Early Surgery or Conservative Care for Asymptomatic Aortic Stenosis at 10 Years.

Early surgery significantly reduced the composite primary endpoint of operative mortality or death from cardiovascular causes compared to conservative care over 10 years.

• A primary-endpoint event occurred in 2 of 73 patients (3%) in the early-surgery group and in 17 of 72 patients (24%) in the conservative-care group.
• Hazard ratio of 0.10 (95% CI, 0.02 to 0.43; P = 0.002) in the intention-to-treat analysis.
• At 10 years, cumulative incidence of operative mortality or death from cardiovascular causes was 1% in the early-surgery group and 19% in the conservative-care group.
• The trial enrolled 145 patients with very severe aortic stenosis randomized 1:1 to early surgery or conservative care.

Early surgery was associated with a lower rate of death from any cause compared to conservative care.

• Death from any cause occurred in 11 patients (15%) in the early-surgery group and in 23 patients (32%) in the conservative-care group.
• Hazard ratio for all-cause mortality was 0.42 (95% CI, 0.21 to 0.86).
• This represents more than a halving of the relative risk of all-cause death with early surgery.

The study population consisted of asymptomatic patients with very severe aortic stenosis defined by specific hemodynamic criteria.

• Very severe aortic stenosis was defined as an aortic-valve area of ≤0.75 cm2 with a peak aortic jet velocity of ≥4.5 m per second.
• Patients were asymptomatic at enrollment.
• A total of 145 patients were randomly assigned in a 1:1 ratio (73 to early surgery, 72 to conservative care).
• The trial was registered under ClinicalTrials.gov number NCT01161732 (RECOVERY trial) and was funded by the Korean Institute of Medicine.

A previous shorter-term analysis of this trial had already demonstrated a significant reduction in operative mortality or cardiovascular death with early surgery.

• The current report extends follow-up to 10 years to assess long-term survival benefit.
• Prior analysis showed early surgery significantly reduced the composite of operative mortality or death from cardiovascular causes, but the long-term survival benefit remained unclear before this analysis.