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

2026-02Artigo científico Acesso aberto
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dc.contributor.authorSerruys, Patrick W.
dc.contributor.authorTobe, Akihiro
dc.contributor.authorvan Royen, Niels
dc.contributor.authorAmat-Santos, Ignacio J.
dc.contributor.authorHudec, Martin
dc.contributor.authorBunc, Matjaz
dc.contributor.authorVan den Branden, Ben J.L.
dc.contributor.authorLaanmets, Peep
dc.contributor.authorUnic, Daniel
dc.contributor.authorMerkely, Bela
dc.contributor.authorHermanides, Renicus S.
dc.contributor.authorNinios, Vlasis
dc.contributor.authorProtasiewicz, Marcin
dc.contributor.authorRensing, Benno J.W.M.
dc.contributor.authorMartin, Pedro L.
dc.contributor.authorFeres, Fausto
dc.contributor.authorDe Sousa Almeida, Manuel
dc.contributor.authorvan Belle, Eric
dc.contributor.authorLinke, Axel
dc.contributor.authorIelasi, Alfonso
dc.contributor.authorMontorfano, Matteo
dc.contributor.authorWebster, Mark
dc.contributor.authorToutouzas, Konstantinos
dc.contributor.authorTeiger, Emmanuel
dc.contributor.authorBedogni, Francesco
dc.contributor.authorVoskuil, Michiel
dc.contributor.authorPan, Manuel
dc.contributor.authorAngerås, Oskar
dc.contributor.authorKim, Won Keun
dc.contributor.authorRothe, Jürgen
dc.contributor.authorAbdel-Wahab, Mohamed
dc.contributor.authorKristić, Ivica
dc.contributor.authorPeral, Vicente
dc.contributor.authorGarg, Scot
dc.contributor.authorTsai, Tsung Ying
dc.contributor.authorThakkar, Ashokkumar
dc.contributor.authorChandra, Udita
dc.contributor.authorSmits, Pieter C.
dc.contributor.authorMorice, Marie Claude
dc.contributor.authorOnuma, Yoshinobu
dc.contributor.authorBaumbach, Andreas
dc.contributor.institutionNOVA Medical School|Faculdade de Ciências Médicas (NMS|FCM)
dc.contributor.institutionComprehensive Health Research Centre (CHRC) - pólo NMS
dc.contributor.pblElsevier Science Publisher B.V.
dc.date.accessioned2026-01-16T18:23:37Z
dc.date.available2026-01-16T18:23:37Z
dc.date.issued2026-02
dc.descriptionPublisher Copyright: © 2025 The Authors
dc.description.abstractBackground: 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 10.89%. The analysis was performed in the intention-to-treat population. Results: The mean age was 80 years, 48% were women, and the median Society of Thoracic Surgeons Predicted Risk of Mortality score was 2.6%. There was no significant difference in the Kaplan-Meier estimates of freedom from the composite endpoint at 365 days (Myval THV 87.0% vs contemporary THVs 86.9%). The Myval THV series was noninferior to the contemporary THVs for the composite endpoint (difference: −0.1%; 1-sided 95% CI: 3.9%; Pnoninferiority < 0.0001). Similarly, there were no significant differences in freedom from the extended composite endpoint (80.5% vs 77.3%; difference: 3.2%; 95% CI: −2.9% to 9.2%; P = 0.33). Conclusions: In the treatment of symptomatic severe native aortic stenosis, the clinical and hemodynamic outcomes of the Myval THV series were comparable to those of contemporary THVs for the 1-year composite of all-cause mortality, all strokes, or procedure- or valve-related hospitalizations.en
dc.description.versionpublishersversion
dc.description.versionpublished
dc.format.extent3789922
dc.identifier.doi10.1016/j.jacc.2025.10.076
dc.identifier.issn0735-1097
dc.identifier.otherPURE: 149233337
dc.identifier.otherPURE UUID: eedb50f3-cba5-4096-95d5-7f754d675483
dc.identifier.otherScopus: 105024734737
dc.identifier.urihttp://hdl.handle.net/10362/199488
dc.identifier.urlhttps://www.scopus.com/pages/publications/105024734737
dc.language.isoeng
dc.peerreviewedyes
dc.subjectEvolut
dc.subjectMyval
dc.subjectrandomized controlled trial
dc.subjectSAPIEN
dc.subjecttranscatheter aortic valve replacement
dc.subjectCardiology and Cardiovascular Medicine
dc.title1-Year Outcomes of Novel Balloon-Expandable vs Contemporary Transcatheter Heart Valves in Severe Aortic Stenosisen
dc.title.subtitleThe LANDMARK Trialen
dc.typejournal article
degois.publication.firstPage362
degois.publication.issue4
degois.publication.lastPage381
degois.publication.titleJournal of the American College of Cardiology
degois.publication.volume87
dspace.entity.typePublication
rcaap.rightsopenAccess

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