Direct oral anticoagulants (DOACs) have become the preferred therapy for stroke prevention in atrial fibrillation (AF), current guidelines recommend DOACs over vitamin K antagonists for stroke prevention in most patients with AF . However, the inherent risk of severe bleeding, although less frequent with DOAC therapy than vitamin K antagonists, may affect the morbidity and mortality of patients.
"These results may aid physicians in evidence-based individualization of edoxaban dosing. However, the approved HDER remains the standard therapy among the available edoxaban dosing regimens for stroke prevention in atrial fibrillation."the research team quoted.
The objective of the present analysis of the ENGAGE AF TIMI-48 trial was to comprehensively compare the net clinical outcome (NCO) of LDER (30 mg once daily, dose reduced to 15 mg in selective patients) versus HDER (60 mg once daily, dose reduced to 30 mg in selective patients).
This study performed a pre-specified analysis of the ENGAGE AF-TIMI 48 trial, comparing patients on LDER versus HDER.
Data analysis revealed some interesting facts.
- The pre-defined primary NCO (stroke/systemic embolism [SEE], major bleeding, death) was less frequent with LDER (7.26% vs. 8.01%; hazard ratio: 0.90; 95% confidence interval: 0.84 to 0.98; p = 0.014).
- The secondary (disabling stroke, life-threatening bleeding, or all-cause mortality) and tertiary pre-defined NCOs (stroke, SEE, life-threatening bleeding, or all-cause mortality) were similar between the 2 dosing regimens.
- Patients randomized to LDER versus HDER had a significantly higher risk of stroke/SEE (2.04% vs. 1.56%; hazard ratio: 1.31; 95% confidence interval: 1.12 to 1.52; p < 0.001).
- Conversely, major bleeding, intracranial hemorrhage, major gastrointestinal bleeding, and life-threatening bleeding occurred significantly less frequently with LDER compared with those of HDER. These findings were supported by multiple pharmacokinetic findings.
"Importantly , a statistically significant reduction in all-cause mortality was observed with LDER compared with warfarin, raising the possibility that this dosing regimen might be beneficial for certain patient profiles."the team concluded.
For the full article follow the link: Steffel J, Ruff CT, Yin O, et al. Randomized, double-blind comparison of half-dose versus full-dose edoxaban in 14,014 patients with atrial fibrillation. J Am Coll Cardiol. 2021;77:1197-1207.
Primary source: Journal of the American College of Cardiology
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