AVATAR
Trial question
What is the role of early SAVR in asymptomatic patients with severe aortic stenosis?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
43.0% female
57.0% male
N = 157
157 patients (67 female, 90 male).
Inclusion criteria: asymptomatic patients with severe aortic stenosis.
Key exclusion criteria: exertional dyspnea; syncope or presyncope; angina; LVEF < 50%; aortic regurgitation ≥ 3+; dilatation of the ascending aorta requiring replacement of aortic root or ascending aorta; significant mitral valve disease; previous cardiac surgery; life expectancy < 3 years.
Interventions
N=78 early SAVR (aortic valve replacement surgery within 8 weeks after randomization).
N=79 conservative management (conventional drug treatment and watchful waiting till symptom onset).
Primary outcome
Death, acute MI, stroke, or unplanned hospitalization for heart failure
15.2%
34.7%
34.7 %
26.0 %
17.4 %
8.7 %
0.0 %
Early
SAVR
Conservative
management
Significant
decrease ▼
NNT = 5
Significant decrease in death, acute MI, stroke, or unplanned hospitalization for HF (15.2% vs. 34.7%; HR 0.46, 95% CI 0.23 to 0.9).
Secondary outcomes
No significant difference in all-cause mortality (9.5% vs. 20.1%; HR 0.56, 95% CI 0.24 to 1.27).
No significant difference in HF hospitalization (4% vs. 12.9%; HR 0.32, 95% CI 0.08 to 1.19).
No significant difference in CV death (9.5% vs. 9.1%; HR 1.02, 95% CI 0.4 to 2.58).
Safety outcomes
No significant difference in serious adverse event.
Conclusion
In asymptomatic patients with severe aortic stenosis, early SAVR was superior to conservative management with respect to death, acute MI, stroke, or unplanned hospitalization for HF.
Reference
Marko Banovic, Svetozar Putnik, Martin Penicka et al. Aortic Valve Replacement Versus Conservative Treatment in Asymptomatic Severe Aortic Stenosis: The AVATAR Trial. Circulation. 2022 Mar;145(9):648-658.
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