LANDMARK trial, highlighting the safety and effectiveness of the Myval Transcatheter Heart Valve (THV) Series, stands out at EuroPCR 2024.
Meril Life Sciences’s LANDMARK trial’s 30 days primary outcomes were presented recently at EuroPCR 2024, Paris, France. The trial involved 768 patients across 31 sites.
The LANDMARK study highlighted the performance of Myval THV series in terms of safety and effectiveness was non-inferior to the contemporary THV series (24.7 per cnt vs. 27.0 per cent, occurrence of primary composite endpoint which is composite of deaths, stroke, major bleeding, acute kidney injury, major vascular complications, moderate or severe valve regurgitation, and the need for new permanent pacemaker implantation as per the third Valve Academic Research Consortium consensus) with no difference in the itemised components of the primary composite endpoints.
The other secondary endpoints including technical success at exit from procedure room, device success at 30 days and early safety at 30 days were comparable in both the groups.
Professor Serruys, Chairman & study director of the LANDMARK trial, said “Myval THV series are novel next-gen THV devices; non-inferior to the Sapien and Evolut THV series. Myval THV series have a unique size matrix incorporating conventional, intermediate and extra-large diameters with increasing diameter steps of 1.5mm that match and fit precisely the multi slice CT scan-defined aortic annulus area of each individual patient, as a result, provides a superior effective orifice area on echocardiography, which may impact on durability and long-term clinical outcomes.
Additionally, the Myval Octacor, with its two rows of octagonal cells and a minimal foreshortening of 19 per cent during expansion, has unique features not paired by any other contemporary design.”
Myval THV series has a versatile range of sizes offering not only traditional sizes (20 mm, 23 mm, 26 mm, 29 mm) but also intermediate (21.5 mm, 24.5 mm, 27.5 mm) and extra-large sizes (30.5 mm and 32 mm). This tailored sizing matrix allows cardiologists to select the appropriate valve size, thus avoiding excessive over- or under-sizing. In the LANDMARK trial, 48.1 per cent of the patients were implanted with the intermediate size of Myval THV series.
The hemodynamic outcomes in terms of valve effective orifice area (EOA) was significantly better for the 23, 26 and 29 mm Myval THV series as compared to Sapien THV series, while there were no significant differences in the pre-procedural annular area. The long-term benefits of the intermediate sizes of THV will be further studied during the subsequent follow-up up to ten years.
As per the Global Principal Investigator, Prof. Andreas Baumbach, “The Landmark trial showed that the Myval THV series performed as safe and effective as contemporary THV series. It is a valve made for everyday clinical practice and an all-comers population. The special feature of intermediate diameters allows for more accurate sizing, which has the potential to translate into improved long-term outcomes. Our patients will be followed up for 10 years and it will be interesting to see the long-term results in the three treatment arms.”
Sanjeev Bhatt, Sr. Vice President – Corporate Strategy at Meril said, ” In a successful development in structural heart interventions, the LANDMARK RCT has revealed compelling results for the novel Myval transcatheter heart valve (THV) series, confirming its non-inferiority to other contemporary THV devices.”