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在选择性穿皮冠状动脉干预 (ALPHEUS) 中,蒂卡格勒与克洛皮多格勒相比:一个随机的,开放的,3b期试验
Johanne Silvain1, Benoit Lattuca2, Farzin Beygui3
1Sorbonne Université, ACTION Study Group, INSERM UMRS1166, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France.
Lancet (London, England)
|November 17, 2020
概括
在选择性穿皮冠状动脉干预 (PCI) 期间,蒂卡格勒在预防心脏周围过程性亡方面没有优于克洛皮多格勒. 尽管提卡格勒增加了轻微的出血事件,但克洛皮多格勒仍然是治疗标准.
科学领域:
- 心脏病学
- 干预心脏病学
- 药理学
背景情况:
- 皮肤冠状动脉干预 (PCI) 相关的肌是影响患者预后的常见并发症.
- 与克洛皮多格勒相比,提卡格勒在选择性PCI环境中的有效性以前没有得到评估.
- 对于接受PCI的患者来说,减少外置性缺血并发症至关重要.
研究的目的:
- 评估在接受高风险选择性PCI的稳定冠心病患者中,提卡格勒对降低心脏周围过程性亡的效果是否优于克洛皮多格勒.
- 在该患者群体中比较蒂卡格勒和克洛皮多格勒的安全性.
主要方法:
- 一项3b期随机开放试验 (ALPHEUS) 涉及49家医院的1910名患者.
- 患有稳定的冠状动脉疾病和高风险特征的患者被随机 (1: 1) 分给提卡格雷罗或克洛皮多格雷尔30天.
- 主要结论是PCI相关的心肌梗塞或在48小时内严重心肌损伤的综合结论;主要的安全结论是严重出血.
主要成果:
- 在降低主要综合结果方面,蒂卡格勒 (35%) 没有优于克洛皮多格勒 (36%).
- 两组之间没有发现重大出血事件的显著差异.
- 与克洛皮多格雷尔 (8%) 相比,在30天后,轻微出血事件的发生率更高 (11%) (OR1. 54, p=0. 0070).
结论:
- 在选择性PCI后,蒂卡格勒在减少心肌周围瘤方面没有表现出优于克洛皮多格勒的优势.
- 虽然Ticagrelor没有增加重大出血,但与较高的轻微出血率有关.
- 这些发现支持继续使用克洛皮多格勒作为选择性PCI的标准治疗方法.
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