Early surgery or conservative care for asymptomatic aortic stenosis (RECOVERY)
Selected in The New England Journal of Medicine by S. Brugaletta , A. N. Calik
The RECOVERY trial sought to compare long-term clinical outcomes of early surgical AVR with conservative care strategy according to the current guidelines in asymptomatic patients with very severe AS.
References
Authors
Kang DH, Park SJ, Lee SA, Lee S, Kim DH, Kim HK, Yun SC, Hong GR, Song JM, Chung CH, Song JK, Lee JW, Park SW.
Reference
N Engl J Med. 2020 Jan 9
Published
November 2019
Link
Read the abstractReviewers
Our Comment
This joint review is part of the PCRonline GLOBAL Journal Club Initiative.
Why this study – the rationale/objective?
Aortic-valve replacement (AVR), either surgical or transcatheter, is the treatment of choice for symptomatic severe aortic stenosis (AS). However, the timing of the intervention is still debated in asymptomatic individuals who constitute one-third of the patients with severe AS at the time of diagnosis. To date, watchful waiting has been recommended for the vast majority of asymptomatic patients because it has been considered that the risk of operative mortality and death related to aortic-valve prosthesis may outweigh the risk of sudden cardiac death during follow-up. The RECOVERY trial sought to compare long-term clinical outcomes of early surgical AVR with conservative care strategy according to the current guidelines in asymptomatic patients with very severe AS.
How was it executed – the methodology?
Asymptomatic patients with very severe AS (aortic valve area [AVA] 0.75 cm2, peak velocity ≥4.5 m/sec, or mean gradient ≥50 mm Hg) were included in this multicenter and randomized trial. Those who reported exertional dyspnea, syncope, presyncope, or angina, who had a positive exercise test, had undergone previous cardiac surgery, had aortic regurgitation or significant mitral valve disease, or who had left ventricular (LV) ejection fraction <%50 were excluded from the study. 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.
What is the main result?
Between July 2010 and April 2015, a total of 145 asymptomatic patients with very severe AS were randomly assigned to early surgery (n=73 patients) or conventional treatment (n=72 patients).
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). Only one (1.4%) of the 73 patients assigned to early surgery and 11 (15%) of 72 patients assigned to conventional treatment died from cardiovascular causes. (hazard ratio 0.09, 95% confidence interval 0.01-0.67, p < 0.05)
As for the secondary outcomes, the cumulative incidence of death from any cause was lower in the early-surgery group than in the conventional treatment. (10.2% vs. 31.8% at 8 years, respectively; p=0.018).
Critical reading and the relevance for clinical practice
The RECOVERY trial found that early surgery (within approximately 2 months after randomization) in asymptomatic patients with severe AS was related to better outcomes (operative mortality; cardiovascular mortality; death from any cause; and hospitalization for heart failure) than a ‘wait and watch’ strategy. It is noteworthy that the benefits of this approach persisted through 8 years, and the number needed to treat to prevent one death from cardiovascular causes within 4 years was only 20 patients — nonetheless, there a few points to be highlighted about the trial.
Firstly, given the low surgical risk of the study population and taking into account the expertise of the surgeons, the operative mortality of the early-surgery group was zero. It is unknown if these results may be reproducible in those centers with less experience or considering high surgical risk patients.
Secondly, exercise testing, which unveils the symptoms in AS, was selectively performed. This might have led to ‘masked’ symptomatic AS, thus may be listed as a limitation of the study.
In conclusion, although the RECOVERY trial emphasized the better outcomes of early surgery in asymptomatic severe AS, it is reasonable to wait the results of the ongoing large, randomized trials of early AVR (AVATAR, ESTIMATE, EARLY-TAVR) in asymptomatic severe AS patients before extending the results of this study to real world.
Considering the results of the present study, which strategy would you prefer in asymptomatic patients with severe AS? Watchful waiting or early intervention?
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