ADVANCE (apixaban)
Trial question
What is the role of apixaban for thromboprophylaxis in patients undergoing hip replacement?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
53.0% female
47.0% male
N = 5407
5407 patients (2881 female, 2526 male)
Inclusion criteria: patients undergoing total hip replacement
Key exclusion criteria: active bleeding, a contraindication to anticoagulant prophylaxis, or the need for ongoing anticoagulant or antiplatelet treatment
Interventions
N=1949 apixaban (2.5 mg PO BID for 35 days after surgery)
N=1917 enoxaparin (40 mg SC every 24 hours for 35 days after surgery)
Primary outcome
Deep venous thrombosis, nonfatal pulmonary embolism, or death from any cause
1.4
3.9
3.9 %
2.9 %
1.9 %
1.0 %
0.0 %
Apixaban
Enoxaparin
Significant decrease ▼
NNT = 40
Significant decrease in DVT, nonfatal PE, or death from any cause (1.4% vs. 3.9%; RR 0.36, 95% CI 0.22 to 0.54)
Secondary outcomes
No significant difference in major and clinically relevant nonmajor bleeding (4.8% vs. 5%; ARD -0.2, 95% CI -1.4 to 1)
Significant decrease in major VTE (0.5% vs. 1.1%; RR 0.4, 95% CI 0.15 to 0.8)
No significant difference in all bleeding events (11.7% vs. 12.6%; ARD -0.9, 95% CI -2.6 to 0.9)
Safety outcomes
No significant differences in major bleeding event, clinically relevant nonmajor bleeding, minor bleeding events.
Conclusion
In patients undergoing total hip replacement, apixaban was superior to enoxaparin with respect to DVT, nonfatal PE, or death from any cause.
Reference
ADVANCE Collaborative Group, Patel A, MacMahon S et al. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N Engl J Med. 2008 Jun 12;358(24):2560-72.
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