Meta-analysis Of The Safety And Effectiveness Of Bivarudine In Percutaneous Coronary Intervention For Patients With Acute Coronary Syndrome

Objective:To evaluate the safety and efficacy of bivalirudin in the Percutaneous coronary intervention(PCI)of acute coronary syndrome patients.Methods:The randomized controlled trials literature of bivalutine(Trial Group)and heparin(control group)for percutaneous coronary intervention in acute coronary syndrome(ACS)were systematically reviewed,which published on Cochrane Library,EMBASE,Pub Med,CNKI,Wanfang Data Network,and VIP Chinese network databases.According to preestablished inclusion and exclusion criteria,eligible information was selected and extracted.Meta-analysis was performed on the ultimate data,which combined with either random-effects model or fixed effects model due to heterogeneity.Heterogeneity was quantified by I~2.The effect value was expressed as relative risk(RR)and 95%confidence interval(CI).In addition,the sensitivity analysis and bias analysis were also performed.Results:A total of 9 articles were included in this study,including 17,629 patients,divided into 2 groups,8,877 in the trial group and 8,752 in the control group.The numbers of major bleeding,all-cause death,major adverse cardiac events and myocardial infarction cases in the trial group and the control group within 30 days were223,269,132,123,561,531,353,340,respectively.Results of Meta-analysis showed that the incidence of major bleeding was reduced by 21.6%in trial group compared with control group(P=0.03)and there was no significant difference in all-cause mortality.in terms of efficacy,there was no significant difference between two groups in the incidence of major adverse cardiac events and myocardial infarction(P>0.05).Bias analysis showed the funnel plot of the four outcomes(the incidence of major bleeding,all-cause mortality,adverse cardiac events,and myocardial infarction indicators)was asymmetric.Further Egger’s test results were analyzed,which indicated there were no significant publication bias in the incidence of major bleeding,major adverse cardiac events,and myocardial infarction.However,Egger’s test result(P<0.05)suggested that there was publication bias in all-cause mortality.After the results were treated by trim and filling method,the effect value obtained was consistent with that before.This indicates that there was a certain publication bias in all-cause mortality,but it did not significantly affect the conclusions.The sensitivity analysis results of the outcome above were relatively robust without significant fluctuations.Inclusion:Compared with unfractionated heparin,Bivalirudin was of higher safety in PCI of acute coronary syndrome patients,which had a 21.6%reduction in the incidence of major bleeding and no significant difference in all-cause mortality within 30 days.In terms of efficacy,there was no significant difference between the incidence of major adverse cardiac events and myocardial infarction within 30 days.