| Title: |
Apixaban outcomes in atrial fibrillation patients with a single-dose reduction criterion: ASPIRE 1-year results |
| Authors: |
Lee, SR; Choi, J; Kwon, S; Ahn, HJ; Lee, KY; Choi, JI; Lee, SH; Heo, JH; Oh, IY; On, YK; Yu, HT; Lee, KN; Kim, NH; Park, HW; Lee, KH; Shin, SY; Park, HS; Han, S; Oh, S; Lip, GYH; Park, JS; Choi, EK |
| Contributors: |
113317; Lee, KN |
| Publication Year: |
2025 |
| Subject Terms: |
Aged; 80 and over; Atrial Fibrillation; Drug Tapering; Embolism; Factor Xa Inhibitors; Female; Frail Elderly; Hemorrhage; Humans; Male; Middle Aged; Off-Label Use; Prospective Studies; Pyrazoles; Pyridones; Republic of Korea; Risk Assessment; Risk Factors; Stroke; Time Factors; Treatment Outcome; Apixaban; Off-label Reduced Dose; On-label Standard Dose |
| Description: |
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. |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
J020556837; http://repository.ajou.ac.kr/handle/201003/34451; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12343049 |
| DOI: |
10.1093/ehjcvp/pvaf018 |
| Availability: |
http://repository.ajou.ac.kr/handle/201003/34451; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12343049; https://doi.org/10.1093/ehjcvp/pvaf018 |
| Accession Number: |
edsbas.7077BC1C |
| Database: |
BASE |