Valvular & structural heart disease
Myocardial Fibrosis and Early Intervention in Asymptomatic Patients With Severe Aortic Stenosis: Insights From the EVOLVED Randomized Clinical Trial
Authors' conclusion
In this study, in asymptomatic patients with severe aortic stenosis, higher midwall fibrosis burden was associated with adverse outcomes. There was no demonstrable heterogeneity by the degree of midwall fibrosis for the treatment effects of early surgical or transcatheter aortic valve replacement compared to clinical surveillance.
Study context
- Population
- Asymptomatic patients with severe AS and midwall fibrosis on CMR
- Participants
- 224 patients
- Comparison
- Early intervention (TAVR or SAVR) vs guideline-directed conservative management, by midwall fibrosis burden
- Primary endpoint
- All-cause death or unplanned AS-related hospitalization
- Follow-up
- Median 42 months
Methodological details24 cardiac centres, UK and Australia, Trial conducted August 2017 to October 2022; data analyzed October 2024 through June 2025
- 24 cardiac centres, UK and Australia
- Trial conducted August 2017 to October 2022; data analyzed October 2024 through June 2025
Primary result
As reported in the abstract
All-cause death or unplanned AS-related hospitalization, by midwall fibrosis burden
Hazard ratio (95% CI)
Fibrosis burden (per 1% increase)association with primary end point
1.23(1.08–1.37)
Early interventionvs Conservative managementhigh fibrosis burden (above median); 12 of 59 vs 17 of 53
0.62(0.29–1.28)
- Low fibrosis burden (below median): no difference in primary outcome between intervention groups
- HR, 1.05; 95% CI, 0.39-2.86
- No interaction between randomization arm and midwall fibrosis burden for the primary end point
- P for interaction = 0.39
Secondary outcomes
| Outcome | Early intervention | Conservative management | HR (95% CI) | |
|---|---|---|---|---|
| Unplanned AS-related hospitalization, per 1% fibrosis increase | 1.22 (1.03–1.40) | |||
| All-cause death, per 1% fibrosis increase | 1.17 (0.98–1.35) | |||
| All-cause death (high fibrosis burden subgroup) | 15% | 19% | 0.84 (0.33–2.07) | |
| Unplanned AS-related hospitalization (high fibrosis burden subgroup) | 7% | 25% | 0.27 (0.08–0.77) | |
| 0.050.21520Hazard ratio (log scale) |
Original publication
Myocardial Fibrosis and Early Intervention in Asymptomatic Patients With Severe Aortic Stenosis: Insights From the EVOLVED Randomized Clinical Trial. JAMA Cardiol. Published 1 June 2026. doi:10.
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