Meta-Analysis Of The Safety And Efficacy Of Rivaroxaban In Patients With Coronary Artery Disease

BACKGROUND:The novel oral anticoagulation agent rivaroxaban is a representative drug for oral direct factor Xa inhibitors.It is wildly used in atrial fibrillation and deep venous thrombosis.On the field of secondary prevention of CAD,some clinical trials are conducted.To explore the efficacy and safety of rivaroxaban applied in secondary prevention of CAD,a meta-analysis of randomized controlled studies(RCTs)will be performed.METHODS:Literatures were searched from databases,such as CNKI,Wanfang.PubMed,Cochrane Library,Embase and Clinical-Trials.gov.Language was set as Chinese and English.After screening,a meta-analysis based on RCTs was conducted.The data was analyzed in a fixed-effect model or a random-effects mode according to the heterogeneity test results.The odds ratio(OR)was used as the analytical statistic for the count data.and the 95%confidence intervals(Cl)were calculated.RESULTS:A total of 5 RCTs were enrolled after screening with a total of 51,900 cases.Major adverse cardiac events(MACE)were significantly reduced in the rivaroxaban group compared with the control group[OR=0.86,95%Cl(0.79,0.93),P=0.0003].All-cause mortality[OR=0.89.95%Cl(0.82,0.97),P=0.009].cardiovascular death[OR=0.88,95%Cl(0.80,0.98).P=0.01]and myocardial infarction(MI)[OR=0.86.95%CI(0.78,0.95),P=0.004]decreased in rivaroxaban group.The incidence of stroke[OR=0.76,95%Cl(0.57,1.03),P=0.07]and stent thrombosis[OR=0.88,95%Cl(0.62.1.26),P=0.49]did not show significant reduction.The risk of major bleeding increased[OR=2.51,95%CI(1.21,5.21),P=0.01],but fatal bleeding[OR=1.36,95%Cl(0.80,2.31).P=0.25]did not increase.Subgroup analysis showed that a relatively high dose of rivaroxaban(5 mg,twice daily)did not further decrease MACE incidence compare than lower dose of rivaroxaban(2.5 mg,twice daily).Base on combination of rivaroxaban,dual antiplatelet therapy did not show an advantage over single antiplatelet therapy.Patients with a history of previous stroke[OR=1.66.95%CI(0.67,3.6),P=0.2]and diabetes lellitus(DM)[OR=0.82,95%CI(0.63,1.07),P=0.15]did not show obvious benefits compared to those without stroke and DM,and MACE did not significantly decrease.Fatal bleeding[OR=1.29,95%Cl(0.5,3.33),P=0.59]and intracranial hemorrhase[OR=1.57,95%Cl(0.80,3.10),P=0.19]events in rivaroxaban(2.5 mg,twice daily)group did not increase significantly.CONCLUSION:For CAD patients,Rivaroxaban plus anti-platelet therapy may reduce MACE,such as all-cause death,cardiovascular death,and MI.But bleeding risk mav increase.Lower dose of rivaroxaban(2.5 ms.twice daily)plus anti-platelet therapy may not increase the risk of fatal bleeding and intracranial hemorrhage.Base on colbination of rivaroxaban.dual antiplatelet therapy may not be prioru than single antiplatelet therapy.Patients with previous stroke and DM may not gain more benefit by using rivaroxaban plus anti-platelet therapy.