Impact of Real-world Off-label dose of Apixaban on long-term clinical outcomes in Heart failure patients with Atrial Fibrillation and Chronic Kidney Disease

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Impact of Real-world Off-label dose of Apixaban on long-term clinical outcomes in Heart failure patients with Atrial Fibrillation and Chronic Kidney Disease

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Co-author 1

Ho Sik Shin 67920@naver.com 1Gospel Hospital, Kosin University College of Medicine, Busan, South Korea,2Transplantation Research Institute, Kosin University College of Medicine, Busan, South Korea Renal Division, Department of Internal Medicine Busan Korea (Republic of) *

Co-author 2

Woosik Yang 67920@naver.com 1Gospel Hospital, Kosin University College of Medicine, Busan, South Korea,2Transplantation Research Institute, Kosin University College of Medicine, Busan, South Korea Renal Division, Department of Internal Medicine Busan Korea (Republic of) -

Co-author 3

Ye Na Kim 67920@naver.com 1Gospel Hospital, Kosin University College of Medicine, Busan, South Korea,2Transplantation Research Institute, Kosin University College of Medicine, Busan, South Korea Renal Division, Department of Internal Medicine Busan Korea (Republic of) -

Co-author 4

Yeonsoon Jung 67920@naver.com 1Gospel Hospital, Kosin University College of Medicine, Busan, South Korea,2Transplantation Research Institute, Kosin University College of Medicine, Busan, South Korea Renal Division, Department of Internal Medicine Busan Korea (Republic of) -

Co-author 5

Hark Rim 67920@naver.com 1Gospel Hospital, Kosin University College of Medicine, Busan, South Korea,2Transplantation Research Institute, Kosin University College of Medicine, Busan, South Korea Renal Division, Department of Internal Medicine Busan Korea (Republic of) -

Co-author 6

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Co-author 9

Co-author 10

Co-author 11

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Co-author 15

Introduction

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 heart failure (HF) patients with NVAF and chronic kidney disease (CKD)

Methods

Our database of HF patients diagnosed with AF and CKD 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 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 370 HF patients with AF and CKD (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).

Conclusion

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 CKD, supporting the apixaban dosing tailored to specific clinical features and drug pharmacokinetics of the Asian patients.

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