Arrhythmias & electrophysiologySecondary analysis
Major Bleeding Risk Assessment With Atrial Fibrillation Post-TAVR
- Secondary analysis of the ENVISAGE-TAVI atrial fibrillation (AF) randomised trial
- on-treatment analysis
- risk score derivation
Authors' conclusion
Five independent predictors of long-term MB were identified in patients with AF requiring oral anticoagulant agents after TAVR and formed the HARHP score to assess MB risk.
Study context
- Population
- Patients with AF after successful transcatheter aortic valve replacement (TAVR)
- Participants
- 1,377 patients
- Comparison
- HARHP risk categories: high vs low and moderate risk
- Primary endpoint
- Major bleeding (MB)
Primary result
As reported in the abstract
MB by HARHP risk category
Hazard ratio (95% CI)P value
High risk vs Low risk
6.54(3.61–11.85)
P < 0.0001High risk vs Moderate risk
2.86(1.62–5.04)
P = 0.0003- Patients with major bleeding (MB)
- 139 (10.1%)
- Mean ± SD on-treatment follow-up
- 1.3 ± 0.8 years
Further findings
HARHP score discrimination (C statistic)
- C statistic at 1-year follow-up
- 0.63
- C statistic at 2-year follow-up
- 0.62
Original publication
Major Bleeding Risk Assessment With Atrial Fibrillation Post-TAVR. JACC Cardiovasc Interv. Published 9 February 2026. doi:10.1016/j.jcin.2025.11.028
Summarised from the published abstract; every number is checked against it