治疗心房患者的阿皮克萨班:多中心随机对照试验
Sean D Pokorney1, Glenn M Chertow2, Hussein R Al-Khalidi1
1Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (S.D.P., H.R.A.-K., D.G., P.D., R.D.L., J.P.M., J.A.R., K.L.T., J.B.W., C.B.G.).
Circulation
|November 6, 2022
概括
在RENAL- AF试验中,没有足够的数据来比较血清透析患者的脑膜动和华法林的中风预防. 出血事件比中风更常见,因此需要对抗凝血风险和益处进行进一步研究.
科学领域:
- 心脏病学
- 肝脏病学
- 药理学
背景情况:
- 在接受血液透析的心房动 (AF) 患者中,关于阿皮克萨班预防中风的安全性和有效性的随机数据有限.
- 末期脏疾病 (ESKD) 患者在血液透析中代表血栓塞栓事件和出血并发症的高风险人群.
研究的目的:
- 在血液透析患者中,比较阿皮克萨班与华法林在中风预防方面的安全性和有效性.
- 在这个特定的患者队列中评估出血事件,中风,死亡率和apixaban的药理动力学.
主要方法:
- 这项前性,随机的,开放的RENAL- AF试验招募了154名接受血液透析的AF患者,CHA 2 DS 2 - VASc得分≥2.
- 患者被分配给阿皮克萨班 (根据特定标准每天两次服用5毫克或每天两次服用2.5毫克) 或根据剂量调整的华法林.
- 主要结局是发生重大或临床相关的非重大出血的时间;次要结局包括中风和死亡率.
主要成果:
- 由于招生问题,该试验过早停止,因此无法比较阿皮克萨班和华法林之间的出血率.
- 大型或临床相关的非大型出血发生率为32% (阿皮克萨班) 和26% (华法林);中风/全身血栓发生率分别为3. 0%和3. 3%.
- 死亡是最常见的重大事件;药物动力学分析显示药物度的重叠不管出血结果如何.
结论:
- 在RENAL- AF试验中,在血液透析中患有ESKD的AF患者中,阿皮克萨班和华法林之间的出血风险差异不足以得出结论.
- 临床相关的出血事件明显比中风更频繁,这凸显了对该群体抗凝血风险和益处的未来研究的需要.
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