Study on safety and efficacy of bivalirudin during primary percutaneous coronary intervention in patients with acute myocardial infarction and diabetes mellitus / 中国介入心脏病学杂志

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 ( Bivalirudin10.1% vs.heparin16.1% vs.Heparin plus tirofiban 20.6%, P=0.031 ) .Compared with heparin plus tirofiban , bivalirudin was associated with a significantly lower NACE rate (P0.05 ) . 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 .