经皮冠状动脉介入治疗术后不同剂量依诺肝素联合替格瑞洛对复杂冠状动脉病变的非ST段抬高型急性冠状动脉综合征患者临床事件的影响Effect of different doses of enoxaparin combined with ticagrelor on clinical events in patients with non-ST-elevation acute coronary syndrome and complex coronary artery lesions after percutaneous coronary intervention
赵烨婧,彭红玉,秦宇君,曹芳英,王平,柳景华
摘要(Abstract):
目的探讨不同剂量依诺肝素联合替格瑞洛在经皮冠状动脉介入治疗(percutaneous coronary intervention,PCI)术后应用的安全性和有效性。方法纳入2015年3月至2016年10月在首都医科大学附属北京安贞医院行PCI的复杂冠状动脉病变的非ST段抬高型急性冠状动脉综合征(NSTE-ACS)患者345例,所有入选患者试验过程中均口服阿司匹林和替格瑞洛治疗。将入选患者在P C I术后随机分为非依诺肝素抗凝治疗组(纳入分析11 0例,非抗凝组)、半量依诺肝素抗凝治疗组(0.5 mg/kg,纳入分析103例,半量抗凝组)、全量依诺肝素抗凝治疗组(1 mg/kg,纳入分析105例,全量抗凝组)。观察的主要终点为三组患者住院期间及术后12个月出血事件的发生情况,次要终点为住院期间、1个月、3个月、12个月主要不良心脑血管事件(main adverse cardiovascular and cerebrovascular events,MACCE)的发生情况。结果主要终点:全量抗凝组较非抗凝组显著增加了患者住院期间总出血事件的发生率(29.5%比13.6%,P=0.005),主要为TIMI小出血发生率的增加(27.6%比13.6%,P=0.012),而未增加TIMI主要出血风险(1.9%比0,P>0.05);而半量抗凝组与非抗凝组住院期间TIMI小出血和主要出血发生率比较,差异均无统计学意义(均P>0.05)。趋势检验显示,PCI术后随着依诺肝素应用剂量的增大,住院期间总出血及小出血发生率均增加,呈线性相关(总出血:趋势P=0.005;小出血:趋势P=0.011)。次要终点:PCI术后三组患者围术期心肌损伤及术后1个月、3个月、12个月随访期间MACCE发生率比较,差异均无统计学意义(均P>0.05)。结论对于复杂冠状动脉病变的NSTE-ACS患者,应用替格瑞洛联合依诺肝素在PCI围术期并未带来额外的临床获益,且全量依诺肝素的皮下应用可增加患者的出血风险,而半量依诺肝素的皮下应用安全性更高。
关键词(KeyWords): 非ST段抬高型急性冠状动脉综合征;复杂冠状动脉病变;替格瑞洛;依诺肝素
基金项目(Foundation): 国家“973”重点基础研究发展计划(2015CB554404);; 国家自然科学基金(81570388)
作者(Author): 赵烨婧,彭红玉,秦宇君,曹芳英,王平,柳景华
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