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

What was studied

This trial looked at people with severe aortic stenosis who had symptoms. Each person got a new heart valve put in through a thin tube. The trial took in 768 people at 31 hospitals. The hospitals were in Europe, New Zealand and Brazil. By chance, people got either the Myval valve or a widely used valve. The widely used valves were SAPIEN or Evolut. Doctors and patients knew which valve was used. This report covers results at 1 year.

What they found

People in the trial had a mean age of 80 years. The team tracked deaths, strokes and hospital stays linked to the valve or the procedure. At 365 days, both groups were free of these events at similar rates. Myval was judged no worse than the other valves on this measure. The team also added a quality of life survey to this measure. Here too, there was no clear gap between the groups.

What it means for patients

The authors say Myval worked about as well as the other valves. This held for deaths, strokes and valve-related hospital stays at 1 year. Results on how well the valves worked in the heart were also alike. This applies to people with severe aortic stenosis who had symptoms.

Why it is not certain yet

Doctors and patients knew which valve each person got. The main test was planned for 30 days, not 1 year. The no-worse test at 1 year was added later. The authors call this later test exploratory. So the 1-year finding is more of a first look. The results here cover only 1 year after the procedure.

Source

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

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