Effectiveness And Safety Of Domestic Bivalirudin Versus Heparins For Patients During Percutaneous Coronary Intervention

Objective: The aim of this study is to evaluate the anticoagulant effectiveness and safety of bivalirudin versus unfractionated heparin in patients who were performed percutaneous coronary interventions(PCI).Methods:From July 2014 to February 2015, patients with coronary heart diseases who were admitted in The First Affiliated Hospital of Dalian Medical University and were performed PCI, were enrolled in this study.They were randomly divided into two groups. It was a retropective, controlled, single centers study. During the procedure, the patients in the two groups were used bivalirudin or ordinary unfractionated heparin respectively. They were all followed up within 30 days. The haemoglobin levels, haematocrit and platelet count were measured before and after PCI. The characteristics of these patients were recorded. The primary outcome was MACE events including death, reinfarction, and new revascularization within 30 days. At the same time, bleeding events in both groups were recorded to access the safety.Results: A total of 174 patients with coronary heart disease were enrolled in thisstudy. Among them, 87 patients were in bivalirudin group and 87 patients in unfractionated heparin group. Within 30 days, we did not found significant difference in MACE between both of groups(1.1% in bivalirudin group and 4.6% in unfractionated heparin group, p=0.368). There were no significant difference of bleeding events as well(4.6% in bivalirudin group and 11.5% in unfractionated heparin group, p=0.162). To be noted, it showed the tendency of lower bleeding events in bivalirudin group. There was also no significant difference in not only major bleeding but also minor bleeding events between the two groups. Compared with the patients in unfractionated heparin group, patients in bivalirudin group have no significant difference in bleedings and MACE either in emergency PCI or elective PCI(p=0.621,p=0.083 in emergency PCI; p=0.458,p=0.405 in elective PCI). The level of haemoglobin, haematocrit and platelet count were not different between the two groups either at baseline or at nadir during hospitalization. In different creatinine clearance patients stratified, there was no significant difference between bivalirudin group and unfractionated group in bleeding(p=1.000 in group 30≤e GFR<60ml/min, p=0.234 in group 60≤e GFR<90ml/min, p=1.000 in group e GFR≥90ml/min). Among patients in bivaliruding group, there was no significant difference in bleeding events if renal function was 30≤e GFR<60ml/minand e GFR>60ml/min(p=0.446).Conclusions: In PCI procedure, bivalirudin is as same as unfractionated heparin, in effectiveness and safety.