RECOVERY Trial Supports Early Surgery in Asymptomatic Patients With Severe Aortic Stenosis

One (1.4%) of 73 patients assigned to early surgery and 11 (15.3%) of 72 patients assigned to conventional treatment died from CV causes.

Duk-Hyun Kang, MD, PhD

Results of the RECOVERY trial demonstrate that early preemptive aortic valve replacement (AVR) versus conservative management in asymptomatic patients with severe aortic stenosis (AS) significantly reduced the rates of operative or cardiovascular death, and death from any cause.

In late-breaking findings presented at the American Heart Association (AHA) 2019 Scientific Sessions in Philadelphia, Duk-Hyun Kang, MD, PhD, with Asan Medical Center in Seoul, South Korea, reported on the comparison of long-term outcomes of early surgery and conventional treatment in asymptomatic AS.

The timing of surgical intervention in this asymptomatic patient population has been controversial, as it was previously unclear whether the risk of death outweighed the risk of AVR. To date, the recommendation has been for watchful observance of these patients.

The Randomized Comparison of Early Surgery versus Conventional Treatment in Very Severe Aortic Stenosis (RECOVERY) study is a prospective, multicenter, open-label, randomized trial in which asymptomatic patients with very severe AS were randomly assigned to early surgery (n=73 patients) or to conventional treatment (n=72 patients).

To be included in the trial, patients had to be between the ages of 20 and 80 years old, with very severe AS (defined as aortic valve area ≤0.75 cm2 with a peak aortic jet velocity ≥4.5 m/s or a mean transaortic gradient ≥50 mmHg), who were candidates for early surgery. Those who had undergone previous cardiac surgery, had a positive exercise test, had significant aortic regurgitation or significant mitral valve disease, had LV ejection fraction <50%, or who reported symptoms such as exertional dyspnea, syncope, or angina were excluded.

The primary end point of the trial was a composite of operative mortality or cardiovascular death, and the major secondary end point was death from any cause.

Patients in the early surgery group were to receive AVR within 2 months of randomization, while patients in the conventional treatment arm were treated according to the current guidelines. They were referred for AVR if they became symptomatic, LVEF < 0.50, or an increase in peak aortic velocity > 0.5 m/s per year.

Baseline clinical characteristics were generally similar across both trial groups, and the median follow-up was 6.2 years (interquartile range, 5.0 to 7.4) and 6.1 years (interquartile range, 4.5 to 7.3) in the early surgery group and conventional treatment group, respectively.

Sixty-nine patients (94.5%) in the early surgery group underwent AVR after randomization, and 52 patients (72.2%) in the conventional arm underwent elective or urgent surgery mainly due to development of symptoms during follow-up, according to the study.

One (1.4%) of 73 patients assigned to early surgery and 11 (15.3%) of 72 patients assigned to conventional treatment died from cardiovascular causes (hazard ratio, 0.12; 95% confidence interval [CI], 0.02 to 0.72; P=0.020) in the intention-to-treat analysis.

In the early surgery group, the rate of primary end point was 1.4% at 4 and 8 years follow-up compared with 5.7% at 4 years and 25.5% at 8 years in the conventional treatment arm (P=0.003 by log-rank test).

Five deaths from any cause (6.8%) were reported in the early surgery group compared with 15 (20.8%) in the conventional treatment group (hazard ratio, 0.33; 95% CI, 0.12 to 0.90; P=0.030), and the rate of death from any cause was higher in the conventional treatment arm compared with the early surgery group (9.7% vs 4.1% at 4 years and 31.8% vs 10.2% at 8 years, respectively; P=0.018 by log-rank test).

The study, “Early Surgery versus Conventional Management for Asymptomatic Severe Aortic Stenosis,” was presented Saturday, November 16, 2019, at AHA 2019.