Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden; Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
Am Heart J. 2023 Jul;261:55-63. doi: 10.1016/j.ahj.2023.03.012. Epub 2023 Mar 27.
Decisions on stroke prevention strategies in patients with atrial fibrillation (AF) depend on the perceived risks of stroke and bleeding with different antithrombotic treatment strategies. The study objectives were to evaluate net clinical outcome with oral anticoagulation (OAC) for the individual patient with AF and to identify clinically relevant thresholds for OAC treatment.
Patients with AF receiving OAC treatment in the randomized ARISTOTLE and RE-LY trials, with available biomarkers for calculation of ABC-AF scores at baseline, were included (n = 23,121). Observed 1-year risk on OAC was compared with predicted 1-year risk if the same patients would not have received OAC using the ABC-AF scores calibrated for aspirin. Net clinical outcome was defined as the sum of stroke and major bleeding risks.
The ratio between the 1-year incidence of major bleeding and stroke/systemic embolism events ranged from 1.4 to 10.6 according to different ABC-AF risk profiles. Net clinical outcome analyses showed that in patients with an ABC-AF-stroke risk >1% per year on OAC (>3% without OAC), treatment with OAC consistently provides larger net clinical benefit than no-OAC treatment. In patients with an ABC-AF-stroke risk <1.0% per year on OAC (<3% without OAC) an individualized balancing of risks regarding OAC or no-OAC treatment is needed.
In patients with AF, the ABC-AF risk scores allow an individual and continuous estimate of the balance between benefits and risks with OAC treatment. This precision medicine tool therefore seems useful as decision support and visualizes the net clinical benefit or harm with OAC treatment (http://www.abc-score.com/abcaf/).
ClinicalTrials.gov identifier NCT00412984 (ARISTOTLE) and NCT00262600 (RE-LY).
房颤（AF）患者的卒中预防策略决策取决于不同抗栓治疗策略的卒中及出血风险。本研究旨在评估 AF 患者应用口服抗凝药（OAC）的净临床结局，并确定 OAC 治疗的临床相关阈值。
纳入 ARISTOTLE 和 RE-LY 随机试验中接受 OAC 治疗且基线时具有 ABC-AF 评分计算相关生物标志物的 AF 患者（n=23121）。采用经阿司匹林校准的 ABC-AF 评分预测如果相同患者未接受 OAC 治疗时的 1 年风险，并将其与 OAC 治疗时的 1 年观察风险进行比较。净临床结局定义为卒中与大出血风险之和。
根据不同的 ABC-AF 风险谱，1 年大出血与卒中/系统性栓塞事件发生率之比为 1.4 至 10.6。净临床结局分析显示，在 OAC 时卒中风险>1%/年的患者（无 OAC 时为>3%），OAC 治疗比不应用 OAC 治疗具有更大的净临床获益。在 OAC 时卒中风险<1.0%/年的患者（无 OAC 时为<3%），需要个体化权衡 OAC 或不应用 OAC 治疗的风险。
在 AF 患者中，ABC-AF 风险评分可对 OAC 治疗的获益与风险之间的平衡进行个体化和连续评估。因此，该精准医学工具似乎可用作决策支持，可视化 OAC 治疗的净临床获益或危害（http://www.abc-score.com/abcaf/）。
ClinicalTrials.gov 标识符 NCT00412984（ARISTOTLE）和 NCT00262600（RE-LY）。
