Hideyuki Kawashima1, Osama Soliman2, Rutao Wang3, Masafumi Ono1, Hironori Hara1, Chao Gao3, Emeline Zeller2, Ashokkumar Thakkar4, Corrado Tamburino5, Francesco Bedogni6, Franz-Josef Neumann7, Holger Thiele8, Mohamed Abdel-Wahab8, Marie-Claude Morice9, Mark Webster10, Liesbeth Rosseel2, Darren Mylotte2, Yoshinobu Onuma2, William Wijns2, Andreas Baumbach11, Patrick W Serruys12. 1. Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland; Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands. 2. Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland. 3. Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland; Department of Cardiology, Radboud University Medical Center, Nijmegen, Netherlands. 4. Meril Life Sciences Pvt. Ltd., India. 5. Ferrarotto Hospital, Policlinico Hospital and University of Catania, Catania, Italy. 6. Department of Cardiology, IRCCS Pol. S. Donato, S. Donato Milanese, Milan, Italy. 7. Department of Cardiology & Angiology II, University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany. 8. Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, Leipzig, Germany. 9. Department of Cardiology, Cardiovascular Institute Paris-Sud, Hopital Privé Jacques Cartier, Ramsay Générale de Santé, Massy, France. 10. Green Lane Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand. 11. William Harvey Research Institute, Queen Mary University of London, and Barts Heart Centre, London, United Kingdom. 12. Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland; NHLI, Imperial College London, London, United Kingdom. Electronic address: patrick.w.j.c.serruys@gmail.com.
Abstract
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.
RCT Entities:
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.
Authors: Mauro Chiarito; Alessandro Spirito; Johny Nicolas; Alexandra Selberg; Giulio Stefanini; Antonio Colombo; Bernhard Reimers; Annapoorna Kini; Samin K Sharma; George D Dangas; Roxana Mehran Journal: J Clin Med Date: 2022-07-30 Impact factor: 4.964