Transcatheter aortic valve implantation vs surgical replacement in low-risk aortic stenosis: time-dependent late mortality in a pooled analysis of trials

The expansion of transcatheter aortic valve implantation (TAVI) to low-risk patients with severe aortic stenosis (AS) has been driven by randomized trials reporting favourable early outcomes and non-inferiority to surgical aortic valve replacement (SAVR), through early and intermediate follow-up.1 However, longer-term assessment is essential for patients with a longer life expectancy, in whom durability, reintervention risk, and survival are central to treatment selection.2 Recently released extended follow-up data from pivotal lower-risk trials have raised concerns that the early advantages of TAVI may attenuate over time, with emerging signals related to late mortality, valve durability, and reintervention.3–5 However, these trials were underpowered to evaluate all-cause mortality as an individual endpoint. Moreover, conventional time-to-event analyses may obscure clinically important time-dependent differences between two treatment strategies exhibiting non-parallel patterns of early and late risk. We therefore conducted a pooled reconstructed time-to-event analysis of randomized low-risk trials with extended follow-up of up to 7 years.

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Publication Details

Journal
European Heart Journal
Published
2026-11-04
DOI
https://doi.org/10.1093/eurheartj/ehag877
Primary Topic
Cardiac Valve Diseases and Treatments
Type
article
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article

Transcatheter aortic valve implantation vs surgical replacement in low-risk aortic stenosis: time-dependent late mortality in a pooled analysis of trials

Rafael Sádaba, Michael Andrew Borger, Torsten Doenst, Volkmar Falk et al.
European Heart Journal
Cardiac Valve Diseases and Treatments
article

Transcatheter aortic valve implantation vs surgical replacement in low-risk aortic stenosis: time-dependent late mortality in a pooled analysis of trials

Rafael Sádaba, Michael Andrew Borger, Torsten Doenst, Volkmar Falk, Samuel Heuts, Patrick O. Myers, Milan Milojevic
article en

Abstract

The expansion of transcatheter aortic valve implantation (TAVI) to low-risk patients with severe aortic stenosis (AS) has been driven by randomized trials reporting favourable early outcomes and non-inferiority to surgical aortic valve replacement (SAVR), through early and intermediate follow-up.1 However, longer-term assessment is essential for patients with a longer life expectancy, in whom durability, reintervention risk, and survival are central to treatment selection.2 Recently released extended follow-up data from pivotal lower-risk trials have raised concerns that the early advantages of TAVI may attenuate over time, with emerging signals related to late mortality, valve durability, and reintervention.3–5 However, these trials were underpowered to evaluate all-cause mortality as an individual endpoint. Moreover, conventional time-to-event analyses may obscure clinically important time-dependent differences between two treatment strategies exhibiting non-parallel patterns of early and late risk. We therefore conducted a pooled reconstructed time-to-event analysis of randomized low-risk trials with extended follow-up of up to 7 years.

European Heart Journal
University of Zurich (CH), Maastricht University Medical Centre (NL), Maastricht University (NL), University Hospital of Zurich (CH), Deutsches Herzzentrum der Charité (DE), Navarre Institute of Health Research (ES), Leipzig Heart Institute (DE), German Centre for Cardiovascular Research (DE), Jena University Hospital (DE), Clinica Universidad de Navarra (ES), Friedrich Schiller University Jena (DE)
Openalex Percentile: Top 12%
Cardiac Valve Diseases and Treatments
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