https://m2.mtmt.hu/ hun 2026-05-25 13:49 JournalArticle 35069403 VALIDATED true Centre for Cardiovascular Medicine and Devices, William Harvey Research Institute, Queen Mary University of London and Barts Heart Centre, London, United Kingdom Cleveland Clinic, London, United Kingdom Department of Cardiology, Radboud University Hospital, Nijmegen, Netherlands CIVERCV, Centro de Investigación Biomédica en red - Enfermedades Cardiovasculares, University Clinical Hospital of Valladolid, Valladolid, Spain Department of Cardiology, University Clinical Hospital of Valladolid, Valladolid, Spain Department of Acute Cardiology, Middle-Slovak Institute Of Cardiovascular Diseases, Banska Bystrica, Slovakia Department of Cardiology, University Medical Centre Ljubljana, Ljubljana, Slovenia Department of Cardiology, Amphia Hospital, Breda, Netherlands Department of Interventional Cardiology, Maastricht University Medical Center, Maastricht, Netherlands Zuyderland Hospital, Limburg, Netherlands Department of Invasive Cardiology, North Estonia Medical Centre, Tallinn, Estonia Department of Cardiac and Transplant Surgery, University Hospital Dubrava, Zagreb, Croatia Heart and Vascular Centre, Semmelweis University Heart and Vascular Centre, Budapest, Hungary Department of Cardiology, Isala Hospital, Zwolle, Netherlands Department of Cardiology, European Interbalkan Medical Center, Thessaloniki, Greece Department of Cardiology, Institute of Heart Diseases, Wrocław Medical University, Wrocław, Poland Department of Cardiology, St Antonius Hospital, Nieuwegein, Netherlands Department of Interventional Cardiology, University Hospital of Gran Canaria Dr Negrín, Las Palmas, Spain Department of Invasive Cardiology, Instituto Dante Pazzanese, Sao Paulo, Brazil CHRC, NOVA Medical School, NOVA University Lisbon, Lisbon, Portugal Department of Interventional Cardiology, Lille University, Lille, France Department of Internal Medicine and Cardiology, University Clinic, Heart Center Dresden, University of Technology Dresden, Dresden, Germany Department of Interventional Cardiology, IRCCS Galeazzi Sant'Ambrogio Hospital, Milan, Italy School of Medicine, Vita-Salute San Raffaele University, Milan, Italy Interventional Cardiology Unit IRCCS San Raffaele Scientific Institute, Milan, Italy Department of Cardiology, Auckland City Hospital, Auckland, New Zealand Department of Cardiology, Hippokration Hospital, Athens, Greece Department of Medico-surgical Cardiovascular and Anaesthesiology, Henri-Mondor University Hospital, Creteil, France Department of Clinical Cardiology, San Donato Hospital, Milan, Italy Department of Interventional Cardiology, University Medical Center Utrecht, Utrecht, Netherlands Department of Cardiology, University Hospital Reina Sofía, University of Córdoba, Córdoba, Spain Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden Department of Clinical and Molecular Medicine, Gothenburg University, Gothenburg, Sweden Department of Cardiology and Angiology, University of Giessen and Marburg, Giessen, Germany Department of Cardiology, Kerckhoff Heart Center, Bad Nauheim, Germany Department of Cardiology and Angiology, University Heart Center Freiburg Bad Krozingen, University Medical Center Freiburg, Freiburg, Germany Department of Cardiology and Angiology, Faculty of Medicine, University of Freiburg, Freiburg, Germany Department of Cardiology, University Hospital of Split, Split, Croatia Department of Cardiology, Son Espases University Hospital, Palma, Spain Department of Cardiology, Royal Blackburn Hospital, Blackburn, United Kingdom Department of Cardiology, School of Medicine, University of Galway, Galway, Ireland Cardiovascular European Research Center, Paris, France Cited By :3 Export Date: 30 September 2024 CODEN: LANCA Correspondence Address: Serruys, P.W.; Department of Cardiology, Ireland; email: patrick.w.j.c.serruys@gmail.com Manufacturers: TAVI Core lab, India Funding text 1: The LANDMARK trial was sponsored by Meril Life Sciences. We thank the data safety monitoring board members (Prof Franz-Josef Neumann, Dr Andrew Simpkin, and Prof Gert Richardt) and clinical events committee members (Prof Jose Luis Pomar, Dr Liesbeth Rosseel, Dr Amal Gamal, Dr Javaid Iqbal, and Dr Alan Soo) for ensuring the safe conduct of the trial and adjudication of events associated with the trial. 0 false 2026-05-23T23:19:02.706+0000 2024-09-09T11:57:14.458+0000 2024-06-25T08:39:52.044+0000 true 10080205 Szalóky-Siki Ágnes /api/admin/10080205 Admin true 2025-03-24T10:59:09.786+0000 2024-09-09T11:57:14.720+0000 true 10080205 Szalóky-Siki Ágnes /api/admin/10080205 Admin true true false true 24 24 /api/publicationtype/24 PublicationType 1 true 24 JournalArticle true 10000359 Study Group true 24 24 /api/publicationtype/24 PublicationType 1 true 24 JournalArticle /api/subtype/10000359 Sokszerzős vagy csoportos szerzőségű szakcikk SubType 104 true 10000359 true 1 /api/category/1 Category true 1 Baumbach, Andreas LANDMARK comparison of early outcomes of newer-generation Myval transcatheter heart valve series with contemporary valves (Sapien and Evolut) in real-world individuals with severe symptomatic native aortic stenosis a randomised non-inferiority trial. true true /api/journal/3012 REVIEWED true false 3012 false 3012 true 0140-6736 1474-547X Journal FOREIGN 403 10445 2695 2708 2695 14 2024 Transcatheter aortic valve implantation is an established, guideline-endorsed treatment for severe aortic stenosis. Precise sizing of the balloon-expandable Myval transcatheter heart valve (THV) series with the aortic annulus is facilitated by increasing its diameter in 1·5 mm increments, compared with the usual 3 mm increments in valve size. The LANDMARK trial aimed to show non-inferiority of the Myval THV series compared with the contemporary THVs Sapien Series (Edwards Lifesciences, Irvine, CA, USA) or Evolut Series (Medtronic, Minneapolis, MN, USA).In this prospective, multinational, randomised, open-label, non-inferiority trial across 31 hospitals in 16 countries (Germany, France, Sweden, the Netherlands, Italy, Spain, New Zealand, Portugal, Greece, Hungary, Poland, Slovakia, Slovenia, Croatia, Estonia, and Brazil), 768 participants with severe symptomatic native aortic stenosis were randomly assigned (1:1) to the Myval THV or a contemporary THV. Eligibility was primarily decided by the heart team in accordance with 2021 European Society of Cardiology guidelines. As per the criteria of the third Valve Academic Research Consortium, the primary endpoint at 30 days was a composite of all-cause mortality, all stroke, bleeding (types 3 and 4), acute kidney injury (stages 2-4), major vascular complications, moderate or severe prosthetic valve regurgitation, and conduction system disturbances resulting in a permanent pacemaker implantation. Non-inferiority of the study device was tested in the intention-to-treat population using a non-inferiority margin of 10·44% and assuming an event rate of 26·10%. This trial is registered with ClinicalTrials.gov, NCT04275726, and EudraCT, 2020-000137-40, and is closed to new participants.Between Jan 6, 2021, and Dec 5, 2023, 768 participants with severe symptomatic native aortic stenosis were randomly assigned, 384 to the Myval THV and 384 to a contemporary THV. 369 (48%) participants had their sex recorded as female, and 399 (52%) as male. The mean age of participants was 80·0 years (SD 5·7) for those treated with the Myval THV and 80·4 years (5·4) for those treated with a contemporary THV. Median Society of Thoracic Surgeons scores were the same in both groups (Myval 2·6% [IQR 1·7-4·0] vs contemporary 2·6% [1·7-4·0]). The primary endpoint showed non-inferiority of the Myval (25%) compared with contemporary THV (27%), with a risk difference of -2·3% (one-sided upper 95% CI 3·8, pnon-inferiority<0·0001). No significant difference was seen in individual components of the primary composite endpoint.In individuals with severe symptomatic native aortic stenosis, the Myval THV met its primary endpoint at 30 days.Meril Life Sciences. true true 2024 true true true false false NONE 2026-05-24 false 63 0 63 36 5 63 62 60 46 63 63 36 36 36 27 0 63 36 63 36 0 1 1 Folyóiratcikk Journal Article 24 63 Könyvrészlet Chapter in Book 25 0 Könyv Book 23 0 Egyéb konferenciaközlemény Conference paper 31 0 Egyéb konferenciakötet Conference proceedings 32 0 Oltalmi formák Protection forms 26 0 Disszertáció Thesis 28 0 Egyéb Miscellaneous 29 0 Alkotás Achievement 22 0 Kutatási adat Research data 33 0 Folyóiratcikk Journal Article 24 0 0 0 Könyvrészlet Chapter in Book 25 0 0 0 Könyv Book 23 0 0 0 Egyéb konferenciaközlemény Conference paper 31 0 0 0 Egyéb konferenciakötet Conference proceedings 32 0 0 0 Oltalmi formák Protection forms 26 0 0 0 Disszertáció Thesis 28 0 0 0 Egyéb Miscellaneous 29 0 0 0 Alkotás 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0.0 journal RatingType 10002 /api/ratingtype/10002 sjr true true ClassificationExternal 2701 /api/classificationexternal/2701 true 2701 true D1 DIRECT true true /api/publication/35069403 <div class="JournalArticle Publication long-list"> <div class="authors"> <img title="Forrásközlemény" style="float: left" src="/frontend/resources/grid/publication-core-icon.png"> <img title="Idézőközlemény" style="float: left" src="/frontend/resources/grid/publication-citation-icon.png"> <div class="autype autype0"> <span class="author-name" >Baumbach Andreas </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" mtid="10002691"><a href="/gui2/?type=authors&mode=browse&sel=10002691" target="_blank">Merkely Bela (<span class="authorship-author-name">Merkely Béla Péter</span> <span class="authorAux-mtmt"> Kardiológia</span>) </a> </span> <span class="author-affil"><span title="Semmelweis Egyetem">SE</span>/<span title="Általános Orvostudományi Kar">AOK</span>/<span title="Klinikum">K</span>/Városmajori 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(38) </div> <div class="autype autype-11"> Kollaborációs közreműködő: <span class="author-name" >Siqueira Dimytri </span> ;&nbsp;&nbsp;&nbsp; et al. (151) </div> <div class="autype autype-29"> Kollaborációs szervezet: <span class="author-affil">LANDMARK trial investigators</span> </div> <div><a target="_blank" href="/api/publication/35069403?labelLang=hun">Összes szerző</a></div> </div> <div class="title"><a href="/gui2/?mode=browse&params=publication;35069403" target="_blank">LANDMARK comparison of early outcomes of newer-generation Myval transcatheter heart valve series with contemporary valves (Sapien and Evolut) in real-world individuals with severe symptomatic native aortic stenosis : a randomised non-inferiority trial..</a></div> <div> <span class="journal-title">LANCET</span> <span class="journal-issn">(<a target="_blank" href="https://portal.issn.org/resource/ISSN/0140-6736">0140-6736</a> <a target="_blank" href="https://portal.issn.org/resource/ISSN/1474-547X">1474-547X</a>)</span>: <span class="journal-volume">403</span> <span class="journal-issue">10445</span> <span class="page"> pp 2695-2708 </span> <span class="year">(2024)</span> </div> <div class="pub-footer"> <span class="language" xmlns="http://www.w3.org/1999/html">Nyelv: Angol | </span> <span class="identifiers"> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="10.1016/S0140-6736(24)00821-3" target="_blank" href="https://doi.org/10.1016/S0140-6736%2824%2900821-3"> DOI </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="001302484900001" target="_blank" href="https://www.webofscience.com/wos/woscc/full-record/001302484900001"> WoS </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="85195311132" target="_blank" href="http://www.scopus.com/record/display.url?origin=inward&eid=2-s2.0-85195311132"> Scopus </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="38795719" target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=38795719&dopt=Abstract"> PubMed </a> </span> </span> <OnlyViewableByAuthor><div class="ratings"> <div class="journal-subject">Folyóirat szakterülete: Scopus - Medicine (miscellaneous)&nbsp;&nbsp;&nbsp;SJR indikátor:&nbsp;D1</div> <div class="journal-subject">Demográfiai Osztályközi Állandó Bizottság IXGJO DEM [1901-]&nbsp;&nbsp;&nbsp;A nemzetközi</div> <div class="journal-subject">Szociológiai Tudományos Bizottság IXGJO SZTB [1901-]&nbsp;&nbsp;&nbsp;A nemzetközi</div> </div></OnlyViewableByAuthor> <div class="publication-citation" style="margin-left: 0.5cm;"> <span title="Nyilvános idézőközlemények összesen, említések nélkül" class="citingPub-count">Nyilvános idéző összesen: 63</span> | Független: 36 | Függő: 27 | Nem jelölt: 0 | WoS jelölt: 60 | Scopus jelölt:&nbsp;46 | WoS/Scopus jelölt:&nbsp;63 | DOI jelölt:&nbsp;62 </div> <div class="publication-citation"> <a target="_blank" href="/api/publication?cond=citations.related;eq;35069403&sort=publishedYear,desc&sort=title"> Idézett közlemények száma: 1 </a> </div> <div class="mtid"><span class="long-pub-mtid">Közlemény: 35069403</span> | <span class="status-data status-VALIDATED"> Egyeztetett </span> Forrás Idéző | <span class="type-subtype">Folyóiratcikk ( Sokszerzős vagy csoportos szerzőségű szakcikk ) </span> | <span class="pub-category">Tudományos</span> | <span class="publication-sourceOfData">kézi felvitel</span> </div> <div class="lastModified">Utolsó módosítás: 2024.09.09. 13:57 Szalóky-Siki Ágnes (SE_KK_Admin5_SZSA, admin) </div> <pre class="comment" style="margin-top: 0; margin-bottom: 0;"><u>Megjegyzés</u>: Centre for Cardiovascular Medicine and Devices, William Harvey Research Institute, Queen Mary University of London and Barts Heart Centre, London, United Kingdom Cleveland Clinic, London, United Kingdom Department of Cardiology, Radboud University Hospital, Nijmegen, Netherlands CIVERCV, Centro de Investigación Biomédica en...</pre> </div></div>