THE MYVAl transcatheter heart valve (THV) series has demonstrated non-inferiority to both the SAPIEN THV series and the Evolut THV series in terms of 30-day safety and effectiveness outcomes for patients with severe aortic stenosis.
Comparative data on transcatheter heart valves remain limited, with few direct head-to-head randomised trials evaluating their performance. The LANDMARK trial was designed to assess the non-inferiority of the balloon-expandable Myval THV series in comparison to the balloon-expandable SAPIEN THV series and the self-expanding Evolut THV series. Given the increasing utilisation of transcatheter aortic valve implantation (TAVI) in clinical practice, it is essential to establish whether newer THVs offer comparable safety and efficacy to well-established alternatives.
The trial enrolled 768 patients, who were randomised in a 1:1 ratio to receive the Myval THV series (n=384) or one of the contemporary alternatives (n=384, with 50% assigned to the SAPIEN THV series and 50% to the Evolut THV series). The primary endpoint was a composite safety and effectiveness measure at 30 days, assessed using Valve Academic Research Consortium (VARC-3) criteria. The Myval THV series achieved non-inferiority against the SAPIEN THV series (24.7% vs 24.1%, risk difference: 0.6% [95% confidence interval {CI}: NA to 8.0], p=0.0033) and the Evolut THV series (24.7% vs 30.0%, risk difference: –5.3% [95% CI: NA to 2.5], p<0.0001). Rates of pacemaker implantation were similar across groups (Myval: 15.0%, SAPIEN: 17.3%, Evolut: 16.8%). At 30 days, the mean pressure gradient and effective orifice area were significantly better with the Myval THV series than the SAPIEN THV series (p<0.0001) but inferior to the Evolut THV series (p<0.0001). Moderate-to-severe prosthetic valve regurgitation was numerically higher with the Evolut THV series (7.4% vs 3.4%, p=0.06) but similar between the Myval and SAPIEN THV series (3.4% vs 1.6%, p=0.32).
These findings support the Myval THV series as a viable alternative to existing THVs in clinical practice. While short-term outcomes are promising, further research is needed to assess long-term durability and haemodynamic performance. Clinicians may consider Myval as part of their decision-making when selecting the most appropriate valve for individual patients undergoing TAVI.
Katrina Thornber, EMJ
Reference
van Royen N et al. Early outcomes of the novel Myval THV series compared to SAPIEN THV series and Evolut THV series in individuals with severe aortic stenosis. EuroIntervention: journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology. 2024;DOI:10.4244/EIJ-D-24-0095.
