| Objective: 1) To evaluate the impact of bivalirudin versus heparin on efficacy and safety outcomes of patients with ST segment elevation myocardial infarction undergoing percutaneous coronary intervention(PCI); 2) to explore the potential relationship between plasma concentrations of soluble P-selectin(sPs), related to thobosis formation and Ps, and AF coupled with thrombosis; 3) To compare the effectiveness and safety between bivalirudin and heparin with tirofiban in patients with acute myocardial infarction by primarypercutaneous coronary intervention. Methods: 1) The databases of PubMed, MEDLINE, Embase, Elsevier, Cochrane Library, CNKI and WanFang Database were retrieved with computer for searching the randomized controlled trials(RCTs) about the bivalirudin versus heparin in patients with STEMI Undergoing PCI. All materials were retrieved and evaluated independently by 2 reviewers, and then given a Meta-analysis by using RevMan 5.3 software. The outcomes mainly are MACE(all-cause death, myocardial infarction, revascularisation), major bleeding, acute and subacute stent thrombosis. 2) Blood samples were taken before operation(before administration), during operation(about 20 minutes) and after operation(end of operation). Serum P-selectin levels were measured, patients were followed-up for 30 days. The main index were hemorrhage within 30 days, acquired thrombocytopenia, and stent thrombosis. 3) 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 injection 0.75 mg.kg-1.h-1 for the first dose. Then they were given 1.75 mg.kg-1.h-1 continuous intravenous infusion until PCI surgery was completed.1.75 mg.kg-1.h-1 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: 1) There were finally 5 RCT included involving 10088 cases. The results of Meta-analysis showed that all-cause death(RR=0.92, 95%CI: 0.73~1.16, P=0.47), myocardial infarction(RR=1.46, 95%CI: 0.94~2.27, P=0.10), stent thrombosis in 30d(RR=1.64, 95%CI: 0.89~3.02, P=0.11), subacute stent thrombosis(24h-30d)(RR=0.88, 95%CI: 0.54~1.42, P=0.60), revascularisation(RR=1.46, 95%CI: 1.10~1.94, P=0.009) did not significantly differ with bivalirudin compared to heparin with or without Glycoprotein ?b/?a Inhibitors. Major bleeding was significantly reduced by bivalirudin compared to heparin(RR=0.61, 95%CI: 0.44~1.00, P=0.05), Bivalirudin increased the risk of acute stent thrombosis(RR=3.76, 95%CI: 2.12~6.66, P<0.00001). 2) A total of 259 patients completed 30 days of follow-up(99.6%). The level of p-selectin was significantly higher in the heparin group(20min after treatment) than in the preoperative group(before treatment), and was also higher in the heparin group(the end of the operation) than in the preoperative group, and the differences are both statistically significant.(P<0.05).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), stent thrombosis(1.6% vs 3.1%; P=0.42), acquired platelet less disease(0.8% vs0; 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%vs15.3%; P=0.009) showed statistical significance. Conclusion: In emergency PCI treated STEMI patients, compared with heparin combined tirofiban treatment, bivalirudin(including continuous 1.75 mg.kg-1.h-1postoperative with the average of 190min).bivalirudin can reducet the level of p-selectinds but heparin increas the level of p-selectinds during STEMI patients PPCI.bivalirudin 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. |
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