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低剂量直接口服抗凝药与左心室尾闭塞后的双抗血小板治疗:ADALA随机临床试验

Xavier Freixa¹, Ignacio Cruz-González², Pedro Cepas-Guillén¹

¹Department of Cardiology, Institut Cardiovascular, IDIBAPS, Hospital Clinic of Barcelona, Barcelona, Spain.

JAMA cardiology

|August 7, 2024

概括

低剂量直接口服抗凝剂 (DOAC) 显示出比双抗血小板疗法 (DAPT) 更好的安全性和有效性概况,适用于接受左心房附属物阻塞 (LAAO) 的患者. 这一发现表明了潜在的新标准的护理,等待更大的试验确认.

科学领域:

心脏病学心脏病学
干预心脏病学干预心脏病学
临床试验临床试验

背景情况:

由于缺乏随机试验,最优的抗血栓治疗后左心房附属体封闭 (LAAO) 仍然没有定义.
穿皮的LAAO是一种抗凝药的替代品,用于预防心房动中风.

研究的目的:

为了比较低剂量直接口服抗凝剂 (DOAC) 与双抗血小板治疗 (DAPT) 在LAAO后三个月的疗效和安全性.
评估LAAO后的主要出血和血栓栓塞事件的复合终点.

主要方法:

该ADALA研究是一项过早终止的,由研究人员发起的,多中心的,前性的,开放的,随机的试验.
90名患者被随机分配,在LAAO后3个月接受低剂量DOAC (阿皮克萨班2.5毫克两次) 或DAPT (阿司匹林加克洛皮多格雷尔).
主要终点是安全性 (主要出血) 和疗效 (血栓栓塞事件,包括设备相关的血栓塞) 的复合.

主要成果:

与DAPT相比,低剂量DOAC与主要终点的显著减少有关 (4.5%对21.7%,HR 0.19,P=.02).
低剂量DOAC组显示了与设备相关的血栓形成率较低 (0% vs 8.7%,P=.04) 和较少重大出血事件的趋势.
两组之间中风或全身血栓塞率没有显著差异.

结论:

在LAAO之后的短期内,低剂量DOAC似乎提供了优越的疗效和安全平衡,而不是DAPT.
由于该研究的样本规模较小和过早终止,应谨慎解释结果.
需要进行更大规模的随机试验来证实这些发现,并建立LAAO后的最终抗血栓指南.

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