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Published on: February 26, 2013
Biomarker-Based ABC-AF Risk Scores for Personalized Treatment to Reduce Stroke or Death in Atrial Fibrillation: A
Jonas Oldgren1,2, Ziad Hijazi2, Håkan Arheden3,4
1Uppsala Clinical Research Center (J.O., H.R., L.W.), Uppsala University, Uppsala, Sweden.
Insights
A new treatment strategy using ABC-AF risk scores for atrial fibrillation (AF) patients did not improve long-term outcomes compared to standard care. This highlights the need for further prospective studies before implementing new risk stratification tools.
Area of Science:
- Cardiology
- Clinical Trials
- Risk Stratification
Background:
- Clinical utility of risk scores for guiding treatment and improving outcomes in atrial fibrillation (AF) is under-evaluated prospectively.
- Biomarker-based risk scores may offer personalized treatment strategies.
- Need for evidence on risk-guided precision medicine in AF management.
Purpose of the Study:
- To evaluate if an ABC-AF risk score-guided multidimensional treatment strategy improves long-term outcomes in AF patients.
- To assess the impact of tailored treatment recommendations based on individual stroke and bleeding risks.
- To compare outcomes between a risk-informed treatment approach and usual care.
Main Methods:
- Multicenter, registry-based, randomized, controlled, open-label study in adult AF patients.
- Active arm: Investigators used ABC-AF scores for treatment decisions, including oral anticoagulant (OAC) choice.
- Control arm: Patient management followed investigator discretion; primary outcome was stroke or death.
Main Results:
- Study prematurely terminated due to safety concerns, leading to underpowered primary objective.
- No significant difference in primary outcome (stroke or death) between active (3.18/100PY) and control (2.67/100PY) arms (HR 1.19; p=0.12).
- Similar rates for secondary outcomes including major bleeding, stroke, death, and composite events between groups.
Conclusions:
- The ABC-AF risk score-guided multidimensional treatment strategy did not demonstrate improved clinical outcomes versus usual care in AF patients.
- Results underscore the necessity for prospective validation of risk stratification tools and precision medicine before routine clinical implementation.
- Further research is needed to confirm the utility of novel risk assessment tools in diverse clinical settings.
Background:
The clinical use of risk scores to guide treatment decisions and improve clinical outcomes has rarely been prospectively evaluated. This study aimed to evaluate whether a biomarker-based ABC-AF risk score-guided multidimensional treatment strategy improves long-term outcomes in patients with AF.
Methods:
The multicenter, registry-based, randomized, controlled, open-label study enrolled adults with AF. In the ABC-AF strategy arm, the investigator was informed of each individual's ABC-AF score risks for stroke and bleeding, which were used as decision support to tailor treatment recommendations, including preference for type of direct oral anticoagulant treatment. In the standard of care arm, patient management was at the discretion of the investigator. Primary outcome was a composite of stroke or death. Secondary outcomes included stroke, death, major bleeding events, and their composite outcome.
Results:
The intention-to-treat population comprised 3933 patients with a median age of 73.7 years; 33.6% were women, 51.3% had paroxysmal AF, 11.2% had a previous stroke or transient ischemic attack, and 85.7% had oral anticoagulant treatment. After randomization, 97.8% in the ABC-AF strategy arm and 92.6% in the standard of care arm received OACs (P<0.0001). Enrollment was prematurely terminated owing to safety concerns with a trend toward higher mortality in patients with CHA2DS2-VASc scores of ≥3, and the study was therefore underpowered for its primary objective. Over a median follow-up of 2.6 years, 175 primary events (3.18/100 patient-years [100PY]) occurred in the ABC-AF strategy and 148 (2.67/100PY) in the standard of care arm (hazard ratio [HR], 1.19 [95% CI, 0.96-1.48]; P=0.12). Major bleeding events were 152 (2.82/100PY) versus 141 (2.61/100PY; HR, 1.08 [95% CI, 0.86-1.36]; P=0.50), stroke 48 (0.87/100PY) versus 41 (0.74/100PY; HR, 1.18 [95% CI, 0.78-1.79]; P=0.44), death 136 (2.44/100PY) versus 113 (2.02/100PY; HR, 1.21 [95% CI, 0.94-1.55]; P=0.13), and rates of composite stroke, death, or major bleeding 277 (5.21/100PY) versus 244 (4.55/100PY; HR, 1.14 [95% CI, 0.96-1.36]; P=0.13). Primary outcome results were similar across ABC-AF score subgroups (interaction P=0.98).
Conclusions:
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. The results emphasize the need for prospective testing of the use of risk stratification and precision medicine tools in different clinical settings before implementation in routine care.
Registration:
URL: https://www.clinicaltrials.gov; Unique identifier: NCT03753490.
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