Higher-dose edoxaban versus warfarin in atrial fibrillation patients with CAD reduced stroke or systemic embolic events (HR 0.65; 95% CI 0.46-0.92; p-INT 0.062 vs no CAD).
RCT
Does edoxaban reduce ischemic and bleeding events compared to warfarin in patients with atrial fibrillation and established coronary artery disease?
Higher-dose edoxaban provides greater relative reductions in ischemic events compared to warfarin in atrial fibrillation patients with established CAD, while maintaining consistent bleeding reductions.
Effect estimate: HR 0.65 (95% CI 0.46-0.92)
p-value: p-INT 0.062
BACKGROUND:: The relative efficacy and safety profile of the oral Factor Xa inhibitor edoxaban compared with warfarin in patients with atrial fibrillation and established coronary artery disease (CAD) has not been analyzed. MATERIALS AND METHODS:: ⩾2. We analyzed the primary trial endpoints (efficacy: stroke or systemic embolic event, safety: International Society on Thrombosis and Haemostasis major bleeding) in patients with versus without CAD, and used interaction testing to assess for treatment effect modification. RESULTS:: and HAS-BLED scores ( p <0.001 for each). Treatment with the higher-dose edoxaban regimen (versus warfarin) in patients with known CAD tended to have a greater reduction in stroke/systemic embolic event compared with patients without CAD (CAD: hazard ratio 0.65 (0.46-0.92) versus no CAD: hazard ratio 0.94 (0.79-1.12), p-INT 0.062) and also in myocardial infarction (CAD: hazard ratio 0.69 (0.49-0.98) versus no CAD: hazard ratio 1.24 (0.89-1.72), p-INT 0.017), while there was a similar reduction in bleeding irrespective of CAD status (hazard ratio 0.81 and 0.80, p-INT 0.97). Presence or absence of CAD did not modify the efficacy or safety profile of the lower-dose edoxaban regimen (versus warfarin). CONCLUSION:: The reduction in ischemic events with the higher-dose edoxaban regimen versus warfarin was greater in patients with CAD, while bleeding was significantly reduced with edoxaban regardless of CAD status. The efficacy and safety profile of the lower-dose edoxaban regimen relative to warfarin was unaffected by CAD status.
Zelniker et al. (Tue,) conducted a rct in Atrial fibrillation and established coronary artery disease. Edoxaban vs. Warfarin was evaluated on Stroke or systemic embolic event (HR 0.65, 95% CI 0.46-0.92, p=p-INT 0.062). Higher-dose edoxaban versus warfarin in atrial fibrillation patients with CAD reduced stroke or systemic embolic events (HR 0.65; 95% CI 0.46-0.92; p-INT 0.062 vs no CAD).