Arrhythmias & electrophysiologySecondary analysis
Major Bleeding With Apixaban vs Aspirin
- Secondary analysis of the ARTESiA randomised trial
- prespecified subanalysis
- international
- double-blind
- double-dummy
Authors' conclusion
Results of this subanalysis of the ARTESiA randomized clinical trial found that although the rate of major gastrointestinal bleeding was higher in patients with SCAF who were treated with apixaban vs aspirin, rates of fatal and intracranial bleeding were not different. Most major bleeding events were nonemergencies characterized by a decrease in hemoglobin level greater than or equal to 2 g/dL. NSAID use, cancer, randomization to apixaban, and increasing age were associated with an increased risk of major bleeding.
Study context
- Population
- Patients with device-detected subclinical AF (subclinical atrial fibrillation (SCAF), 6 min–24 h) and CHA2DS2-VASc ≥3 or prior strokereceived treatment
- Participants
- 3,961 patients
- Comparison
- Apixaban vs aspirin
- Apixabann = 1,989
- Aspirinn = 1,972reference
- Primary endpoint
- Major bleeding (ISTH criteria, blinded adjudication)
- Follow-up
- Mean 3.5 years
Primary result
Major bleeding · mean (SD) follow-up 3.5 (1.8) years
Hazard ratio
1.80
95% CI 1.26–2.57
Events by treatment group
As reported in the abstract
Further findings
per 100 patient-years
| Outcome | Apixaban | Aspirin | HR (95% CI) | P value | |
|---|---|---|---|---|---|
| Intracranial bleeding | 0.33 | 0.40 | 0.82 (0.43–1.57) | ||
| Fatal bleeding | 0.10% | 0.16% | 0.63 (0.20–1.91) | ||
| Gastrointestinal bleeding | 0.89% | 0.40% | 2.23 (1.32–3.78) | ||
| 0.20.5125Hazard ratio (log scale) |
Index major bleeds at critical sites · critical sites
P = 0.03
Intracranial Apixaban 18.6% [16 of 86] · Aspirin 42.6% [20 of 47] · P = 0.003
Factors associated with major bleeding
- Nonsteroidal anti-inflammatory drug (NSAID) use, HR
- 10.25 (95% CI 6.57-15.99)
- Cancer, HR
- 2.87 (95% CI 1.49-5.53)
- Randomization to apixaban, HR
- 1.84 (95% CI 1.29-2.63)
- Age per 5-year increase, HR
- 1.47 (95% CI 1.28-1.67)
- Most major bleeds were nonemergencies with hemoglobin decrease ≥2 g/dL
Original publication
Summarised from the published abstract; every number is checked against it