低剂量阿皮克萨班在HeartMate 3 LVAD患者中,ApixiVAD试验的中间分析,一个随机对照研究
Bruno Schnegg1, Ricardo Deveza2, Sumita Barua3
1Department of Cardiology, Centre for Advanced Heart Failure, Inselspital, Bern University Hospital, Bern, Switzerland.
概括
降低剂量的阿皮克萨班在左心室辅助器件 (LVAD) 患者中显示出抗凝固的前景,可能平衡出血风险和疗效. 需要进一步的研究来证实这些初步发现在高级心力衰竭管理中.
科学领域:
- 心脏病学 心脏病学
- 医疗器械 医疗器械
- 药理学 药理学是指药理学的学科.
背景情况:
- 左心室辅助器件 (LVAD) 对晚期心力衰竭至关重要,但需要抗凝药.
- 像维生素K对抗剂 (VKAs) 等常规抗凝剂存在挑战,包括可变的国际规范化比率和治疗范围 (TTR) 中的次优时间,导致并发症增加.
- 在历史上,直接口服抗凝剂 (DOAC) 在LVAD患者中是禁忌的.
研究的目的:
- 在患有HeartMate 3 LVAD的患者中,与标准VKA相比,评估降低剂量阿皮克萨班的安全性和有效性.
- 为了评估这一患者群体中血栓栓塞事件,出血和死亡的发生率.
- 探索阿皮克萨班作为LVAD接受者的替代抗凝剂的潜力.
主要方法:
- 该ApixiVAD研究是一项1:1随机化,开放标签的试验试验.
- 稳定的HeartMate 3 LVAD患者的TTR> 60%被随机分配给接受降低剂量阿皮克萨班 (2.5 mg每天两次) 或标准VKAs.
- 阿司匹林的使用不是强制性的,主要结局包括血栓栓塞事件,出血和死亡.
主要成果:
- 44名患者被随机分配:21人接受阿皮克萨班,23人接受VKA.
- 随访时间中位数为6个月. 在阿皮克萨班和VKA组之间,无事件生存时间相似 (HR 1.46,95% CI 0.64-3.35).
- 艾皮克萨班组的出血率低于之前的大型研究报告的出血率,血栓发生率没有增加.
结论:
- 初步结果表明,降低剂量的阿皮克萨班 (每天两次2.5毫克) 可能在LVAD患者的出血风险和抗凝血疗效之间提供有利的平衡.
- 观察到的出血率令人鼓舞地低,但不影响抗血栓保护.
- 这些发现产生了假设,需要在更大规模的前性试验中进行进一步调查.
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