阿皮克萨班与阿司匹林治疗源不明的栓塞性中风
Tobias Geisler1, Timea Keller1, Peter Martus2
1Department of Cardiology and Angiology, Eberhard Karls University Tübingen, Tübingen, Germany.
NEJM evidence
|February 6, 2024
概括
在患有源不明的栓塞性中风 (ESUS) 患者中,阿皮克萨班在预防新的缺血性病变方面并没有证明优于阿司匹林. 这项研究发现,阿皮克萨班与阿司匹林在此群体中对预防中风没有显著的益处.
科学领域:
- 神经学 神经学
- 心脏病学 心脏病学
- 临床试验 临床试验
背景情况:
- 之前的试验表明,里瓦罗克萨班和达比加特兰在不确定的来源的栓塞性中风 (ESUS) 中并不优于阿司匹林.
- 与阿司匹林相比,阿皮克萨班在ESUS患者中具有心血管血栓风险因素的疗效仍然未知.
研究的目的:
- 评估阿皮克萨班在预防ESUS患者出现新的缺血病变方面是否优于阿司匹林,ESUS患者具有已确定的心血管栓塞风险因素.
- 为了比较阿皮克萨班和阿司匹林治疗之间的缺血病变率和出血事件.
主要方法:
- 一个多中心的,随机的,开放的标签试验比较阿皮克萨班 (5毫克每天两次) 与阿司匹林 (100毫克每天一次) 在ESUS患者.
- 患者至少有一个心房动或门的风险因素;心脏监测是强制性的.
- 主要结局是12个月后的脑MRI上出现新的缺血病变.
主要成果:
- 阿皮克萨班不优于阿司匹林;新的缺血病变发生在阿皮克萨班组的13.6%,而阿司匹林组的16.0% (aOR 0.79;95% CI 0.42-1.48).
- 两组之间出血率相似 (阿皮克萨班的累计发病率为2.9%,阿司匹林为4.2%).
- 由于基于临时分析的徒劳,试验被提前终止.
结论:
- 在丰富的ESUS群体中,阿皮克萨班治疗在预防新的缺血病变方面没有比心脏监测引导的阿司匹林更优越.
- 这些发现表明,目前的抗凝血剂在特定的ESUS患者亚组中可能不会比阿司匹林提供额外的益处.
- 可能需要进一步的研究来确定ESUS患者具有特定风险因素的最佳抗血栓策略.
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