Meril Life Sciences announced one-year results from its pivotal LANDMARK trial at EuroPCR 2025 in Paris, demonstrating that its Myval transcatheter heart valve (THV) series achieved non-inferiority compared to established contemporary valves in patients with symptomatic severe aortic stenosis.
The LANDMARK trial represents the first randomized non-inferiority study comparing Meril's balloon-expandable Myval THV series against both the balloon-expandable Sapien THV series and self-expandable Evolut THV series in a head-to-head design.
Key One-Year Outcomes
The trial's primary endpoint data showed the Myval THV series achieved non-inferiority to contemporary THVs in terms of the one-year clinical efficacy composite endpoint (Myval: 13% vs. Contemporary THVs: 13.1%, difference: -0.1%, one-sided 95% CI: 3.9%, Pnoninferiority < 0.0001).
When examining the composite endpoint of clinical efficacy combined with quality of life (QoL), outcomes remained comparable between the valve systems (Myval: 19.5% vs. Contemporary THVs: 22.7%, difference: -3.2%, 95% CI: -9.2 to 2.9, P=0.33).
Patient survival rates at one year were nearly identical between the treatment arms (Myval: 92.8% vs. Contemporary THVs: 92.9%), providing strong evidence for the safety profile of the Myval system.
Hemodynamic parameters—critical indicators of valve performance—including effective orifice area (EOA), mean pressure gradient (PG), and incidence of moderate or greater aortic regurgitation remained stable and similar across all treatment arms.
Expert Perspectives
Professor Patrick Serruys, Chairman and Study Director of the LANDMARK trial, highlighted the significance of the study design: "This trial reflects a new era in comparative valve research. The meticulous design and adherence to VARC-3 standards, including QoL endpoints, mark it as a pivotal study."
He further emphasized the clinical implications: "The data not only validate the safety and efficacy of the Myval THV series, but also spotlight its adaptability to complex anatomies. This versatility is exactly what clinicians need to deliver precision care across a broad spectrum of patients."
Professor Andreas Baumbach, Global Principal Investigator, noted the unique comparative approach of the trial: "For the first time, we've benchmarked Myval against both balloon-expandable and self-expanding platforms in a rigorous randomized setting. The one-year results demonstrate that the new generation Myval THV series can match global standards in safety and efficacy."
Trial Design and Scope
The LANDMARK trial was designed as a prospective, randomized, multicenter, open-label, non-inferiority study involving 768 patients who underwent Transcatheter Aortic Valve Implantation (TAVI) for the treatment of aortic stenosis. Patient enrollment began on January 6, 2021, and concluded on December 5, 2023.
The study spanned 31 clinical sites across 16 countries, including Brazil, New Zealand, and several European nations. The 30-day primary composite endpoints from the trial have already been published in The Lancet and EuroIntervention.
Importantly, the LANDMARK trial is designed to follow patients for a full decade, aiming to generate long-term insights into clinical and echocardiographic outcomes, with particular focus on valve durability and sustained performance.
Industry Implications
Mr. Sanjeev Bhatt, Senior Vice President of Corporate Strategy at Meril, emphasized the broader significance of the results: "The LANDMARK trial represents a significant milestone not just for Meril, but for the global TAVI community. The strong one-year results affirm the Myval THV series as a next-generation solution that delivers consistent safety, clinical efficacy, and improved quality of life across geographies."
He added that as "the only head-to-head trial of its kind to include both balloon-expandable and self-expanding valves, it reinforces Myval THV series's versatility and real-world relevance for diverse patient anatomies and healthcare systems."
The positive results from this landmark study may influence clinical decision-making in structural heart programs worldwide, potentially expanding treatment options for patients with severe aortic stenosis requiring transcatheter intervention.
