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CC BY-NC-ND 4.0 · Thromb Haemost 2022; 122(08): 1384-1396
DOI: 10.1055/a-1731-3922
Stroke, Systemic or Venous Thromboembolism

Effectiveness and Safety of Oral Anticoagulants in the Treatment of Acute Venous Thromboembolism: A Nationwide Comparative Cohort Study in France

Autoren

  • Laurent Bertoletti 

    1   Service de Médecine Vasculaire et Thérapeutique, CHU de St-Etienne, Saint-Etienne, France
    2   INSERM, UMR1059, Université Jean-Monnet, Paris, France
    3   INSERM, CIC-1408, CHU de Saint-Etienne; all in F-42055, Saint-Etienne, France

  • Gaelle Gusto

    4   Certara France, Evidence and Access, Paris, France

  • Artak Khachatryan

    5   Certara UK, Evidence and Access, London, United Kingdom

  • Nadia Quignot 

    4   Certara France, Evidence and Access, Paris, France

  • Jose Chaves

    6   Pfizer SLU, Internal Medicine, Global Medical Affairs, Madrid, Spain

  • Audrey Moniot

    7   Pfizer SAS, Internal Medicine, Medical Affairs, Paris, France

  • Ruth Mokgokong 

    8   Pfizer Ltd, Health Economics and Outcomes Research, Tadworth, United Kingdom

Funding This study was sponsored by Pfizer and Bristol Myers Squibb.
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Abstract

Introduction Data from clinical trials indicate that direct oral anticoagulants (DOACs) are noninferior and safer than conventional therapy (low-molecular-weight heparin followed by a vitamin K antagonist [VKA]) for treating venous thromboembolism (VTE), which includes deep vein thrombosis and pulmonary embolism (PE). This study compared the effectiveness and safety of DOACs and conventional therapy in a real-world setting.

Methods This observational study used French national claims data of adult, treatment-naïve patients diagnosed with VTE (majority PE) who were hospitalized and treated for VTE with a DOAC (apixaban or rivaroxaban) or VKAs during 2013 to 2018. Patients with active cancer were excluded. After propensity score matching for each DOAC-VKA comparison, risks of bleeding, recurrent VTE, and all-cause mortality were compared at 6 months. Cox proportional hazards regression was used to estimate adjusted hazard ratios of the endpoints.

Results A total of 58,137 patients were included (10,775 VKAs, 10,440 apixaban, 36,922 rivaroxaban). Propensity score-matched cohort sizes were 7,503 for apixaban and 9,179 for rivaroxaban. The hazard ratio (95% confidence interval) was significantly lower for apixaban than VKAs for bleeding requiring hospitalization (0.43 [0.32–0.59]), all-cause death (0.61 [0.51–0.74]), and first recurrent VTE (0.67 [0.52–0.85]). The hazard ratio was also significantly lower for rivaroxaban than VKAs for all-cause death (0.63 [0.53–0.74]) but not for bleeding requiring hospitalization (0.86 [0.69–1.07]) or first recurrent VTE (0.91 [0.74–1.13]).

Conclusion Apixaban was associated with superior safety and effectiveness than VKAs. All-cause mortality was lower in both DOACs than VKAs. Our results support recommendations to use DOACs over VKAs for the treatment of VTE.

Keywords

venous thromboembolism - anticoagulants - apixaban - rivaroxaban - bleeding

Supplementary Material



Publikationsverlauf

Eingereicht: 09. September 2021

Angenommen: 26. November 2021

Accepted Manuscript online:
04. Januar 2022

Artikel online veröffentlicht:
10. März 2022

© 2022. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)

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