API-CAT Trial. ACC 2025
API-CAT Trial. ACC 2025.
Published in The New England Journal of medicine ,March 29, 2025.
Summary:
1-Background
Although the risk of recurrent “DVT,PE” or venous thromboembolism(VTE) decreases over time in patients with active cancer and VTE, the risk of bleeding is still considerable. Clinical guidelines recommend continuing anticoagulant therapy for as long as the cancer is active or cancer treatment is ongoing. However, it is unknown whether a reduced dose of an oral anticoagulant is effective in preventing recurrent thromboembolic events(DVT, PE)and decreasing bleeding risk.
The API-CAT trial evaluated the effectiveness and safety of a reduced-dose apixaban regimen (2.5 mg twice daily) compared to the full dose (5 mg twice daily) for preventing recurrent venous thromboembolism (VTE) in patients with cancer-associated VTE who had completed six months of anticoagulant therapy.
2-Methods
This was an international, double-blind, phase 3 randomized controlled trial (RCT) that included 1,766 patients with active cancer and VTE (proximal deep-vein thrombosis or pulmonary embolism). Patients were randomized to receive either full-dose or reduced-dose apixaban for 12 months. The primary efficacy endpoint was recurrent VTE, while the key secondary safety endpoint was clinically relevant bleeding.
All-cause mortality rates were also similar between groups (17.7% vs. 19.6%).
3-Conclusion
The study demonstrated that reduced-dose apixaban (2.5 mg twice daily) was as effective as the full dose (5 mg twice daily) in preventing recurrent VTE while significantly lowering the risk of clinically relevant bleeding in patients with cancer-associated VTE.
https://www.nejm.org/doi/full/10.1056/NEJMoa2416112
