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Early Surgery or Conservative Care for Asymptomatic Aortic Stenosis

Authors
 Duk-Hyun Kang  ;  Sung-Ji Park  ;  Seung-Ah Lee  ;  Sahmin Lee  ;  Dae-Hee Kim  ;  Hyung-Kwan Kim  ;  Sung-Cheol Yun  ;  Geu-Ru Hong  ;  Jong-Min Song  ;  Cheol-Hyun Chung  ;  Jae-Kwan Song  ;  Jae-Won Lee  ;  Seung-Woo Park 
Citation
 NEW ENGLAND JOURNAL OF MEDICINE, Vol.382(2) : 111-119, 2020 
Journal Title
 NEW ENGLAND JOURNAL OF MEDICINE 
ISSN
 0028-4793 
Issue Date
2020
MeSH
Aged ; Aortic Valve/surgery* ; Aortic Valve Stenosis/mortality ; Aortic Valve Stenosis/surgery* ; Aortic Valve Stenosis/therapy ; Asymptomatic Diseases/therapy ; Cardiovascular Diseases/mortality ; Conservative Treatment* ; Female ; Follow-Up Studies ; Humans ; Incidence ; Kaplan-Meier Estimate ; Male ; Middle Aged ; Patient Acuity ; Postoperative Complications/mortality
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.).
Full Text
https://www.nejm.org/doi/full/10.1056/NEJMoa1912846
DOI
10.1056/NEJMoa1912846
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Hong, Geu Ru(홍그루) ORCID logo https://orcid.org/0000-0003-4981-3304
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/175251
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