The Randomized Controlled Trial Of Bivalirudin And Unfractionated Heparin In Arteriosclerosis Obliterans Treated With Interventional Therapy

Objective: The aim of this study is to evaluate the anticoagulant effectiveness and safety of bivalirudin versus unfractionated heparin(UFH)in patients who were performed percutaneous peripheral intervention(PPI).Methods: From August 2015 to January 2017,patients with arteriosclerosis obliterans(ASO)who were admitted in The Beijing Chaoyang Hispital Affiliated of Capital Medical University and were performed PPI,were enrolled in this study.They were randomly divided into bivalirudin group(88 cases),unfractionated heparin group(93 cases).It was a prospective,randomized controlled,single center study.During the procedure,the patients in the two groups were used bivalirudin or unfractionated heparin respectively.In bivalirudin group,they were given intravenous injection 0.4mg/kg for the first dose.Then they were given 1.0mg/kg/h continuous intravenous infusion until PPI surgery was completed.UFH group were given intravenous injection 60U/kg.The activated clotting time(ACT)before and 5min later after giving anticoagulants were measured.The characteristics of these patients were recorded.The main effect indicators were the surgical successful rates and thrombosis during and 3 days after the operation.At the same time,bleeding events and death in both groups were recorded to access the safety.Results:Both of the two groups have no death,thrombosis and massive hemorrhage.The surgical successful rates in two groups were 90.91%(bivalirudin group)and 88.17%(UFH group),there was no statistical significance.The minor bleeding rate in bivalirudin group was 2.27% and 5.38% in UFH group.Yet there was no statistical significance between them.Conclusions:1.The effectiveness of bivalirudin is as same as UFH in PPI to a certain extent.2.The safety of bivalirudin is not bad than UFH,but we can't get the concliusion that bivalirudin is better than UFH.