1-Year Outcomes of Novel Balloon-Expandable vs Contemporary Transcatheter Heart Valves in Severe Aortic Stenosis: The LANDMARK Trial.
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Serruys Patrick W, Tobe Akihiro, van Royen Niels, Amat-Santos Ignacio J, Hudec Martin, Bunc Matjaz, Van den Branden Ben J L, Laanmets Peep, Unic Daniel, Merkely Bela, Hermanides Renicus S, Ninios Vlasis, Protasiewicz Marcin, Rensing Benno J W M, Martin Pedro L, Feres Fausto, De Sousa Almeida Manuel, van Belle Eric, Linke Axel, Ielasi Alfonso, Montorfano Matteo, Webster Mark, Toutouzas Konstantinos, Teiger Emmanuel, Bedogni Francesco, Voskuil Michiel, Pan Manuel, Angerås Oskar, Kim Won-Keun, Rothe Jürgen, Abdel-Wahab Mohamed, Kristić Ivica, Peral Vicente, Garg Scot, Tsai Tsung-Ying, Thakkar Ashokkumar, Chandra Udita, Smits Pieter C, Morice Marie-Claude, Onuma Yoshinobu, Baumbach Andreas, LANDMARK Investigators
Аннотация
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).