OBJECTIVE: To systematically review the effect of stroke efficacy and bleeding risk of edoxaban versus warfarin in the prevention of patients with atrial fibrillation, and provide evidence-based reference for clinical treatment. METHODS: Retrieved from Cochrane Library, Medline, EMBase, CJFD, Wangfang Database and VIP Database, randomized controlled trials (RCT) about the stroke efficacy and bleeding risk of edoxaban versus warfarin in patients with atrial fibrillation were collected. Meta-analysis was performed for the incidences of stoke and excessive hemorrhage by using Rev Man 5.3 software after data extract. RESULTS: Totally 13 RCTs were included, involving 24 950 patients. Results of Meta-analysis showed, compared with warfarin group, there were no significant differences in the incidences of stoke [RR=0.97,95%CI(0.88,1.08),P=0.60] and excessive hemorrhage [RR=0.84,95%CI(0.59,1.19),P=0.33] in edoxaban group. But the subgroup analysis showed, when daily dose of edoxaban was more than 30 mg, the incidence of stroke in edoxaban group was significantly lower than warfarin group [RR=0.84, 95% CI(0.72, 0.97),P=0.02]; when it was 30 mg, the incidence of excessive bleeding in edoxaban group was significantly lower than warfarin group [RR=0.46, 95%CI(0.35,0.61),P<0.001], the difference was statistically significant. CONCLUSIONS: Compared with warfarin, higher doses(>30 mg/d)of edoxaban can more effectively prevent the occurrence of stroke and low doses(30 mg/d) can reduce the risk of excessive bleeding.