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, ClinicalTrials.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 with 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 the early AVR group (n = 78) or the 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 = .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 = .012, for all-cause death and HR 0.21; 95% CI 0.06-0.73, P = .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.

Anesteziology Department 'Institute Banjica' Belgrade Serbia

Belgrade Medical School University of Belgrade Serbia

Cardiac Surgery Department University Clinical Center of Serbia Belgrade Serbia

Cardiology Department Bichat Hospital APHP and Universite Paris Cité Paris France

Cardiology Department University Clinical Center of Serbia Pasterova 2 11000 Belgrade Serbia

Cardiovascular Center OLV Hospital Aalst Belgium

Clinic of Cardiac and Vascular Diseases Institute of Clinical Medicine Faculty of Medicine Vilnius University Vilnius Lithuania

Clinical Trial Service Unit and Epidemiological Studies Unit Nuffield Department of Population Health University of Oxford Oxford UK

CorDynamix Redwood City CA USA

Department of Cardiac Surgery Institute of Cardiovascular Diseases Vojvodina Sremska Kamenica Serbia

Department of Cardiac Surgery Medical University of Silesia Katowice Poland

Department of Cardiac Surgery University of Zagreb School of Medicine and University Hospital Center Zagreb Zagreb Croatia

Department of Cardiology Institute for Clinical and Experimental Medicine Prague Czech Republic

Department of Cardiology University Clinical Center 'Bezanijska Kosa' Belgrade Serbia

Department of Cardiology University Hospital Dubrava Zagreb Croatia

Department of Internal Medicine General Hospital 'Pozarevac' Pozarevac Serbia

Division of Cardiac Surgery Cardiovascular and Thoracic Department University of Turin Turin Italy

Division of Cardiology and Structural Heart Diseases Medical University of Silesia Katowice Poland

Faculty of Medicine Hradec Králové Charles University Hradec Kralove Czech Republic

Faculty of Medicine University of Novi Sad Novi Sad Serbia

Mach Ventures Menlo Park CA USA

Sabah Al Ahmad Cardiac Center Amiri Hospital Kuwait City Kuwait

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ClinicalTrials.gov
NCT02436655