TY - JOUR
T1 - 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
T2 - a randomised non-inferiority trial
AU - Baumbach, Andreas
AU - van Royen, Niels
AU - Amat-Santos, Ignacio J
AU - Hudec, Martin
AU - Bunc, Matjaz
AU - Ijsselmuiden, Alexander
AU - Laanmets, Peep
AU - Unic, Daniel
AU - Merkely, Bela
AU - Hermanides, Renicus S
AU - Ninios, Vlasis
AU - Protasiewicz, Marcin
AU - Rensing, Benno J W M
AU - Martin, Pedro L
AU - Feres, Fausto
AU - De Sousa Almeida, Manuel
AU - van Belle, Eric
AU - Linke, Axel
AU - Ielasi, Alfonso
AU - Montorfano, Matteo
AU - Webster, Mark
AU - Toutouzas, Konstantinos
AU - Teiger, Emmanuel
AU - Bedogni, Francesco
AU - Voskuil, Michiel
AU - Pan, Manuel
AU - Angerås, Oskar
AU - Kim, Won-Keun
AU - Rothe, Jürgen
AU - Kristić, Ivica
AU - Peral, Vicente
AU - Garg, Scot
AU - Elzomor, Hesham
AU - Tobe, Akihiro
AU - Morice, Marie-Claude
AU - Onuma, Yoshinobu
AU - Soliman, Osama
AU - Serruys, Patrick W
N1 - Publisher Copyright:
© 2024 Elsevier Ltd
PY - 2024/6/22
Y1 - 2024/6/22
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85195311132&partnerID=8YFLogxK
U2 - 10.1016/S0140-6736(24)00821-3
DO - 10.1016/S0140-6736(24)00821-3
M3 - Article
C2 - 38795719
SN - 0140-6736
VL - 403
SP - 2695
EP - 2708
JO - Lancet (London, England)
JF - Lancet (London, England)
IS - 10445
ER -