Direct Comparison of Dabigatran, Rivaroxaban, and Apixaban for Effectiveness and Safety in Non-valvular Atrial Fibrillation

Retrospective Analysis Comparing the Safety and Efficacy of NOACs: Objectives Using a large U.S. administrative database, compare the effectiveness and safety of dabigatran, rivaroxaban, and apixaban in clinical practice Medical claims data from October 1, 2010 through February 28, 2015 were examined Primary outcomes were stroke, systemic embolism and major bleeding Noseworthy PA et al. Chest. 2016. doi:10.1016/j.chest.2016.07.013

Retrospective Analysis Comparing the Safety and Efficacy of NOACs: Objectives Three one-to-one propensity-score matched cohorts of patients with non-valvular AF who were users of dabigatran, rivaroxaban, or apixaban was created Rivaroxaban versus dabigatran [N=31,574] Apixaban versus dabigatran [N=13,084] Apixaban versus rivaroxaban [N=13,130]) Noseworthy PA et al. Chest. 2016. doi:10.1016/j.chest.2016.07.013

Event Rate per 100 Person-Years Retrospective Analysis Comparing the Safety and Efficacy of NOACs: Results Effectiveness: Primary Outcome (Stroke or Systemic Embolism) Event Rate per 100 Person-Years Hazard Ratio (95% CI) P Rivaroxaban vs. Dabigatran N=15,787 N=15,787 1.12 1.03 1.00 (0.75, 1.32) 0.99 Favor Rivaroxaban Favor Dabigatran Apixaban vs. Dabigatran N=6,542 N=6,542 1.22 1.17 0.82 (0.51, 1.31) 0.41 Favor Apixaban Favor Dabigatran Apixaban vs. Rivaroxaban N=6,565 N=6,565 1.21 1.03 1.05 (0.64, 1.72) 0.85 Favor Apixaban Favor Rivaroxaban 0.0 0.5 2.0 1.0 1.5 Noseworthy PA et al. Chest. 2016. doi:10.1016/j.chest.2016.07.013

Event Rate per 100 Person-Years Retrospective Analysis Comparing the Safety and Efficacy of NOACs: Results Safety: Primary Outcome (Major Bleeding) Event Rate per 100 Person-Years Hazard Ratio (95% CI) P Rivaroxaban vs. Dabigatran N=15,787 N=15,787 3.77 2.58 1.30 (1.10, 1.53) <0.01 Favor Rivaroxaban Favor Dabigatran Apixaban vs. Dabigatran N=6,542 N=6,542 2.06 3.25 0.50 (0.36, 0.70) <0.001 Favor Apixaban Favor Dabigatran Apixaban vs. Rivaroxaban N=6,565 N=6,565 2.01 4.55 0.39 (0.28, 0.54) <0.001 Favor Apixaban Favor Rivaroxaban 0.0 0.5 2.0 1.0 1.5 Noseworthy PA et al. Chest. 2016. doi:10.1016/j.chest.2016.07.013

Event Rate per 100 Person-Years Retrospective Analysis Comparing the Safety and Efficacy of NOACs: Results Safety: Secondary Outcome (Intracranial Bleeding) Event Rate per 100 Person-Years Hazard Ratio (95% CI) P 0.0 0.5 2.0 3.0 1.0 1.5 2.5 Rivaroxaban vs. Dabigatran N=15,787 N=15,787 0.53 0.26 1.79 (1.12, 2.86) 0.02 Favor Rivaroxaban Favor Dabigatran Apixaban vs. Dabigatran N=6,542 N=6,542 0.25 0.34 0.65 (0.25, 1.65) 0.36 Favor Apixaban Favor Dabigatran Apixaban vs. Rivaroxaban N=6,565 N=6,565 0.25 0.43 0.56 (0.21, 1.45) 0.23 Favor Apixaban Favor Rivaroxaban Noseworthy PA et al. Chest. 2016. doi:10.1016/j.chest.2016.07.013

Retrospective Analysis Comparing the Safety and Efficacy of NOACs: Results No differences were found between the three NOACs in the risk of stroke or systemic embolism for rivaroxaban vs. dabigatran, apixaban vs. dabigatran and apixaban vs. rivaroxaban Rivaroxaban was associated with increased risk of major bleeding and intracranial bleeding compared to dabigatran Apixaban was associated with lower major bleeding risk vs. dabigatran and rivaroxaban Noseworthy PA et al. Chest. 2016. doi:10.1016/j.chest.2016.07.013

Retrospective Analysis Comparing the Safety and Efficacy of NOACs: Summary Dabigatran, rivaroxaban, and apixaban appear to have equivalent effectiveness Apixaban appears to be associated with lower risk of major bleeding whereas rivaroxaban is associated with higher risk of major bleeding Noseworthy PA et al. Chest. 2016. doi:10.1016/j.chest.2016.07.013