Early outcomes of the novel Myval THV series compared to SAPIEN THV series and Evolut THV series in individuals with severe aortic stenosis.

ABSTRACT:

Background

There are limited head-to-head randomised trials comparing the performance of different transcatheter heart valves (THVs).

Aims

We aimed to evaluate the non-inferiority of the balloon-expandable Myval THV series compared to the balloon-expandable SAPIEN THV series or the self-expanding Evolut THV series.

Methods

The LANDMARK trial randomised 768 patients in a 1:1 ratio, (Myval THV series [n=384] vs contemporary series with 50% SAPIEN THV series [n=192] and 50% Evolut THV series [n=192]). The non-inferiority of Myval over the SAPIEN or Evolut THV series in terms of the 30-day primary composite safety and effectiveness endpoint as per the third Valve Academic Research Consortium (VARC-3) was tested in an intention-to-treat population with a predefined statist

SUBMITTER: Royen NV 

PROVIDER: S-EPMC11729642 | biostudies-literature | 2025 Jan

REPOSITORIES: biostudies-literature