Valvular & structural heart disease
Randomised study for the Optimal Treatment of symptomatic patients with low-gradient severe Aortic valve Stenosis and preserved left ventricular ejection fraction (ROTAS trial)
Primary resultResult — go to the resultHazard ratio 0.76 95% CI 0.24–2.39- stopped early (insufficient recruitment)
- Stopped early because of insufficient recruitment
Authors' conclusion
Because of the small number of included patients and short follow-up the ROTAS trial was underpowered and unable to demonstrate a difference in the study endpoint between treatment arms.
Study context
- Population
- Symptomatic patients with low-gradient severe aortic stenosis (AS) and preserved left ventricular ejection fraction (LVEF) (>50%), severity confirmed by dobutamine stress echocardiography and/or CT-aortic calcium score
- Participants
- 52 patients
- Comparison
- Aortic valve replacement (AVR) vs medical treatment
- AVRn = 26
- Medical treatment (MT)n = 26reference
- Primary endpoint
- Composite of:
- Overall death
- CV hospitalisation
- Follow-up
- Mean 14±7 months
Primary result
As reported in the abstract
Hazard ratio
0.76
95% CI 0.24–2.39
P = 0.63
Events by treatment group
AVR vs MT
HR 0.76 (95% CI 0.24–2.39); P = 0.63
Further findings
| Outcome | AVR | MT | |
|---|---|---|---|
| Class I criteria for AVR or severe symptoms justifying cross-over to AVR (MT group) | Not reported in the abstract | 42% | AVR: not reported in the abstract |
Original publication
Randomised study for the Optimal Treatment of symptomatic patients with low-gradient severe Aortic valve Stenosis and preserved left ventricular ejection fraction (ROTAS trial). Heart. Published 28 August 2024. doi:10.
Summarised from the published abstract; every number is checked against it