Key result
Underdosed apixaban shows no difference in thrombosis or death versus standard dosing in HF, AF, and ESKD.
Why the study?
Real-world physician choices of apixaban dosing according to kidney function are inconsistent, and data were needed on the long-term clinical outcomes of off-label dosing in HF patients with NVAF and ESKD.
Does off-label underdosed apixaban affect the risk of systemic thrombotic events, death, or bleeding compared to standard or overdosed apixaban in heart failure patients with atrial fibrillation and end-stage kidney disease?
Cohort (n=370)
Does off-label underdosed apixaban affect the risk of systemic thrombotic events, death, or bleeding compared to standard or overdosed apixaban in heart failure patients with atrial fibrillation and end-stage kidney disease?
Answers are grounded in this paper and cite their sources.
Off-label underdosing of apixaban in Asian heart failure patients with atrial fibrillation and end-stage kidney disease did not significantly alter the risk of systemic thrombotic events, death, or bleeding compared to standard dosing.
Background Apixaban represent one of the cornerstone treatments to prevent cardioembolic events in patients with nonvalvular atrial fibrillation (NVAF). However, the choices of Apixaban dose guided by the decision-making process of the physician, which considers specific according to kidney functions are inconsistent in the real-world practice. Purpose The objective of the present study is to evaluate the effects of real-world Off-label dose of Apixaban on long-term clinical outcomes in heart failure (HF) patients with NVAF and End Stage Kidney Disease (ESKD) Methods Our database of HF patients diagnosed with AF and ESKD from 2018 to 2024 was used to obtain laboratory, echocardiography, electrocardiogram (ECG), and clinical outcomes data. Inclusion criteria were all HF patients with AF and ESKD using Apixaban. And we compared bleeding, systemic thrombotic events including stroke/systemic embolism and death according to off-label real -world dose of Apixaban. Results Among 370 HF patients with AF and ESKD (78.4±9.7 years), 197 (53.2%) patients took off-label underdosed Apixaban. Difference in the baseline characteristics was not observed among patients including CHA2DS2 VASc score and HASBLED score. During the median 18-month follow-up, there was no significant difference of systemic thrombotic events including stroke/systemic embolism and death (P=0.705) in the off-label underdosed Apixaban group vs. those with standard dose or off-label overdosed Apixaban. And, there was also no significant difference of bleeding to off-label real-world dose of Apixaban (off-label underdose vs. standard dose, P=0.600; off-label overdose vs. standard dose, P=0.395; off-label underdose vs. off-label overdose, P=0.469). however, in multivariate analysis, CHA2DS2VASc score was independent risk factors for systemic thrombotic events (OR 1.994; CI 1.084-3.669; P=0.027). Conclusions There was no significant difference of systemic thrombotic events including stroke/systemic embolism and death with no difference in the risk of bleeding in HF patients with AF and ESKD, supporting the apixaban dosing tailored to specific clinical features and drug pharmacokinetics of the Asian patients.
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Im et al. (2025) conducted a cohort in Heart failure with atrial fibrillation and end stage kidney disease (n=370). Apixaban vs. Standard dose or off-label overdose was evaluated on Systemic thrombotic events including stroke/systemic embolism and death (p=0.705). Off-label underdosed apixaban showed no significant difference in systemic thrombotic events or death compared to standard or overdosed apixaban in HF patients with AF and ESKD (P=0.705).
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