Patients with cancer are at elevated risk for venous thromboembolism events (VTE), even while receiving anticoagulant therapy. Standard treatment includes six months of anticoagulation, but patients with active cancer continue to face a substantial risk of VTE after anticoagulant discontinuation. Clinical guidelines recommend continued anticoagulation for as long as cancer remains active, though this extended treatment also increases the risk of bleeding complications, which persists over time. Limited data exists on anticoagulant regimens beyond six months. A reduced dose may offer a safer alternative, but its efficacy and safety compared to full dose regimen requires prospective assessment.
Study design
The phase III API-CAT trial is a randomised, double-blind, non-inferiority study designed to evaluate the efficacy of reduced dose of apixaban in preventing recurrent VTE in patients with cancer. Eligible participants had active cancer and a history of proximal deep-vein thrombosis or pulmonary embolism, and had completed at least six months of anticoagulant therapy. Participants were randomly assigned (1:1) to receive oral apixaban at a reduced (2.5 mg) or full (5.0 mg) dose twice daily for twelve months. The primary endpoint was centrally adjudicated, fatal or nonfatal recurrent VTE over a 12-month follow-up period, assessed in a non-inferiority analysis. The key secondary outcome was clinically relevant bleeding, assessed in superiority analysis.
Results
A total of 1,766 patients were randomly assigned to receive reduced-dose apixaban (N= 866) and the full dose (N= 900). Median treatment duration was 11.8 months. Recurrent VTE occurred in 2.1% of the reduced dose group and 2.8% of the full dose group (HR[95%CI]: 0.76[0.41–1.41], p= 0.001). Clinically relevant bleeding occurred in 12.1% of patients in the reduced dose group compared to 15.6% in the full dose group (HR[95%CI]: 0.75[0.58–0.97], p= 0.03). The 12-month mortality rates were similar between the two groups with 17.7% in the reduced dose group and 19.6% in the full dose group (HR[95%CI]: 0.96[0.86–1.06]). Serious AE occurred in 39.8% of patients receiving the reduced dose and 43.8% receiving the full dose.
Conclusion
Extended anticoagulation with reduced-dose apixaban was shown to be non-inferior to the full dose in preventing recurrent VTE in patients with active cancer. The reduced dose resulted in a lower incidence of clinically relevant bleeding than the full dose.
Reference
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