Apixaban and Valve Thrombosis After Transcatheter Aortic Valve Replacement: The ATLANTIS-4D-CT Randomized Clinical Trial Substudy.

Gilles Montalescot, Alban Redheuil, Flavien Vincent, Steffen Desch, Mauro De Benedictis, Hélène Eltchaninoff, Dietmar Trenk, Jean-Michel Serfaty, Etienne Charpentier, Khaoula Bouazizi, Mikael Prigent, Paul Guedeney, Tomy Salloum, Sergio Berti, Angel Cequier, Thierry Lefèvre, Pascal Leprince, Johanne Silvain, Eric Van Belle, Franz-Josef Neumann, Jean-Jacques Portal, Eric Vicaut, Jean-Philippe Collet

Journal: JACC. Cardiovascular interventions 2022;15(18):1794-1804

PMID: 36137682

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Abstract

BACKGROUND

Subclinical obstructive valve thrombosis after transcatheter aortic valve replacement (TAVR) is of uncertain frequency and clinical impact.

OBJECTIVES

The aim of this study was to determine the effects of apixaban vs standard of care on post-TAVR valve thrombosis detected by 4-dimensional (4D) computed tomography.

METHODS

The randomized ATLANTIS (Anti-Thrombotic Strategy to Lower All Cardiovascular and Neurologic Ischemic and Hemorrhagic Events After Trans-Aortic Valve Implantation for Aortic Stenosis) trial demonstrated that apixaban 5 mg twice daily was not superior to standard of care (vitamin K antagonists or antiplatelet therapy) after successful TAVR and was associated with similar safety but with more noncardiovascular deaths. Three months after randomization, 4D computed tomography was proposed to all patients to determine the percentage of patients with ≥1 prosthetic valve leaflet with grade 3 or 4 reduced leaflet motion or grade 3 or 4 hypoattenuated leaflet thickening (the primary endpoint) in the intention-to-treat population.

RESULTS

Seven hundred sixty-two participants had complete multiphase datasets and were included in the 4D computed tomographic analysis. The primary endpoint occurred in 33 (8.9%) and 51 (13.0%) patients in the apixaban and standard-of-care groups, respectively. It was reduced with apixaban vs antiplatelet therapy (OR: 0.51; 95% CI: 0.30-0.86) but not vs vitamin K antagonists (OR: 1.80; 95% CI: 0.62-5.25) (P = 0.037). The composite of death, myocardial infarction, any stroke, or systemic embolism at 1 year occurred in 10.7% (n = 9 of 84) and 7.1% (n = 48 of 178) of patients with and without subclinical valve thrombosis at 90 days, respectively (HR: 1.68; 95% CI: 0.82-3.44).

CONCLUSIONS

Apixaban reduced subclinical obstructive valve thrombosis in the majority of patients who underwent TAVR without having an established indication for anticoagulation. This study was not powered for clinical outcomes. (Anti-Thrombotic Strategy After Trans-Aortic Valve Implantation for Aortic Stenosis [ATLANTIS]; NCT02664649).

Address: Sorbonne Université, ACTION Group, INSERM UMRS 1166, Hôpital Pitié-Salpêtrière (AP-HP), Institut de Cardiologie, Paris, France.; Sorbonne Université, Laboratoire Imagerie Biomédicale, ICAN, ACTION Group, Hôpital Pitié-Salpêtrière (AP-HP), Institut de Cardiologie, Paris, France.; CHU Lille, Institut Cœur Poumon, Pôle Cardiovasculaire et Pulmonaire, ACTION Group, Inserm U1011, Institut Pasteur de Lille, EGID, Université de Lille, Lille, France.; Department of Internal Medicine/Cardiology, Heart Center Leipzig at University of Leipzig, Leipzig, Germany.; Azienda Ospedaliera Ordine Mauriziano di Torino, Torino, Italy.; Normandie Université, UNIROUEN, U1096, CHU Rouen, Département de Cardiologie, FHU CARNAVAL, Rouen, France.; Division of Cardiology and Angiology II, University Heart Centre Freiburg, Bad Krozingen, Germany.; Hôpital Guillaume et René Laennec, Institut du Thorax-Clinique Cardiologique, Unité d'Imagerie Cardiaque et Vasculaire Diagnostique, Nantes, France.; Fondazione Toscana G. Monasterio, Ospedale del Cuore G. Pasquinucci, Massa, Italy.; Hospital Universitario de Bellvitge, University of Barcelona, Heart Disease Institute, L'Hospitalet de Llobregat, Barcelona, Spain.; Hôpital Privé Jacques Cartier, Institut Cardiovasculaire Paris Sud, Massy, France.; Sorbonne Université, Hôpital Pitié-Salpêtrière (AP-HP), Institut de Cardiologie, Chirurgie Cardiaque, Paris, France.; Unité de Recherche Clinique Lariboisière St-Louis, ACTION Group, Hôpital St-Louis & Fernand Widal, Paris, France.; Sorbonne Université, ACTION Group, INSERM UMRS 1166, Hôpital Pitié-Salpêtrière (AP-HP), Institut de Cardiologie, Paris, France. Electronic address: [email protected].

DOI: 10.1016/j.jcin.2022.07.014

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MeSH Terms: Anticoagulants, Aortic Valve, Aortic Valve Stenosis, Fibrinolytic Agents, Four-Dimensional Computed Tomography, Heart Valve Prosthesis, Humans, Platelet Aggregation Inhibitors, Pyrazoles, Pyridones, Risk Factors, Thrombosis, Transcatheter Aortic Valve Replacement, Treatment Outcome, Vitamin K