Table 1. Pivotal randomized trials comparing NOAC's with warfarin for patients with non-valvular atrial fibrillation.
Trial | Study drug | No. | Mean CHA2DS2-VASc score | Outcome |
---|---|---|---|---|
RE-LY6) | Dabigatran | 18,113 | 2.2 | Lower rates of stroke and systemic embolism with dabigatran but similar rates of major hemorrhage |
ROCKET AF7) | Rivaroxaban | 14,246 | 3.5 | Rivaroxaban was noninferior to warfarin for the prevention of stroke or systemic embolism |
There was no difference in the risk of major bleeding; intracranial and fatal bleeding however occurred less frequently in the rivaroxaban group | ||||
ARISTOTLE8) | Apixaban | 18,201 | 2.1 | Apixaban was superior to warfarin in preventing stroke or systemic embolism, and caused less bleeding and was associated with lower mortality |
ENGAGE AF9) | Edoxaban | 21,105 | 2.8 | Edoxaban was noninferior to warfarin with respect to the prevention of stroke or systemic embolism and was associated with lower rates of bleeding and death from cardiovascular causes |
ARISTOTLE = apixaban for reduction in stroke and other thromboembolic events in atrial fibrillation; ENGAGE AF= effective anticoagulation with factor Xa next generation in atrial fibrillation; NOAC = novel oral anticoagulants; RE-LY= Randomized Evaluation of Long-term anticoagulant therapY; ROCKET AF = rivaroxaban once daily oral direct factor Xa inhibition compared with vitamin K antagonism for prevention of stroke and embolism trial in atrial fibrillation.