1-Year Outcomes of Novel Balloon-Expandable vs Contemporary Transcatheter Heart Valves in Severe Aortic Stenosis

作者：Patrick Serruys, Akihiro Tobe, Niels van Royen, Ignacio J. Amat‐Santos, Martin Hudec, Matjaž Bunc, Ben J L Van den Branden, Peep Laanmets, Daniel Unić, Béla Merkely, Renicus S. Hermanides, Vlasis Ninios, Marcin Protasiewicz, Benno J. Rensing, Pedro Martín, Fausto Feres, Manuel Almeida, Eric Van Belle, Axel Linke, Alfonso Ielasi, Matteo Montorfano, Mark Webster, Konstantinos Toutouzas, Emmanuel Teíger, Francesco Bedogni, Michiel Voskuil, Manuel Pan, Oskar Angerås, Won-Keun Kim, Jürgen Rothe, Mohamed Abdel Wahab, Ivica Kristić, Vicente Peral, Scot Garg, Tsung‐Ying Tsai, Ashokkumar Thakkar, Udita Chandra, Pieter C. Smits, Marie‐Claude Morice, Yoshinobu Onuma, Andreas Baumbach, Adriaan O. Kraaijeveld, Afonso Oliveira, Alberto Cervone, Alessandro Cosenza, Andrea Nagy, Adriaan O. Kraaijeveld, Afonso Oliveira, Alberto Cervone, Alessandro Cosenza, Andrea Nagy, Andreas Ioannidis, Apostolia Marvaki, Ármin Kisiczki, Arnold Béla Ferencz, Asma Ansari, Barbara Belini, Carlos Baladrón, Cedric Delhaye, Christian Valina, Ciro Vella, Csilla Czimbalmos, Daniel Sjöholm, Biomedical Scientist, Dario Pellegrini, Dimytri Siqueira, Dirk Jan van Ginkel, Dirk Westermann, Dolores Mesa, Dorival Della Togna, Elisabeth Chen, Ervina Unic, Faridun Daniel Rahimi Nedjat, Felix Woitek, Filippo Russo, Flavien Vincent, Fotini Ereliadou, Francois Pontana, Geert Versteeg, Georgios Papadopoulos, Ignacio Gallo, Igor Rudez, Ilias Ninios, Irzal Hadzibegovic, Ivana Jurin, Jana Ambrożič, Jennifer Hommel, Jeroen Vos, José María Nóvoa Medina, João Brito, Jurriën M. ten Berg, Kilian Franke, Leo Timmers, Leonidas Koliastasis, Levente Molnar, Louis Nakayama Ohe, Luca A. Ferri, Luca Testa, Lukas Liptak, Luka Vitez, Madjid Boukantar, Mandy Fish, Manuel Belo Costa, Marco B. Ancona, Maria Drakopoulou, Mariano Pellicano, Mario García-Gómez, Martijn Meuwissen, Martin Czerny, Matthias Renker, Maurizio Tespili, Menno van Gameren, Michael G. Dickinson, Michał Kosowski, Michelle Uelskaja, Miha Šušteršič, Miroslaw Ferenc, Mohamed Bechiri, Mohamed Mouden, Mojca Bercar, Monika Zeleznikova, Monér AlChay, Mostafa M. Mokhles, My Barbe, Biomedical Scientist, Nawras Diab, Nedy Brambilla, Neha Bharti, Niels Stens, Nikola Pavlovic, Nikolaos Ktenopoulos, Nikolaus Löffelhardt, Norman Mangner, Odysseas Katsaros, Pari Allahyari, Petra Poliacikova, Pierre-Vladimir Ennezat, Pim van der Harst, Piotr Kubler, Romain Gallet, Primoź Holc, Pétur Pétursson, Rajni Prasad, Remigio Leonora, Roland Papp, Rui Campante Teles, Sander Bramer, Sandesh Joshi, Savica Gjorgjievska, Shirin Bakhtari, Sime Manola, Sina Porouchani, Sofie Andreen, Sofía Campillo, Soledad Ojeda, Sotirios Evangelou, Stephan Haussig, Sunita Jaiswal, Tacianne Rolemberg Braga Delamain, Tania Rodríguez Gabella, Thibault Pamart, Thomas C. Dessing, Tom Denimal, Tomislav Sipic, Verónica Quevedo Nelson, Vibhuti Bhatt, Vincent Balmette, Warner Postma, Yash Patil, Andreas Baumbach · 发表于：Journal of the American College of Cardiology · 年份：2025 · DOI：10.1016/j.jacc.2025.10.076 · 被引用次数：7 · 研究领域：Cardiac Valve Diseases and Treatments、Aortic Disease and Treatment Approaches、Congenital Heart Disease Studies

BACKGROUND: In the LANDMARK trial, the Myval balloon-expandable transcatheter heart valve (THV) series was noninferior to the most commonly used contemporary SAPIEN and Evolut Series THVs for the 30-day early safety endpoint in participants with symptomatic severe native aortic stenosis. OBJECTIVES: The current report from the LANDMARK trial describes clinical outcomes, hemodynamic performances, and quality of life at 1 year. METHODS: This open-label, noninferiority trial enrolled 768 participants across 31 hospitals in Europe, New Zealand, and Brazil. Participants were randomly assigned (1:1) to receive either a Myval THV series or a contemporary THV (SAPIEN or Evolut series). The composite endpoint at 1 year included all-cause mortality, all strokes, and procedure- or valve-related hospitalizations. Clinical efficacy was defined as freedom from the composite endpoint. As recommended in Valve Academic Research Consortium-3, the previous composite endpoint combined with the assessment of quality of life at baseline and 1 year with the 12-Item Short Form Health Survey was reported as an extended composite endpoint. The noninferiority hypothesis was prespecified for the assessment of the primary endpoint at 30 days. Considering the specific 1-year composite endpoints of Valve Academic Research Consortium-3 and the event rate of 27.23% derived from recent studies, an a posteriori descriptive and exploratory noninferiority hypothesis was introduced with a noninferiority margin of...