Abstract 16587: Edoxaban Associated With Fewer Serious Adverse Events and Lower Mortality Than Warfarin, Regardless of Burden of Comorbidities: Insights From the ENGAGE AF-TIMI 48 Trial

Background: Atrial fibrillation (AF) is more frequent in elderly pts and those with underlying cardiac and other comorbidities. The multicenter ENGAGE AF-TIMI 48 trial compared efficacy and safety of edoxaban vs warfarin in 21105 pts with AF over a mean follow up of 2.8 yrs. We hypothesized that despite more adverse events in pts with mod-high comorbidity, the benefits of edoxaban over warfarin would be similar to that seen in pts with less comorbidity. Methods: Pts were classified using the Charlson Comorbidity Index (CCI) as low comorbidity (CCI <4, n=15860 pts) or mod-high comorbidity (CCI ≥4, n=5245 pts). Outcomes included study drug discontinuation, serious (non-bleeding) adverse events (SAEs), hepatic events, new neoplasms, and all cause death. Results: Pts with CCI <4 were more likely male, with higher BMI, enrolled in NA, and received fewer cardiac co-medications. They had higher CHA2DS2VASc (mean 5.2 vs 4.0) and HASBLED (2.7 vs 2.4) scores, and higher median TTR with warfarin (69 vs 67%), P≤0.001...