Real-world 30-day data show noninferiority of new TAVR valve vs. other contemporary valves
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Key takeaways:
- A new TAVR valve showed noninferiority vs. other contemporary valves in a real-word study.
- The novel valve also had a larger effective orifice area vs. other available prosthetic valves.
A new prosthetic aortic valve with a wider range of intermediate sizing was noninferior at 30 days vs. other contemporary transcatheter aortic valves, a speaker reported.
Early outcomes of the randomized, noninferiority, real-world LANDMARK trial were presented at EuroPCR.
“The LANDMARK trial is a multinational ... randomized, noninferiority trial on safety and effectiveness at 30 days in patients with severe symptomatic native aortic stenosis according to the ESC guidelines of 2021,” Patrick W. Serruys, MD, PhD, established professor of interventional medicine and innovation at the University of Galway and the Research Centre for Advanced Imaging and Core Laboratory in Galway, Ireland, said during a press conference. “The Myval transcatheter heart valve series are compared to contemporary valves — Sapien and Evolut [transcatheter heart valve] series — in real-world patients, including small aortic annulus and bicuspid valve.”
Overall, 768 patients were randomly assigned 1:1 to the trial valve (Myval, Meril Life Sciences) or other contemporary TAVR valves (Sapien 3 and Sapien 3 Ultra, Edwards Lifesciences; Evolut R, Evolut Pro, Evolut Pro+ and Evolut Flex, Medtronic).
The composite primary endpoint included all-cause mortality, stroke, Bleeding Academic Research Consortium (BARC) type 3 and 4 bleeding, stage 2 to 4 acute kidney injury, moderate or severe TAVR valve regurgitation, new permanent pacemaker implantation and major vascular complications.
Serruys said, unlike other contemporary valves, the trial valve is produced in more intermediate sizes, with 1.5 mm stepped increments from 20 mm to 32 mm. For the present analysis, the 30.5 mm and 32 mm valves were excluded and are being evaluated in an ongoing separate registry.
With 24.7% of the study valve cohort experiencing a component of the 30-day primary composite endpoint compared with 27% of the contemporary valve cohort, the study valve met noninferiority (P < .0001), Serruys said at the press conference.
The researchers observed no significant differences between the study valve and other contemporary valves for any of the individual components of the primary endpoint.
The effective orifice area of the study valve was significantly larger compared with the Edwards Lifesciences valves at most sizes (P for 20 mm = 0.78; P for 23, 26 and 29 mm = .01).
There was no significant difference in the effective orifice area of the study valve compared with the Medtronic valves (P for 26 mm = 1; P for 29 mm = .48), according to the presentation.
Serruys said the study will be published in The Lancet on May 21.
Serruys and colleagues concluded that the favorable effective orifice area profile could be attributed to its wider range of intermediate sizes, which may affect valve durability.
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Serruys PW, et al. Major late-breaking trials from EuroPCR 2024. Presented at: EuroPCR; May 14-17, 2024; Paris.
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