比伐卢定在尿毒症依赖透析并急性冠脉综合征患者经皮冠状动脉介入治疗中的抗凝疗效和安全性研究

Anticoagulant Efficacy and Safety of Bivalirudin in Percutaneous Coronary Intervention of Patients with Uremia Dependent Dialysis and Acute Coronary Syndrome

背景肾功能不全患者介入治疗出血风险高,术中抗凝需严密监测凝血指标。比伐卢定作为新型抗凝药,在肾功能不全的急性冠脉综合征(ACS)患者介入治疗中的抗凝疗效和安全性如何尚无指南明确推荐,且欠缺大样本研究证实。目的探讨比伐卢定在尿毒症依赖透析并ACS患者经皮冠状动脉介入治疗(PCI)中的抗凝疗效和安全性。方法选取2015年10月—2019年12月在中国医学科学院阜外医院深圳医院被诊断为尿毒症依赖透析并ACS且行PCI的患者66例,依据PCI前的抗凝用药情况分为普通肝素组(n=33)和比伐卢定组(n=33)。普通肝素组患者PCI前给予普通肝素,PCI中根据冠状动脉病变情况联用替罗非班;比伐卢定组患者PCI前先予以比伐卢定负荷剂量,静脉推注0.75 mg/kg后以0.25 mg•kg^-1•h^-1静脉泵入,PCI后继续静脉泵入不超过4 h。比较两组患者PCI途径、植入支架个数、主动脉内球囊反搏(IABP)使用情况、冠状动脉病变情况、替罗非班使用情况,PCI后1、7 d的血小板计数(PLT)及PCI后30 d出血情况,PCI后30 d支架内血栓、主要不良心血管事件(MACE)发生情况及死亡原因。结果两组患者PCI途径、植入支架个数、IABP使用率、冠状动脉病变情况、替罗非班使用率比较,差异均无统计学意义(P>0.05)。两组患者PCI后1、7 d PLT及PCI后30 d轻度出血、严重出血发生率比较,差异无统计学意义(P>0.05)。两组患者PCI后30 d支架内血栓、MACE发生率比较,差异无统计学意义(P>0.05)。比伐卢定组1例患者死于顽固性心力衰竭并心源性休克;普通肝素组1例患者死于原发心搏骤停,1例患者死于脑卒中继发大面积脑出血。结论比伐卢定在尿毒症依赖透析并ACS患者PCI中的抗凝疗效及安全性均较好,不劣于普通肝素,其可作为临床上有肝素使用禁忌证的患者PCI中的抗凝方法。

Background Patients with renal insufficiency have a high bleeding risk of interventional therapy,and should be closely monitored for intraoperative anticoagulation.As a new anticoagulant,bivalirudin has not been recommended in the guidelines for the anticoagulant efficacy and safety in interventional therapy of acute coronary syndrome(ACS)patients with renal insufficiency,and there is a lack of large sample data.Objective To investigate the anticoagulant efficacy and safety of bivalirudin in percutaneous coronary intervention(PCI)of patients with uremic dependent dialysis and ACS.Methods From October 2015 to December 2019,66 patients with uremia dependent dialysis and ACS who underwent PCI in Shenzhen Hospital,Fuwai Hospital,Chinese Academy of Medical Sciences were selected.According to the anticoagulant medication before PCI,the patients were divided into unfractionated heparin group(n=33)and bivalirudin group(n=33).Patients in the unfractionated heparin group,unfractionated heparin was given before PCI,and tirofiban was used in combination with coronary artery disease during PCI;the patients in bivalirudin group were given loading dose of bivalirudin before PCI,intravenous injection of 0.75 mg/kg was followed by intravenous infusion of 0.25 mg•kg-1•h-1.After PCI,continuous intravenous infusion was not more than 4 h.The PCI route,the number of stents implanted,the use of intra aortic balloon pump(IABP),coronary artery disease,tirofiban use,platelet count(PLT)at 1 and 7 days after PCI,bleeding at 30 days after PCI,stent thrombosis and major adverse cardiovascular events(MACE)at 30 days after PCI and causes of death of the two groups were compared.Results There was no significant difference in PCI route,the number of stents implanted,IABP usage rate,coronary artery disease and tirofiban usage rate between the two groups(P>0.05).There was no significant difference in PLT at 1 and 7 days after PCI and the incidence of mild bleeding and severe bleeding at 30 days after PCI between the two groups(P>0.05).There was no significant difference in the incidence of stent thrombosis and MACE at 30 days after PCI between the two groups(P>0.05).One patient in the bivalirudin group died of intractable heart failure and cardiogenic shock;one patient in the heparin group died of primary cardiac arrest and one patient died of massive cerebral hemorrhage secondary to stroke.Conclusion Bivalirudin has good anticoagulant efficacy and safety in PCI in patients with uremic dependent dialysis and ACS,and is not inferior to unfractionated heparin.It can be used as an anticoagulation method in PCI for patients with clinical contraindications to heparin use.