AMPLIFY-EXT (apoxaban 5 mg)
Trial question
What is the role of apixaban in patients with VTE?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
43.0% female
57.0% male
N = 1642
1642 patients (705 female, 937 male).
Inclusion criteria: patients with VTE.
Key exclusion criteria: contraindication to continued anticoagulant therapy or requiring an ongoing anticoagulant therapy, dual antiplatelet therapy, or aspirin at a dose > 165 mg/day; hemoglobin level of < 9 mg/dL; platelet count < 100,000/mm²; serum creatinine level > 2.5 mg/dL.
Interventions
N=813 apixaban (5 mg BID for 12 months).
N=829 placebo (matching placebo BID for 12 months).
Primary outcome
Symptomatic recurrent venous thromboembolism or death from venous thromboembolism
1.7%
8.8%
8.8 %
6.6 %
4.4 %
2.2 %
0.0 %
Apixaban
Placebo
Significant
decrease ▼
NNT = 14
Significant decrease in symptomatic recurrent VTE or death from VTE (1.7% vs. 8.8%; RR 0.2, 95% CI 0.11 to 0.34).
Secondary outcomes
Significant decrease in symptomatic recurrent VTE or death from any cause (4.2% vs. 11.6%; RR 0.36, 95% CI 0.25 to 0.53).
No significant difference in non-VTE-related CV death, MI, or stroke (0.6% vs. 1.3%; RR 0.47, 95% CI 0.16 to 1.33).
Significant decrease in recurrent VTE, VTE-related death, MI, stroke, or CVD-related death (2.3% vs. 10%; RR 0.23, 95% CI 0.14 to 0.38).
Safety outcomes
No significant differences in major bleeding, clinically relevant nonmajor bleeding, and adverse events.
Significant differences in VTE, VTE-related death, MI, stroke, CVD-related death, or major bleeding (2.5% vs. 10.4%).
Conclusion
In patients with VTE, apixaban was superior to placebo with respect to symptomatic recurrent VTE or death from VTE.
Reference
Agnelli G, Buller HR, Cohen A et al. Apixaban for extended treatment of venous thromboembolism. N Engl J Med. 2013 Feb 21;368(8):699-708.
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