Table 4. Review of the Landmark Trials in Atrial Fibrillation and the Use of Novel Anticoagulants2834
DrugTrialDesignTreatmentDurationTTR (%)PatientsMean CHAD2 ScoreEfficacy/OutcomeSafety/Outcome
DabigatranRE-LYBlindedVKA/dabigatran (150 mg bid)24 months6418,113 patients with nonvalvular Afib2.1Stroke or systemic emboli, 1.11%
Dabigatran 1.69% VKA group
Major bleeding in 2.71%
Dabigatran in 3.36% of VKA group
RivaroxabanRocket AFDBVKA/rivaroxaban (20 mg daily)30 months5514,264 patients with nonvalvular Afib3.5Stroke or systemic emboli 1.7% rivaroxaban 2.2% VKA groupMajor bleeding: 3.6% in rivaroxaban group, 3.4% in VKA group
X-VertDBVKA/rivaroxaban (20 mg daily)Months551504 patients needed cardioversion for Afib3.2Stroke or systemic emboli: 0.5% in rivaroxaban group and 1.02 in the VKA groupMajor bleeding: 0.61% in rivaroxaban group vs 0.8% in VKA group
ApixabanAVVEROUSDBASA/apixaban 5 mg bid or 2.5 mg bid13 months625,599 patients with nonvalvular Afib could not take warfarin2.1Stroke or systemic emboli: 1.6% in apixaban group vs 3.7% in the ASA groupMajor bleeding: 1.4% in apixaban group vs 1.2% in ASA group
ARISTOTLEDBVKA/apixaban 5 mg bid or 2.5 mg bid22 months6218,201 patients with nonvalvular Afib2.1Stroke or systemic emboli 1.27% apixaban 1.6% VKA groupMajor bleeding 2.1 apixaban 3.09% VKA group
EdoxabanENGAGE-TIMI 48DBVKA/edoxaban 60 mg daily and 30 mg daily34 months6421,105 patients with nonvalvular Afib2.8Stroke or systemic emboli: 1.18% in edoxaban group vs 1.5% in VKA groupMajor bleeding: 2.75% in edoxaban group vs 3.43% in VKA group
  • Afib, atrial fibrillation; ASA, aspirin; DB, double blind; TTR, time in therapeutic range; VKA, Vitamin K antagonist.