Arrhythmias & electrophysiologySecondary analysis
Patients With Atrial Fibrillation Taking Nonsteroidal Anti-Inflammatory Drugs and Oral Anticoagulants in the ARISTOTLE Trial
- Secondary analysis of the ARISTOTLE randomised trial
- time-dependent Cox proportional hazards models
Authors' conclusion
Incident NSAID use was associated with major and clinically relevant nonmajor bleeding, but not with gastrointestinal bleeding. The safety and efficacy of apixaban versus warfarin appeared not significantly to be altered by NSAID use.
Study context
- Population
- Patients with AF at increased risk of stroke in ARISTOTLE, without severe renal (creatine clearance ≤30 mL/min) or liver diseaseARISTOTLE n=18,201
- Participants
- 17,423 patients
- Comparison
- Incident NSAID use vs never use in patients on apixaban or warfarin
- Baseline NSAID usen = 832
- Incident NSAID usen = 2,185
- Primary endpoint
- Major bleeding
- Follow-up
- Median 1.8 (1.4, 2.3) years
Primary result
As reported in the abstract
Hazard ratio
1.61
95% CI 1.11–2.33
Incident NSAID use vs Never users
HR 1.61 (95% CI 1.11–2.33)
Secondary outcomes
| Outcome | HR (95% CI) | |
|---|---|---|
| Clinically relevant nonmajor bleeding | 1.70 (1.16–2.48) | |
| 0.512Hazard ratio (log scale) |
History of bleeding · baseline
Gastrointestinal bleeding
- Incident NSAID use not associated with gastrointestinal bleeding
Interaction NSAID use × randomised treatment
- No significant interaction for any outcome
Original publication
Patients With Atrial Fibrillation Taking Nonsteroidal Anti-Inflammatory Drugs and Oral Anticoagulants in the ARISTOTLE Trial. Circulation. Published 21 November 2019. doi:10.1161/circulationaha.119.041296
Summarised from the published abstract; every number is checked against it