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

• Published in: Thrombosis and haemostasis Vol. 118; no. 9; p. 1668
• Main Authors: Agnelli, Giancarlo, Becattini, Cecilia, Bauersachs, Rupert, Brenner, Benjamin, Campanini, Mauro, Cohen, Alexander, Connors, Jean Marie, Fontanella, Andrea, Gussoni, Gualberto, Huisman, Menno V, Lambert, Catherine, Meyer, Guy, Muñoz, Andres, Abreu de Sousa, Joaquim, Torbicki, Adam, Verso, Melina, Vescovo, Giorgio
• Format: Journal Article
• Language: English
• Published: Germany 01-09-2018
• Subjects: Acute Disease; Administration, Oral; Adult; Anticoagulants - therapeutic use; Dalteparin - therapeutic use; Equivalence Trials as Topic; Europe; Follow-Up Studies; Humans; Multicenter Studies as Topic; Neoplasms - complications; Neoplasms - drug therapy; Prospective Studies; Pyrazoles - therapeutic use; Pyridones - therapeutic use; Treatment Outcome; United States; Venous Thromboembolism - complications; Venous Thromboembolism - drug therapy; United States; Europe
• ISSN: 2567-689X
• DOI: 10.1055/s-0038-1668523

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.