与华法林相比,重度肾功能不全患者应用利伐沙班大出血更少

2019-05-31 佚名 中国循环杂志

约1/10的非瓣膜性房颤(NVAF)患者伴有中重度肾功能不全,8%~10%的患者进行血液透析。

约1/10的非瓣膜性房颤(NVAF)患者伴有中重度肾功能不全,8%~10%的患者进行血液透析。

虽然目前没有随机对照研究对华法林或新型口服抗凝药物在基线肌酐清除率(CrCl)<25 ml/min的患者中的应用进行评价,但是在美国的临床实践中,约1/4进行血液透析的房颤患者采用不同剂量的新型口服抗凝药物进行卒中预防

美国医学杂志(Am J Med)在线发表了一项回顾性医疗索赔数据库分析,发现对于重度肾功能不全或血液透析患者,利伐沙班与华法林相比可显着减少大出血。

研究纳入2012年1月至2017年12月间美国Truven MarketScan商业保险索赔数据库中既往未接受口服抗凝药治疗、伴有4期或5期慢性肾脏病(CKD)且有至少12个月医保记录的非瓣膜性房颤患者。

利伐沙班与华法林队列的基线特征差异采用基于倾向性评分的逆概率加权法进行调整,匹配的变量包括人口统计学特征、合并症、CHA2DS2-VASc评分因素、调整的HAS-BLED评分因素以及基线合并使用的非口服抗凝药物。主要疗效终点为卒中或体循环栓塞复合终点,主要安全性终点为大出血。

经调整组间基线特征均衡性良好

研究共纳入1896例使用利伐沙班的患者(38.7%使用剂量<20mg/d)和4848例使用华法林的患者;经调整后,组间基线特征均衡性良好;中位年龄为72岁,中位CHA2DS2-VASc评分为4分;随访时间为1.4年,抗凝疗程为112天;88%的患者基线诊断为慢性肾脏病5期和/或进行血液透析。

CKD 4-5期或血液透析的非瓣膜性房颤患者,利伐沙班较华法林显着减少大出血

利伐沙班卒中或体循环栓塞发生率与华法林无显着性差异(HR=0.55, 95%CI 0.27-1.10)。然而,与华法林相比,利伐沙班显着降低大出血风险32%(HR=0.68, 95%CI 0.47-0.99)。

包括29977例患者的北美Fresenius医疗注册研究(覆盖美国48个洲约1500个透析诊所及30%的透析患者)显示,利伐沙班很快就被采纳用于伴有终末期肾病的非瓣膜性房颤患者中;自美国食品药品监督管理局2011年11月批准利伐沙班上市,仅161天即首次被用于慢性透析患者,截至2015年1月使用率达3%。

截至2015年12月,美国肾脏数据系统报告显示约1/4血液透析患者起始采用新型口服抗凝药抗凝治疗。但事实上,美国和欧洲指南并不支持新型口服抗凝药用于CrCl<15 ml/min或血液透析患者。

有趣的是,在本研究中尽管入组患者CrCl<30 ml/min(大部分为CKD 5期或透析),但是仅38.7%的患者根据说明书采用低剂量利伐沙班(<20 mg/d)。

总之,尽管指南并未推荐,但是在美国利伐沙班已被大量用于伴有CKD 4或5期及血液透析的非瓣膜性房颤患者。在这种人群中,利伐沙班与华法林相比显着减少大出血。

未来仍需进一步研究验证利伐沙班在重度肾功能不全患者中的疗效和安全性,并明确最佳给药剂量。

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    2020-01-28 yese
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    2019-06-02 cmsvly
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    2019-06-01 133d9d3cm85暂无昵称

    学习了,谢谢

    0

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指南提示:体重过重(>120kg)或过轻(<60kg)的患者慎用非维生素K拮抗剂类的口服抗凝药,因为缺乏这类人群的相关数据。ARISTOTLE试验是关于阿哌沙班(与华法林对比)降低房颤患者中风和其他血栓事件风险效应的随机性研究,共包含18201位受试者。现研究人员根据体重(≤60,>60–120,>120 kg)对ARISTOTLE试验的受试者重新分层,采用Cox回顾模型来

JACC:极低体重房颤患者的抗凝治疗——DOACs vs 华法林

目前,对于非瓣膜性房颤(AF)和极低体重(50kg)患者,直接口服抗凝药物(DOACs)的有效性和安全性尚不清楚。本研究的目的旨在评估和比较DOACs和华法林对极低体重AF患者的效果。本研究纳入了韩国国家数据库中的接受口服抗凝药物治疗的体重≤60kg的AF患者(DOACs n=14013;华法林 n=7576),并用倾向性评分调整两组患者。分析结果显示,与华法林相比,DOACs 与更低的缺血性卒中