API-CAT
Trial question
Is extended anticoagulation with reduced-dose apixaban noninferior to full-dose apixaban in patients with active cancer and proximal DVT or PE?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
57.0% female
43.0% male
N = 1766
1766 patients (1000 female, 766 male).
Inclusion criteria: patients with active cancer and proximal DVT or PE who had completed at least 6 months of anticoagulation therapy.
Key exclusion criteria: isolated subsegmental PE without associated DVT; isolated distal DVT of the legs; isolated upper extremity DVT or superior vena cava thrombosis; mechanical heart valve; antiphospholipid syndrome; conditions increasing the risk of serious bleeding; life expectancy < 12 months; pregnancy or lactation.
Interventions
N=866 reduced-dose apixaban (at a dose of 2.5 mg BID for 12 months).
N=900 full-dose apixaban (at a dose of 5 mg BID for 12 months).
Primary outcome
Recurrent venous thromboembolism
2.1%
2.8%
2.8 %
2.1 %
1.4 %
0.7 %
0.0 %
Reduced-dose
apixaban
Full-dose
apixaban
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in recurrent VTE (2.1% vs. 2.8%; sHR 0.76, 95% CI 0.41 to 1.41).
Secondary outcomes
Significant decrease in clinically relevant bleeding (12.1% vs. 15.6%; sHR 0.75, 95% CI 0.58 to 0.97).
No significant difference in death from any cause (17.7% vs. 19.6%; HR 0.96, 96% CI 0.86 to 1.06).
No significant difference in recurrent symptomatic VTE, major bleeding, or death (19.9% vs. 22.1%; HR 0.96, 96% CI 0.87 to 1.07).
Safety outcomes
No significant difference in major bleeding.
Significant difference in major or clinically relevant nonmajor bleeding (12.1% vs. 15.6%).
Conclusion
In patients with active cancer and proximal DVT or PE who had completed at least 6 months of anticoagulation therapy, reduced-dose apixaban was noninferior to full-dose apixaban with respect to recurrent VTE.
Reference
Isabelle Mahé, Marc Carrier, Didier Mayeur et al. Extended Reduced-Dose Apixaban for Cancer-Associated Venous Thromboembolism. N Engl J Med. 2025 Mar 29. Online ahead of print.
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