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LANDMARK comparison of early outcomes of newer-generation Myval transcatheter heart valve series with contemporary valves (Sapien and Evolut) in real-world individuals with severe symptomatic native aortic stenosis: a randomised non-inferiority trial.
Baumbach, Andreas; van Royen, Niels; Amat-Santos, Ignacio J; Hudec, Martin; Bunc, Matjaz; Ijsselmuiden, Alexander; Laanmets, Peep; Unic, Daniel; Merkely, Bela; Hermanides, Renicus S; Ninios, Vlasis; Protasiewicz, Marcin; Rensing, Benno J W M; Martin, Pedro L; Feres, Fausto; De Sousa Almeida, Manuel; van Belle, Eric; Linke, Axel; Ielasi, Alfonso; Montorfano, Matteo; Webster, Mark; Toutouzas, Konstantinos; Teiger, Emmanuel; Bedogni, Francesco; Voskuil, Michiel; Pan, Manuel; Angerås, Oskar; Kim, Won-Keun; Rothe, Jürgen; Kristic, Ivica; Peral, Vicente; Garg, Scot; Elzomor, Hesham; Tobe, Akihiro; Morice, Marie-Claude; Onuma, Yoshinobu; Soliman, Osama; Serruys, Patrick W.
Afiliação
  • Baumbach A; Centre for Cardiovascular Medicine and Devices, William Harvey Research Institute, Queen Mary University of London and Barts Heart Centre, London, UK; Cleveland Clinic, London, UK.
  • van Royen N; Department of Cardiology, Radboud University Hospital, Nijmegen, Netherlands.
  • Amat-Santos IJ; CIVERCV, Centro de Investigación Biomédica en red - Enfermedades Cardiovasculares, University Clinical Hospital of Valladolid, Valladolid, Spain; Department of Cardiology, University Clinical Hospital of Valladolid, Valladolid, Spain.
  • Hudec M; Department of Acute Cardiology, Middle-Slovak Institute Of Cardiovascular Diseases, Banska Bystrica, Slovakia.
  • Bunc M; Department of Cardiology, University Medical Centre Ljubljana, Ljubljana, Slovenia.
  • Ijsselmuiden A; Department of Cardiology, Amphia Hospital, Breda, Netherlands; Department of Interventional Cardiology, Maastricht University Medical Center, Maastricht, Netherlands; Zuyderland Hospital, Limburg, Netherlands.
  • Laanmets P; Department of Invasive Cardiology, North Estonia Medical Centre, Tallinn, Estonia.
  • Unic D; Department of Cardiac and Transplant Surgery, University Hospital Dubrava, Zagreb, Croatia.
  • Merkely B; Heart and Vascular Centre, Semmelweis University Heart and Vascular Centre, Budapest, Hungary.
  • Hermanides RS; Department of Cardiology, Isala Hospital, Zwolle, Netherlands.
  • Ninios V; Department of Cardiology, European Interbalkan Medical Center, Thessaloniki, Greece.
  • Protasiewicz M; Department of Cardiology, Institute of Heart Diseases, Wroclaw Medical University, Wroclaw, Poland.
  • Rensing BJWM; Department of Cardiology, St Antonius Hospital, Nieuwegein, Netherlands.
  • Martin PL; Department of Interventional Cardiology, University Hospital of Gran Canaria Dr Negrín, Las Palmas, Spain.
  • Feres F; Department of Invasive Cardiology, Instituto Dante Pazzanese, Sao Paulo, Brazil.
  • De Sousa Almeida M; CHRC, NOVA Medical School, NOVA University Lisbon, Lisbon, Portugal.
  • van Belle E; Department of Interventional Cardiology, Lille University, Lille, France.
  • Linke A; Department of Internal Medicine and Cardiology, University Clinic, Heart Center Dresden, University of Technology Dresden, Dresden, Germany.
  • Ielasi A; Department of Interventional Cardiology, IRCCS Galeazzi Sant'Ambrogio Hospital, Milan, Italy.
  • Montorfano M; School of Medicine, Vita-Salute San Raffaele University, Milan, Italy; Interventional Cardiology Unit IRCCS San Raffaele Scientific Institute, Milan, Italy.
  • Webster M; Department of Cardiology, Auckland City Hospital, Auckland, New Zealand.
  • Toutouzas K; Department of Cardiology, Hippokration Hospital, Athens, Greece.
  • Teiger E; Department of Medico-surgical Cardiovascular and Anaesthesiology, Henri-Mondor University Hospital, Creteil, France.
  • Bedogni F; Department of Clinical Cardiology, San Donato Hospital, Milan, Italy.
  • Voskuil M; Department of Interventional Cardiology, University Medical Center Utrecht, Utrecht, Netherlands.
  • Pan M; Department of Cardiology, University Hospital Reina Sofía, University of Córdoba, Córdoba, Spain.
  • Angerås O; Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden; Department of Clinical and Molecular Medicine, Gothenburg University, Gothenburg, Sweden.
  • Kim WK; Department of Cardiology and Angiology, University of Giessen and Marburg, Giessen, Germany; Department of Cardiology, Kerckhoff Heart Center, Bad Nauheim, Germany.
  • Rothe J; Department of Cardiology and Angiology, University Heart Center Freiburg Bad Krozingen, University Medical Center Freiburg, Freiburg, Germany; Department of Cardiology and Angiology, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
  • Kristic I; Department of Cardiology, University Hospital of Split, Split, Croatia.
  • Peral V; Department of Cardiology, Son Espases University Hospital, Palma, Spain.
  • Garg S; Department of Cardiology, Royal Blackburn Hospital, Blackburn, UK.
  • Elzomor H; Department of Cardiology, School of Medicine, University of Galway, Galway, Ireland.
  • Tobe A; Department of Cardiology, School of Medicine, University of Galway, Galway, Ireland.
  • Morice MC; Cardiovascular European Research Center, Paris, France.
  • Onuma Y; Department of Cardiology, School of Medicine, University of Galway, Galway, Ireland.
  • Soliman O; Department of Cardiology, School of Medicine, University of Galway, Galway, Ireland.
  • Serruys PW; Department of Cardiology, School of Medicine, University of Galway, Galway, Ireland. Electronic address: patrick.w.j.c.serruys@gmail.com.
Lancet ; 403(10445): 2695-2708, 2024 Jun 22.
Article em En | MEDLINE | ID: mdl-38795719
ABSTRACT

BACKGROUND:

Transcatheter aortic valve implantation is an established, guideline-endorsed treatment for severe aortic stenosis. Precise sizing of the balloon-expandable Myval transcatheter heart valve (THV) series with the aortic annulus is facilitated by increasing its diameter in 1·5 mm increments, compared with the usual 3 mm increments in valve size. The LANDMARK trial aimed to show non-inferiority of the Myval THV series compared with the contemporary THVs Sapien Series (Edwards Lifesciences, Irvine, CA, USA) or Evolut Series (Medtronic, Minneapolis, MN, USA).

METHODS:

In this prospective, multinational, randomised, open-label, non-inferiority trial across 31 hospitals in 16 countries (Germany, France, Sweden, the Netherlands, Italy, Spain, New Zealand, Portugal, Greece, Hungary, Poland, Slovakia, Slovenia, Croatia, Estonia, and Brazil), 768 participants with severe symptomatic native aortic stenosis were randomly assigned (11) to the Myval THV or a contemporary THV. Eligibility was primarily decided by the heart team in accordance with 2021 European Society of Cardiology guidelines. As per the criteria of the third Valve Academic Research Consortium, the primary endpoint at 30 days was a composite of all-cause mortality, all stroke, bleeding (types 3 and 4), acute kidney injury (stages 2-4), major vascular complications, moderate or severe prosthetic valve regurgitation, and conduction system disturbances resulting in a permanent pacemaker implantation. Non-inferiority of the study device was tested in the intention-to-treat population using a non-inferiority margin of 10·44% and assuming an event rate of 26·10%. This trial is registered with ClinicalTrials.gov, NCT04275726, and EudraCT, 2020-000137-40, and is closed to new participants.

FINDINGS:

Between Jan 6, 2021, and Dec 5, 2023, 768 participants with severe symptomatic native aortic stenosis were randomly assigned, 384 to the Myval THV and 384 to a contemporary THV. 369 (48%) participants had their sex recorded as female, and 399 (52%) as male. The mean age of participants was 80·0 years (SD 5·7) for those treated with the Myval THV and 80·4 years (5·4) for those treated with a contemporary THV. Median Society of Thoracic Surgeons scores were the same in both groups (Myval 2·6% [IQR 1·7-4·0] vs contemporary 2·6% [1·7-4·0]). The primary endpoint showed non-inferiority of the Myval (25%) compared with contemporary THV (27%), with a risk difference of -2·3% (one-sided upper 95% CI 3·8, pnon-inferiority<0·0001). No significant difference was seen in individual components of the primary composite endpoint.

INTERPRETATION:

In individuals with severe symptomatic native aortic stenosis, the Myval THV met its primary endpoint at 30 days.

FUNDING:

Meril Life Sciences.
Assuntos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Estenose da Valva Aórtica / Próteses Valvulares Cardíacas / Substituição da Valva Aórtica Transcateter Limite: Aged / Aged80 / Female / Humans / Male Idioma: En Revista: Lancet Ano de publicação: 2024 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Estenose da Valva Aórtica / Próteses Valvulares Cardíacas / Substituição da Valva Aórtica Transcateter Limite: Aged / Aged80 / Female / Humans / Male Idioma: En Revista: Lancet Ano de publicação: 2024 Tipo de documento: Article