Original Research

DOI: 10.4244/EIJ-D-24-00951

Early outcomes of the novel Myval THV series compared to SAPIEN THV series and Evolut THV series in individuals with severe aortic stenosis

Niels van Royen1, MD, PhD; Ignacio J. Amat-Santos2,3, MD, PhD; Martin Hudec4, MD, PhD; Matjaz Bunc5, MD, PhD; Alexander Ijsselmuiden6,7, MD, PhD; Peep Laanmets8, MD; Daniel Unic9, MD, PhD; Béla Merkely10, MD; Renicus S. Hermanides11, MD, PhD; Vlasis Ninios12, MD; Marcin Protasiewicz13, MD, PhD; Benno J.W.M. Rensing14, MD, PhD; Pedro L. Martin15, MD, PhD; Fausto Feres16, MD; Manuel De Sousa17, MD, PhD; Eric Van Belle18, MD, PhD; Axel Linke19, MD; Alfonso Ielasi20, MD; Matteo Montorfano21,22, MD; Mark Webster23, MBChB; Konstantinos Toutouzas24, MD, PhD; Emmanuel Teiger25, MD, PhD; Francesco Bedogni26, MD; Michiel Voskuil27, MD, PhD; Manuel Pan28, MD, PhD; Oskar Angerås29,30, MD, PhD; Won-Keun Kim31,32, MD; Jürgen Rothe33,34, MD; Ivica Kristić35, MD, PhD; Vicente Peral36, MD, PhD; Ben J.L. Van den Branden6, MD; Dirk Westermann33, MD; Barbara Bellini22, MD; Mario Garcia-Gomez2,3, MD; Akihiro Tobe37, MD; Tsung-Ying Tsai37,38, MD; Scot Garg39,40, MD, PhD; Ashokkumar Thakkar41, PhD; Udita Chandra41, PhD; Marie-Claude Morice42,43, MD, PhD; Osama Soliman37, MD, PhD; Yoshinobu Onuma37,44, MD, PhD; Patrick W. Serruys37, MD, PhD; Andreas Baumbach45,46, MD, PhD

Abstract

Background: There are limited head-to-head randomised trials comparing the performance of different transcatheter heart valves (THVs).

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.

Sign in to read
the full article

Forgot your password?
No account yet?
Sign up for free!

Create my pcr account

Join us for free and access thousands of articles from EuroIntervention, as well as presentations, videos, cases from PCRonline.com

Volume 21 Number 2
Jan 20, 2025
Volume 21 Number 2
View full issue


Key metrics

Suggested by Cory

EXPERT REVIEW

10.4244/EIJ-D-18-00544 Sep 7, 2018
Appraisal of key trials in aortic and mitral fields
Capranzano P et al
free

Clinical research

10.4244/EIJ-D-23-00344 Sep 18, 2023
Clinical outcomes of TAVI with the Myval balloon-expandable valve for non-calcified aortic regurgitation
Sanchez-Luna JP et al
free

10.4244/EIJV15I15A236 Feb 7, 2020
Strengths and weaknesses of different types of TAVI study
De Backer O and Søndergaard L
free

Editorial

10.4244/EIJ-E-24-00065 Apr 21, 2025
From invasive gradients to pressure recovery: rethinking long-standing paradigms
Joner M and Mylotte D
free

AORTIC VALVE INTERVENTIONS

10.4244/EIJV12SYA12 Sep 18, 2016
Upcoming TAVI trials: rationale, design and impact on clinical practice
Capodanno D and Leon MB
free
Trending articles
309.93

State-of-the-Art Review

10.4244/EIJ-D-21-00695 Nov 19, 2021
Transcatheter treatment for tricuspid valve disease
Praz F et al
free
166.7

Expert review

10.4244/EIJ-D-21-00690 May 15, 2022
Crush techniques for percutaneous coronary intervention of bifurcation lesions
Moroni F et al
free
92.2

State-of-the-Art Review

10.4244/EIJ-D-20-01296 Aug 27, 2021
Management of cardiogenic shock
Thiele H et al
free
76

State-of-the-Art

10.4244/EIJ-D-23-00840 Sep 2, 2024
Aortic regurgitation: from mechanisms to management
Baumbach A et al
free
72.85

State-of-the-Art

10.4244/EIJ-D-24-00386 Feb 3, 2025
Mechanical circulatory support for complex, high-risk percutaneous coronary intervention
Ferro E et al
free
58.3

Clinical research

10.4244/EIJ-D-23-00344 Sep 18, 2023
Clinical outcomes of TAVI with the Myval balloon-expandable valve for non-calcified aortic regurgitation
Sanchez-Luna JP et al
free
56.65

Clinical research

10.4244/EIJ-D-20-01155 Oct 20, 2021
A deep learning algorithm for detecting acute myocardial infarction
Liu W et al
free
33.9

CLINICAL RESEARCH

10.4244/EIJ-D-17-00381 Oct 11, 2017
Stent malapposition and the risk of stent thrombosis: mechanistic insights from an in vitro model
Foin N et al
free
33.65

State-of-the-Art

10.4244/EIJ-D-23-00606 Jan 1, 2024
Targeting inflammation in atherosclerosis: overview, strategy and directions
Waksman R et al
free
X

The Official Journal of EuroPCR and the European Association of Percutaneous Cardiovascular Interventions (EAPCI)

EuroPCR EAPCI
PCR ESC
Impact factor: 7.6
2023 Journal Citation Reports®
Science Edition (Clarivate Analytics, 2024)
Online ISSN 1969-6213 - Print ISSN 1774-024X
© 2005-2025 Europa Group - All rights reserved