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

Marko Banovic, Bernard Iung, Jozef Bartunek, Milika Asanin, Branko Beleslin, Bojan Biocina, Filip Casselman, Mark da Costa, Marek Deja, Hrvoje Gasparovic, Petr Kala, Lois Labrousse, Zlatibor Loncar, Jelena Marinkovic, Ivana Nedeljkovic, Milan Nedeljkovic, Peter Nemec, Serge D. Nikolic, Michael Pencina, Martin PenickaArsen Ristic, Faisal Sharif, Guy Van Camp, Marc Vanderheyden, Wojtek Wojakowski, Svetozar Putnik

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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.
Original languageEnglish
Pages (from-to)147-153
JournalAmerican Heart Journal
Volume174
DOIs
Publication statusPublished - Apr 2016

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