Early surgery reduces cardiovascular death risk in asymptomatic very severe aortic stenosis over 10 years

BACKGROUND: Among asymptomatic patients with severe aortic stenosis, a previous analysis showed that the risk of a composite of death during surgery or within 30 days after surgery (called operative mortality) or death from cardiovascular causes was significantly lower with early surgery than with conservative care. However, the long-term survival benefit of early surgery, as compared with conservative care, remains unclear. METHODS: We randomly assigned asymptomatic patients with very severe aortic stenosis (defined as an aortic-valve area of ≤0.75 cm with a peak aortic jet velocity of ≥4.5 m per second) in a 1:1 ratio to undergo early surgery or receive conservative care. The primary end point was a composite of operative mortality or death from cardiovascular causes during the 10-year follow-up period. RESULTS: A total of 145 patients underwent randomization. In an intention-to-treat analysis, a primary end-point event occurred in 2 of 73 patients (3%) in the early-surgery group and in 17 of 72 (24%) in the conservative-care group (hazard ratio, 0.10; 95% confidence interval [CI], 0.02 to 0.43; P = 0.002). At 10 years, the cumulative incidence of operative mortality or death from cardiovascular causes was 1% in the early-surgery group and 19% in the conservative-care group. Death from any cause occurred in 11 patients (15%) in the early-surgery group and in 23 (32%) in the conservative-care group (hazard ratio, 0.42; 95% CI, 0.21 to 0.86). CONCLUSIONS: Among asymptomatic patients with very severe aortic stenosis, early surgery led to a lower risk of a composite of operative mortality or death from cardiovascular causes than conservative care at 10 years. (Funded by the Korean Institute of Medicine; RECOVERY ClinicalTrials.gov number, NCT01161732.).