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August 11, 2026CirculationOpen Access

Aortic Valve Replacement Versus Conservative Treatment in Asymptomatic Severe Aortic Stenosis: The AVATAR Trial

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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).

Discussion

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Overview

May support early surgery in asymptomatic severe AS; hypothesis-generating, needs RCT confirmation.

Key Points

  • This trial aims to evaluate the safety and efficacy of early aortic valve replacement (SAVR) in asymptomatic patients with severe aortic stenosis.
  • International prospective randomized controlled trial with 157 patients conducted across 9 centers in 7 European countries.
  • Inclusion criteria defined by specific hemodynamic measurements and mandatory negative exercise testing.
  • Primary outcome assessed was a composite of all-cause death, acute myocardial infarction, stroke, or unplanned hospitalization for heart failure.
  • Patients undergoing early surgery experienced a significantly lower incidence of the primary composite end point (hazard ratio 0.46 [95% CI, 0.23–0.90]; P=0.02).
  • Total events observed were 39: 13 in early surgery and 26 in conservative treatment groups.
  • Operative mortality in the early surgery group was 1.4%, with 92.3% of patients receiving SAVR.

Study Design

Type

RCT (n=157)

Randomization

randomly allocated

Multicenter

Yes

Structured PICO

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?

P
Population
157 asymptomatic patients with severe aortic stenosis and normal left ventricular function, followed for a median of 32 months.
I
Intervention
Early surgical aortic valve replacement (SAVR)
C
Comparator
Conservative treatment according to guidelines
O
Outcome
Composite end point of all-cause death, acute myocardial infarction, stroke, or unplanned hospitalization for heart failurecomposite

Main Result

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.

Cite This Study

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).

synapsesocial.com/papers/6a7b75cf64158d369a3e3663https://doi.org/10.1161/circulationaha.121.057639
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