Meta-Analysis Comparing Biavlirudin Versus Heparin Monotherapy On Safety In Percutaneous Coronary Intervention

Objective:Using a systematic review and meta-analysis to compare outcomes bivalirudin versus heparin monotherapy on safety (incidence of MACEs, death, MI, major bleeding and transfusion) on percutaneous coronary intervention. This method can provide reference for clinical.Method:Articles were selected from PubMed, EMbase, Cochrane Library, CBM, CNKI, VIP and Wan-Fang database (all searches are starting in Jan1990and ending in May2013) for relevant information on controlled clinical trials. The RevMan5.2software was used for statistical analysis. The Modified Jadad scale and NOS scale were used for evaluate the quality for randomized controlled trials and observational studies, respectively. Outcomes were reported as Odds Ratio (OR) and the95%confidence interval (95%CI) for all studies. We examined heterogeneity across studies with the Q and I2test statistic methods. When P>0.1and I2<50%were considered to indicate homogeneity and then use the fixed effect model. When P<0.1and I2>50%were considered to indicate heterogeneity and then use the random effects model. Statistical test was used x2test method. When P≤0.05was considered the combined statistics values of included studies have statistically significant. Finally, we used the sensitivity and publication bias assessment method for further analysis results.Result:We retained14studies (29226paitents) about the comparing biavlirudin versus heparin monotherapy on safety in PCI, among which9studies (21712paitents) are observational studies and5studies (7514paitents) are RCT. In the all studies, most patients mean age were similar (67years old),69%of the patients were male,37%of patients with diabetes and21%of patients with chronic renal failure.The analysis shows that bivalirudin lower than heparin in mortality and the incidence of major bleeding in PCI. The bivalirudin group relative reduction55.2%in the mortality compared to heparin group,[0.17%VS0.39%, ORcom=0.38,95%CI=[0.25,0.59], P<0.0001], the bivalirudin group relative reduction24.2%in the incidence of major bleeding compared to heparin group,[2.01%VS2.65%, ORcom=0.67,95%CI=[0.55,0.80],P=0.0001].The bivalirudin had no obviously decrease compared with heparin in the incidence of MI in PCI. The bivalirudin group relative reduction8.4%in the incidence of MI compared to heparin group,[4.43%VS4.84%, ORcom=0.97,95%CI=[0.77,1.23],P=0.83].The bivalirudin had no significant difference compared with heparin in the incidence of MACEs and transfusion in PCI. The bivalirudin group relative reduction13.5%in the incidence of MACEs compared to heparin group,[4.96%VS5.73%, ORcom=0.95,95%CI=[0.78,1.16],P=0.59],The bivalirudin group relative reduction7.9%in the incidence of transfusion compared to heparin group,[2.90%VS3.15%, ORcom=0.91,95%CI=[0.76,1.08], P=0.28].Conclusion:The bivalirudin is superior to heparin in mortality and the incidence of major bleeding in PCI. The bivalirudin had no obviously decrease compare with heparin in the incidence of MI in PCI, and these two drugs basically similar. The bivalirudin had no significant difference in the incidence of MACEs and transfusion in PCI and pending further system analysis based on expand the sample size.