AXIOMATIC-TKR (high-dose)
Trial question
What is the role of high-dose milvexian in the prevention of VTE in patients undergoing knee arthroplasty?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
68.0% female
32.0% male
N = 383
383 patients (260 female, 123 male)
Inclusion criteria: patients aged ≥ 50 years undergoing elective unilateral total knee arthroplasty
Key exclusion criteria: contraindications to enoxaparin; history of severe hepatic impairment or previous VTE; long-term use of antithrombotic therapy other than aspirin; inability to undergo venography
Interventions
N=131 milvexian (at a dose of 200 mg BID)
N=252 enoxaparin (at a dose of 40 mg once daily)
Primary outcome
Venous thromboembolism
8
21
21.0 %
15.8 %
10.5 %
5.3 %
0.0 %
Milvexian
Enoxaparin
Significant decrease ▼
NNT = 7
Significant decrease in VTE (8% vs. 21%; RR 0.37, 95% CI 0.19 to 0.69)
Safety outcomes
No significant differences in any bleeding, major bleeding or clinically relevant nonmajor bleeding.
Conclusion
In patients aged ≥ 50 years undergoing elective unilateral total knee arthroplasty, milvexian was superior to enoxaparin with respect to VTE.
Reference
Jeffrey I Weitz, John Strony, Walter Ageno et al. Milvexian for the Prevention of Venous Thromboembolism. N Engl J Med. 2021 Dec 2;385(23):2161-2172.
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