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Randomized Controlled Trial
. 2024 Feb:268:94-103.
doi: 10.1016/j.ahj.2023.11.019. Epub 2023 Dec 4.

Design and rationale of the evaluation of transcatheter aortic valve replacement compared to surveillance for patients with asymptomatic severe aortic stenosis: The EARLY TAVR trial

Philippe Généreux  1 , Allan Schwartz  2 , Brad Oldemeyer  3 , David J Cohen  4 , Björn Redfors  5 , Heather Prince  6 , Yanglu Zhao  6 , Brian R Lindman  7 , Philippe Pibarot  8 , Martin B Leon  9
Affiliations
Randomized Controlled Trial

Design and rationale of the evaluation of transcatheter aortic valve replacement compared to surveillance for patients with asymptomatic severe aortic stenosis: The EARLY TAVR trial

Philippe Généreux et al. Am Heart J. 2024 Feb.

Abstract

Background: For patients with asymptomatic, severe aortic stenosis (AS) and preserved left ventricular ejection fraction, current guidelines recommend clinical surveillance every 6 to 12 months. To date, no randomized trials have examined whether an early intervention with transcatheter aortic valve replacement (TAVR) will improve outcomes among these patients.

Study design and objectives: EARLY TAVR is a prospective, randomized, controlled, and multicenter trial, with an event-based design. Asymptomatic severe AS patients (n = 900) are randomized 1:1 to either clinical surveillance or TAVR with the Edwards SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve. Patients are stratified by whether they are able to perform a treadmill stress test. The primary end point is death, stroke, or unplanned cardiovascular hospitalization. Patients who are asymptomatic but have a positive stress test will be followed in a registry and undergo aortic valve replacement as per current guidelines.

Conclusions: EARLY TAVR is the largest randomized trial to date assessing the role of early intervention among patients with asymptomatic severe AS compared to clinical surveillance and the first to study the role of TAVR.

Trial registration number: NCT03042104.

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Conflict of interest statement

Disclosure Philippe Généreux: Abbott Vascular: Consultant, advisor, speaker fees; Abiomed: Consultant, advisor, speaker fees; Boston Scientific: Consultant; CARANX Medical: Consultant; Cardiovascular System Inc: Consultant, PI eclipse trial; Edwards LifeSciences: Consultant, advisor, speaker fees, proctor, institutional research grant, PI EARLY-TAVR trial, PI PROGRESS trial; GE Healthcare: Consultant; iRhythm technologies: Consultant; Medtronic: Consultant, advisor, speaker fees; Opsens: Consultant; Pi-Cardia: Equity, consultant; puzzle medical: equity, consultant; Saranas: Equity, consultant; Shockwave: Consultant, speaker fees; Siemens: Consultant; Soundbite Medical Inc: Equity, consultant; Teleflex: Consultant; 4C medical: Consultant, PI feasibility study. Heather Prince and Yanglu Zhao are employees of Edwards Lifesciences. David J. Cohen: Research grant support from Edwards Lifesciences, Abbott, Boston Scientific. Consulting income from Edwards Lifesciences, Abbott, Boston Scientific, Medtronic. Brian Lindman: consulting payments and investigator-initiated research grants from Edwards Lifesciences. Philippe Pibarot: Institutional funding from Edwards Lifesciences, Medtronic, Pi-Cardia, Cardiac Success, Roche Diagnostics for echocardiography core laboratory analyses, blood biomarker analyses, and research studies in the field of interventional and pharmacologic treatment of valvular heart diseases, for which he received no personal compensation. Martin B. Leon: Institutional clinical research grants from Abbott, Boston Scientific, Edwards, and Medtronic. All other authors have no disclosures.

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