Early outcomes of the novel Myval THV series compared to SAPIEN THV series and Evolut THV series in individuals with severe aortic stenosis.
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Royen Niels van, Amat-Santos Ignacio J, Hudec Martin, Bunc Matjaz, Ijsselmuiden Alexander, Laanmets Peep, Unic Daniel, Merkely Béla, Hermanides Renicus S, Ninios Vlasis, Protasiewicz Marcin, Rensing Benno J W M, Martin Pedro L, Feres Fausto, Sousa Manuel De, Belle Eric Van, 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, Van den Branden Ben J L, Westermann Dirk, Bellini Barbara, Garcia-Gomez Mario, Tobe Akihiro, Tsai Tsung-Ying, Garg Scot, Thakkar Ashokkumar, Chandra Udita, Morice Marie-Claude, Soliman Osama, Onuma Yoshinobu, Serruys Patrick W, Baumbach Andreas
Аннотация
AIMS: We aimed to evaluate the non-inferiority of the balloon-expandable Myval THV series compared to the balloon-expandable SAPIEN THV series or the self-expanding Evolut THV series.
METHODS: The LANDMARK trial randomised 768 patients in a 1:1 ratio, (Myval THV series [n=384] vs contemporary series with 50% SAPIEN THV series [n=192] and 50% Evolut THV series [n=192]). The non-inferiority of Myval over the SAPIEN or Evolut THV series in terms of the 30-day primary composite safety and effectiveness endpoint as per the third Valve Academic Research Consortium (VARC-3) was tested in an intention-to-treat population with a predefined statistical power of 80% (1-sided alpha of 5%) for a non-inferiority margin of 10.44%.
RESULTS: The Myval THV series achieved non-inferiority for the primary composite endpoint over the SAPIEN THV series (24.7% vs 24.1%, risk difference [95% confidence interval {CI}]: 0.6% [not applicable {NA} to 8.0]; p=0.0033) and the Evolut THV series (24.7% vs 30.0%, risk difference [95% CI]: -5.3% [NA to 2.5]; p<0.0001). The incidences of pacemaker implantation were comparable (Myval THV series: 15.0%, SAPIEN THV series: 17.3%, Evolut THV series: 16.8%). At 30 days, the mean pressure gradient and effective orifice area were significantly better with the Myval THV series compared to the SAPIEN THV series (p<0.0001) and better with the Evolut THV series than with the Myval THV series (p<0.0001). At 30 days, the proportion of moderate to severe prosthetic valve regurgitation was numerically higher with the Evolut THV series compared to the Myval THV series (7.4% vs 3.4%; p=0.06), while not significantly different between the Myval THV series and the SAPIEN THV series (3.4% vs 1.6%; p=0.32).
CONCLUSIONS: The Myval THV series is non-inferior to the SAPIEN THV series and the Evolut THV series in terms of the primary composite endpoint at 30 days.
CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: NCT04275726; EudraCT number 2020-000,137-40.