Abstract: FR-PO1163
Impact of Real-World, Off-Label Dose of Apixaban on Long-Term Clinical Outcomes in Patients with Atrial Fibrillation and CKD
Session Information
- CKD: Kidney Function and Extrarenal Complications
October 25, 2024 | Location: Exhibit Hall, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: CKD (Non-Dialysis)
- 2302 CKD (Non-Dialysis): Clinical, Outcomes, and Trials
Authors
- Rim, Hark, Kosin University Gospel Hospital, Busan, Korea (the Republic of)
- Bak, Byeonghwa, Kosin University Gospel Hospital, Busan, Korea (the Republic of)
- Kim, Ye na, Kosin University Gospel Hospital, Busan, Korea (the Republic of)
- Shin, Ho Sik, Kosin University Gospel Hospital, Busan, Korea (the Republic of)
- Jung, Yeonsoon, Kosin University Gospel Hospital, Busan, Korea (the Republic of)
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.
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 NVAF patients with chronic kidney disease
(CKD)
Methods
Our database of AF patients diagnosed with CKD from 2018 to 2023 was used to
obtain laboratory, echocardiography, electrocardiogram (ECG), and clinical outcomes data.
Inclusion criteria were all AF patients with CKD 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 635 patients with AF and CKD (76.9±10.4 years), 335 (52.8%) 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, a lower incidence of bleeding events (P=0.001) was observed in
the off-label underdosed Apixaban group compared to those with standard dose or off-label
overdosed Apixaban. However, there was no significant difference of systemic thrombotic
events including stroke/systemic embolism and death according to off-label real-world dose
of Apixaban (off-label underdose vs. standard dose, P=1.000; off-label overdose vs. standard
dose, P=1.000; off-label underdose vs. off-label overdose, P=0.609). In multivariate analysis,
HASBLED score was independent risk factors for bleeding events (OR 9.650; CI 1.998-
46.622; P=0.005).
Conclusion
Compared with standard or off-label overdose of Apixaban, off-label
underdose of Apixaban was associated with a lower risk of bleeding in patients with AF and
CKD, with no difference in the risk of stroke/systemic embolism or death, supporting the
apixaban dosing tailored to specific clinical features and drug pharmacokinetics of the Asian
patients.