ArticleEuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology2025
Early outcomes of the novel Myval THV series compared to SAPIEN THV series and Evolut THV series in individuals with severe aortic stenosis.
Article in EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04275726 (A Prospective, Multinational, Multicentre, Open-label, Randomised, Non-inferiority Trial to Compare Safety and Effectiveness of Meril's Myval Transcatheter Heart Valve), which is not on this map. Cited by 12 papers, 3 of them syntheses that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Prospective, Multinational, Multicentre, Open-label, Randomised, Non-inferiority Trial to Compare Safety and Effectiveness of Meril's Myval Transcatheter Heart Valve (THV) Series vs. Contemporary Valves (Edwards's Sapien THV Series and Medtronic's Evolut THV Series) in Patients With Severe Symptomatic Native Aortic Valve Stenosis
Who cites it
12 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- Supra-Annular Self-Expanding Versus Intra-Annular Balloon-Expandable Transcatheter Aortic Valve Implantation: A Meta-Analysis of Valve-Related Outcomes.Reviews in cardiovascular medicine · 2026Pooled it
- Myval versus Contemporary Valves in Patients Undergoing Transcatheter Aortic Valve Implantation: A Systematic Review and Meta-Analysis.Anatolian journal of cardiology · 2025Pooled it
- Effectiveness and Safety of Myval Versus Other Transcatheter Valves in Patients Undergoing TAVI: A Meta-Analysis.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2025Pooled it
- Understanding prosthesis patient mismatch in aortic valve replacement: from pitfalls to clinical impact.Cardiovascular intervention and therapeutics · 2026Review
- Balloon-Expandable Versus Self-Expandable Transcatheter Aortic Valve Implantation Devices: A Contemporary Systematic Review.Journal of clinical medicine · 2026Review
- Impact of Early Nonfatal Complications After Transcatheter Aortic Valve Implantation on 1-Year Mortality and Quality of Life: Insights From the LANDMARK Trial.Structural heart : the journal of the Heart Team · 2026Article
- Effective orifice area after Myval and SAPIEN transcatheter valve implantation stratified by flow status: insights from the LANDMARK trial.International journal of cardiology. Heart & vasculature · 2026Article
- A comparison of transcatheter aortic valve prosthesis platforms: Myval, Sapien, and Evolut in severe symptomatic aortic stenosis and low-moderate risk patients.Radiology and oncology · 2025Article
- Review
- The new balloon-expandable Myval transcatheter heart valve: only good news?EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2025Article
- Glimpse Into the Hemodynamic Performance of Myval Series vs Sapien 3 Ultra Resilia.Structural heart : the journal of the Heart Team · 2025Article
- Myval transcatheter heart valve system: a new TAVI contender and remaining uncertainties.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2025Article
Corrections and comments
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Authors and funding
44 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThere are limited head-to-head randomised trials comparing the performance of different transcatheter heart valves (THVs).
aimsWe 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.
methodsThe 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%.
resultsThe 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).
conclusionsThe 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 registrationClinicalTrials.gov: NCT04275726; EudraCT number 2020-000,137-40.
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