Hot Line 5: ABC-AF
31 Aug 2025
Hot Line ESC Congress 2025 No benefit seen when ABC-AF risk scores are used to personalise treatment
“While novel biomarker-based risk scores have been validated in different populations, the clinical utility of risk scores to guide treatment decisions and improve clinical outcomes has rarely been prospectively evaluated,” explained Professor Jonas Oldgren (Uppsala University - Uppsala, Sweden). “We performed a pragmatic registry-based trial to evaluate whether tailoring treatment recommendations based on patients’ ABC-AF risk scores improves outcomes as compared with usual guideline-based care in patients with atrial fibrillation (AF).”
Almost 4,000 patients with AF – newly or previously diagnosed – were randomised to an ABC-AF risk score-guided treatment strategy or to standard of care. In the active group, ABC-AF-stroke score (Age, Biomarkers [NT-proBNP and hs-troponin T] and Clinical history of stroke/transient ischaemic attack) and the ABC-AF-bleeding score (Age, Biomarkers [growth differentiation factor 15, haemoglobin and hs-troponin T] and Clinical history of bleeding) were calculated. The investigators used the scores to decide on medical treatments and other interventions. Patients in the control group were managed in accordance with usual practices at the discretion of the investigator. The primary outcome was the composite of stroke or death, with data retrieved from mandatory national registers with complete coverage of all in-patient care at Swedish hospitals and vital status for all Swedish residents. Enrolment was prematurely terminated owing to safety concerns with a trend towards higher mortality in patients with CHA2DS2-VASc scores ≥3.
After randomisation, the proportion of patients receiving any oral anticoagulants (OACs) increased to 97.8% in the active group and 92.6% in the control group (p<0.0001). In both groups, there were changes in the use of direct OACs, reductions in the use of warfarin and antiplatelets, and increased statin prescription.
Over a median follow-up of 2.6 years, the primary outcome occurred at a similar rate between the groups.
The rate was 3.18/100 patient-years (100PY) in the active group and 2.67/100PY in the control group (hazard ratio [HR] 1.19; 95% CI 0.96 to 1.48; p=0.12). There were no significant differences in the active vs. control groups in the rate of stroke (HR 1.18; 95% CI 0.78 to 1.79; p=0.44) or death (HR 1.21; 95% CI 0.94 to 1.55; p=0.13). Major bleeding events occurred at a similar rate in the active vs. control group (HR 1.08; 95% CI 0.86 to 1.36; p=0.50).
Prof. Oldgren concluded: “We found no benefit of individually tailored, multidimensional treatment recommendations based on ABC-AF-stroke and ABC-AF-bleeding risk scores compared with usual guideline-based care in this study population who had lower-than-expected event rates. Due to premature termination of recruitment, the study was underpowered for its primary objective, but we will continue to follow-up randomised patients to assess any long-term effects. Overall, the results emphasise the need for prospective testing of the utility of risk stratification and precision medicine tools in different clinical settings before being implemented for tailoring of treatment in routine clinical care.”
