刘畅, 谢恩睿, 段一璇, 倪雅娟, 李青, 高登峰, 邓捷. 比伐芦定在急性冠脉综合征患者PCI围术期的有效性及安全性[J]. 心脏杂志, 2022, 34(4): 413-416, 421. DOI: 10.12125/j.chj.202108035
    引用本文: 刘畅, 谢恩睿, 段一璇, 倪雅娟, 李青, 高登峰, 邓捷. 比伐芦定在急性冠脉综合征患者PCI围术期的有效性及安全性[J]. 心脏杂志, 2022, 34(4): 413-416, 421. DOI: 10.12125/j.chj.202108035
    Chang LIU, En-rui XIE, Yi-xuan DUAN, Ya-juan NI, Qing LI, Deng-feng GAO, Jie DENG. Efficacy and safety of bivalirudin in treatment of acute coronary syndrome patients during perioperative period of percutaneous coronary intervention[J]. Chinese Heart Journal, 2022, 34(4): 413-416, 421. DOI: 10.12125/j.chj.202108035
    Citation: Chang LIU, En-rui XIE, Yi-xuan DUAN, Ya-juan NI, Qing LI, Deng-feng GAO, Jie DENG. Efficacy and safety of bivalirudin in treatment of acute coronary syndrome patients during perioperative period of percutaneous coronary intervention[J]. Chinese Heart Journal, 2022, 34(4): 413-416, 421. DOI: 10.12125/j.chj.202108035

    比伐芦定在急性冠脉综合征患者PCI围术期的有效性及安全性

    Efficacy and safety of bivalirudin in treatment of acute coronary syndrome patients during perioperative period of percutaneous coronary intervention

    • 摘要:
        目的  探索比伐芦定在急性冠脉综合征(ACS)患者接受经皮冠状动脉介入(PCI)治疗围术期应用的有效性及安全性。
        方法  收集2018年1月~2020年6月收治的接受PCI治疗且术前应用阿司匹林与替格瑞洛作为双联抗血小板治疗的ACS患者309例,根据围术期应用的抗凝方案分为比伐芦定组和肝素联用血小板糖蛋白Ⅱb/Ⅲa受体抑制剂(GPI)组(肝素GPI组),分别收集到58例和251例。进行1:1比例的倾向性评分匹配(两组均n=50),通过门诊及电话随访统计终点事件发生情况。主要终点为术后30 d净不良临床事件(NACE)发生率,定义为包括符合美国出血学术研究联合会出血标准(BARC)的全部出血和主要不良心脑血管事件(MACCE),即包括各种原因引起死亡、紧急的靶罪犯血管需行再次血运重建(uTVR)、心肌梗死、卒中的复合终点。次要终点为术后30 d和6月内的MACCE事件及全部出血,以及术后6月内的NACE。
        结果  两组术后30 d的NACE事件、MACCE事件、全部出血事件以及术后6月发生的NACE事件、MACCE事件及全部出血的发生率差异均无统计学意义。两组术后30 d发生符合BARC(3~5)型出血事件的发生率差异无统计学意义。其中在CRUSADE评分>30分的中-高危出血风险的人群中应用比伐芦定可以降低PCI术后30 d的NACE事件发生率(P<0.05)(比伐芦定组与肝素GPI组的NACE事件发生率分别为 0 %与 6.0%)。
        结论  ①比伐芦定在给予替格瑞洛的ACS患者PCI围术期时应用具有有效的抗栓作用且不增加临床大出血风险;②应用比伐芦定可以降低CRUSADE评分>30分的中-高危出血风险患者术后30 d发生NACE事件的风险。

       

      Abstract:
        AIM  To investigate the efficacy and safety of bivalirudin in acute coronary syndrome (ACS) patients during the perioperative period of percutaneous coronary intervention (PCI).
        METHODS  A retrospective analysis was conducted in 309 PCI patients who received aspirin plus ticagrelor as antiplatelet pretreatment from January 2018 to June 2020 in the First and Second Affiliated Hospital of Xi’an Jiaotong University. According to antithrombotic therapy during perioperative period of PCI, the patients were divided into two groups: the bivalirudin group and the heparin plus Gp IIb/IIIa inhibitor (GPI) group. Based on the clinical and demographic variables, 1∶1 propensity score matching was conducted and the patients were followed up by phone. The primary endpoint was 30-day net adverse clinical event (NACE), defined by any bleeding as defined by the Bleeding Academic Research Consortium (BARC) and a composite of major adverse cardiac or cerebral events (MACCE), including all-cause death, urgent ischemia-driven target vessel revascularization (uTVR), reinfarction and stroke. The secondary endpoints were 30-day and 6-month MACCE and any bleeding, as well as 6-month NACE.
        RESULTS  Among the 309 patients who underwent PCI, 58 patients were assigned to the bivalirudin group and 251 patients to heparin plus GpⅡb/Ⅲa inhibitor group. After propensity score matching, each of the two groups included 50 patients respectively. No statistical difference was found between the two groups in the incidence of 30-day NACE, MACCE, any bleeding and 6-month NACE, MACCE and all bleeding. Nor was the difference found in the incidence of 30-day BARC3-5 . However, the risk of 30-day NACE was found to have reduced in bivalirudin-treated medium-to-high bleeding risk ACS patients with >30 scores ranked by the CRUSADE bleeding score (Bivalirudin vs. Heparin plus GPI, 0 vs. 6.0%, P<0.05).
        CONCLUSION  Bivalirudin is efficacious and safe in ACS patients after asprin plus ticagrelor combination therapy during the perioperative period of PCI. Bivalirudin reduces the risk of 30-day NACE in ACS patients with medium to high bleeding risk.

       

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