Pulmonary vascular disease & thromboembolismRandomised controlled trial
Extended Reduced-Dose Apixaban for Cancer-Associated Venous Thromboembolism
- Randomised controlled trial
- double-blind
- non-inferiority
- blinded central outcome adjudication
- Median treatment duration 11.8 months (IQR 8.3 to 12.1)
Authors' conclusion
Extended anticoagulation with reduced-dose apixaban was noninferior to full-dose apixaban for the prevention of recurrent venous thromboembolism in patients with active cancer. The reduced dose led to a lower incidence of clinically relevant bleeding complications than the full dose.
Study context
- Population
- Patients with active cancer and proximal DVT or PE who had completed ≥6 months of anticoagulant therapy
- Participants
- 1,766 patients
- Comparison
- Reduced-dose vs full-dose apixaban
- Reduced dosen = 866
- Full dosen = 900reference
- Primary endpoint
- Centrally adjudicated fatal or nonfatal recurrent VTE (non-inferiority margin 2.00 for upper 95% CI boundary of subhazard ratio)
Primary result
Recurrent VTE
Adjusted subhazard ratio
0.76
95% CI 0.41–1.41
P = 0.001 for non-inferiority
Events by treatment group
As reported in the abstract
Secondary outcomes
| Outcome | Reduced dose | Full dose | adjusted HR (95% CI) | |
|---|---|---|---|---|
| Mortality | 17.7% | 19.6% | 0.96 (0.86–1.06) | |
| 0.512Adjusted hazard ratio (log scale) |
Safety
Clinically relevant bleeding (key secondary, superiority)
adjusted subhazard ratio 0.75 (0.58–0.97) · P = 0.03
Original publication
Extended Reduced-Dose Apixaban for Cancer-Associated Venous Thromboembolism. N Engl J Med. Published 29 March 2025. doi:10.1056/nejmoa2416112
Summarised from the published abstract; every number is checked against it