Extended Anticoagulant Treatment with Full- or Reduced-Dose Apixaban in Patients with Cancer-Associated Venous Thromboembolism: Rationale and Design of the API-CAT Study.

Abstract

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.

• Authors: Isabelle Mahé, Giancarlo Agnelli, Cihan Ay, Aristotelis Bamias, Cecilia Becattini, Marc Carrier, Céline Chapelle, Alexander T Cohen, Philippe Girard, Menno V Huisman, Frederikus A Klok, Juan J López-Núñez, Anthony Maraveyas, Didier Mayeur, Olivier Mir, Manuel Monreal, Marc Righini, Charles M Samama, Kostas Syrigos, Sebastian Szmit, Adam Torbicki, Peter Verhamme, Eric Vicaut, Tzu-Fei Wang, Guy Meyer, Silvy Laporte
• Journal: Thrombosis and haemostasis (Thromb Haemost) Vol. 122 Issue 4 Pg. 646-656 (04 2022) ISSN: 2567-689X [Electronic] Germany
• PMID: 34535037 (Publication Type: Journal Article, Randomized Controlled Trial)
• Copyright: 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/).

Chemical References

• Anticoagulants
• Pyrazoles
• Pyridones
• apixaban

Topics

• Anticoagulants (adverse effects)
• Hemorrhage (epidemiology)
• Humans
• Neoplasms (drug therapy)
• Pyrazoles
• Pyridones (adverse effects)
• Venous Thromboembolism (diagnosis, drug therapy, prevention & control)