Front Cardiovasc Med. 2024;11:1367623.

Clinical characteristics of apixaban prescription in AF patients with single dose-reduction criterion: the ASPIRE (efficAcy and safety of aPixaban in rEal-world practice in Korean frail patients with atrial fibrillation) study.

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제1저자 최정민, 이소령 · 교신저자 최의근, 한성욱

PMID 38915744 PMC11194408 DOI 10.3389/fcvm.2024.1367623 IF 3 순환기내과

소속 (18)

Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.
Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea.
Department of Internal Medicine, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul, Republic of Korea.
Department of Cardiology, Dong-A University Hospital, Busan, Republic of Korea.
Division of Cardiology, Department of Internal Medicine, Korea University College of Medicine and Korea University Anam Hospital, Seoul, Republic of Korea.
Division of Cardiology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Department of Internal Medicine, Kosin University Gospel Hospital, Busan, Republic of Korea.
Department of Internal Medicine, Seoul National University Bundang Hospital, Gyeonggi, Republic of Korea.
Department of Cardiology, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.
Department of Internal Medicine, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.
Department of Cardiology, Ajou University School of Medicine, Suwon, Republic of Korea.
Department of Internal Medicine, Wonkwang University Hospital, Iksan, Republic of Korea.
Department of Internal Medicine, Chonnam National University Hospital, Gwangju, Republic of Korea.
Department of Cardiovascular Medicine, Chonnam National University Medical School, Gwangju, Republic of Korea.
Cardiovascular & Arrhythmia Center, Chung-Ang University Hospital, Seoul, Republic of Korea.
Liverpool Centre for Cardiovascular Science at University of Liverpool, Liverpool John Moores University and Liverpool Chest and Heart Hospital, Liverpool, United Kingdom.
Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.
Division of Cardiology, Department of Internal Medicine, Keimyung University Dongsan Hospital, Daegu, Republic of Korea.

Abstract

BACKGROUND Data on off-label reduced dose risk among patients with atrial fibrillation (AF) who qualify for a single-dose reduction of apixaban is scarce.

OBJECTIVES We prospectively assessed apixaban dosing and clinical characteristics in AF patients meeting a dose reduction criterion.

METHODS The multicentre, prospective cohort study, the efficAcy and Safety of aPixaban In REal-world practice in Korean frail patients with AF (ASPIRE), encompasses patients with AF who met the criteria for a single-dose reduction of apixaban and were given varying doses of apixaban, either the on-label standard dose or the off-label reduced dose.

RESULTS Of 2,000 patients (mean age 74.3 ± 7.9 years, 55.8% women), 29.7% were ≥80 years, 62.6% weighed ≤60 kg, and 7.8% had serum creatinine ≥1.5 mg/dL. Of these, 51.3% were prescribed an off-label reduced dose of apixaban. The off-label group was characterized with older age, more comorbidities, and antiplatelet agents, while the on-label group had more prior strokes. Physicians preferred off-label reduced dose in the "marginal zone," defined as age 75-80 years, weight 60-65 kg, and creatinine levels 1.2-1.5 mg/dL.

CONCLUSIONS In real-world clinical setting of the Korean population, off-label reduced dose apixaban was administered to nearly half of the patients who qualified for a single dose reduction. This reduced dosage was more commonly prescribed to patients with frail characteristics, while patients with a history of stroke were more often given the standard dose as per the label. A future study is planned to contrast the safety and effectiveness of the standard dose against the reduced dose of apixaban in this population.

Keywords

apixabanatrial fibrillationclinical characteristicsdoseoff-label reduced dose

Figures

**Figure 1** Study flow. The flow diagram of the present study is shown.

**Figure 2** Proportion of on-label standard-dose and off-label reduced in each inclusion criteria. The doughnut charts show the proportion of on-label standard-dose and off-label reduced in each inclusion criteria (total, age ≥80 years, body weight ≤60 kg, and serum creatinine ≥1.5 mg/dL). More than half of total population were prescribed with off-label reduced dose apixaban.

**Figure 3** The violin plot of additional dose reduction criteria in each inclusion criteria. Among all inclusion criteria groups, the off-label reduced group was more likely to be distributed in the marginal zone.

**Figure 4** Graphical abstract of the study. In a multicenter, prospective cohort study of South Korean participants with atrial fibrillation, half of the patients who met one apixaban criterion received off-label reduced doses in real-world practice. Physicians were more likely to prescribe reduced doses to frail patients, whereas those with a history of strokes received on-label doses.

그림 출처: PubMed Central 공개 논문 (PMC11194408)

Conflict of interest statement

S-RL: Speaking fees from Bayer, BMS/Pfizer, Biosense Webster, Daiichi-Sankyo, Sanofi-Aventis, Daewoong Pharmaceutical Co., Samjinpharm, Seers Technology, Biotronik, Boston Scientific and Medtronic. Consultant for Biosense Webster. SL: Research grant and/or honoraria from Bayer, BMS/Pfizer, Biosense Webster, Biotronik, Boston Scientific, Chong Kun Dang, Daewoong Pharmaceutical Co., Daiichi-Sankyo, Medtronic, Norvatis, Seers Technology and Skylabs. E-KC: Research grants or speaking fees from Abbott, Bayer, BMS/Pfizer, Biosense Webster, Chong Kun Dang, Daewoong Pharmaceutical Co., Daiichi-Sankyo, DeepQure, Dreamtech Co., Ltd., Jeil Pharmaceutical Co. Ltd., Medtronic, Samjinpharm, Seers Technology, and Skylabs. GL: Consultant and speaker for BMS/Pfizer, Boehringer Ingelheim, Anthos, and Daiichi-Sankyo. He is a National Institute for Health and Care Research (NIHR) Senior Investigator and co-principal investigator of the AFFIRMO project on multimorbidity in AF, which has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No 899871. No fees are received personally, and no fees are related to this work. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

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