急性心肌梗死合并糖尿病患者急诊经皮冠状动脉介入治疗围术期应用比伐芦定的安全性与有效性：BRIGHT 研究预设亚组分析

摘要

Objective To evaluate the safety and efficacy of bivalirudin in patients with acute myocardial infarction ( AMI) and diabetes undergoing primary percutaneous coronary intervention ( PCI) . Methods BRIGHT was a multicenter , randomized , controlled study which enrolled AMI patients underwent primary PCI in 83 Chinese centers between August 2012 and June 2013.All patients were randomly assigned to receive bivalirudin , heparin or heparin plus tirofiban. This study was a prespecified subgroup analysis of the BRIGHT study.A total of 465 diabetics in the BRIGHT study were included , consisted of 168 in the bivalirudin group , 137 in the heparin group and 160 in the heparin plus tirofiban group .Primary endpoint was net adverse clinical event ( NACE) at 30 days, which was defined as a composite of major adverse cardiac and cerebral events ( MACCE ) and any bleedings .Results The incidences of NACE at 30 days were significantly different among three arms ( Bivalirudin:10.1% vs.heparin:16.1% vs.Heparin plus tirofiban 20.6%, P=0.031 ) .Compared with heparin plus tirofiban , bivalirudin was associated with a significantly lower NACE rate (P<0.01).Bivalirudin treatment significantly reduced bleeding events at 30 days compared with heparin and heparin plus tirofiban ( 3.0% vs.7.3% vs.12.5%, P <0.01 ) .The 30-day incidences of MACCE and stent thrombosis were similar among the three groups ( P>0.05 ) . Conclusions The use of bivalirudin has dramatically reduced the rate of bleeding and did not increase the incidence of ischemic events compared with heparin and heparin plus tirofiban , indicating a better safety and efficacy profile of bivalirudin during primary PCI in patients with AMI and diabetes .%目的：评估急性心肌梗死（ acute myocardial infarction ，AMI）合并糖尿病患者急诊行经皮冠状动脉介入治疗（ percutaneous coronary intervention ， PCI ）围术期应用比伐芦定的安全性及有效性。方法选取BRIGHT研究中AMI合并糖尿病行急诊PCI患者465例，其中比伐芦定组168例，肝素组137例，肝素联合替罗非班组160例。主要终点为术后30 d净不良临床事件（ net adverse clinical event，NACE），包括主要不良心脑血管事件（major adverse cardiac and cerebral events ，MACCE）及全部出血事件。结果所有患者均完成30 d临床随访。比伐芦定组NACE事件[17例（10．1％）比33例（20．6％），P＝0．008]及全部出血事件[5例（3．0％）比20例（12．5％），P＝0．001]发生率显著低于肝素联合替罗非班组；与肝素组相比有降低趋势[NACE：17例（10．1％）比22例（16．1％），P＝0．122；全部出血事件：5例（3．0％）比10例（7．3％），P＝0．082]，但差异均无统计学意义。三组间 MACCE和支架内血栓发生率比较，差异均无统计学意义（均P＞0．05）。结论 AMI合并糖尿病患者急诊PCI围术期应用比伐芦定安全有效，与应用肝素或肝素联合替罗非班相比，可降低术后30 d的NACE和出血事件风险，且不增加MACCE和支架内血栓风险。