在植入药物释放支架后,Ticagrelor加阿司匹林治疗1个月,其次是Ticagrelor单一治疗23个月 vs 阿司匹林加克洛皮多格雷尔或Ticagrelor治疗12个月,其次是阿司匹林单一治疗12个月:多中心,开放式,随机优势试验
Pascal Vranckx1, Marco Valgimigli2, Peter Jüni3
1Jessa Ziekenhuis, Faculty of Medicine and Life Sciences at the Hasselt University, Hasselt, Belgium.
Lancet (London, England)
|September 1, 2018
概括
与标准的双重抗血小板治疗相比,单独服用蒂卡格勒并没有改善皮肤冠状动脉干预后的结果. 在这两组治疗中,死亡率和心肌梗塞率没有显著差异.
科学领域:
- 心脏病学
- 药理学
- 临床试验
背景情况:
- 皮肤冠状动脉干预 (PCI) 需要有效的抗血小板治疗来预防不良事件.
- 标准的双抗血小板治疗 (DAPT) 涉及阿司匹林和P2Y12抑制剂,通常持续12个月.
- 正在研究新的抗血小板策略,以优化PCI后的结果.
研究的目的:
- 在接受PCI的患者中,评估一个月的DAPT疗法与蒂卡格勒罗和阿司匹林,其次是单一治疗,是否优于标准的DAPT.
- 在实验组和对照组之间比较2年内全因死亡率或新的Q波心肌梗塞.
- 评估与基于提卡格勒的新疗法相关的安全性,特别是重大出血事件 (BARC级别3或5).
主要方法:
- GLOBAL LEADERS是一项随机,开放的优势试验,涉及130个地点的15968名患者.
- 患者接受了Ticagrelor加阿司匹林1个月,然后仅服用Ticagrelor,或标准DAPT (阿司匹林加克洛皮多格雷尔或Ticagrelor) 12个月,然后服用阿司匹林.
- 主要终点是2年内全因死亡率或新的Q波心肌梗塞;关键的次要终点是严重出血.
主要成果:
- 主要终点发生在实验组的3. 81%与对照组的4. 37% (率比0. 87; p=0. 073) 中,没有显示出统计学意义上的差异.
- 在急性冠状动脉综合征和稳定的冠状动脉疾病分组中没有观察到治疗效果的显著差异.
- 在两组中,严重出血率 (BARC级别为3或5) 是相似的 (2.04%对2.12%;率比为0.97;p=0.77).
结论:
- 一个月的DAPT疗法与蒂卡格洛尔和阿司匹林,其次是蒂卡格洛尔单一治疗,在降低PCI后死亡率或心肌梗塞方面并不优于标准的DAPT.
- 新型基于蒂卡格勒的治疗方案与标准的DAPT之间,安全性概况,包括重大出血风险是可比的.
- 目前标准的DAPT疗法仍然是用生物A9释放支架进行PCI的患者的有效治疗选择.
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