Methodological Appraisal of Ongoing Trial of Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement in Younger Patients: From Incentives to Guideline-Informing Evidence

In order to generate guideline-informing evidence for extending TAVI to younger patients with severe AS, the trial should prioritise hard adverse endpoints, tighten NI margins, mandate extended follow-up, standardise the surgical comparator, and adequately power the bicuspid subgroup. Without these revisions, continuing the study under the current protocol risks yielding biased, non-guideline informative results.

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Publication Details

Journal
European Journal of Cardio-Thoracic Surgery
Published
2025-11-06
DOI
https://doi.org/10.1093/ejcts/ezaf348
Primary Topic
Cardiac Valve Diseases and Treatments
Type
article
Field-Weighted Citation Impact
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article

Methodological Appraisal of Ongoing Trial of Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement in Younger Patients: From Incentives to Guideline-Informing Evidence

Rafael Sádaba, Michael Andrew Borger, Volkmar Falk, Filip Casselman et al.
European Journal of Cardio-Thoracic Surgery
Cardiac Valve Diseases and Treatments
article

Methodological Appraisal of Ongoing Trial of Transcatheter Aortic Valve Implantation Versus Surgical Aortic Valve Replacement in Younger Patients: From Incentives to Guideline-Informing Evidence

Rafael Sádaba, Michael Andrew Borger, Volkmar Falk, Filip Casselman, Sanjay Kaul, Vinay Badhwar, Matthias Siepe, Patrick O. Myers, Milan Milojevic, Joseph E Bavaria
article en

Abstract

In order to generate guideline-informing evidence for extending TAVI to younger patients with severe AS, the trial should prioritise hard adverse endpoints, tighten NI margins, mandate extended follow-up, standardise the surgical comparator, and adequately power the bicuspid subgroup. Without these revisions, continuing the study under the current protocol risks yielding biased, non-guideline informative results.

European Journal of Cardio-Thoracic SurgeryVol. 67(12)
University of Bern (CH), West Virginia University (US), Cedars-Sinai Medical Center (US), University Hospital of Bern (CH), University Hospital of Zurich (CH), Deutsches Herzzentrum der Charité (DE), University Hospital of Geneva (CH), Navarre Institute of Health Research (ES), Leipzig Heart Institute (DE), Institute for Cardiovascular Diseases of Vojvodina (RS), German Centre for Cardiovascular Research (DE), Cardiovascular Research Center (BR), University Hospitals Geneva Medical Center (US), Hôpital de la Tour (CH), École Polytechnique Fédérale de Lausanne (CH), Geneva College (US), Charité - Universitätsmedizin Berlin (DE), Jefferson College (US), Universidad de Navarra (ES)
Openalex Percentile: Top 44%
Cardiac Valve Diseases and Treatments
DOISourceOpenAlex
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