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Comparative Study
. 2024 Jun 22;403(10445):2695-2708.
doi: 10.1016/S0140-6736(24)00821-3. Epub 2024 May 22.

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

Andreas Baumbach  1 , Niels van Royen  2 , Ignacio J Amat-Santos  3 , Martin Hudec  4 , Matjaz Bunc  5 , Alexander Ijsselmuiden  6 , Peep Laanmets  7 , Daniel Unic  8 , Bela Merkely  9 , Renicus S Hermanides  10 , Vlasis Ninios  11 , Marcin Protasiewicz  12 , Benno J W M Rensing  13 , Pedro L Martin  14 , Fausto Feres  15 , Manuel De Sousa Almeida  16 , Eric van Belle  17 , Axel Linke  18 , Alfonso Ielasi  19 , Matteo Montorfano  20 , Mark Webster  21 , Konstantinos Toutouzas  22 , Emmanuel Teiger  23 , Francesco Bedogni  24 , Michiel Voskuil  25 , Manuel Pan  26 , Oskar Angerås  27 , Won-Keun Kim  28 , Jürgen Rothe  29 , Ivica Kristić  30 , Vicente Peral  31 , Scot Garg  32 , Hesham Elzomor  33 , Akihiro Tobe  33 , Marie-Claude Morice  34 , Yoshinobu Onuma  33 , Osama Soliman  33 , Patrick W Serruys  35 ; LANDMARK trial investigators
Collaborators, Affiliations
Comparative Study

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

Andreas Baumbach et al. Lancet. .

Erratum in

  • Department of Error.
    [No authors listed] [No authors listed] Lancet. 2024 Jun 22;403(10445):2694. doi: 10.1016/S0140-6736(24)01259-5. Lancet. 2024. PMID: 38908879 No abstract available.
  • Department of Error.
    [No authors listed] [No authors listed] Lancet. 2025 Mar 1;405(10480):700. doi: 10.1016/S0140-6736(25)00353-8. Lancet. 2025. PMID: 40023648 No abstract available.

Abstract

Background: 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).

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.

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Conflict of interest statement

Declaration of interests NvR reports grant funding and personal fees from Abbott; grants from Philips, Biotronik, and Medtronic; and personal fees from MicroPort, Bayer, and RainMed Medical outside the submitted work. IJA-S reports being a proctor for Medtronic, Boston Scientific, and Meril Life Sciences. AIj reports consulting fees from Meril Life Sciences, Medtronic, Angiocare, Keystone Heart, PulseCath, Salveo, Abbott, Philips, Fysicon, Cardiawave, Pi Medical, and Svelte. DU reports lecture and educational event fees from Medtronic; a lecture fee from and being a proctor for Meril Life Sciences; and being a member of the Medtronic EMEA surgical advisory board. RSH reports grant funding from Bayer; and speaker fees from Amgen, Novartis, and Abbott outside the submitted work. MW reports institutional research funding from Emboline, Meril Life Sciences, Edwards Lifesciences, and TransAortic Medical. MPa reports honoraria from Boston Scientific, Philips, and Abbott. OA reports research grants and lecture fees from and being a proctor for Abbott; and advisory board participation for and support for attending meetings from Meril Life Sciences. W-KK reports honoraria or consultancy fees from Abbott, Boston Scientific, Edwards Lifesciences, Meril Life Sciences, and Hi-D Imaging; and participation on an advisory board or data and safety monitoring board for Abbott and Boston Scientific. JR reports being a consultant with Medtronic and Qatma; being a proctor for Medtronic; and travel support for attending meetings from Meril Life Sciences, Edwards Lifesciences, Abbott, Medtronic, and Boston Scientific. AT reports a grant from the Fukuda Foundation for Medical Technology. SG reports honoraria or consultancy fees from Biosensors. PWS reports consultancy fees from SMT, Novartis, Meril Life Sciences, Xeltis, and Philips. All other authors declare no competing interests.

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