Arrhythmias & electrophysiologyCohort study
Associations of Apixaban Dose With Safety and Effectiveness Outcomes in Patients With Atrial Fibrillation and Severe Chronic Kidney Disease
- Retrospective cohort study
- inverse probability of treatment weighting
- Fine-Gray subdistribution hazard model (competing risk of death)
Authors' conclusion
Compared with 2.5 mg, use of 5 mg apixaban was associated with a higher risk of bleeding in patients with atrial fibrillation and severe chronic kidney disease, with no difference in the risk of stroke/systemic embolism or death
Study context
- Population
- Patients with AF and CKD stage 4/5 initiating apixaban, Optum Labs Data Warehouse EHR data, 2013–2021
- Participants
- 4,313 apixaban new users
- Exposure
- Apixaban 5 mg vs 2.5 mg
- 5 mgn = 1,705
- 2.5 mgn = 2,608reference
- Outcome
- Bleeding and stroke/systemic embolism
Main finding
As reported in the abstract
5 mg
4.9 events per 100 person-years
Bleeding · Stroke/systemic embolism 3.3 events per 100 person-years
2.5 mg
2.9 events per 100 person-years
Bleeding · Stroke/systemic embolism 3.0 events per 100 person-years
5 mg vs 2.5 mgIncidence rate difference, events per 100 person-years (95% CI)
bleeding
2.0(0.6–3.4)
stroke/systemic embolism
0.2(−1.0 to 1.4)
5 mg vs 2.5 mgSubdistribution hazard ratio (95% CI)
bleeding
1.63(1.04–2.54)
stroke/systemic embolism
1.01(0.59–1.73)
Observational data: associations, not effects.
Further findings
events per 100 person-years
| Outcome | 5 mg | 2.5 mg | incidence rate difference (events per 100 person-years) (95% CI) | |
|---|---|---|---|---|
| Death | 9.9 | 9.4 | 0.5 (−1.6 to 2.6) | |
| −2024Difference, events per 100 person-years (linear scale) |
| Outcome | HR (95% CI) | |
|---|---|---|
| Death | 1.03 (0.77–1.38) | |
| 0.512Hazard ratio (log scale) |
Safety
events per 100 person-years
| Outcome | 5 mg | 2.5 mg | subdistribution HR (95% CI) | |
|---|---|---|---|---|
| Bleeding | 4.9 | 2.9 | 1.63 (1.04–2.54) | |
| 0.20.5125Subdistribution hazard ratio (log scale) |
Original publication
Associations of Apixaban Dose With Safety and Effectiveness Outcomes in Patients With Atrial Fibrillation and Severe Chronic Kidney Disease. Circulation. Published 8 September 2023. doi:10.1161/circulationaha.123.065614
Summarised from the published abstract; every number is checked against it