ENGAGE AF-TIMI 48
Effective Anticoagulation with Factor Xa Next Generation in AF
Patient / Population Intervention / Exposure Comparison Outcome
In 21,105 patients with AF at moderate-to-high stroke risk, edoxaban was non-inferior to warfarin for stroke or systemic embolism, with less bleeding.
N
21,105
Design
Double-blind, double-dummy RCT
Endpoint
Stroke or systemic embolism
Relevance
2
ResultHigher-dose edoxaban non-inferior; major bleed 2.75 %/yr vs 3.43 %/yr; intracranial bleeding roughly halved.
Giugliano RP, et al. N Engl J Med. 2013;369(22):2093-2104. 10.1056/NEJMoa1310907
Discussion & critique
Completed the four-NOAC evidence base. Reduced efficacy at high creatinine clearance led to a US label restriction — a reminder that NOAC dosing is not one-size-fits-all.