20.500.12556/DiRROS-28380 1-year outcomes of novel balloon-expandable vs contemporary transcatheterheart valves in severe aortic stenosis the LANDMARK trial 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 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. (LANDMARK Trial: a Randomised Controlled Trial of Myval THV [LANDMARK]; NCT04275726) Evolut Myval SAPIEN randomized controlled trial transcatheter aortic valve replacement Evolut Myval SAPIEN randomizirano kontrolirana raziskava perkutana zamenjava aortne zaklopke true false true Angleški jezik Slovenski jezik Neznano 2026-03-16 13:56:06 2026-03-16 13:56:06 2026-03-24 03:51:44 0000-00-00 00:00:00 2026 0 0 Nasl. z nasl. zaslona; Opis vira z dne 16. 3. 2026; str. 362-381 issue 4 Vol. 87 2026 0000-00-00 Zaloznikova Objavljeno NiDoloceno 0000-00-00 0000-00-00 0000-00-00 616.126 1558-3597 10.1016/j.jacc.2025.10.076 271822083 RAZ_Serruys_Patrick_W._2026.pdf RAZ_Serruys_Patrick_W._2026.pdf 1 19563509E538E949909002538072FE0C 4f6d26aa3b26b154ebe026f9c5bc583233f44d6ad7a971f7f04f647c5c895a12 aacb5d9a-2137-11f1-a455-001a4af901a5 https://dirros.openscience.si/Dokument.php?lang=slv&id=41967 https://www.jacc.org/doi/10.1016/j.jacc.2025.10.076 1 811b95df-2137-11f1-a455-001a4af901a5 https://dirros.openscience.si/Dokument.php?lang=slv&id=41966 Univerzitetni klinični center Ljubljana 0 0 0