Meril Life Sciences announced one-year results from its pivotal LANDMARK trial, presented during the prestigious Late-Breaking Trial session at EuroPCR 2025, one of the world’s premier cardiology conferences held annually in Paris, France. The LANDMARK trial is the first randomized non-inferiority trial comparing the balloon-expandable Myval THV series with other contemporary balloon-expandable Sapien THV series and self-expandable Evolut THV series in patients with symptomatic severe aortic stenosis.
The Myval THV series demonstrated non-inferiority to contemporary THVs in terms of 1-year clinical efficacy composite endpoint (Myval THV Series: 13% vs. Contemporary THV: 13.1%, difference: -0.1%, one-sided 95% CI: 3.9%, Pnoninferiority < 0.0001).
Additionally, in the composite endpoint of clinical efficacy combined with QoL, outcomes were comparable (Myval THV Series: 19.5% vs. Contemporary THVs: 22.7%, difference: -3.2%, 95% CI: -9.2 to 2.9, P=0.33). Hemodynamic parameters 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.
Survival rates were nearly identical (Myval THV Series: 92.8% vs. Contemporary THVs: 92.9%), and QoL improvements were comparable, reinforcing the overall safety and durability of the Myval THV series in everyday clinical use
