Why the study?
Indications for early surgical aortic valve replacement in asymptomatic patients with severe aortic stenosis and normal left ventricular function remain debated.
Does early surgical aortic valve replacement reduce the composite of all-cause death, acute myocardial infarction, stroke, or unplanned hospitalization for heart failure in asymptomatic patients with severe aortic stenosis and normal left ventricular function compared with conservative treatment?
Population
157 asymptomatic patients with severe AS and normal left ventricular function
Comparison
Early SAVR vs conservative treatment
Design
Investigator-initiated international prospective randomized controlled trial
Follow-up
Overall median follow-up was 32 months
Key result
Early surgical aortic valve replacement reduced all-cause death, MI, stroke, or unplanned heart failure hospitalization compared with conservative treatment (HR 0.46; 95% CI 0.23-0.90; P=0.02).
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May support early surgery in asymptomatic severe AS; hypothesis-generating, needs RCT confirmation.
RCT (n=157)
randomly allocated
Yes
Does early surgical aortic valve replacement reduce the composite of all-cause death, acute myocardial infarction, stroke, or unplanned hospitalization for heart failure in asymptomatic patients with severe aortic stenosis and normal left ventricular function compared with conservative treatment?
Hazard Ratio: 0.46 (95% CI 0.23–0.9)
Absolute Event Rate: 16.7% vs 32.9%
p-value: p=0.02
Early surgical aortic valve replacement significantly reduces major adverse cardiovascular events in asymptomatic patients with severe aortic stenosis and normal left ventricular function compared to a conservative strategy.
A 2021 study conducted an RCT in asymptomatic severe aortic stenosis (n=157). Early surgical aortic valve replacement (SAVR) vs. Conservative treatment according to guidelines was evaluated on Composite of all-cause death, acute myocardial infarction, stroke, or unplanned hospitalization for heart failure (HR 0.46, 95% CI 0.23-0.90, p=0.02). Early surgical aortic valve replacement reduced all-cause death, MI, stroke, or unplanned heart failure hospitalization compared with conservative treatment (HR 0.46; 95% CI 0.23-0.90; P=0.02).