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Observational Study
. 2025 Aug 12;11(5):403-411.
doi: 10.1093/ehjcvp/pvaf018.

Apixaban outcomes in atrial fibrillation patients with a single-dose reduction criterion: ASPIRE 1-year results

So-Ryoung Lee  1   2 , JungMin Choi  1 , Soonil Kwon  1 , Hyo-Jeong Ahn  1 , Kyung-Yeon Lee  1 , Jong-Il Choi  3 , Sung Ho Lee  4 , Jung Ho Heo  5 , Il-Young Oh  6 , Young Keun On  7 , Hee Tae Yu  8 , Kwang-No Lee  9 , Nam-Ho Kim  10 , Hyung Wook Park  11   12 , Ki Hong Lee  11   12 , Seung Yong Shin  13 , Hyoung-Seob Park  14 , Seongwook Han  15 , Seil Oh  1   2 , Gregory Y H Lip  2   16   17 , Jong-Sung Park  18 , Eue-Keun Choi  1   2
Affiliations
Observational Study

Apixaban outcomes in atrial fibrillation patients with a single-dose reduction criterion: ASPIRE 1-year results

So-Ryoung Lee et al. Eur Heart J Cardiovasc Pharmacother. .

Abstract

Aims: This study, using a prospective cohort, evaluated the effectiveness and safety of off-label reduced-dose apixaban vs. the on-label dose in atrial fibrillation (AF) patients meeting a single-dose reduction criterion.

Methods and results: The efficAcy and Safety of aPixaban In REal-world practice in Korean frail patients with AF (ASPIRE) study is a multicentre, prospective observational cohort involving AF patients who met a single-dose reduction criterion of apixaban. Patients were divided into two groups: an on-label standard dose (5 mg twice daily) and an off-label reduced dose (2.5 mg twice daily). The primary effectiveness outcome was stroke/systemic embolism (SSE), and the primary safety outcome was major bleeding. Of 1944 patients (mean age 74.3 ± 7.9 years, 56% women), 997 (51%) were receiving off-label reduced-dose apixaban. The off-label reduced-dose group was older, had more comorbidities, higher concomitant antiplatelet use, and higher CHA2DS2-VASc and HAS-BLED scores. During follow-up (1.0 ± 0.2 year), crude incidence rates were 0.9 vs. 0.7 per 100 person-years for SSE and 0.5 vs. 1.0 for major bleeding in the on-label vs. off-label groups. After inverse probability of treatment weighting, the off-label reduced-dose group showed no significant differences in the risk of SSE [hazard ratio (HR) 0.67, 95% confidence interval (CI) 0.28-1.59, P = 0.370] and major bleeding (HR 1.38, 95% CI 0.44-4.35, P = 0.578) compared with the on-label standard dose group.

Conclusion: In Korean patients with AF meeting a single-dose reduction criterion of apixaban, off-label reduced-dose apixaban showed no significant differences in SSE and major bleeding compared with the on-label standard dose. These findings suggest that individualized anticoagulation strategies, such as reduced-dose apixaban, may be beneficial for patients with a high risk of bleeding.

Keywords: Apixaban; Atrial fibrillation; Off-label reduced dose; On-label standard dose.

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Figures

Graphical Abstract
Graphical Abstract
Clinical outcomes of apixaban in atrial fibrillation patients with a single-dose reduction criterion: 1-year outcome of the ASPIRE study. In a prospective cohort study of 1944 Asian atrial fibrillation patients meeting a single-dose reduction criterion for apixaban, off-label reduced-dose apixaban showed no significant differences in the risk of stroke/systemic embolism, major bleeding, or all-cause mortality compared with the on-label standard dose. Abbreviation: CI, confidence interval; HR, hazard ratio.
Figure 1
Figure 1
Study flow. The overall enrolment flow is presented.
Figure 2
Figure 2
Kaplan–Meier curves of clinical outcomes after inverse probability of treatment weighting. After IPTW, Kaplan–Meier curves showed comparable risks for most outcomes, except for stroke/systemic embolism. Abbreviations: CRNMB, clinically relevant non-major bleeding; IPTW, inverse probability of treatment weighting; MI, myocardial infarction; TIA, transient ischaemic attack.
See this image and copyright information in PMC

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