| The efficacy and safety of on-label reduced-dose apixaban in patients with atrial fibrillation in real-world practice |
Min-Su Jung1, Jongmin Hwang1
, Seongwook Han1
, Hyoung-Seob Park1, Tae-Wan Chung1, Eue-Keun Choi2, Il-Young Oh3, Hyung Wook Park4, Sung Ho Lee5, Jong-Sung Park6, Yae Min Park7, Gyo-Seung Hwang8, Dong-Hyeok Kim9, Jin-Kyu Park10, Jong-Il Choi11, and on behalf of the INSPIRE study investigators |
1Division of Cardiology, Department of Internal Medicine, Keimyung University Dongsan Hospital, Daegu, Korea
2Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea
3Cardiovascular Center, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea
4Department of Cardiovascular Medicine, Chonnam National University Hospital, Gwangju, Korea
5Division of Cardiology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Korea
6Department of Cardiology, Dong-A University College of Medicine, Busan, Korea
7Department of Internal Medicine, Gachon University Gil Medical Center, Gachon University College of Medicine, Incheon, Korea
8Department of Cardiology, Ajou University School of Medicine, Suwon, Korea
9Division of Cardiology, Ewha Womans University Seoul Hospital, Seoul, Korea
10Department of Cardiology, Hanyang University Seoul Hospital, Seoul, Korea
11Division of Cardiology, Department of Internal Medicine, Anam Hospital, Korea University College of Medicine, Seoul, Korea |
Corresponding Author:
Jongmin Hwang , Tel: +82-53-258-7717, Fax: +82-53-258-4630, Email: dsmcep@gmail.com
Seongwook Han , Tel: +82-53-427-7504, Fax: +82-53-258-4630, Email: swhanepdoc@gmail.com
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Received: December 23, 2025; Revised: February 28, 2026; Accepted: April 3, 2026. |
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| Abstract |
Background/Aims: In pivotal randomized trials, only a small proportion of patients received the reduced apixaban dose, limiting the generalizability of those findings. We evaluated the efficacy and safety of on-label reduced-dose apixaban in Korean patients with atrial fibrillation (AF).
Methods: Patients with non-valvular AF meeting on-label criteria for reduced-dose apixaban (2.5 mg twice daily) were enrolled. Eligible patients fulfilled at least two criteria: age ≥ 80 years, body weight ≤ 60 kg, or serum creatinine ≥ 1.5 mg/dL. The primary efficacy outcome was stroke or systemic embolism; primary safety outcome was major bleeding. The secondary composite outcome included myocardial infarction, heart failure hospitalization, cardiac intervention, and all-cause mortality.
Results: A total of 1,655 patients were enrolled (mean age 82.8 ± 4.4 yr; 60.5% female). During 1,467.6 patient-years of follow-up, stroke or systemic embolism occurred at 1.64 per 100 patient-years and major bleeding at 3.00 per 100 patient-years. In multivariate analysis, prior stroke/TIA (HR 2.59, p = 0.034), congestive heart failure (CHF) (HR 2.31, p = 0.041), and diabetes mellitus (DM) (HR 2.26, p = 0.047) were significant independent predictors of stroke/systemic embolism. For major bleeding, CHF (HR 2.48, p = 0.003) and severe renal impairment (eGFR 15–29 mL/min/1.73 m2; HR 3.33, p = 0.007) were significant predictors. The secondary composite outcome was independently associated with older age, CHF, DM, and graded renal impairment.
Conclusions: The INSPIRE study provides real-world evidence supporting guideline-directed reduced-dose apixaban in Asian populations, while identifying high-risk subgroups requiring careful patient selection and individualized management strategies. |
| Keywords:
Atrial fibrillation ; Anticoagulants ; Stroke ; Bleeding |
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