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Publications

Journal Article Ahead of print

PubMed: 42844166 DOI: 10.1093/ehjci/jeag280

Rivaroxaban for Stroke Prevention in Hypertrophic Cardiomyopathy Without Atrial Fibrillation and With Impaired Left Atrial Reservoir Strain: Design and Rationale of the LA-HCM Randomized Trial.

Eur Heart J Cardiovasc Imaging

Authors: Erwan Donal, Adrien A L Wazzan, Olivier Lairez, Philippe Charron, Nicolas Piriou, Loic Biere, Patricia Reant, Ombeline Paglia, Fabien Labombarda, Jean-Christophe Eicher, Gilles Barone-Rochette, Hélène Ridon, Gilbert Habib, Olivier Huttin, Nadia Aissaoui, Damien Logeart, Charles Fauvel, Nathan Mewton, Elena Galli, Eve Cariou, Anne Bernard, Jean-Sébastien Hulot, Laurent Fauchier, Pascale Palassin, Jean-Christophe Ferre, Anne Ganivet, Alexandre Mansour, Emmanuel Oger

Affiliations

  • University of Rennes, CHU Rennes, Inserm, LTSI - UMR 1099, F-35000 Rennes, France.
  • Department of Cardiology, Toulouse University Hospital, Université de Toulouse, Toulouse, France.
  • Sorbonne Université, AP-HP, Hôpital Pitié-Salpêtrière, Reference Center for Inherited Cardiac Diseases, Paris, France.
  • Department of Cardiology, Nantes University Hospital, CNRS, INSERM, l'institut du thorax, Nantes Université, Nantes, France.
  • Department of Cardiology, Angers University Hospital, Université d'Angers, Angers, France.
  • Department of Cardiology, Bordeaux University Hospital, Université de Bordeaux, Bordeaux, France.
  • Department of Cardiology, Hôpital Privé Jacques Cartier, Ramsay Santé, Massy, France.
  • Department of Cardiology, Caen University Hospital, Normandie Université, Caen, France.
  • Department of Cardiology, Dijon Bourgogne University Hospital, Université de Bourgogne, Dijon, France.
  • Department of Cardiology, Grenoble Alpes University Hospital, Université Grenoble Alpes, Grenoble, France.
  • Department of Cardiology, Tours University Hospital, Université de Tours, Tours, France.
  • Department of Cardiology, La Timone University Hospital, Aix-Marseille Université, Marseille, France.
  • Department of Cardiology, Nancy University Hospital, Université de Lorraine, Nancy, France.
  • Department of Cardiology, AP-HP, Hôpital Européen Georges-Pompidou, Université Paris Cité, Paris, France.
  • Department of Cardiology, AP-HP, Hôpital Lariboisière, Université Paris Cité, Paris, France.
  • Department of Cardiology, Rouen University Hospital, Normandie Université, Rouen, France.
  • Department of Cardiology, Hospices Civils de Lyon, Hôpital Louis Pradel, Université Claude Bernard Lyon 1, Lyon, France.
  • Department of Cardiology, Rennes University Hospital, Université de Rennes, Rennes, France.
  • Department of Cardiology, Tours University Hospital, Inserm U1327, Université de Tours, Tours, France.
  • Université Paris Cité, INSERM, PARCC, European Georges Pompidou Hospital, AP-HP, Paris, France.
  • DMU CARTE, AP-HP, Paris, France.
  • Department of Cardiology, Lille University Hospital, Université de Lille, Lille, France.
  • Service de radiologie et imagerie médicale, centre hospitalier universitaire de Rennes, université de Rennes, 35000 Rennes, France.
  • Clinical Research and Innovation Department, Rennes University Hospital, Rennes, France.
  • Department of Anesthesia and Critical Care,Inserm, IRSET, UMR_S 1085, University Hospital of Rennes, Univ Rennes, CHU Rennes, Rennes, 35000, France.
  • Department of Clinical Pharmacology, Rennes University Hospital, Université de Rennes, Rennes, France.

Abstract

Current stroke prevention strategies in hypertrophic cardiomyopathy (HCM) rely on the detection of atrial fibrillation (AF), although thromboembolic events may occur before arrhythmia is documented. These observations support atrial cardiomyopathy as the substrate for thrombogenesis and highlight the need for imaging-guided risk stratification. Left atrial reservoir strain (LARS), derived from speckle-tracking echocardiography, detects atrial dysfunction earlier than left atrial enlargement and has been associated with AF and thromboembolic events. The LA-HCM trial evaluates whether rivaroxaban reduces thromboembolic events in patients with HCM, sinus rhythm, no documented AF, and impaired LARS. LA-HCM is a prospective, multicentre, randomized, open-label trial with blinded endpoint adjudication (PROBE design), sponsored by Rennes University Hospital and conducted in 17 French centres. A total of 532 adults with HCM, sinus rhythm, no documented AF, and core-laboratory-confirmed LARS ≤20% are randomized 1:1 to rivaroxaban or standard care. Participants are followed for 24 months. The primary endpoint is the composite of all-cause death, myocardial infarction, ischemic stroke-including newly detected silent cerebral infarction on paired baseline and 24-month brain MRI-and systemic embolism at 24 months. LA-HCM tests whether rivaroxaban improves outcomes in a population with HCM, no documented AF, and impaired LARS. It evaluates a LARS-based treatment-allocation strategy but is not designed to validate the predictive utility or optimal threshold of LARS.

MeSH

Stroke, Rivaroxaban, Atrial Fibrillation, Cardiomyopathy, Hypertrophic, Cardiomyopathies