Comparison Of Safety And Effectiveness Of Using Bivalirudin Versus Unfractionated Heparin In Diabetes Mellitus Undergoing Percutaneous Coronary Intervention

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:Enrolled AMI patients underwent primary PCI in 2years between January 2015 and December 2016.According to the random principle,all patients were randomly assigned to receive bivalirudin,heparin.A total of 316 diabetics were included,consisted of 160 in the bivalirudin group,156 in the heparin group.To observe age,sex,BMI,history,for example:smoking,hypertension,stroke,STEMI,or NSTEMI,and PCI,Killip ?,heart beat,blood pressure,LVEF,hemoglobin,platelet,blood fat and Ccr?60 ml/min and so on in two groups and characteristics of interventional diagnosis and treatment:CAG,PCI or CABQ drugs in preoperative preparation and operation,and the style of coronary artery,single,double or three.Following-up 30days,observing the prognosis and safety.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),including recurrent myocardial infarction,angina,heart failure,malignant arrhythmia,cardiac shock,sudden death and stroke and any bleedings,including BRAC 1-5 styles and stent thrombosis and thrombocytopenia..RESULTS:1.There was no significant difference in coronary artery disease between the two groups,but the results showed that patients with acute myocardial infarction with diabetes mellitus had severe coronary artery disease,and the proportion of patients with three lesions increased significantly2.The incidences of NACE at 30 days were significantly different among two arms(Bivalirudin:8.1%vs.Heparin:16.7%,P=0.031).3.Bivalirudin treatment significantly reduced bleeding events at 30 days compared with heparin(1.3%vs.6.4%,P=0.017).4.The 30-day incidences of MACCE and stent thrombosis were similar among the two groups(P>0.05).CONCLUSION:1.The study found that patients with acute myocardial infarction with diabetes mellitus had a serious coronary artery disease and multiple small vascular lesions.2.The study indicates a better safety and efficacy profile of bivalirudin during primary PCI in patients with AMI and diabetes.3.The use of bivalirudin has dramatically reduced the rate of bleeding and did not increase the incidence of ischemic and stent thrombosis events compared with heparin.