RECOVERY (asymptomatic aortic stenosis)
Trial question
What is the role of early SAVR in asymptomatic patients with very severe aortic stenosis?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
51.0% female
49.0% male
N = 145
145 patients (74 female, 71 male).
Inclusion criteria: asymptomatic patients with very severe aortic stenosis.
Key exclusion criteria: exertional dyspnea; syncope; presyncope or angina; LVEF < 50%; clinically significant aortic regurgitation or mitral valve disease; age > 80 years; medical condition such as cancer.
Interventions
N=73 early SAVR (early aortic valve replacement surgery performed within 2 months of randomization).
N=72 conservative management (conventional treatment).
Primary outcome
Rate of death during or within 30 days after surgery or CV death during the entire follow-up
1%
15%
15.0 %
11.3 %
7.5 %
3.8 %
0.0 %
Early
SAVR
Conservative
management
Significant
decrease ▼
NNT = 7
Significant decrease in the rate of death during or within 30 days after surgery or CV death during the entire follow-up (1% vs. 15%; HR 0.09, 95% CI 0.01 to 0.67).
Secondary outcomes
Significant decrease in death from any cause (7% vs. 21%; HR 0.33, 95% CI 0.12 to 0.9).
No significant difference in clinical thromboembolic event (1% vs. 6%; HR 0.3, 95% CI 0.04 to 2.31).
No significant difference in hospitalization for HF (0% vs. 11%; HR 0.05, 95% CI 0 to 1.05).
Conclusion
In asymptomatic patients with very severe aortic stenosis, early SAVR was superior to conservative management with respect to the rate of death during or within 30 days after surgery or CV death during the entire follow-up.
Reference
Duk-Hyun Kang, Sung-Ji Park, Seung-Ah Lee et al. Early Surgery or Conservative Care for Asymptomatic Aortic Stenosis. N Engl J Med. 2020 Jan 9;382(2):111-119.
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