Valvular & structural heart disease
Efficacy and Safety of Edoxaban in Anticoagulant Therapy Early After Surgical Bioprosthetic Valve Replacement: A Randomized Clinical Trial
Primary result · Stroke or systemic embolismResult — go to the resultRisk difference −1.03% 95% CI −4.34 to 1.95%Authors' conclusion
Edoxaban is a potential alternative anticoagulant therapy early after bioprosthetic valve replacement.
Study context
- Population
- Patients within 3 months following bioprosthetic valve replacement at the aortic or mitral position or bothincluded in the final analysis, 410 enrolled
- Participants
- 389 patients
- Comparison
- Edoxaban compared with warfarin within 3 months following bioprosthetic valve replacement
- Edoxaban groupn = 195
- Warfarin groupn = 194
- Primary endpoint
- stroke or systemic embolism
Primary result
As reported in the abstract
Risk difference
−1.03%
95% CI −4.34 to 1.95%
Events by treatment group
Edoxaban group vs warfarin group
risk difference −1.03% (95% CI −4.34 to 1.95%)
Secondary outcomes
| Outcome | Edoxaban group | Warfarin group |
|---|---|---|
| Intracardiac thrombus | did not occur in any of the patients | 1.0% |
Safety
| Outcome | Edoxaban group | Warfarin group | Risk difference (95% CI) | |
|---|---|---|---|---|
| Major bleeding | 4.1% | 1.0% | 3.07% (−0.67 to 7.27%) | |
| −50510Difference (linear scale) |
| Outcome | Edoxaban group | Warfarin group |
|---|---|---|
| Fatal bleeding or intracranial hemorrhage | No fatal bleeding or intracranial hemorrhage | 1 fatal intracranial hemorrhage |
Original publication
Efficacy and Safety of Edoxaban in Anticoagulant Therapy Early After Surgical Bioprosthetic Valve Replacement: A Randomized Clinical Trial. Circ Cardiovasc Interv. Published 12 May 2025. doi:10.
Summarised from the published abstract; every number is checked against it