The LANDMARK trial presentation, delivered by Prof. Patrick W. Serruys at EuroPCR 2026, detailed the two-year clinical outcomes of contemporary transcatheter aortic valve implantation (TAVI) devices.
The aim of the study was to evaluate the long-term clinical outcomes and safety (2 years) of the Myval THV valve series compared with widely established contemporary valves, including Sapien and Evolut.
This was a prospective, randomized 1:1 non-inferiority trial. A total of 768 patients with symptomatic severe aortic stenosis were enrolled across 31 centers in 16 countries. The study population was predominantly low risk, with a median STS score of 2.6%.
The study evaluated a composite clinical efficacy endpoint including all-cause mortality, stroke, and valve- or procedure-related hospitalization.
Results were comparable between both groups, with event-free survival rates of 79.1% for Myval versus 81.9% for contemporary valves (p=0.39).
Regarding all-cause mortality, survival was 87.3% in the Myval group versus 89.2% in the contemporary valve group, with no statistically significant differences (p=0.43).
No significant differences were observed in stroke rates or valve-/procedure-related hospitalizations either (p=0.13 and p=0.46, respectively).
Subgroup analyses also demonstrated comparable outcomes:
- Small aortic annuli (≤430 mm²): no significant differences in clinical efficacy were observed between Myval and contemporary valves (p=0.97).
- Women: clinical efficacy remained similar between both valve groups (82.0% for Myval versus 86.2% for contemporary valves; p=0.36).
Conclusions: Myval Demonstrated Sustained Two-Year Safety and Efficacy Compared With Sapien and Evolut
The Myval valve series demonstrated comparable safety and clinical efficacy outcomes versus Sapien and Evolut valves after two years of follow-up. These findings reinforce the long-term performance and safety profile of Myval, even in challenging populations such as patients with small aortic annuli and women.
Original Title: LANDMARK Trial: Two-Year Outcomes of Contemporary TAVI Valves.
Presented by Prof. Patrick W. Serruys at EuroPCR 2026 Congress.
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