里瓦罗克萨班用于预防COVID-19的门诊患者的血栓事件,住院和死亡:随机临床试验
Gregory Piazza1, Alex C Spyropoulos2,3,4, Judith Hsia5,6
1Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (G.P.).
Circulation
|May 8, 2023
概括
在非住院COVID-19患者中,预防性里瓦洛克萨班并没有减少主要的血栓事件,住院或死亡. 由于发病率较低和招生问题,PREVENT- HD试验提前停止.
科学领域:
- 心脏病学
- 传染性疾病
- 血液学
背景情况:
- COVID-19增加了静脉和动脉血栓和呼吸衰竭的风险.
- 在非住院COVID-19患者中评估预防性抗凝血效益至关重要.
研究的目的:
- 评估利瓦洛克萨班的预防性抗凝药是否能减少高风险的非住院COVID-19患者的血栓形成,住院或死亡.
主要方法:
- PREVENT-HD试验是对1284名未住院的COVID-19患者进行的双盲,安慰剂控制的研究.
- 患者每天接受口服里瓦罗克萨班 (10 mg) 或安慰剂,持续35天.
- 主要结局:血栓事件,住院或死亡的组合;安全性:危急部位或致命的出血.
主要成果:
- 由于招生挑战和低发病率,该研究提前结束.
- 里瓦洛克萨班组:事件发生率为3. 4%;安慰剂组:事件发生率为3. 0% (HR,1. 16;P=0. 63).
- 没有发生关键部位或致命的出血;在里瓦洛克萨班组发生了一次重大出血.
结论:
- 在非住院COVID-19患者中,利瓦洛克萨班并没有显著降低血栓形成风险的复合终点.
- 试验的过早结束限制了最终的结论.
- 可能需要进一步的研究来澄清抗凝剂在这一群体中的作用.
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