Niels Royen; Ignacio Amat-Santos; Martin Hudec; Matjaz Bunc; Alexander Ijsselmuiden; Peep Laanmets; Daniel Unic; Béla Merkely; Renicus Hermanides; Vlasis Ninios; Marcin Protasiewicz; Benno Rensing; Pedro Martin; Fausto Feres; Manuel Sousa; Eric Belle; Axel Linke; Alfonso Ielasi; Matteo Montorfano; Mark Webster; Konstantinos Toutouzas; Emmanuel Teiger; Francesco Bedogni; Michiel Voskuil; Manuel Pan; Oskar Angerås; Won-Keun Kim; Jürgen Rothe; Ivica Kristić; Vicente Peral; Ben Van den Branden; Dirk Westermann; Barbara Bellini; Mario Garcia-Gomez; Akihiro Tobe; Tsung-Ying Tsai; Scot Garg; Ashokkumar Thakkar; Udita Chandra; Marie-Claude Morice; Osama Soliman; Yoshinobu Onuma; Patrick Serruys; Andreas Baumbach

doi:10.4244/EIJ-D-24-00951

The Official Journal of EuroPCR and the European Association of Percutaneous Cardiovascular Interventions (EAPCI)

Your reference journal for coronary, valvular and structural interventions

Original Research

DOI: 10.4244/EIJ-D-24-00951

Early outcomes of the novel Myval THV series compared to SAPIEN THV series and Evolut THV series in individuals with severe aortic stenosis

Niels van Royen¹, MD, PhD; Ignacio J. Amat-Santos²^,³, MD, PhD; Martin Hudec⁴, MD, PhD; Matjaz Bunc⁵, MD, PhD; Alexander Ijsselmuiden⁶^,⁷, MD, PhD; Peep Laanmets⁸, MD; Daniel Unic⁹, MD, PhD; Béla Merkely¹⁰, MD; Renicus S. Hermanides¹¹, MD, PhD; Vlasis Ninios¹², MD; Marcin Protasiewicz¹³, MD, PhD; Benno J.W.M. Rensing¹⁴, MD, PhD; Pedro L. Martin¹⁵, MD, PhD; Fausto Feres¹⁶, MD; Manuel De Sousa¹⁷, MD, PhD; Eric Van Belle¹⁸, MD, PhD; Axel Linke¹⁹, MD; Alfonso Ielasi²⁰, MD; Matteo Montorfano²¹^,²², MD; Mark Webster²³, MBChB; Konstantinos Toutouzas²⁴, MD, PhD; Emmanuel Teiger²⁵, MD, PhD; Francesco Bedogni²⁶, MD; Michiel Voskuil²⁷, MD, PhD; Manuel Pan²⁸, MD, PhD; Oskar Angerås²⁹^,³⁰, MD, PhD; Won-Keun Kim³¹^,³², MD; Jürgen Rothe³³^,³⁴, MD; Ivica Kristić³⁵, MD, PhD; Vicente Peral³⁶, MD, PhD; Ben J.L. Van den Branden⁶, MD; Dirk Westermann³³, MD; Barbara Bellini²², MD; Mario Garcia-Gomez²^,³, MD; Akihiro Tobe³⁷, MD; Tsung-Ying Tsai³⁷^,³⁸, MD; Scot Garg³⁹^,⁴⁰, MD, PhD; Ashokkumar Thakkar⁴¹, PhD; Udita Chandra⁴¹, PhD; Marie-Claude Morice⁴²^,⁴³, MD, PhD; Osama Soliman³⁷, MD, PhD; Yoshinobu Onuma³⁷^,⁴⁴, MD, PhD; Patrick W. Serruys³⁷, MD, PhD; Andreas Baumbach⁴⁵^,⁴⁶, MD, PhD

1. Department of Cardiology, Radboud University Hospital, Nijmegen, the Netherlands; 2. Centro de Investigación Biomédica en Red - Enfermedades Cardiovasculares (CIBERCV), Instituto de Salud Carlos III, Madrid, Spain; 3. Department of Cardiology, Hospital Clínico Universitario de Valladolid, Valladolid, Spain; 4. Department of Acute Cardiology, Middle-Slovak Institute of Cardiovascular Diseases, Banska Bystrica, Slovakia; 5. Department of Cardiology, University Medical Centre Ljubljana, Ljubljana, Slovenia; 6. Department of Cardiology, Amphia Hospital, Breda, the Netherlands; 7. Zuyderland Hospital, Limburg, the Netherlands; 8. Department of Invasive Cardiology, North Estonia Medical Centre, Tallinn, Estonia; 9. Department of Cardiac and Transplant Surgery, University Hospital Dubrava, Zagreb, Croatia; 10. Heart and Vascular Center, Semmelweis University, Budapest, Hungary; 11. Department of Cardiology, Isala Hospital, Zwolle, the Netherlands; 12. Department of Cardiology, European Interbalkan Medical Center, Thessaloniki, Greece; 13. Department of Cardiology, Institute of Heart Diseases, Wroclaw Medical University, Wroclaw, Poland; 14. Department of Cardiology, St Antonius Hospital, Nieuwegein, the Netherlands; 15. Department of Interventional Cardiology, University Hospital of Gran Canaria Dr Negrín, Las Palmas de Gran Canaria, Spain; 16. Department of Invasive Cardiology, Instituto Dante Pazzanese, São Paulo, Brazil; 17. CHRC, NOVA Medical School, NOVA University Lisbon, Lisbon, Portugal; 18. Department of Interventional Cardiology, Lille University, Lille, France; 19. Department of Internal Medicine and Cardiology, University Clinic, Heart Center Dresden, University of Technology Dresden, Dresden, Germany; 20. Department of Interventional Cardiology, IRCCS Ospedale Galeazzi Sant’Ambrogio, Milan, Italy; 21. 22. School of Medicine, Vita-Salute San Raffaele University, Milan, Italy; 22. Interventional Cardiology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy; 23. Department of Cardiology, Auckland City Hospital, Auckland, New Zealand; 24. Department of Cardiology, Hippokration Hospital, Athens, Greece; 25. Department of Interventional Cardiology, Henri Mondor University Hospital, Créteil, France; 26. Department of Clinical Cardiology, San Donato Hospital, Milan, Italy; 27. Department of Cardiology, University Medical Center Utrecht, Utrecht, the Netherlands; 28. Department of Cardiology, University Hospital Reina Sofía, University of Córdoba, IMIBIC, CIBERCV, Córdoba, Spain; 29. Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden; 30. Department of Molecular and Clinical Medicine, Institute of Medicine, University of Gothenburg, Gothenburg, Sweden; 31. Department of Cardiology & Angiology, University of Giessen and Marburg, Gießen, Germany; 32. Department of Cardiology, Kerckhoff Heart Center, Bad Nauheim, Germany; 33. Department of Cardiology and Angiology, Campus Bad Krozingen, University Heart Center-University of Freiburg, Bad Krozingen, Germany; 34. Faculty of Medicine, University of Freiburg, Freiburg, Germany; 35. Department of Cardiology, University Hospital of Split, Split, Croatia; 36. Department of Cardiology University Hospital Son Espases, Health Research Institute of the Balearic Islands (IdISBa), Palma, Balearic Islands, Spain; 37. Department of Cardiology, School of Medicine, University of Galway, Galway, Ireland; 38. Cardiovascular Center, Taichung Veterans Hospital, Taiwan; 39. Department of Cardiology, Royal Blackburn Hospital, Blackburn, United Kingdom; 40. School of Medicine, University of Central Lancashire, Preston, United Kingdom; 41. Department of Clinical Research, Meril Life Sciences Pvt. Ltd., Vapi, India; 42. Cardiovascular European Research Center (CERC), Massy, France; 43. ICPS, Hôpital privé Jacques Cartier, Massy, France; 44. Galway University Hospital, Galway, Ireland; 45. Centre for Cardiovascular Medicine and Devices, William Harvey Research Institute, Queen Mary University of London and Barts Heart Centre, London, United Kingdom; 46. Cleveland Clinic, London, United Kingdom

Abstract

Background: There are limited head-to-head randomised trials comparing the performance of different transcatheter heart valves (THVs).

Aims: We aimed to evaluate the non-inferiority of the balloon-expandable Myval THV series compared to the balloon-expandable SAPIEN THV series or the self-expanding Evolut THV series.

Methods: The LANDMARK trial randomised 768 patients in a 1:1 ratio, (Myval THV series [n=384] vs contemporary series with 50% SAPIEN THV series [n=192] and 50% Evolut THV series [n=192]). The non-inferiority of Myval over the SAPIEN or Evolut THV series in terms of the 30-day primary composite safety and effectiveness endpoint as per the third Valve Academic Research Consortium (VARC-3) was tested in an intention-to-treat population with a predefined statistical power of 80% (1-sided alpha of 5%) for a non-inferiority margin of 10.44%.

Results: The Myval THV series achieved non-inferiority for the primary composite endpoint over the SAPIEN THV series (24.7% vs 24.1%, risk difference [95% confidence interval {CI}]: 0.6% [not applicable {NA} to 8.0]; p=0.0033) and the Evolut THV series (24.7% vs 30.0%, risk difference [95% CI]: –5.3% [NA to 2.5]; p<0.0001). The incidences of pacemaker implantation were comparable (Myval THV series: 15.0%, SAPIEN THV series: 17.3%, Evolut THV series: 16.8%). At 30 days, the mean pressure gradient and effective orifice area were significantly better with the Myval THV series compared to the SAPIEN THV series (p<0.0001) and better with the Evolut THV series than with the Myval THV series (p<0.0001). At 30 days, the proportion of moderate to severe prosthetic valve regurgitation was numerically higher with the Evolut THV series compared to the Myval THV series (7.4% vs 3.4%; p=0.06), while not significantly different between the Myval THV series and the SAPIEN THV series (3.4% vs 1.6%; p=0.32).

Conclusions: The Myval THV series is non-inferior to the SAPIEN THV series and the Evolut THV series in terms of the primary composite endpoint at 30 days. Clinical trial registration: ClinicalTrials.gov: NCT04275726; EudraCT number 2020-000,137-40.

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