在接受皮肤冠状动脉干预的患者中定义高出血风险
Philip Urban1,2, Roxana Mehran3, Roisin Colleran4
1La Tour Hospital, Geneva, Switzerland (P.U.).
Circulation
|May 23, 2019
概括
对于接受穿皮冠状动脉干预的患者来说,标准化高出血风险的定义至关重要. 高出血风险学术研究联盟 (ARC-HBR) 制定了一项共识定义,以改善临床试验和决策.
科学领域:
- 心脏病学
- 临床试验
- 医疗器械法规
背景情况:
- 在皮肤冠状动脉干预 (PCI) 中缺乏高出血风险 (HBR) 的标准化定义,阻碍了临床试验和决策.
- 在PCI程序中,对HBR患者的识别和管理至关重要.
研究的目的:
- 为接受PCI的高出血风险患者制定共识定义.
- 为临床试验设计,数据解释和监管审查提供一致性.
主要方法:
- 召集了国际专家,监管机构和行业观察员组成的高出血风险学术研究联盟 (ARC-HBR).
- 在2018年4月 (华盛顿特区) 和2018年10月 (法国巴黎) 举行了两次共识会议.
- 审查了可用的证据,以建立HBR的务实定义.
主要成果:
- 为接受PCI的高出血风险患者制定了一项共识定义.
- 该定义旨在在临床试验中标准化HBR患者的识别.
结论:
- 拟议的ARC-HBR共识定义提供了一种务实的方法来一致识别HBR患者.
- 这一定义将提高临床试验的一致性,帮助决策,并支持PCI干预的监管审查.
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