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N Engl J Med. 2020 Jan 9;382(2):111-119. doi: 10.1056/NEJMoa1912846. Epub 2019 Nov 16.

Early Surgery or Conservative Care for Asymptomatic Aortic Stenosis.

Author information

1
From the Division of Cardiology (D.-H. Kang, S.-A.L., S.L., D.-H. Kim, J.-M.S., J.-K.S.) and the Departments of Cardiothoracic Surgery (C.-H.C., J.-W.L.) and Biostatistics (S.-C.Y.), Asan Medical Center, College of Medicine, University of Ulsan, the Division of Cardiology, Samsung Medical Center, Sungkyunkwan University School of Medicine (S.-J.P., S.-W.P.), the Division of Cardiology, Severance Hospital (G.-R.H.), and the Cardiovascular Center, Seoul National University Hospital (H.-K.K.) - all in Seoul, South Korea.

Abstract

BACKGROUND:

The timing and indications for surgical intervention in asymptomatic patients with severe aortic stenosis remain controversial.

METHODS:

In a multicenter trial, we randomly assigned 145 asymptomatic patients with very severe aortic stenosis (defined as an aortic-valve area of ≤0.75 cm2 with either an aortic jet velocity of ≥4.5 m per second or a mean transaortic gradient of ≥50 mm Hg) to early surgery or to conservative care according to the recommendations of current guidelines. The primary end point was a composite of death during or within 30 days after surgery (often called operative mortality) or death from cardiovascular causes during the entire follow-up period. The major secondary end point was death from any cause during follow-up.

RESULTS:

In the early-surgery group, 69 of 73 patients (95%) underwent surgery within 2 months after randomization, and there was no operative mortality. In an intention-to-treat analysis, a primary end-point event occurred in 1 patient in the early-surgery group (1%) and in 11 of 72 patients in the conservative-care group (15%) (hazard ratio, 0.09; 95% confidence interval [CI], 0.01 to 0.67; P = 0.003). Death from any cause occurred in 5 patients in the early-surgery group (7%) and in 15 patients in the conservative-care group (21%) (hazard ratio, 0.33; 95% CI, 0.12 to 0.90). In the conservative-care group, the cumulative incidence of sudden death was 4% at 4 years and 14% at 8 years.

CONCLUSIONS:

Among asymptomatic patients with very severe aortic stenosis, the incidence of the composite of operative mortality or death from cardiovascular causes during the follow-up period was significantly lower among those who underwent early aortic-valve replacement surgery than among those who received conservative care. (Funded by the Korean Institute of Medicine; RECOVERY ClinicalTrials.gov number, NCT01161732.).

PMID:
31733181
DOI:
10.1056/NEJMoa1912846
[Indexed for MEDLINE]

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