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 - 18/03/16

Doi : 10.1016/j.ahj.2016.02.001

Marko Banovic, MD, PhD, FESC, FACC ^a,^b,^{^⁎} , Bernard Iung, MD, PhD ^c, Jozef Bartunek, MD, PhD ^d, Milika Asanin, MD, PhD ^a,^b, Branko Beleslin, MD, PhD ^a,^b, Bojan Biocina, MD, PhD ^e, Filip Casselman, MD, PhD ^d, Mark da Costa, MD, PhD ^f, Marek Deja, MD, PhD ^g, Hrvoje Gasparovic, MD, PhD ^e, Petr Kala, MD, PhD ^h,ⁱ, Lois Labrousse, MD, PhD ^j, Zlatibor Loncar, MD, PhD ^a, Jelena Marinkovic, MD, PhD ^a,^b, Ivana Nedeljkovic, MD, PhD ^a,^b, Milan Nedeljkovic, MD, PhD ^a,^b, Peter Nemec, MD, PhD ^h, Serge D. Nikolic, PhD ^k, Michael Pencina, MD, PhD ^l, Martin Penicka, MD, PhD ^d, Arsen Ristic, MD, PhD ^a,^b, Faisal Sharif, MD, PhD ^f, Guy Van Camp, MD ^d, Marc Vanderheyden, MD, PhD ^d, Wojtek Wojakowski, MD, PhD ^g, Svetozar Putnik, MD, PhD ^a,^b,^{^⁎⁎}
^a Belgrade Medical School, Belgrade, Serbia
^b University Clinical Centre of Serbia, Belgrade, Serbia
^c University Hospital Bichat, Paris, France
^d Cardiovascular Center Aalst, OLV Hospital, Aalst, Belgium
^e Clinical Center “Rebro”, Zagreb, Croatia
^f University Hospital Galway, Galway, Republic of Ireland
^g Medical University of Silesia, Katowice, Poland
^h Centre of Cardiovascular Surgery and Transplantations, Medical Faculty of Masaryk University, Brno, Czech Republic
ⁱ University Hospital Brno and Medical Faculty of Masaryk University, Brno, Czech Republic
^j Hôpital Cardiologique de Haut Lévèque, Pessac, France
^k Bioventrix, San Ramon, CA
^l Biostatistics and Bioinformatics, Duke Clinical Research Institute, Duke University, Durham, NC

^⁎Reprint requests: Marko Banovic, MD, PhD, FESC, FACC, Assistant Professor, Cardiology Dpt. Clinical Center of Serbia, Pasterova 2, 11000 Belgrade, Serbia.Cardiology Dpt. Clinical Center of SerbiaPasterova 2Belgrade11000Serbia^⁎⁎Reprint requests: Svetozar Putnik, MD, PhD, Cardiac Surgery Department, Clinical Center of Serbia, Pasterova 2, 11000 Belgrade, Serbia.Cardiac Surgery Department, Clinical Center of SerbiaPasterova 2Belgrade11000Serbia

Résumé

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.

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Plan

Diagnostic procedures

Sample size and statistical considerations

	RCT No. NCT02436655.
	Stefan James, MD, PhD served as guest editor for this article.

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Vol 174

P. 147-153 - avril 2016 Retour au numéro

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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 - 18/03/16

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