vs non-use · edoxaban2.87 (1.26–6.53)
Bleeding by anticoagulantNSAID use vs non-use · warfarin1.46 (1.07–1.98)

NSAID subtypes

Results were consistent across NSAID subtypes.

Original publication

Bleeding risk using non-steroidal anti-inflammatory drugs in anticoagulated patients with atrial fibrillation: a nationwide cohort study. Eur Heart J Qual Care Clin Outcomes. Published 5 August 2025. doi:10.1093/ehjqcco/qcaf076

Summarised from the published abstract; every number is checked against it

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