作为一种抗凝固策略,活性可逆的直接因子IXa抑制剂在接受皮肤冠状动脉干预的患者中首次临床应用
Mauricio G Cohen1, Drew A Purdy, Joseph S Rossi
1Cardiovascular Division, University of Miami Miller School of Medicine, Miami, FL 33136, USA. mgcohen@med.miami.edu
Circulation
|July 28, 2010
概括
针对IXa因子的REG1系统证明了受控的抗凝固作用和皮肤穿透冠状动脉干预的有效逆转,有望预防缺血事件而不会增加出血风险.
科学领域:
- 心血管医学 心血管医学
- 药理学 药理学 是一个学科.
- 生物技术是生物技术.
背景情况:
- 需要抗凝剂来平衡缺血并发症预防与出血风险.
- 该 REG1 系统提供通过一对RNA 吸血酶 (RB006 和 RB007) 提供受控的抗凝.
研究的目的:
- 评估REG1系统在皮肤冠状动脉干预 (PCI) 中的抗凝和活性逆转的临床转化.
主要方法:
- 2a期研究,有2组随机分配给REG1或PCI后未分离的肝素.
- 在RB007.7中,REG1抗凝作用 (RB006) 被部分或完全逆转.
- 终点包括出血,缺血事件和药学动力学测量 (激活凝血时间).
主要成果:
- 所有手术都是成功的,没有血栓性并发症.
- REG1显示有2种缺血事件;非分离的肝素显示有1种缺血事件和1种严重出血.
- RB007有效地逆转了RB006,使得可以及时移除大腿.
结论:
- 该研究成功地证明了REG1系统的因子IXa抑制和活性逆转的临床应用.
- 这种新型抗凝平台为PCI环境中的进一步临床研究提供了基础.
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