LANDMARK RCT Early Outcomes Published for Meril’s Myval THV Series

June 6, 2024—Meril Life Sciences, an India-based medical device company, announced that the early outcomes in the LANDMARK randomized controlled trial (RCT) of the company’s Myval transcatheter heart valve (THV) series have been published by Global Principal Investigator Professor Andreas Baumbach, MD, et al in The Lancet.

In May, the company announced the presentation of the 30-day primary outcomes as a late-breaking trial at EuroPCR 2024 in Paris, France.

LANDMARK was composed of 768 patients with severe symptomatic native aortic stenosis who underwent transcatheter aortic valve replacement at 31 sites in 16 countries. The first patient was enrolled on January 6, 2021. The last patient was enrolled on December 5, 2023.

As summarized in the company’s press release, the LANDMARK study showed that the performance of Myval THV series in terms of safety and effectiveness was noninferior to the contemporary THV series in the occurrence of the primary endpoint (24.7% vs 27%).

The primary endpoint is a composite of death, stroke, major bleeding, acute kidney injury, major vascular complication, moderate or severe valve regurgitation, and the need for new permanent pacemaker implantation as per VARC-3, the third Valve Academic Research Consortium consensus.

Additionally, there was no significant difference in the individual 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 groups.

“The LANDMARK trial showed that the Myval THV series performed as safe and effective as contemporary THV series,” commented Prof. Baumbach in Meril’s press release. “It is a valve made for everyday clinical practice and an all-comers population.”

Prof. Baumbach added, “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.”

Prof. Patrick W. Serruys, MD, who serves as Chairman and Study Director of the LANDMARK trial, stated in the press release, “Myval THV series are novel next-gen THV devices; noninferior to the Sapien (Edwards Lifesciences) and Evolut (Medtronic) THV series.”

Prof. Serruys continued, “Myval THV series have a unique size matrix incorporating conventional, intermediate, and extra-large diameters with increasing diameter steps of 1.5 mm that match and fit precisely the multislice 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% during expansion, has unique features not paired by any other contemporary design.”

Meril’s Myval THV series includes a range of intermediate and extra-large sizes to provide accessible and tailored solutions to a wide range of patients. The devices may help to provide solutions for patients with complex anatomy, including small annuli and bicuspid aortic valves, stated the company.

Myval’s range of sizes includes traditional sizes (20, 23, 26, and 29 mm), intermediate sizes (21.5, 24.5, and 27.5 mm), and extra-large sizes (30.5 and 32 mm). In the LANDMARK trial, 48% of the patients were implanted with the intermediate size of Myval THV series.

Meril noted that the hemodynamic outcomes in terms of valve effective orifice area were significantly better for the 23-, 26-, and 29-mm Myval THV series compared to Sapien THV series; there were no significant differences in the preprocedural annular area. The long-term benefits in patient prognosis and valve durability of the intermediate sizes of THV will be further studied during the subsequent follow-up for up to 10 years, advised the company.