Objective: To compare the effectiveness and safety between bivalirudin and heparin with tirofiban in patients with acute myocardial infarction by primary percutaneous coronary intervention. Methods: A randomized controlled, open-label experiment was performed. Between October 8 2013 and May 26 2015 in the First Affiliated Hospital of Xinjiang Medical University, 260 cases of hospitalized patients with acute ST-segment elevation myocardial infarction(STEMI) who accepted emergency PCI were enrolled in the study. They were randomly divided into bivalirudin group(129 cases), heparin plus tirofiban group(131 cases).In bivalirudin group, they were given intravenous injection0.75mg/kg for the first dose. Then they were given 1.75mg/(kg.h) continuous intravenous infusion until PCI surgery was completed.1.75mg/(kg.h) intravenous infusion was followed after the surgery and sustained with an average time of 190 min. Patients were followed-up for 30 days. The main effect indicators were 30 days of net adverse clinical events, including major adverse cardiac and cerebrovascular events(including all-cause death, secondary myocardial infarction, ischemia-driven target vessel revascularization and stroke) and bleeding. Security potency index was the thrombocytopenia and stent thrombosis that obtained within 30 days. Results: A total of 259 patients completed 30 days of follow-up(99.6%). 14 cases(10.9%) in the bivalirudin group and 32 cases(24.4%)in heparin plus tirofiban group showed 30 days of net adverse clinical events(relative risk[RR], 0.45; 95%CI, 0.19~0.75; P=0.004). Two major adverse cardiac and cerebrovascular events(a given group bivalirudin 5.4%, heparin plus tirofiban 9.2%; P=0.25), stentthrombosis(1.6% vs 3.1%; P=0.42), acquired platelet less disease(0.8% vs 0; P=0.32) and the incidence of acute stent thrombosis(0 vs 0.8%; P=0.25) showed statistical significance.Incidence of 30 days bleeding events between bivalirudin group and heparin plus tirofiban group(5.4% vs 15.3%; P=0.009) showed statistical significance. Conclusion: In emergency PCI treated STEMI patients, compared with heparin combined tirofiban treatment, bivalirudin(including continuous 1.75mg/(kg.h) postoperative with the average of 190min) can reduce the incidence of net adverse clinical events in 30 days. The main reason was bivalirudin can reduce bleeding event rate while major adverse cardiovascular events and stent thrombosis were not increased. |