Arrhythmias & electrophysiologyMeta-analysis
Bleeding Outcomes in Patients Treated With Asundexian in Phase II Trials
- Pooled analysis of 3 phase II randomised trials
Authors' conclusion
Analyses of phase II trials involving >500 bleeds highlight the potential for improved safety of asundexian compared with apixaban and similar safety compared with placebo.
Study context
- Population
- Patients with atrial fibrillation (AF), recent acute MI or stroke in phase II asundexian trialsAF n = 755
- Participants
- 249 / 254 / 250 / 840 / 843 / 845 / 851
- Comparison
- Asundexian vs apixaban or placebo
- Asundexian 20 mg (AF)n = 249
- Asundexian 50 mg (AF)n = 254
- Apixaban (AF)n = 250reference
- Asundexian 10 mg (acute myocardial infarction (AMI)/stroke)n = 840
- Asundexian 20 mg (AMI/stroke)n = 843
- Asundexian 50 mg (AMI/stroke)n = 845
- Placebo (AMI/stroke)n = 851reference
- Outcome
- Major or clinically relevant nonmajor (CRNM) bleeding (International Society on Thrombosis and Hemostasis (ISTH) criteria)
Pooled result
As reported in the abstract
Major/CRNM bleeding
| Group | Value | IR per 100 patient-years |
|---|---|---|
| Asundexian 20 mg (AF) | 3 events | 5.47 |
| Asundexian 50 mg (AF) | 1 events | not calculable |
| Apixaban (AF) | 6 events | 11.10 |
| Asundexian 10 mg (AMI/stroke) | 44 events | 7.55 |
| Asundexian 20 mg (AMI/stroke) | 42 events | 7.04 |
| Asundexian 50 mg (AMI/stroke) | 56 events | 9.63 |
| Placebo (AMI/stroke) | 41 events | 6.99 |
Further pooled results
Association between asundexian exposure and major/clinically relevant nonmajor (CRNM) bleeding
- No significant association
Most common sites of major/CRNM bleeding with asundexian
- Gastrointestinal, respiratory, urogenital and skin
Safety
| Outcome | Values |
|---|---|
| All bleeding | Asundexian 20 mg (AF) 12 events · IR per 100 patient-years 22.26 · Asundexian 50 mg (AF) 10 events · IR per 100 patient-years 18.21 · Apixaban (AF) 26 events · IR per 100 patient-years 50.56 · Asundexian 10 mg (AMI/stroke) 107 events · IR per 100 patient-years 19.57 · Asundexian 20 mg (AMI/stroke) 123 events · IR per 100 patient-years 22.45 · Asundexian 50 mg (AMI/stroke) 130 events · IR per 100 patient-years 24.19 · Placebo (AMI/stroke) 129 events · IR per 100 patient-years 23.84 |
Original publication
Bleeding Outcomes in Patients Treated With Asundexian in Phase II Trials. J Am Coll Cardiol. Published 13 February 2024. doi:10.1016/j.jacc.2023.12.004
Summarised from the published abstract; every number is checked against it