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.
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Baumbach Andreas, van Royen Niels, Amat-Santos Ignacio J, Hudec Martin, Bunc Matjaz, Ijsselmuiden Alexander, 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, Kristić Ivica, Peral Vicente, Garg Scot, Elzomor Hesham, Tobe Akihiro, Morice Marie-Claude, Onuma Yoshinobu, Soliman Osama, Serruys Patrick W, LANDMARK trial investigators
Аннотация
METHODS: 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.
FINDINGS: 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.
INTERPRETATION: In individuals with severe symptomatic native aortic stenosis, the Myval THV met its primary endpoint at 30 days.
FUNDING: Meril Life Sciences.