Abstract Body (Do not enter title and authors here): Hypothesis and Purpose: The long-term survival benefit of early surgery, as compared with conservative management, in asymptomatic patients with severe aortic stenosis (AS) remains unclear. We now report the final results of the RECOVERY trial, with an extended follow-up of over 10 years.
Study Design and Methods: The design and methods of this trial have been published previously.
Population Studied: Eligible patients were asymptomatic, and had severe AS (aortic valve area ≤ 0.75 cm² with peak aortic jet velocity ≥ 4.5 m/sec or mean transaortic gradient ≥ 50 mmHg).
Interventions: Early surgical aortic valve replacement (AVR) within 2 months of randomization versus conservative management according to the current guidelines.
Power Calculations: Details about power calculations have been published previously.
Primary End Points: A composite of operative mortality or death from cardiovascular causes that occurred during the entire follow-up period.
Secondary End Points: Death from any cause, repeat AVR, clinical thromboembolic events, and hospitalization for heart failure (HF) during follow-up.
Main Results: The baseline characteristics were well balanced between the two treatment groups. There was no AVR-related mortality in both groups. The intermediate-term results of this trial have been published previously. Data collection ended in May 2025, when the last enrolled patient had completed 10 years of follow-up. The median follow-up was 11.8 years (interquartile range, 10.2 to 13.2).
In an intention-to-treat analysis, 2 (2.7%) of 73 patients in the early-surgery group and 17 (23.6%) of 72 patients in the conservative-management group died from cardiovascular causes (hazard ratio in the early-surgery group, 0.10; 95% CI, 0.02 to 0.43; P= 0.002) (Table). A total of 11 deaths (15.1%) from any cause occurred in the early-surgery group and 23 (31.9%) in the conservative-management group (hazard ratio, 0.42; 95% CI, 0.21 to 0.86). The cumulative incidences of cardiovascular mortality and death from any cause were significantly lower in the early-surgery group than in the conservative-management group (Figure 1 and 2). The rate of hospitalization for HF was lower in the early-surgery group (P= 0.015).
Conclusions: The extended follow-up of the RECOVERY trial over 10 years demonstrates that among asymptomatic patients with severe AS, the rates of the primary end point and death from any cause were significantly lower with early surgery than with conservative management.