Apixaban versus Dalteparin for the Treatment of Acute Venous Thromboembolism in Patients with Cancer: The Caravaggio Study.

Agnelli, Giancarlo;Becattini, Cecilia;Bauersachs, Rupert;Brenner, Benjamin;Caravaggio Study Investigators;et.al.
(2018) Thrombosis and Haemostasis : international journal for vascular biology and medicine — Vol. 118, n° 9, p. 1668-1678 (2018)

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Authors
  • Agnelli, Giancarlo
    Author
  • Becattini, Cecilia
    Author
  • Bauersachs, Rupert
    Author
  • Brenner, Benjamin
    Author
  • Lambert, CatherineUCLouvain
    Author
  • Caravaggio Study Investigators
    Collaborator
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Abstract
International and national guidelines recommend low-molecular-weight heparin for the treatment of venous thromboembolism (VTE) in patients with cancer. The aim of the Caravaggio study is to assess whether oral apixaban is non-inferior to subcutaneous dalteparin for the treatment of acute proximal deep vein thrombosis and/or pulmonary embolism in patients with cancer. The study is an investigator-initiated, multi-national, prospective, randomized, open-label with blind end-point evaluation (PROBE), non-inferiority clinical trial (NCT03045406). Consecutive patients are randomized to receive oral apixaban or subcutaneous dalteparin for 6 months. Apixaban is given at a dose of 10 mg twice daily for the first 7 days and then 5 mg twice daily; dalteparin is given at a dose of 200 IU/kg for the first month and then 150 IU/kg once daily. The primary outcome of the study is objectively confirmed recurrent VTE as assessed by a central independent adjudication committee unaware of study treatment allocation. The primary safety outcome is major bleeding defined according to the guidelines of the International Society of Thrombosis and Haemostasis. Assuming a 6-month incidence of the primary outcome of 7% with dalteparin and an upper limit of the two-sided 95% confidence interval of the hazard ratio below the pre-specified margin of 2.00, 1,168 patients will be randomized considering an up to 20% loss in total patient-years ( = 80%; one-sided = 0.025). The Caravaggio study has the potential, along with other recently performed or on-going studies, to make less cumbersome the management of VTE in patients with cancer by replacing parenteral with oral anticoagulation.
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Agnelli, G., Becattini, C., Bauersachs, R., Brenner, B., Campanini, M., Cohen, A., Connors, J. M., Fontanella, A., Gussoni, G., Huisman, M. V., Lambert, C., Meyer, G., Muñoz, A., Abreu de Sousa, J., Torbicki, A., Verso, M., & Vescovo, G. (2018). Apixaban versus Dalteparin for the Treatment of Acute Venous Thromboembolism in Patients with Cancer: The Caravaggio Study. Thrombosis and Haemostasis : international journal for vascular biology and medicine, 118(9), 1668-1678. https://doi.org/10.1055/s-0038-1668523 (Original work published 2018)