Objective. To determine the timing of surgical intervention in asymptomatic patients with severe aortic stenosis.
Design. Open-label, multicenter, randomized controlled study.
Setting and participants. A total of 145 asymptomatic patients with very severe aortic stenosis were randomly assigned to early surgery or conservative care.
Main outcome measures. The primary endpoint was a composite of operative mortality or death from a cardiovascular cause during follow-up. The major secondary endpoint was death from any cause during follow-up.
Main results. The primary endpoint occurred in 1 of 73 patients (1%) in the early surgery group and 11 of 72 patients (15%) in the conservative care group (hazard ratio [HR], 0.09; 95% confidence interval [CI], 0.01-0.67, P = 0.003). The secondary endpoint occurred in 7% of patients in the early surgery group and 21% of patients in the conservative care group (HR, 0.33; 95% CI, 0.12-0.90).
Conclusion. Among asymptomatic patients with very severe aortic stenosis, the incidence of the composite of operative mortality or death from cardiovascular causes during follow-up was significantly lower among those who underwent early valve replacement surgery compared to those who received conservative care.