比伐芦定用于高龄患者冠状动脉介入治疗围术期的有效性和安全性临床观察

Efficacy and safety of bivalirudin in percutaneous coronary intervention for elderly patients during perioperative period

目的评估高龄患者经皮冠状动脉介入治疗围术期应用比伐芦定的有效性和安全性。方法选取2018年5月1日至2019年4月3日在北京阜外医院住院并行冠状动脉介入治疗的高龄患者136例。根据术中使用抗凝药物情况将患者分为比伐芦定组和普通肝素组,两组患者各68例。观察比较两组围术期主要不良心血管事件(MACEs)和总的出血及并发症事件的发生情况。结果比伐芦定组对比肝素组,其MACEs总计为18例vs15例(26.5%vs 22.1%),差异无统计学意义(P=0.55)。总的出血和并发症总计为5例vs11例(7.4%vs 16.2%),提示总的出血和并发症在比伐芦定组有下降趋势,但未达到显著的统计学差异(P=0.11)。其中严重出血(BARC 3-5型)和并发症事件为1例vs 6例(1.5%vs 8.8%),有显著统计学差异(P=0.05)。结论在高龄的非急诊冠状动脉介入治疗患者中应用比伐芦定,相比肝素可明显减少严重出血和并发症的发生率,且不增加MACEs的发生率。

Objective To evaluate the efficacy and safety of bivalirudin in elderly patients undergoing percutaneous coronary intervention during perioperative period.Methods We choosed 136 patients Older Than 70 Years from May 1,2018 to April 3,2019 in Fuwai Hospital who were treated with bivalirudin(68 cases)or unfractionated heparin(UFH)(68 cases).The primary efficacy end point was the incidence of major adverse cardiac events(MACEs,composite of all-cause mortality,cardiac death,stent thrombosis,periprocedural myocardial scathe,periprocedural myocardial infarction,or additional unplanned target lesion revascularization,or any other post-PCI ischemic event)in-hospital.The primary safety end point was the incidence of any bleeding or entry-site complications after percutaneous coronary intervention.Results Occurrence of the MACEs were 26.5%in the bivalirudin group and 22.1%in the UFH group(P=0.55).The efficacy end points did not significantly differ between the groups.Occurrence of the total bleeding events and complications were 7.4%in the bivalirudin group and 16.2%in the UFH group(P=0.11).Total bleeding events and complications decreased in the bivalirudin group,but no significant statistical difference was achieved.Occurrence of the severe bleeding events type 3-5 of BARC and complications were 1.5%in the bivalirudin group and 8.8%in the UFH group(P=0.05).It was signally decreased in the bivalirudin group.There were statistically significant differences.Conclusion The application of bivalirudin in non-emergency coronary intervention for elderly patients can significantly reduce the incidence of severe bleeding and complications compared with heparin,and does not increase the incidence of MACEs.