Key result
Myval THV shows no benefit over contemporary valves for the 30-day composite endpoint.
Why the study?
The LANDMARK trial reported non-inferiority of the Myval THV series compared with contemporary standard THV series for a 30-day composite endpoint, but further comparative performance analysis was needed.
Does the Myval THV series improve outcomes compared to contemporary standard THV series in patients with severe aortic stenosis when evaluated using a win ratio analysis?
RCT (n=768)
Open-label
1:1
Yes
Does the Myval THV series improve outcomes compared to contemporary standard THV series in patients with severe aortic stenosis when evaluated using a win ratio analysis?
This exploratory analysis evaluates the performance of the Myval THV series against contemporary standard THVs using a win ratio approach.
Myval should not yet be preferred; larger randomized trials are needed to assess any advantage.
The LANDMARK trial reported the non-inferiority of the Myval transcatheter heart valve (THV) series compared with the contemporary standard THV series (Sapien and Evolut) for a 30-day composite endpoint in patients with severe aortic stenosis. This exploratory study compared the performance of the Myval THV series with the contemporary THV series using the win ratio analysis.
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Tobe et al. (2025) conducted an RCT in Severe symptomatic native aortic stenosis (n=768). Myval transcatheter heart valve series vs. Contemporary THV series (Sapien and Evolut) was evaluated on Win ratio of the 30-day primary composite endpoint (hierarchical assessment of death, stroke, bleeding, major vascular complication, PVR, AKI, and new PPI) (Win ratio 1.12, 95% CI 0.84-1.48, p=0.43). The Myval transcatheter heart valve series showed a numerically higher but statistically non-significant win ratio compared to contemporary valves for the 30-day composite endpoint (win ratio 1.12).
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