Heart failure & cardiomyopathies
Transcatheter Aortic Valve Replacement in Patients With Systolic Heart Failure and Moderate Aortic Stenosis: TAVR UNLOAD
Primary resultResult — go to the resultWin ratio 1.31 95% CI 0.91–1.88Authors' conclusion
TAVR was not superior to AS surveillance for the primary hierarchical composite endpoint in patients with moderate AS and HFrEF on GDMT.
Study context
- Population
- Patients with heart failure with reduced ejection fraction (HFrEF) on guideline-directed medical therapy (GDMT) with moderate aortic stenosis (AS) suitable for transfemoral TAVRmedian follow-up 23 months
- Participants
- 178 patients
- Comparison
- TAVR vs clinical AS surveillance
- TAVRn = 89
- Clinical aortic stenosis surveillance (CASS)n = 89reference
- Primary endpoint
- Hierarchical composite of:
- All-cause death
- Disabling stroke
- Disease-related hospitalizations and HF equivalents
- Change from baseline in KCCQ Overall Summary Score
Methodological detailsinvestigator-initiated, international, 1:1 randomisation
- Investigator-initiated
- International
- 1:1 randomisation
Primary result
As reported in the abstract
Win ratio
1.31
95% CI 0.91–1.88
P = 0.14
By group
TAVR vs CASS
win ratio 1.31 (95% CI 0.91–1.88); P = 0.14
Further findings
| Outcome | TAVR | CASS | P value | |
|---|---|---|---|---|
| Change in KCCQ Overall Summary Score · 1 year | 12.8 ± 21.9 points | 3.2 ± 22.8 points | P = 0.018 | |
| Crossover to TAVR in CASS · median 12 months postrandomization | Not reported in the abstract | 43% | TAVR: not reported in the abstract |
- Crossover to TAVR in CASS: 35 had progressed to severe AS
Original publication
Transcatheter Aortic Valve Replacement in Patients With Systolic Heart Failure and Moderate Aortic Stenosis: TAVR UNLOAD. J Am Coll Cardiol. Published 28 October 2024. doi:10.
Summarised from the published abstract; every number is checked against it