AMPLIFY
Trial question
What is the role of apixaban in patients with acute VTE?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
41.0% female
59.0% male
N = 5395
5395 patients (2228 female, 3167 male)
Inclusion criteria: patients with acute VTE
Key exclusion criteria: active bleeding, a high risk of bleeding, or other contraindications to treatment with enoxaparin and warfarin, cancer and long-term treatment with low-molecular-weight heparin was planned, or dual antiplatelet therapy
Interventions
N=2609 apixaban (10 mg PO BID for 7 days, followed by 5 mg PO BID for 6 months)
N=2635 warfarin (subcutaneous enoxaparin, followed by warfarin)
Primary outcome
Recurrent symptomatic venous thromboembolism or death related to venous thromboembolism
2.3
2.7
2.7 %
2.0 %
1.4 %
0.7 %
0.0 %
Apixaban
Warfarin
Difference not exceeding
nonferiority margin ✓
Difference not exceeding nonferiority margin in recurrent symptomatic VTE or death related to VTE (2.3% vs. 2.7%; RR 0.84, 95% CI 0.6 to 1.18)
Secondary outcomes
No significant difference in VTE or death from cardiovascular cause (2.3% vs. 2.9%; RR 0.8, 95% CI 0.57 to 1.11)
No significant difference in VTE or death from any cause (3.2% vs. 3.9%; RR 0.82, 95% CI 0.61 to 1.08)
Significant decrease in VTE, death related to VTE, or major bleeding (2.8% vs. 4.5%; RR 0.62, 95% CI 0.47 to 0.83)
Safety outcomes
No significant difference in any adverse event.
Significant difference in major bleeding (0.6% vs. 1.8%) and major bleeding plus clinically relevant nonmajor bleeding (4.3% vs. 9.7%).
Conclusion
In patients with acute VTE, apixaban was noninferior to warfarin with respect to recurrent symptomatic VTE or death related to VTE.
Reference
Agnelli G, Buller HR, Cohen A et al. Oral apixaban for the treatment of acute venous thromboembolism. N Engl J Med. 2013 Aug 29;369(9):799-808.
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