title: Rationale and design of the Aortic Valve replAcemenT versus conservative treatment in Asymptomatic seveRe aortic stenosis (AVATAR trial): A randomized multicenter controlled event-driven trial.
abstract: Aortic valve replacement (AVR) therapy is an obvious choice for symptomatic severe aortic stenosis (AS) patients as it improves symptoms, left ventricular function, and survival. The treatment decisions and indication for AVR in asymptomatic patients with severe AS and normal left ventricular ejection fraction are less well established and the subject of ongoing debate. Many efforts have been made to define the best treatment option in asymptomatic AS patients with normal left ventricular ejection fraction. Retrospective and observational data imply that elective AVR for asymptomatic severe AS may lead to improvement in outcomes in comparison to surgery performed after onset of symptoms. The AVATAR trial will aim to assess outcomes among asymptomatic AS patients randomized to either elective early AVR or medical management with vigilant follow-up. In the latter group, AVR would be delayed until either the onset of symptoms or changes in predefined echocardiographic parameters. To the best of the authors' knowledge, it will be the first large prospective, randomized, controlled, multicenter clinical trial that will evaluate the safety and efficacy of elective AVR in this specific group of patients.
authors.affiliation: Belgrade Medical School, Belgrade, Serbia; University Clinical Centre of Serbia, Belgrade, Serbia. Electronic address: markobanovic71@gmail.com.
authors.forename: Marko
authors.initials: M
authors.lastname: Banovic
authors.affiliation: University Hospital Bichat, Paris, France.
authors.forename: Bernard
authors.initials: B
authors.lastname: Iung
authors.affiliation: Cardiovascular Center Aalst, OLV Hospital, Aalst, Belgium.
authors.forename: Jozef
authors.initials: J
authors.lastname: Bartunek
authors.affiliation: Belgrade Medical School, Belgrade, Serbia; University Clinical Centre of Serbia, Belgrade, Serbia.
authors.forename: Milika
authors.initials: M
authors.lastname: Asanin
authors.affiliation: Belgrade Medical School, Belgrade, Serbia; University Clinical Centre of Serbia, Belgrade, Serbia.
authors.forename: Branko
authors.initials: B
authors.lastname: Beleslin
authors.affiliation: Clinical Center "Rebro", Zagreb, Croatia.
authors.forename: Bojan
authors.initials: B
authors.lastname: Biocina
authors.affiliation: Cardiovascular Center Aalst, OLV Hospital, Aalst, Belgium.
authors.forename: Filip
authors.initials: F
authors.lastname: Casselman
authors.affiliation: University Hospital Galway, Galway, Republic of Ireland.
authors.forename: Mark
authors.initials: M
authors.lastname: da Costa
authors.affiliation: Medical University of Silesia, Katowice, Poland.
authors.forename: Marek
authors.initials: M
authors.lastname: Deja
authors.affiliation: Clinical Center "Rebro", Zagreb, Croatia.
authors.forename: Hrvoje
authors.initials: H
authors.lastname: Gasparovic
authors.affiliation: Centre of Cardiovascular Surgery and Transplantations, Medical Faculty of Masaryk University, Brno, Czech Republic; University Hospital Brno and Medical Faculty of Masaryk University, Brno, Czech Republic.
authors.forename: Petr
authors.initials: P
authors.lastname: Kala
authors.affiliation: Hôpital Cardiologique de Haut Lévèque, Pessac, France.
authors.forename: Lois
authors.initials: L
authors.lastname: Labrousse
authors.affiliation: Belgrade Medical School, Belgrade, Serbia.
authors.forename: Zlatibor
authors.initials: Z
authors.lastname: Loncar
authors.affiliation: Belgrade Medical School, Belgrade, Serbia; University Clinical Centre of Serbia, Belgrade, Serbia.
authors.forename: Jelena
authors.initials: J
authors.lastname: Marinkovic
authors.affiliation: Belgrade Medical School, Belgrade, Serbia; University Clinical Centre of Serbia, Belgrade, Serbia.
authors.forename: Ivana
authors.initials: I
authors.lastname: Nedeljkovic
authors.affiliation: Belgrade Medical School, Belgrade, Serbia; University Clinical Centre of Serbia, Belgrade, Serbia.
authors.forename: Milan
authors.initials: M
authors.lastname: Nedeljkovic
authors.affiliation: Centre of Cardiovascular Surgery and Transplantations, Medical Faculty of Masaryk University, Brno, Czech Republic.
authors.forename: Peter
authors.initials: P
authors.lastname: Nemec
authors.affiliation: Bioventrix, San Ramon, CA.
authors.forename: Serge D
authors.initials: SD
authors.lastname: Nikolic
authors.affiliation: Biostatistics and Bioinformatics, Duke Clinical Research Institute, Duke University, Durham, NC.
authors.forename: Michael
authors.initials: M
authors.lastname: Pencina
authors.affiliation: Cardiovascular Center Aalst, OLV Hospital, Aalst, Belgium.
authors.forename: Martin
authors.initials: M
authors.lastname: Penicka
authors.affiliation: Belgrade Medical School, Belgrade, Serbia; University Clinical Centre of Serbia, Belgrade, Serbia.
authors.forename: Arsen
authors.initials: A
authors.lastname: Ristic
authors.affiliation: University Hospital Galway, Galway, Republic of Ireland.
authors.forename: Faisal
authors.initials: F
authors.lastname: Sharif
authors.affiliation: Cardiovascular Center Aalst, OLV Hospital, Aalst, Belgium.
authors.forename: Guy
authors.initials: G
authors.lastname: Van Camp
authors.affiliation: Cardiovascular Center Aalst, OLV Hospital, Aalst, Belgium.
authors.forename: Marc
authors.initials: M
authors.lastname: Vanderheyden
authors.affiliation: Medical University of Silesia, Katowice, Poland.
authors.forename: Wojtek
authors.initials: W
authors.lastname: Wojakowski
authors.affiliation: Belgrade Medical School, Belgrade, Serbia; University Clinical Centre of Serbia, Belgrade, Serbia. Electronic address: svetozar073@yahoo.com.
authors.forename: Svetozar
authors.initials: S
authors.lastname: Putnik
mesh_terms: D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000628:therapy*; D017023:Coronary Angiography; D015150:Echocardiography, Doppler; D005080:Exercise Test; D005260:Female; D005500:Follow-Up Studies; D019918:Heart Valve Prosthesis Implantation / Q000379:methods*; D006801:Humans; D008297:Male; D011379:Prognosis; D011446:Prospective Studies; D012720:Severity of Illness Index; D013997:Time Factors