在患有癌症和急性低风险肺栓塞的患者中,里瓦罗克萨班18个月与6个月:开放式多中心随机临床试验 (ONCO PE试验)
Yugo Yamashita1, Takeshi Morimoto2, Nao Muraoka3
1Department of Cardiovascular Medicine, Graduate School of Medicine, Kyoto University, Japan (Y.Y., K.O.).
Circulation
|November 18, 2024
概括
在患有低风险肺栓塞 (PE) 的癌症患者中,与6个月治疗相比,18个月的里瓦洛克萨班显著减少了复发性静脉血栓塞 (VTE),而没有增加严重出血的风险.
科学领域:
- 心脏病学
- 癌症学
- 药理学
背景情况:
- 对于急性低风险肺栓塞 (PE) 的癌症患者,最佳抗凝治疗持续时间尚不清楚.
- 长期治疗可能会预防血栓形成,但会增加出血风险.
研究的目的:
- 在癌症和急性低风险PE患者中,比较18个月和6个月的里瓦洛克萨班治疗的疗效和安全性.
主要方法:
- 一个多中心的随机临床试验,涉及178名患有低风险PE的患者 (简化PE严重性指数得分为1).
- 患者接受了18个月或6个月的里瓦罗克萨班治疗.
- 主要终点:18个月的复发性静脉血栓栓塞 (VTE).
- 主要的二次终点:18个月大出血.
主要成果:
- 在接受18个月治疗的患者中,5. 6%的患者出现了复发性静脉突发症,而在接受6个月治疗的患者中,这一比例为19. 1% (概率比,0. 25;P=0. 01).
- 严重出血发生在18个月组的7. 8% 和6个月组的5. 6% (P=0. 55).
结论:
- 在患有低风险PE的癌症患者中,18个月的里瓦罗克萨班治疗优于6个月的治疗.
- 延长时间并没有显著增加严重出血的风险.
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