Arrhythmias & electrophysiology
Apixaban for stroke prevention in subclinical atrial fibrillation detected by an implantable cardiac monitor: A subgroup analysis of ARTESiA
Authors' conclusion
In ARTESiA, patients with ICM experienced a stroke rate of 2.6%/year on aspirin, higher than that in the remaining trial population. The risk was significantly reduced by apixaban, consistent with the overall ARTESiA results.
Study context
- Population
- Patients with a pacemaker (PM), implantable cardioverter-defibrillator (ICD), or implantable cardiac monitor (ICM) and with subclinical atrial fibrillationparticipants in ARTESiA, stratified by device type · ICM 209 · PM/ICD 3,803
- Participants
- 4,012 patients
- Comparison
- Apixaban vs aspirin, stratifying by device type
Methodological detailsrandomized
- Randomized
Primary result
As reported in the abstract
Stroke or systemic embolism, ICM cohort
Apixaban
0.3%/year
1 of 103 events
Aspirin
2.6%/year
9 of 106 events
apixaban vs aspirinHazard ratio (95% CI)
Stroke or systemic embolism, ICM cohort
0.11(0.01–0.88)
- Absolute risk reduction with apixaban
- ARR 2.31%/year (95% CI 0.55–4.07)
Further findings
| Outcome | Apixaban | Aspirin | HR (95% CI) | |
|---|---|---|---|---|
| Stroke or systemic embolism, PM/ICD cohort | 0.8%/year | 1.2%/year | 0.69 (0.49–0.98) | |
| 0.512Hazard ratio (log scale) |
| Outcome | ARR (95% CI) |
|---|---|
| Stroke or systemic embolism, PM/ICD cohortAbsolute risk reduction with apixaban | 0.36%/year (0.02–0.70) |
- Stroke or systemic embolism, PM/ICD cohort: Pinteraction = .078 and .002, respectively (HR and ARR)
- Baseline characteristics, ICM vs PM/ICD: ICM Age 74.9 ± 7.4 · Female 50.2% · Previous stroke 24.9%
- Baseline characteristics, ICM vs PM/ICD: PM/ICD Age 76.9 ± 7.6 · Female 35.3% · Previous stroke 7.7%
Safety
| Outcome | Apixaban | Aspirin | HR (95% CI) | |
|---|---|---|---|---|
| Major bleeding, ICM cohort | 1.3%/year | 1.1%/year | 1.13 (0.30–4.31) | |
| 0.20.5125Hazard ratio (log scale) |
- Major bleeding, ICM cohort: Pinteraction = .808 and .406, respectively (HR and ARR)
Major bleeding, ICM cohort
- No significant difference in HR or ARR across the device types
Original publication
Apixaban for stroke prevention in subclinical atrial fibrillation detected by an implantable cardiac monitor: A subgroup analysis of ARTESiA. Heart Rhythm. Published 5 August 2025. doi:10.
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