比伐芦定在冠状动脉慢性完全闭塞病变经皮冠状动脉介入治疗围术期应用中的有效性和安全性临床观察

目的评估冠状动脉慢性完全闭塞(CTO)病变患者经皮冠状动脉介入治疗(PCI)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24日至2019年3月12日在北京阜外医院住院并行CTO-PCI患者78例。根据术中使用抗凝药物情况将患者分为比伐芦定组(39例)和普通肝素组(39例)。观察比较两组术后主要不良心血管事件(MACE)和总出血及并发症事件的发生情况。结果比伐芦定组与普通肝素组围术期心肌损伤发生率(2.6%比5.1%,P=0.556)、围术期心肌梗死发生率(15.4%比10.3%,P=0.498)比较,差异均无统计学意义。两组患者在全因死亡、心脏死亡、计划外的血运重建、缺血事件上均未见不良事件,差异均无统计学意义(均P>0.05)。比伐芦定组与普通肝素组出血学术研究联合会分型(BARC)1型出血事件发生率(12.8%比10.3%,P=0.723)、BARC 2型出血事件发生率(2.6%比0,P>0.999)比较,差异均无统计学意义。两组患者均未发生BARC 3~5型严重出血事件。两组患者冠状动脉穿孔发生率(0比2.6%,P>0.999)比较,差异无统计学意义。结论与常规应用肝素抗凝治疗比较,比伐芦定在CTO-PCI中的应用是安全和有效的,在出血高风险患者中应用能否获益仍需较大样本的研究进一步证实。

Efficacy and safety of bivalirudin in percutaneous coronary intervention for chronic total occlusion lesion during perioperative period

Objective To evaluate the efficacy and safety of bivalirudin in coronary chronic total occlusion(CTO)lesion undergoing percutaneous coronary intervention(PCI)during perioperative period.Methods We chose 78 patients with CTO lesion from May 24,2018 to March 12,2019 in Fuwai hospital who were treated with bivalirudin(39 cases)or unfractionated heparin(UFH)(39 cases).The primary e fficacy endpoint of the incidence of major adverse cardiac events(MACE)and the primary safety endpoint of the incidence of any bleeding or complications were observed between the two groups.Results In hospital periprocedural myocardial injury rates were 2.6% in the bivalirudin group and 5.1% in the UFH group(P=0.556),and periprocedural myocardial infarction rates were 15.4% in the bivalirudin group and 10.3% in the UFH group(P=0.498),there was no significant statistical dif ference.The e fficacy endpoints did not significantly dif fer between the groups.There was not MACE,composite of all-cause mortality,cardiac death,stent thrombosis,or additional unplanned target lesion revascularization,or any other post-PCI ischemic event.Occurrence of the bleeding events type 1 of BARC were 12.8% in the bivalirudin group and 10.3% in the UFH group(P=0.723)and type 2 of BARC were 2.6% in the bivalirudin group and 0 in the UFH group(P>0.999).There was no bleeding events type 3-5 of BARC.Coronary perforation rates were 0 in the bivalirudin group and 2.6% in the UFH group(P>0.999).The safety endpoint did not significantly dif fer between the groups.Conclusions In CTO patients undergoing percutaneous coronary intervention,our data indicates that bivalirudin appears to be comparable in e fficacy and safety to UFH.In CTO patients at high risk for bleeding with bivalirudin,further research is needed to confirm its advantages.