Study on safety and efficacy of bivalirudin during primary percutaneous coronary intervention in patients with acute myocardial infarction and diabetes mellitus
10.3969/j.issn.1004-8812.2016.09.001
- VernacularTitle: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
- Author:
Lijun ZHAO
;
Ming LIANG
;
Jing LI
;
Jingjing RONG
;
Jingyang SUN
;
Yi LI
;
Yaling HAN
- Publication Type:Journal Article
- Keywords:
Bivalirudin;
Diabetes;
Acute myocardial infarction;
Percutaneous coronary intervention
- From:
Chinese Journal of Interventional Cardiology
2016;24(9):481-486
- CountryChina
- Language:Chinese
-
Abstract:
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 .
