Rivaroxaban and risk of myocardial infarction: insights from a meta-analysis and trial sequential analysis of randomized clinical trials.

OBJECTIVE: To evaluate the risk of myocardial infarction (MI) associated with the use of rivaroxaban. METHODS: We searched PubMed, CINAHL, Cochrane CENTRAL, Scopus, and the Web of Science for randomized controlled trials of rivaroxaban that reported on MI as clinical outcomes. We express the associations as odds ratios and their 95% confidence intervals. A trial sequential analysis was carried out to ensure validity of our findings. RESULTS: Nine trials were selected (N=53 827), including one study on stroke prophylaxis in atrial fibrillation, two in acute coronary syndrome, four of short-term prophylaxis of deep venous thrombosis, and two for treatment of deep venous thrombosis/pulmonary embolism. Control arms included warfarin, enoxaparin, or placebo administration. Rivaroxaban was associated with a significantly lower risk of MI compared with the agents used in the control group (odds ratio, 0.82; 95% confidence interval, 0.72-0.94; P=0.004). No heterogeneity was noted in the risk (I=0%; P=0.55); trial sequential analysis reinforced the validity of our findings. CONCLUSION: Rivaroxaban is associated with a significantly lower risk of MI in a broad spectrum of patients when tested against different controls. © 2013 Wolters Kluwer Health | Lippincott Williams & Wilkins.