Meril's Myval Transcatheter Heart Valve Shows Comparable One-Year Outcomes to Leading Competitors in LANDMARK Trial
核心洞察
The LANDMARK trial, the first multicenter randomized controlled trial comparing three leading transcatheter heart valve platforms, demonstrated comparable one-year clinical efficacy between Meril's Myval THV series (搜索) and established competitors Sapien and Evolut systems.
Myval THV series (搜索) achieved 87% composite clinical efficacy at one year, matching Sapien (86.9%) and Evolut (86.9%) systems, while showing the lowest incidence of moderate aortic regurgitation (搜索) at 1.6%.
The trial enrolled 768 patients across 31 sites in 16 countries, with results published in prestigious journals including The Lancet and Journal of the American College of Cardiology.
Meril Life Sciences (搜索) presented compelling one-year outcomes from the pivotal LANDMARK Randomized Controlled Trial at PCR London Valves 2025, demonstrating that its Myval transcatheter heart valve (THV) series performs comparably to established market leaders in treating patients with symptomatic severe aortic stenosis (搜索).
The LANDMARK trial represents a significant milestone as the first-ever multicenter randomized controlled trial to directly compare three leading THV platforms: the balloon-expandable Myval THV series (搜索) against both the balloon-expandable Sapien THV series (搜索) and the self-expanding Evolut THV series (搜索).
Comparable Clinical Efficacy Across Platforms
At one-year follow-up, the Myval THV series (搜索) demonstrated comparable composite clinical efficacy, defined as freedom from all-cause mortality, all stroke, and procedure- or valve-related hospitalization. The results showed 87% efficacy for Myval THV Series, 86.9% for Sapien THV series (搜索), and 86.9% for Evolut THV series (搜索).
The trial also evaluated an extended clinical efficacy endpoint that included quality of life deterioration, reflecting sustained clinical benefit over time. These extended outcomes remained consistent across platforms, with measurements of 80.5% for Myval THV Series (搜索), 75.0% for Sapien THV Series (搜索), and 79.7% for Evolut THV Series (搜索).
Superior Hemodynamic Performance
A notable finding was that the Myval THV series (搜索) demonstrated the lowest incidence of moderate aortic regurgitation (搜索) at 1.6%, reinforcing the system's hemodynamic stability and valve performance at one-year. This metric is particularly significant for long-term valve durability and patient outcomes.
Small Annulus Patient Population
A post-hoc analysis focusing on patients with small aortic annulus further confirmed comparable one-year composite efficacy outcomes. Results showed 91% efficacy for Myval THV Series (搜索) versus 89% for Sapien THV series (搜索), and 91% for Evolut THV series (搜索), demonstrating the valve's versatility across diverse patient anatomies.
Expert Commentary on Clinical Significance
Professor Patrick W. Serruys, Chairman and Study Director of the LANDMARK Trial, emphasized the study's importance: "The LANDMARK trial continues to provide the global TAVI community with meaningful comparative insight. By bringing together three leading THV platforms in a rigorously designed randomized study, we are able to better understand differences that matter clinically, particularly in valve stability and sustained hemodynamic performance."
Professor Andreas Baumbach, Global Principal Investigator, highlighted the study's unique design: "This study is unique in its ability to benchmark performance across balloon-expandable and self-expanding valves under identical trial conditions. The consistency seen in both standard and extended clinical efficacy endpoints demonstrates that the Myval THV series (搜索) performs on par with established global systems."
Trial Design and Scope
The LANDMARK trial was a prospective, randomized, multicenter, open-label, non-inferiority trial involving 768 patients who underwent Transcatheter Aortic Valve (搜索) Implantation (TAVI) for severe symptomatic native aortic stenosis. Patient enrollment occurred from January 6, 2021, to December 5, 2023, across 31 sites in 16 countries including Brazil, New Zealand, and various European nations.
The trial's 30-day primary composite endpoint results have been published in The Lancet and EuroIntervention, while the one-year results appeared in the Journal of the American College of Cardiology (JACC), demonstrating the non-inferiority of the Myval THV series (搜索) compared with contemporary THVs.
Long-term Follow-up Plans
The LANDMARK trial will continue patient follow-up for ten years to evaluate valve performance, long-term clinical stability, and echocardiographic performance, providing crucial data for the evolving TAVI landscape.
Sanjeev Bhatt, Senior Vice President – Corporate Strategy at Meril, noted: "The LANDMARK trial reflects our commitment to building robust clinical evidence that enables confident clinical decision-making. The continued performance of the Myval THV series (搜索) across diverse patient populations, including those with complex or smaller anatomies, reinforces its role as a next-generation therapy solution."