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连续或选择性地将高出血风险患者纳入MASTER DAPT查日志和试验日志

Antonio Landi¹, Dik Heg², Enrico Frigoli³

¹Cardiocentro Ticino Institute, Ente Ospedaliero Cantonale (EOC), Università della Svizzera Italiana, CH-6900, Lugano, Switzerland; The Faculty of Biomedical Sciences, University of Italian Switzerland (USI), CH-6900 Lugano, Switzerland.

European journal of internal medicine

|May 4, 2024

概括

查日志显示,在接受皮肤冠状动脉干预 (PCI) 的患者中,高出血风险 (HBR) 特性是常见的. 然而,与一般HBR人群相比,试验参与者表现出选择偏差.

科学领域:

心脏病学心脏病学
临床试验临床试验
医疗保健服务研究医疗服务研究

背景情况:

查日志可以评估患者子集的流行和分布,减轻随机试验和现实世界注册表中固有的选择偏差.
了解高出血风险 (HBR) 特征的现实世界患病率对于患者管理至关重要.
临床试验的外部有效性,如MASTER DAPT试验,需要与现实世界的数据进行评估.

研究的目的:

在接受皮肤冠状动脉干预 (PCI) 的患者中确定HBR特征的患病率和分布.
通过比较MASTER DAPT试验的人群与通过查日志识别的连续HBR患者来评估MASTER DAPT试验的外部有效性

主要方法:

查日志记录了65个试验地点连续接受PCI的患者.
确定了HBR特征的患病率,包括PRECISE-DAPT得分,晚年,口服抗凝剂 (OAC) 的使用和贫血.
对同意参与试验的HBR患者的人口统计和临床数据与所有连续HBR患者进行了比较.

主要成果:

在2847名连续患者中,38.6%被确定为HBR.
最常见的HBR特征是PRECISE-DAPT得分≥25,其次是晚年和OAC使用.
同意的HBR患者年龄较大,更可能是男性,使用OAC较高,有更多先前的脑血管事件,但与连续的HBR患者相比,高PRECISE-DAPT得分的患病率较低.

结论:

在连续和选择性纳入的HBR患者之间,HBR标准的分布有所不同.
这些差异表明,在MASTER DAPT试验人群中存在选择偏差.
查日志为真实世界患者群体和潜在的试验概括性问题提供了宝贵的见解.

关键词:

抗血小板治疗是一种抗血小板疗法.双重抗血小板疗法双重抗血小板疗法高出血风险高出血风险通过皮肤进行冠状动脉干预.

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