Aortic valve replacement versus conservative treatment in asymptomatic severe aortic stenosis: long-term follow-up of the AVATAR trial

Banovic M 1 , Putnik S 1 , Da Costa BR 2 , Penicka M 3 , Deja MA 4 , Kotrc M 5 Show all authors , Kockova R 6 , Glaveckaite S 7 , Gasparovic H 8 , Pavlovic N 9 , Velicki L 10 , Salizzoni S 11 , Wojakowski W 12 , Van Camp G 2 , Gradinac S 13 , Laufer M 14 , Tomovic S 1 , Busic I 1 , Bojanic M 15 , Ristic A 1 , Klasnja A 16 , Matkovic M 1 , Boskovic N 17 , Zivic K 17 , Jovanovic M 18 , Nikolic SD 19 , Iung B 20 , Bartunek J 2

Affiliations 

  • 1 Belgrade Medical School, University of Belgrade, Serbia
  • 2 Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, United Kingdom
  • 3 Cardiovascular Center, OLV Hospital, Aalst, Belgium
  • 4 Department of Cardiac Surgery, Medical University of Silesia, Katowice, Poland
  • 5 Department of Cardiology, Institute for Clinical and Experimental Medicine, Prague, Czech Republic
  • 6 Charles University, Faculty of medicine Hradec Králové, Czech Republic
  • 7 Clinic of Cardiac and Vascular Diseases, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Vilnius, Lithuania
  • 8 Department of Cardiac Surgery, University of Zagreb School of Medicine and University Hospital Center Zagreb, Zagreb, Croatia
  • 9 University Hospital Dubrava, Zagreb, Croatia
  • 10 Faculty of Medicine, University of Novi Sad, Novi Sad, Serbia and Institute of Cardiovascular Diseases Vojvodina, Sremska Kamenica, Serbia
  • 11 Division of Cardiacsurgery, Cardiovascular and Thoracic Department, University of Turin, Italy
  • 12 Division of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland
  • 13 Sabah Al Ahmad Cardiac Center, Amiri Hospital, Kuwait
  • 14 Mach Ventures, Menlo Park, California, USA
  • 15 Anesteziology Department, "Institute Banjica"; Serbia
  • 16 University Clinical Center "Bezanijska Kosa", Serbia
  • 17 Cardiology Department, University Clinical Center of Serbia, Belgrade, Serbia
  • 18 General Hospital "Pozarevac", Serbia
  • 19 CorDynamix, Redwood City, CA, USA
  • 20 Cardiology Department, Bichat Hospital APHP and Universite Paris-Cité, France
Eur Heart J, 2024 Sep 01.
PMID: 39217448 DOI: 10.1093/eurheartj/ehae585

Abstract

BACKGROUND AND AIMS: The question of when and how to treat truly asymptomatic patients with severe aortic stenosis (AS) and normal left ventricular (LV) systolic function is still subject to debate and ongoing research. Here, the results of extended follow-up of the AVATAR trial are reported (NCT02436655, clinical trials.gov).

METHODS: The AVATAR trial randomly assigned patients with severe, asymptomatic AS and LV ejection fraction ≥50% to undergo either early surgical aortic valve replacement (AVR) or conservative treatment with watchful waiting strategy. All patients had negative exercise stress testing. The primary hypothesis was that early AVR will reduce a primary composite endpoint comprising all-cause death, acute myocardial infarction, stroke or unplanned hospitalization for heart failure (HF), as compared to conservative treatment strategy.

RESULTS: A total of 157 low-risk patients (mean age 67 years, 57% men, mean Society of Thoracic Surgeons score 1.7%) were randomly allocated to either early AVR group (n=78) or conservative treatment group (n=79). In an intention-to-treat analysis, after a median follow-up of 63 months, the primary composite endpoint outcome event occurred in 18/78 patients (23.1%) in the early surgery group and in 37/79 patients (46.8%) in the conservative treatment group (hazard ratio [HR] early surgery vs. conservative treatment 0.42; 95% confidence interval [CI] 0.24-0.73, p=0.002). The Kaplan-Meier estimates for individual endpoints of all-cause death and HF hospitalization were significantly lower in the early surgery compared with the conservative group (HR 0.44; 95% CI 0.23-0.85, p=0.012 for all-cause death, and HR 0.21; 95% CI 0.06-0.73, p=0.007 for HF hospitalizations).

CONCLUSIONS: The extended follow-up of the AVATAR trial demonstrates better clinical outcomes with early surgical AVR in truly asymptomatic patients with severe AS and normal LV ejection fraction compared with patients treated with conservative management on watchful waiting.

TRIAL REGISTRATION NUMBER: NCT02436655 (ClinicalTrials.gov).

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

Similar publications