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Editor's Choice – External Applicability of the COMPASS and VOYAGER-PAD Trials on Patients with Symptomatic Lower Extremity Artery Disease in France: The COPART Registry

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  • Additional Information
    • Contributors:
      Equipe Vieillissement (CERPOP); Centre d'Epidémiologie et de Recherche en santé des POPulations (CERPOP); Université Toulouse III - Paul Sabatier (UT3); Université de Toulouse (UT)-Université de Toulouse (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Toulouse III - Paul Sabatier (UT3); Université de Toulouse (UT)-Université de Toulouse (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM); Service de Médecine Vasculaire CHU Toulouse; Pôle Cardiovasculaire et Métabolique CHU Toulouse; Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse); Neuroépidémiologie Tropicale (NET); CHU Limoges-Institut d'Epidémiologie Neurologique et de Neurologie Tropicale-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Génomique, Environnement, Immunité, Santé, Thérapeutique (GEIST); Université de Limoges (UNILIM)-Université de Limoges (UNILIM); Service de cardiologie CHU Limoges; CHU Limoges; Service de Chirurgie Thoracique et Vasculaire - Médecine vasculaire CHU Limoges; Médico-Chirurgical de Valvulopathies et Cardiomyopathies, Chirurgie Cardiaque Adulte, Cardiologie Interventionnelle Structurelle Adulte CHU Bordeaux; Centre Hospitalier Universitaire de Bordeaux (CHU Bordeaux); Paris-Centre de Recherche Cardiovasculaire (PARCC (UMR_S 970/ U970)); Hôpital Européen Georges Pompidou APHP (HEGP); Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpitaux Universitaires Paris Ouest - Hôpitaux Universitaires Île de France Ouest (HUPO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité); Fédération de Cardiologie CHU Toulouse; Service Cardiologie CHU Toulouse; Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Pôle Cardiovasculaire et Métabolique CHU Toulouse; STROMALab; Université de Toulouse (UT)-Université de Toulouse (UT)-Ecole Nationale Vétérinaire de Toulouse (ENVT); Institut National Polytechnique (Toulouse) (Toulouse INP); Université de Toulouse (UT)-Université de Toulouse (UT)-Institut National Polytechnique (Toulouse) (Toulouse INP); Université de Toulouse (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Etablissement Français du Sang-Centre National de la Recherche Scientifique (CNRS)
    • Publication Information:
      CCSD
      Elsevier
    • Publication Date:
      2021
    • Collection:
      Université Toulouse III - Paul Sabatier: HAL-UPS
    • Abstract:
      The COPART registry is supported by the French Vascular Medicine Society (SFMV) and received grants from Toulouse University Hospital, AstraZeneca France, Bayer France, Bristol-Myers Squibb (BMS) France, and Sanofi-Aventis France. ; International audience ; Objective: The aim of this study was to examine the external applicability of the COMPASS and the VOYAGER-PAD trials in patients with lower extremity artery disease (LEAD) in the real world.Methods: This was a multicentre retrospective analysis of prospectively collected COPART data, a French multicentre registry of patients hospitalised for symptomatic LEAD. The proportion of patients eligible for the combination of rivaroxaban 2.5 mg twice daily plus aspirin based on either COMPASS or VOYAGER-PAD criteria is reported. The one year cumulative incidence of outcomes between eligible and non-eligible patients, as well as eligible patients vs. control arms of the COMPASS (LEAD patient subgroup) and the VOYAGER-PAD trials were compared. Analyses were performed using Cox models.Results: Of 2 259 evaluable patients, only 679 (30.1%) were eligible for a low dose rivaroxaban plus aspirin regimen. Others were not eligible because of the need for anticoagulant (48.5% and 38.9% of patients meeting COMPASS and VOYAGER-PAD exclusion criteria, respectively) or dual antiplatelet therapy use (15.7% and 16.5%, respectively), high bleeding risk (14.4% and 11.6%, respectively), malignancy (26.1% and 21.0%, respectively), history of ischaemic/haemorrhagic stroke (21.1% and 19.8%, respectively), and severe renal failure (13.2% and 10.5%, respectively). COMPASS and VOYAGER-PAD eligible and ineligible patients were at higher risk of ischaemic events than participants in these trials. The one year cumulative incidences were 6.0% (95% CI 4.3 - 8.1) in the COMPASS eligible subset vs. 3.5% (95% CI 2.9 - 4.3) in the COMPASS control arm for major adverse cardiovascular events, and 27.9% (95% CI 19.9 - 38.3) in the VOYAGER-PAD eligible subset vs. 6.0% (95% CI 5.3 - 6.9) in the VOYAGER-PAD ...
    • Relation:
      info:eu-repo/semantics/altIdentifier/pmid/34330647; PUBMED: 34330647
    • Accession Number:
      10.1016/j.ejvs.2021.05.028
    • Online Access:
      https://ut3-toulouseinp.hal.science/hal-04501575
      https://ut3-toulouseinp.hal.science/hal-04501575v1/document
      https://ut3-toulouseinp.hal.science/hal-04501575v1/file/S1078588421004445.pdf
      https://doi.org/10.1016/j.ejvs.2021.05.028
    • Rights:
      http://creativecommons.org/licenses/by-nc/ ; info:eu-repo/semantics/OpenAccess
    • Accession Number:
      edsbas.7FADB3FA