Biomarker-Based ABC-AF Risk Scores for Personalized Treatment to Reduce Stroke or Death in Atrial Fibrillation: A Registry-Based, Multicenter, Randomized, Controlled Study
Abstract
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 (P2DS2-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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 3,933 participants or records.
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