以生物标志物为基础的ABC-AF风险评分,以减少心房中风或死亡 - 基于注册的多中心随机对照研究
Jonas Oldgren1, Ziad Hijazi2, Håkan Arheden3
1Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden; Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden.
Circulation
|August 30, 2025
概括
与标准治疗相比,使用ABC- AF风险评分的新治疗策略对心房患者没有改善长期结果. 这凸显了在实施新的风险分层工具之前需要进行进一步的前性研究.
科学领域:
- 心脏病学
- 临床试验
- 风险分层
背景情况:
- 风险评分对治疗指导和改善心房 (AF) 结果的临床效用被低估了.
- 基于生物标志物的风险评分可以提供个性化的治疗策略.
- 需要关于风险导向精准医学的证据.
研究的目的:
- 评估以ABC-AF风险评分为指导的多维治疗策略是否能改善AF患者的长期结果.
- 根据个人中风和出血风险,评估量身定制的治疗建议的影响.
- 将风险知情治疗方法与常规护理之间的结果进行比较.
主要方法:
- 在成年AF患者中进行多中心,基于注册的随机,受控的开放性研究.
- 活跃组:研究人员使用ABC-AF分数来做出治疗决定,包括口服抗凝剂 (OAC) 的选择.
- 对照组:患者管理遵循研究人员的裁量权;主要结局是中风或死亡.
主要成果:
- 由于安全问题,研究提前结束,导致主要目标不足.
- 主要结局 (中风或死亡) 在活跃组 (3.18/100PY) 和对照组 (2.67/100PY) 之间没有显著差异 (HR 1. 19; p=0. 12).
- 二次性结局,包括重大出血,中风,死亡和组合事件的发病率相似.
结论:
- 在ABC- AF风险评分指导的多维治疗策略中,AF患者的临床结果与通常治疗相比没有改善.
- 结果强调在常规临床实施之前,需要对风险分层工具和精准医学进行前性验证.
- 需要进一步的研究来证实新型风险评估工具在不同临床环境中的有用性.
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