Transcatheter aortic valve implantation (TAVI) has long been established as a reliable, non-surgical alternative for the treatment of severe symptomatic aortic stenosis. While currently used valves (such as the Sapien and Evolut series) continue to be assessed for long-term outcomes, the newly developed Myval transcatheter valve system has attracted attention for its potential effectiveness in this field. The LANDMARK trial is the first large-scale randomized controlled study directly comparing this new-generation balloon-expandable valve, Myval, with contemporary valves (Sapien and Evolut).

The objective of this study was to evaluate the clinical efficacy, safety, and hemodynamic performance of the Myval valve in comparison to contemporary balloon-expandable valves based on non-inferiority principles.

A total of 768 patients were randomized in a 1:1 ratio to receive either the Myval valve (n=384) or contemporary valves [Sapien (n=192) + Evolut (n=192)]. The study was conducted across 31 centers in 16 countries. The primary endpoint was a composite of all-cause mortality, stroke, and valve/procedure-related hospitalizations, as defined by VARC-3 criteria. Follow-up was scheduled at 30 days, 6 months (via telephone), 1 year, and at 2, 5, 7, and 10 years. This manuscript reports the outcomes at the 1-year follow-up.

Baseline characteristics were balanced between groups (mean age 80 years, mean STS score ~3%, NYHA Class III/IV: 54% vs. 51%). All patients had severe aortic stenosis with comparable mean gradients and valve areas (Myval: 39.9 mmHg, area: 0.7 cm²; Contemporary valves: 38.7 mmHg, area: 0.7 cm²). At 1-year follow-up, both groups showed similar outcomes in terms of mean valve area (2.09 vs. 2.10 cm²), mean gradient (8.2 vs. 7.6 mmHg), and moderate-to-severe aortic regurgitation (1.6% vs. 3.3%). There were no significant differences in mortality (7.2% vs. 7.1%), stroke (5.7% vs. 3.4%), or hospitalization (4.3% vs. 5.4%). The primary composite endpoint (death + stroke + valve-related hospitalization) occurred in 13.0% of the Myval group and 13.1% of the contemporary valve group (difference: -0.1%, one-sided 95% CI upper bound: 3.9%). Statistical non-inferiority was achieved (p-noninferiority <0.0001).

Based on the 1-year outcomes of the LANDMARK trial, the Myval transcatheter valve demonstrated comparable safety, efficacy, and hemodynamic performance to contemporary valves such as Sapien and Evolut, positioning it as a strong candidate among next-generation valve technologies.

The LANDMARK trial demonstrates that in patients with severe aortic stenosis at low-to-intermediate surgical risk, the Myval valve is equivalent to the Sapien and Evolut valves in terms of efficacy and safety. The upper limit of the one-sided 95% confidence interval being 3.9% confirms statistical non-inferiority (p-noninferiority <0.0001). Although the trial currently reports only 1-year outcomes, longer-term follow-up data are awaited to assess durability and long-term safety. Nevertheless, the available data suggest that Myval may be considered a first-line option, particularly in anatomically complex cases.