The efficacy, safety, and net clinical outcomes of edoxaban versus warfarin in patients with atrial fibrillation were independent of the degree of comorbidity present (P-interaction > 0.10).
RCT (n=21,105)
randomized
Does edoxaban improve net clinical outcomes compared to warfarin in patients with atrial fibrillation across different burdens of comorbidities?
The efficacy and safety of edoxaban compared with warfarin in patients with atrial fibrillation are consistent regardless of the patient's burden of non-cardiac comorbidities.
p-value: p=>0.10
AIMS: Non-vitamin K antagonist oral anticoagulants represent a new option for prevention of embolic events in patients with atrial fibrillation (AF). However, little is known about the impact of non-cardiac comorbidities on the efficacy and safety profile of these drugs. METHODS AND RESULTS: In a post hoc analysis of the ENGAGE AF-TIMI 48 trial, we analysed 21 105 patients with AF followed for an average of 2.8 years and randomized to either a higher-dose edoxaban regimen (HDER), a lower-dose edoxaban regimen, or warfarin. We used the updated Charlson Comorbidity Index (CCI) to stratify the patients according to the burden of concomitant disease (CCI = 0, 1, 2, 3, and ≥4). The treatment groups were then compared for safety, efficacy, and net clinical outcomes across CCI categories. There were 32.0%, 7.3%, 42.1%, 12.7%, and 6.0% of patients with CCI scores of 0, 1, 2, 3, and ≥4, respectively. A CCI score ≥4 was associated with significantly higher rates of thromboembolic events, bleeding, and death compared to CCI = 0 (P 0.10 for each). CONCLUSION: Although increasing CCI scores are associated with worse outcomes, the efficacy, safety, and net clinical outcomes of edoxaban vs. warfarin were independent of the degree of comorbidity present.
Nicolau et al. (Wed,) conducted a rct in atrial fibrillation (n=21,105). Edoxaban vs. warfarin was evaluated on primary net clinical outcome (stroke/systemic embolism, major bleeding, or death) (p=>0.10). The efficacy, safety, and net clinical outcomes of edoxaban versus warfarin in patients with atrial fibrillation were independent of the degree of comorbidity present (P-interaction > 0.10).