N Engl J Med

Reduced-dose apixaban effective for cancer-associated VTE

May 8, 2025

Extended anticoagulation with reduced-dose apixaban was noninferior to full-dose apixaban for preventing recurrent venous thromboembolism (VTE) in patients with active cancer. The reduced dose was associated with a lower incidence of clinically relevant bleeding, suggesting a safer profile for long-term management of cancer-associated VTE.

Study details: The API-CAT randomized, double-blind, noninferiority trial involved 1,766 patients with active cancer and VTE who’d completed ≥6 months of anticoagulant therapy and were randomized to either reduced-dose (2.5 mg) or full-dose (5.0 mg) apixaban twice daily for 12 months. The primary outcome was recurrent VTE, and the key secondary outcome was clinically relevant bleeding.

Results: The reduced-dose apixaban group had a cumulative incidence of recurrent VTE of 2.1% compared with 2.8% in the full-dose group (adjusted subhazard ratio, 0.76; 95% confidence interval [CI], 0.41 - 1.41; P=0.001 for noninferiority). Clinically relevant bleeding occurred in 12.1% of the reduced-dose group vs. 15.6% of the full-dose group (adjusted subhazard ratio, 0.75; 95% CI, 0.58 - 0.97; P=0.03). Mortality rates were similar between groups.

Source:

Mahé I, et al; API-CAT Investigators. (2025, April 10). N Engl J Med. Extended Reduced-Dose Apixaban for Cancer-Associated Venous Thromboembolism. https://pubmed.ncbi.nlm.nih.gov/40162636/