Rationale and design of a randomized clinical trial comparing safety and efficacy of myval transcatheter heart valve versus contemporary transcatheter heart valves in patients with severe symptomatic aortic valve stenosis: The LANDMARK trial.

BACKGROUND

The recent approval of transcatheter aortic valve replacement (TAVR) in patients with low operative risk has paved the way for the introduction of novel and potentially improved technologies. The safety and efficacy of these novel technologies should be investigated in randomized control trials against the contemporary TAVR devices. The objective of the LANDMARK trial is to compare the balloon-expandable Myval transcatheter heart valve (THV) series with contemporary THV (SAPIEN THV and Evolut THV series) series in patients with severe symptomatic native aortic stenosis.

METHODS/DESIGN

The LANDMARK trial (ClinicalTrials.govNCT04275726, EudraCT number 2020-000,137-40) is a prospective, randomized, multinational, multicenter, open-label, and noninferiority trial of approximately 768 patients treated with TAVR via the transfemoral approach. Patients will be allocated in a 1:1 randomization to Myval THV series (n = 384) or to contemporary THV (n = 384) (either of SAPIEN THV or Evolut THV series). The primary combined safety and efficacy endpoint is a composite of all-cause mortality, all stroke (disabling and nondisabling), bleeding (life-threatening or disabling), acute kidney injury (stage 2 or 3), major vascular complications, prosthetic valve regurgitation (moderate or severe), and conduction system disturbances (requiring new permanent pacemaker implantation), according to the Valve Academic Research Consortium-2 criteria at 30-day follow-up. All patients will have follow-up to 10 years following TAVR.

SUMMARY

The LANDMARK trial is the first randomized head-to-head trial comparing Myval THV series to commercially available THVs in patients indicated for TAVR. We review prior data on head-to-head comparisons of TAVR devices and describe the rationale and design of the LANDMARK trial.

Informations de copyright

Copyright © 2020 The Authors. Published by Elsevier Inc. All rights reserved.

Déclaration de conflit d'intérêts

Disclosure Dr. Soliman and Dr. Onuma report institutional research grants related to their work as the chairman of cardiovascular imaging core labs of several clinical trials and registry sponsored by industry, for which they receive no direct compensation. Dr. Bedogni reports personal fees from Medtronic, personal fees from Boston Scientific, personal fees from Abbott, personal fees from Terumo, personal fees from Meril Life Sciences. Dr. Neumann reports personal fees from Amgen, personal fees from Boehringer Ingelheim, personal fees from Daiichi Sankyo, grants and personal fees from Pfizer, grants and personal fees from Biotronic, grants and personal fees from Edwards Lifesciences, grants from Medtronic, grants and personal fees from Bayer Healthcare, personal fees from Novartis, grants from GlaxoSmithKline, grants and personal fees from Boston Scientific, personal fees from Ferrer, outside the submitted work. Dr. Abdel-Wahab reports other from Boston Scientific, other from Medtronic, outside the submitted work. Dr. Webster has received institutional research grants from Edwards Lifesciences, Medtronic, Boston Scientific, Biotronik, Emboliner and Medeon Biodesign. Dr. Morice is a minor shareholder of electroducer. Dr. Mylotte is a consultant for Medtronic, Boston Scientific, and Microport. Dr. Wijns reports grants and personal fees from MicroPort, outside the submitted work; and co-founder of Argonauts, an innovation facilitator. Dr. Baumbach reports Institutional Research Support from Abbott Vascular and honoraria from Astra Zeneca, Sinomed, Microport, Abbott Vascular, Cardinal Health, KSH, outside the submitted work. Dr. Serruys reports personal fees from Biosensors, Medtronic, Micel Technologies, Sinomedical Sciences Technology, St. Jude Medical, Philips/Volcano, Xeltis, and HeartFlow, outside the submitted work. All other authors have no conflict of interest to declare.