The Myval THV demonstrated a mean effective orifice area of 2.12 cm2 at 1 year, larger than the Sapien THV (1.95 cm2, p=0.002) but smaller than the Evolut THV (2.25 cm2, p=0.01).
RCT (n=768)
1:1
Yes
Does the Myval transcatheter heart valve provide a different 1-year effective orifice area compared to Sapien and Evolut valves in patients with symptomatic severe aortic stenosis?
At 1 year post-TAVI, the Myval balloon-expandable valve demonstrated a larger effective orifice area than the Sapien valve but a smaller area than the Evolut valve.
p-value: p=0.002 vs Sapien; p=0.01 vs Evolut
Abstract Background In the LANDMARK trial, the Myval balloon-expandable balloon transcatheter heart valve (THV) series demonstrated non-inferiority compared with the two most commonly used contemporary THVs – Sapien and Evolut series – at 30 days and 1 year. Purpose This substudy reports the detailed echocardiographic assessment at 1 year. Methods The LANDMARK trial is a multicentre randomized trial comparing the performance of the Myval THV series with the contemporary THV series. A total of 768 patients with symptomatic severe aortic stenosis were randomized to either the Myval or contemporary group. Patients in the contemporary group were further randomized 1:1 to receive a Sapien or Evolut series. One-year echocardiograms were analysed at an independent core laboratory. Echocardiographic parameters, including effective orifice area (EOA), were stratified according to implanted valve size, computed tomography-based preprocedural aortic annulus area, sex, and stroke volume index (SVi). Analyses were performed in the as-treated population. Results One-year echocardiographic data with available EOA were obtained in 629 patients (Myval 304, Sapien 164, and Evolut 161). Mean EOA was 2.12±0.55, 1.95±1.84, and 2.25±2.20 cm2 for Myval, Sapien and Evolut, respectively (Myval vs Sapien, p=0.002; Myval vs Evolut, p=0.01). Myval and Sapien showed a stepwise increase in EOA according to valve size (Figure 1). In patients with small annulus (≦430 mm2), EOA was 1.82±0.48, 1.64±0.50, and 2.18±0.50 cm2, respectively (Myval vs Sapien, p=0.03; Myval vs Evolut, p0.0001). When aortic annulus area was further divided into four categories based on the manufacturer’s recommended ranges for Sapien valve sizes (273-345, 338-430, 430-546, 540-680 mm2), similar results were observed. In female patients, EOA was 1.96±0.54, 1.69±0.45, and 2.25±0.49 cm2 (Myval vs Sapien, p=0.0001; Myval vs Evolut, p0.0001). Across all valve types, patients with low flow status (SVi35 ml/m2) had smaller EOA compared with those with normal flow (SVi 35-50 ml/m2), whereas those with high flow (SVi50) had larger EOA. Whitin each flow category, Myval demonstrated larger EOA than Sapien but smaller than Evolut. Conclusions A comprehensive assessment of 1-year echocardiographic data was performed. Irrespective of stratification, Myval had higher EOA than Sapien where as small EOA than Evolut.EOA per valve type and sizeFor image description, please refer to the figure legend and surrounding text. EOA stratified by aortic annulus areaFor image description, please refer to the figure legend and surrounding text.
Tobe et al. (2026) conducted an RCT in symptomatic severe aortic stenosis (n=768). Myval THV series vs. Sapien or Evolut THV series was evaluated on Mean effective orifice area (EOA) at 1 year (p=p=0.002 vs Sapien; p=0.01 vs Evolut). The Myval THV demonstrated a mean effective orifice area of 2.12 cm2 at 1 year, larger than the Sapien THV (1.95 cm2, p=0.002) but smaller than the Evolut THV (2.25 cm2, p=0.01).