Valvular & structural heart disease

1-Year Outcomes of Novel Balloon-Expandable vs Contemporary Transcatheter Heart Valves in Severe Aortic Stenosis: The LANDMARK Trial

J Am Coll CardiolPublished Randomised controlled trial

Authors' conclusion

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.

Study context

Population
Symptomatic severe native AS, 31 hospitals in Europe, New Zealand and Brazil
Participants
768 participants
Comparison
Myval balloon-expandable transcatheter heart valve (THV) vs contemporary THVs
Primary endpoint
Freedom from composite endpoint (Kaplan-Meier)
Follow-up
365 days
Methodological detailsopen-label, noninferiority, multicentre (31 hospitals)
  • Open-label
  • Noninferiority
  • Multicentre (31 hospitals)

Primary result

Freedom from composite endpoint (Kaplan-Meier)

Difference

−0.1%

1-sided 95% CI 3.9%

P < 0.0001 for non-inferiority

By group

As reported in the abstract

Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.

Original publication

1-Year Outcomes of Novel Balloon-Expandable vs Contemporary Transcatheter Heart Valves in Severe Aortic Stenosis: The LANDMARK Trial. J Am Coll Cardiol. Published 16 November 2025. doi:10.1016/j.jacc.2025.10.076

Summarised from the published abstract; every number is checked against it

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