Arrhythmias & electrophysiologyRandomised controlled trial
Biomarker-Based ABC-AF Risk Scores for Personalized Treatment to Reduce Stroke or Death in Atrial Fibrillation: A Registry-Based, Multicenter, Randomized, Controlled Study
- Randomised controlled trial
- multicentre
- registry-based
- open-label
- prematurely terminated
- Enrollment prematurely terminated owing to safety concerns with a trend toward higher mortality in patients with CHA2DS2-VASc ≥3
Authors' conclusion
The individually tailored multidimensional treatment strategy, based on ABC-AF risk scores, did not improve clinical outcomes compared with usual guideline-based care in patients with AF.
Study context
- Population
- Adults with AFITT population
- Participants
- 3,933 adults
- Comparison
- ABC-AF risk score-guided treatment strategy vs standard of care
- Primary endpoint
- Composite of:
- Stroke
- Death
- Follow-up
- Median 2.6 years
Primary result
Stroke or death
Hazard ratio
1.19
95% CI 0.96–1.48
P = 0.12
Events by treatment group
ABC-AF strategy
3.18/100 patient-years
175 events
Standard of care
2.67/100PY
148 events
ABC-AF strategy vs Standard of care
HR 1.19 (95% CI 0.96–1.48); P = 0.12
As reported in the abstract
Secondary outcomes
Stroke · median follow-up 2.6 years
- Stroke, ABC-AF strategy vs Standard of care: 48 (0.87/100PY) vs 41 (0.74/100PY)
- HR 1.18 (95% CI 0.78-1.79); P=0.44
- ITT
Death · median follow-up 2.6 years
- Death, ABC-AF strategy vs Standard of care: 136 (2.44/100PY) vs 113 (2.02/100PY)
- HR 1.21 (95% CI 0.94-1.55); P=0.13
- ITT
Composite of stroke, death or major bleeding · median follow-up 2.6 years
- Stroke, death or major bleeding, ABC-AF strategy vs Standard of care: 277 (5.21/100PY) vs 244 (4.55/100PY)
- HR 1.14 (95% CI 0.96-1.36); P=0.13
- ITT
Safety
Major bleeding · median follow-up 2.6 years
- Major bleeding, ABC-AF strategy vs Standard of care: 152 (2.82/100PY) vs 141 (2.61/100PY)
- HR 1.08 (95% CI 0.86-1.36); P=0.50
- ITT
Original publication
Biomarker-Based ABC-AF Risk Scores for Personalized Treatment to Reduce Stroke or Death in Atrial Fibrillation: A Registry-Based, Multicenter, Randomized, Controlled Study. Circulation. Published 30 August 2025. doi:10.1161/circulationaha.125.076725
Summarised from the published abstract; every number is checked against it