Valvular & structural heart diseaseRandomised controlled trial
Early Intervention in Patients With Asymptomatic Severe Aortic Stenosis and Myocardial Fibrosis
- Randomised controlled trial
- open-label
- masked end point
- multicentre (24 cardiac centres, UK and Australia)
- August 2017 to October 2022; final follow-up July 26, 2024
Authors' conclusion
In asymptomatic patients with severe aortic stenosis and myocardial fibrosis, early aortic valve intervention had no demonstrable effect on all-cause death or unplanned aortic stenosis-related hospitalization.
Study context
- Population
- Asymptomatic patients with severe AS and myocardial fibrosisplanned 356
- Participants
- 224 patients
- Comparison
- Early valve intervention vs guideline-directed conservative management
- Early interventionn = 113
- Guideline-directed conservative managementn = 111reference
- Primary endpoint
- All-cause death or unplanned AS-related hospitalisation (time to first event)
Primary result
As reported in the abstract
Each group vs guideline-directed conservative managementHazard ratio (95% CI)P value
Early intervention
0.79(0.44–1.43)
P = 0.44Each group vs guideline-directed conservative managementBetween-group difference, % (95% CI)
Early intervention
−4.82(−15.31% to 5.66%)
Secondary outcomes
| Outcome | Early intervention | Guideline-directed conservative management | Estimate | |
|---|---|---|---|---|
| All-cause death | 14% | 13% | HR 1.22 (95% CI 0.59–2.51) | |
| Unplanned AS hospitalisation | 6% | 17% | HR 0.37 (95% CI 0.16–0.88) | |
| NYHA class II-IV symptoms · 12 months | 19.7% | 37.9% | OR 0.37 (95% CI 0.20–0.70) | |
| 0.10.31310Ratio (log scale) |
Prespecified secondary end points
- 7 of 9 showed no significant difference
Original publication
Early Intervention in Patients With Asymptomatic Severe Aortic Stenosis and Myocardial Fibrosis. JAMA. Published 21 January 2025. doi:10.1001/jama.2024.22730
Summarised from the published abstract; every number is checked against it