AVERT
Trial question
What is the effect of thromboprophylaxis with apixaban in intermediate-to-high-risk ambulatory patients with cancer who were starting chemotherapy?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
57.0% female
43.0% male
N = 563
563 patients (323 female, 240 male)
Inclusion criteria: ambulatory patients with cancer who were at intermediate-to-high risk for VTE and were initiating chemotherapy
Key exclusion criteria: increased risk for clinically significant bleeding, hepatic disease associated with coagulopathy, basal cell carcinoma, SCC, acute leukemia, myeloproliferative neoplasm, stem cell transplantation
Interventions
N=288 apixaban (2.5 mg BID for 180 days)
N=275 placebo (identical tablets BID for 180 days)
Primary outcome
Rate of venous thromboembolism within 180 days
4.2
10.2
10.2 %
7.6 %
5.1 %
2.5 %
0.0 %
Apixaban
Placebo
Significant decrease ▼
NNT = 16
Significant decrease in the rate of VTE within 180 days (4.2% vs. 10.2%; HR 0.41, 95% CI 0.26 to 0.65)
Secondary outcomes
Significant increase in major bleeding in modified intention-to-treat analysis (3.5% vs. 1.8%; HR 2, 95% CI 1.01 to 3.95)
Safety outcomes
No significant differences in major bleeding during treatment period (2.1% vs. 1.1%; HR 1.89, 95% CI 0.39-9.24).
Conclusion
In ambulatory patients with cancer who were at intermediate-to-high risk for VTE and were initiating chemotherapy, apixaban was superior to placebo with respect to the rate of VTE within 180 days.
Reference
Carrier M, Abou-Nassar K, Mallick R et al. Apixaban to Prevent Venous Thromboembolism in Patients with Cancer. N Engl J Med. 2019 Feb 21;380(8):711-719.
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