Biomarker-Based ABC-AF Risk Scores for Personalized Treatment to Reduce Stroke or Death in Atrial Fibrillation: A Registry-Based, Multicenter, Randomized, Controlled Study

作者：Jonas Oldgren, Ziad Hijazi, Håkan Arheden, Anna Björkenheim, Viveka Frykman, Magnus Janzon, Annica Ravn‐Fischer, Henrik Renlund, Anders Själander, Torbjörn Åkerfeldt, Lars Wallentin · 发表于：Circulation · 年份：2025 · DOI：10.1161/circulationaha.125.076725 · 被引用次数：6 · 研究领域：Atrial Fibrillation Management and Outcomes、Antiplatelet Therapy and Cardiovascular Diseases、Acute Ischemic Stroke Management

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 CHA 2 DS 2 -VASc scores of ≥3, and the study was therefore underpowered for its primary object...