One-year outcomes from the LANDMARK trial show the Myval transcatheter heart valve (THV) series is noninferior to contemporary THVs for treating symptomatic severe native aortic stenosis.¹ The results demonstrate comparable clinical efficacy and haemodynamic performance at 1 year.

Methodology

LANDMARK (NCT04275726) was a prospective, randomised, open-label, noninferiority trial conducted across 31 hospitals in Europe, New Zealand, and Brazil. The study enrolled 768 patients (mean age 80 years, 48% women) with symptomatic severe native aortic stenosis suitable for transfemoral transcatheter aortic valve replacement (TAVR).¹

Patients were randomly assigned 1:1 to receive either a Myval series THV (n=384) or a contemporary THV (n=384), with the contemporary group equally allocated between SAPIEN (Edwards Lifesciences) and Evolut (Medtronic) devices. The primary composite endpoint at 1 year included all-cause mortality, all strokes, and procedure- or valve-related hospitalisations. Clinical efficacy was defined as freedom from this composite endpoint.¹

Results

At 365 days, there was no significant difference in the Kaplan-Meier estimates for freedom from the composite endpoint, with rates of 87.0% in the Myval group and 86.9% in the contemporary THV group. The Myval THV series met the criteria for noninferiority compared to the contemporary valves (difference: −0.1%; 1-sided 95% CI: 3.9%; Pnoninferiority < 0.0001).¹

No significant differences were observed in the individual components of the endpoint, including all-cause mortality (7.2% vs 7.1%) and all stroke (5.7% vs 3.4%). The rate of new permanent pacemaker implantation in pacemaker-naïve patients was similar between groups (17.6% vs 19.1%; p=0.68).¹

Echocardiographic analysis at 1 year showed that, compared with the SAPIEN group, the Myval group had lower mean pressure gradients (9.51 mmHg vs 10.54 mmHg; p=0.047) and larger effective orifice area (2.11 cm² vs 1.95 cm²; p=0.0056). Conversely, compared with the Evolut group, the Myval group had higher mean pressure gradients (9.51 mmHg vs 6.53 mmHg; p<0.0001).¹

In Practice

The investigators concluded that "in the treatment of symptomatic severe native aortic stenosis, the clinical and hemodynamic outcomes of the Myval THV series were comparable to those of contemporary THVs for the 1-year composite of all-cause mortality, all strokes, or procedure- or valve-related hospitalizations."¹ The findings suggest the Myval THV is a safe and effective alternative to established devices in this patient population. The trial plans to follow patients for up to 10 years to assess long-term outcomes and valve durability.

This study was funded by Meril Life Sciences.

Disclaimer

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References

1. Serruys PW, Tobe A, van Royen N, et al. 1-Year Outcomes of Novel Balloon-Expandable vs Contemporary Transcatheter Heart Valves in Severe Aortic Stenosis: The LANDMARK Trial. JACC. 2026;87(4):362–381. https://doi.org/10.1016/j.jacc.2025.10.076