Abstract 9103: Rivaroxaban Use is Associated with Reduced Risk of Myocardial Infarction-Insights from a Meta-analysis and Trial Sequential Analysis of Randomized Clinical Trials
Introduction: There has been recent evidence to suggest an increased risk of myocardial infarction (MI) with the use of the direct thrombin inhibitor, dabigatran etexilate-approved in the US for prevention of stroke in non-valvular atrial fibrillation. Hypothesis: We systematically evaluated the risk of MI associated with use of the other drug, recently approved for the same indication-rivaroxaban, an oral factor Xa inhibitor.
Methods: We searched PubMed, CINAHL, Cochrane CENTRAL, Scopus, and the Web of Science. Randomized controlled trials of rivaroxaban that reported on myocardial infarction as clinical outcomes. The fixed-effects Mantel-Haenszel (M-H) test was used to evaluate the effect of rivaroxaban on MI, in the absence of heterogeneity. Trial sequential analysis (TSA) was performed to ensure validity of our findings.
Results: Seven trials were selected (N=45,566), including 1 study of stroke prophylaxis in atrial fibrillation, 2 in acute coronary syndrome, and 4 of short-term prophylaxis of deep venous thrombosis. Control arms included warfarin, enoxaparin, or placebo administration. Rivaroxaban was associated with a significantly lower risk of MI than that seen with agents used in the control group; OR, 0.82; 95% CI, 0.72-0.93; P=0.002). No heterogeneity was noted in the risk (I2=0%; P=0.82), TSA reinforced validity of our findings.
Conclusions: Rivaroxaban is associated with a significantly lower risk of MI in a broad spectrum of patients when tested against different controls. We recommend the use of rivaroxaban over dabigatran for nonvalvular AF particularly in patients at high risk of acute coronary events.
- © 2012 by American Heart Association, Inc.