The Efficacy And Safety Of Bivalirudin In STEMI Patients Undergoing Percutaneous Coronary Intervention Following Thrombolytic Therapy

Objective:Most of the previous clinical trials on the application of bivalirudin in percutaneous coronary intervention（PCI）excluded patients with preoperative intravenous thrombolysis.However,such patients are not in a minority in actual clinical work,and they are faced with higher risk of ischemia and bleeding.The purpose of this study was to evaluate the efficacy and safety of bivalirudin in ST-segment elevation myocardial infarction（STEMI）patients during PCI after intravenous thrombolysis.In order to find an optimal anticoagulant program to reduce bleeding complications while protecting patients from ischemic complications.Method:We performed a retrospective analysis of a total of 210 STEMI patients who received intravenous thrombolytic therapy in primary hospitals and were transferred to the Department of Cardiovascular Medicine of the Second Hospital of Jilin University from January 2017 to July 2021,all patients underwent PCI within 24 hours.According to the different application of anticoagulant drugs during PCI,the patients were divided into two groups.There were 111 patients received bivalirudin and 99 patients received heparin.We collect and analyze the clinical data and prognosis of patients in the two groups.The primary end point was bleeding events during hospitalization;Major adverse cardiovascular events（MACE）during hospitalization included cardiogenic death,recurrent myocardial infarction,stroke,and ischemia-driven target vessel revascularization;Stent thrombosis;Net adverse clinical events（NACE）included bleeding complications,MACE,and stent thrombosis.And the incidence of MACE 6 months after discharge.Logistic regression analysis was used to explore the influencing factors of bleeding events.In addition,the duration of intravenous thrombolytic therapy was collected for 156 of all patients.The patients were divided into two groups according to the time window of PCI after intravenous thrombolysis.There were 95 patients in group A（the interval between intravenous thrombolysis and PCI was less than 6 hours）and 61 patients in group B（the interval between intravenous thrombolysis and PCI was 6-24hours）.The incidence of bleeding events,MACE,stent thrombosis and NACE during hospitalization in 2 groups were analyzed.Finally,the incidence of adverse events was compared between the bivalirudin group and the heparin group in patients who underwent PCI within 6 hours after intravenous thrombolysis.Results:1.A total of 210 patients were included in this study.The average age of all patients was 58.7±8.7 years old,and most of them were male.There was no statistical difference in general baseline data between the two groups.There were statistically significant differences in AST,TBil,IBil,TC,FIB,double vessel disease,LCX disease and intraoperative thrombus aspiration（P<0.05）.These statistically different factors were included in logistic regression analysis,and no correlation was found between these factors and bleeding events.2.Comparison of preoperative and postoperative Hb and HCT levels:there was no statistical difference in preoperative baseline Hb and HCT levels between the two groups（P>0.05）.The levels of Hb and HCT showed a decreasing trend after operation,which were statistically different from those before operation（P<0.05）.The minimum value of postoperative Hb and the minimum value of HCT were statistically different between the two groups（P=0.005;P=0.039）,which was lower in heparin group.3.The incidence of bleeding events during hospitalization in the two groups was as follows: 11 patients（9.91%）in the bivalirudin group,and15 patients（15.15%）in the heparin group.TIMI minor bleeding: 7 patients（6.31%）in the bivalirudin group,and 7 patients（7.07%）in the heparin group;TIMI minor bleeding: 4 patients（3.6%）in the bivalirudin group,and 8 patients（8.08%）in the heparin group;There was no significant difference between groups（P>0.05）.There was no TIMI major bleeding in the two groups.4.The incidence of MACE during hospitalization in the two groups was as follows: 2 patients（1.8%）in the bivalirudin group and 3 patients（3.03%）in the heparin group,all of which were cardiogenic deaths.There was no significant difference between groups（P>0.05）.5.The incidence of stent thrombosis during hospitalization in the two groups was as follows: there was 1 patient（0.9%）received bivalirudin occurred subacute stent thrombosis.No stent thrombosis occurred in the heparin group.6.The incidence of NACE during hospitalization in the two groups was as follows: 14 patients（12.61%）in the bivalirudin group and 18 patients（18.18%）in the heparin group.There was no significant difference between groups（P>0.05）.7.The incidence of 6 months MACE after discharge in the two groups was as follows: there were 7 patients（6.31%）in the bivalirudin group,including 2 patients（1.8%）of cardiogenic death,1 patient（0.9%）of recurrent myocardial infarction,2 patients（1.8%）of stroke and 2patients（1.8%）of ischemia-driven target vessel revascularization.There were 10 patients（10.1%）in the heparin group,including 2 patients（2.02%）with cardiac death,3 patients（3.03%）with stroke,and 5 patients（5.05%）with ischemia-driven target vessel revascularization.There was no significant difference between groups（P>0.05）.8.The analysis and comparison results of group A（interval from intravenous thrombolysis to PCI was less than 6 hours）and group B（interval from intravenous thrombolysis to PCI was 6-24 hours）showed statistically significant difference in the incidence of bleeding events during hospitalization between the two groups（17.89% in group A,6.65%in group B;P=0.043）.In group A,4 patients（4.21%）died during hospitalization.There was 1 patient（1.64%）occurred subacute stent thrombosis in group B.There was a statistical difference in NACE between the two groups during hospitalization（22.11% in group A,8.2% in group B;P=0.023）.9.There were no statistically significant differences in bleeding events,MACE and NACE between the bivalirudin group and the heparin group among patients who underwent PCI 6 hours after intravenous thrombolysis.（P>0.05）.Conclusions:1.For STEMI patients undergoing PCI after intravenous thrombolytic therapy,bivalirudin has a tendency to reduce bleeding complications and does not increase the risk of ischemic complications,which is safer than ordinary heparin.2.STEMI patients undergoing PCI within 6-24 hours after intravenous thrombolysis had a lower risk of bleeding and ischemic complications than those who underwent PCI less than 6 hours after intravenous thrombolysis.