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

Eur Heart J Cardiovasc Pharmacother. 2025 Aug 12;11(5):403-411. doi: 10.1093/ehjcvp/pvaf018.

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.

Publication types

  • Observational Study
  • Multicenter Study
  • Comparative Study

MeSH terms

  • Aged
  • Aged, 80 and over
  • Atrial Fibrillation* / diagnosis
  • Atrial Fibrillation* / drug therapy
  • Atrial Fibrillation* / epidemiology
  • Drug Tapering
  • Embolism* / diagnosis
  • Embolism* / epidemiology
  • Embolism* / prevention & control
  • Factor Xa Inhibitors* / administration & dosage
  • Factor Xa Inhibitors* / adverse effects
  • Female
  • Frail Elderly
  • Hemorrhage / chemically induced
  • Humans
  • Male
  • Middle Aged
  • Off-Label Use
  • Prospective Studies
  • Pyrazoles* / administration & dosage
  • Pyrazoles* / adverse effects
  • Pyridones* / administration & dosage
  • Pyridones* / adverse effects
  • Republic of Korea / epidemiology
  • Risk Assessment
  • Risk Factors
  • Stroke* / diagnosis
  • Stroke* / epidemiology
  • Stroke* / prevention & control
  • Time Factors
  • Treatment Outcome

Substances

  • apixaban
  • Pyridones
  • Pyrazoles
  • Factor Xa Inhibitors