Myval THV demonstrates non-inferiority in LANDMARK trial

New Delhi: Meril Life Sciences has announced findings from its LANDMARK trial. Revealed on 15th May at EuroPCR 2024 in Paris, France, the study has been recognized as one of the top three late-breaking trials at the event, marking a significant potential shift in interventional cardiology practices. 

The LANDMARK trial evaluated the performance of the Myval Transcatheter Heart Valve (THV) series against contemporary THV devices, focusing on safety and effectiveness over a 30-day period. The results demonstrated non-inferiority of the Myval THV series, with a 24.7% occurrence of the primary composite endpoint compared to 27.0% in contemporary THV devices. The primary composite endpoint encompassed various factors, including death, stroke, major bleeding, acute kidney injury, major vascular complications, valve regurgitation, and the need for new permanent pacemaker implantation.

Secondary endpoints, such as technical success immediately after the procedure, device success at 30 days, and early safety at 30 days, showed comparable outcomes between the Myval and other THV groups.

Professor Serruys, Chairman and study director of the LANDMARK trial, noted, “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 2 rows of octagonal cells and a minimal foreshortening of 19% during expansion, has unique features not paired by any other contemporary design.”

The Myval THV series stands out for its versatile range of sizes, including traditional sizes (20 mm, 23 mm, 26 mm, 29 mm), intermediate sizes (21.5 mm, 24.5 mm, 27.5 mm), and extra-large sizes (30.5 mm, 32 mm). This tailored sizing allows cardiologists to select the optimal valve size, reducing the risk of over- or under-sizing. Notably, 48.1% of patients in the LANDMARK trial received intermediate-sized valves.

Professor Andreas Baumbach, Global Principal Investigator, stated, “The LANDMARK trial showed that the Myval THV series performed as safe and effective as contemporary THV series. 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.”

Mr. Sanjeev Bhatt, Senior Vice President of Corporate Strategy at Meril, expressed, “The results of LANDMARK trial are not just a win for us but for the entire medical community and, most importantly, for patients undergoing TAVI. This study not only reinforces the safety and efficacy of the Myval THV series but also highlights its adaptability to challenging anatomical structures.”