Extended Anticoagulant Treatment with Full- or Reduced-Dose Apixaban in Patients with Cancer-Associated Venous Thromboembolism : Rationale and Design of the API-CAT Study
Mahé, Isabelle (Université de Paris (França))
Agnelli, Giancarlo (University of Perugia)
Ay, Cihan (Medical University of Vienna)
Bamias, Aristotelis (National & Kapodistrian University of Athens)
Becattini, Cecilia (University of Perugia)
Carrier, Marc (Department of Medicine, University of Ottawa)
Chapelle, Céline (Université Jean Monnet)
Cohen, Alexander T. (King's College London)
Girard, Philippe (Département de Pneumologie, Institut Mutualiste Montsouris)
Huisman, Menno V. (Department of Medicine − Thrombosis and Hemostasis, Leiden University Medical Center)
Klok, Frederikus A. (Department of Medicine − Thrombosis and Hemostasis, Leiden University Medical Center)
López Núñez, Juan José (Universitat Autònoma de Barcelona. Departament de Medicina)
Maraveyas, Anthony (Hull University Teaching Hospitals NHS Trust (Regne Unit))
Mayeur, Didier (Centre Georges-Francois Leclerc (França))
Mir, Olivier (Institut Gustave-Roussy (França))
Monreal, Manuel (Universidad Católica San Antonio de Murcia)
Righini, Marc (Geneva University Hospitals)
Samama, Charles M. (Department of Anaesthesia, Hôpital Cochin (França))
Syrigos, Kostas (Department of Medicine, National & Kapodistrian University)
Szmit, Sebastian (Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Centre of Postgraduate Medical Education, European Health Centre (Polònia))
Torbicki, Adam (Departments of Pulmonary Circulation, Thromboembolic Diseases, and Cardiology, Centre of Postgraduate Medical Education, European Health Centre (Polònia))
Verhamme, Peter (University Hospitals Leuven (Bèlgica))
Vicaut, Eric (Université de Paris)
Wang, Tzu-Fei (Department of Medicine, University of Ottawa)
Meyer, Guy (Sorbonne Paris Cité)
Laporte, Silvy (Université Jean Monnet)

Data:	2021
Resum:	Cancer-associated thrombosis (CT) is associated with a high risk of recurrent venous thromboembolic (VTE) events that require extended anticoagulation in patients with active cancer, putting them at risk of bleeding. The aim of the API-CAT study (NCT03692065) is to assess whether a reduced-dose regimen of apixaban (2. 5 mg twice daily [bid]) is noninferior to a full-dose regimen of apixaban (5 mg bid) for the prevention of recurrent VTE in patients with active cancer who have completed ≥6 months of anticoagulant therapy for a documented index event of proximal deep-vein thrombosis and/or pulmonary embolism. API-CAT is an international, randomized, parallel-group, double-blind, noninferiority trial with blinded adjudication of outcome events. Consecutive patients are randomized to receive apixaban 2. 5 or 5 mg bid for 12 months. The primary efficacy outcome is a composite of recurrent symptomatic or incidental VTE during the treatment period. The principal safety endpoint is clinically relevant bleeding, defined as a composite of major bleeding or nonmajor clinically relevant bleeding. Assuming a 12-month incidence of the primary outcome of 4% with apixaban and an upper limit of the two-sided 95% confidence interval of the hazard ratio <2. 0, 1,722 patients will be randomized, assuming an up to 10% loss in total patient-years (β = 80%; α one-sided = 0. 025). This trial has the potential to demonstrate that a regimen of extended treatment for patients with CT beyond an initial 6 months, with a reduced apixaban dose, has an acceptable risk of recurrent VTE recurrence and decreases the risk of bleeding.
Nota:	Funding: Funding for the study is provided by the BMS-Pfizer Alliance.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Venous thromboembolism ; Cancer ; Apixaban ; Randomized
Publicat a:	Thrombosis and Haemostasis, Vol. 122 (september 2021) , p. 646-656, ISSN 2567-689X

DOI: 10.1055/a-1647-9896
PMID: 34535037

11 p, 362.8 KB

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