AXIOMATIC-TKR Trial

 1. The study randomized 1,242 patients undergoing knee arthroplasty to one of seven postoperative regimens of milvexian (25 mg, 50 mg, 100 mg, or 200 mg twice daily or 25 mg, 50 mg, or 200 mg once daily) or the anticoagulant enoxaparin (40 mg once daily). The primary efficacy outcome was venous thromboembolism, and the primary safety outcome was bleeding. 2. Results found that in those patients taking milvexian twice daily, venous thromboembolism developed in 21% population taking 25 mg, in 11% of the population taking 50 mg, in 9% population taking 100 mg, and in 8% of the population taking 200 mg. 3. Among those on the milvexian once-daily regimen, venous thromboembolism developed in 25% population taking 25 mg, in 24% population taking 50 mg, and in 7% population taking 200 mg. While in those assigned enoxaparin, venous thromboembolism occurred in 21%. 4. According to researchers, the dose-response relationship with twice-daily milvexian was significant (one-sided P<0.001), and the 12% incidence of venous thromboembolism with twice-daily milvexian was significantly lower than the prespecified benchmark of 30%. They also noted that bleeding rates of any severity were similar (4%) in those taking milvexian and enoxaparin. Serious adverse events were reported in 2% of patients in the milvexian group compared with 4% in the enoxaparin group. 5. Thus the use of the oral factor eleven (a )inhibitor, milvexian, reduced the risk of postoperative thromboembolism in patients undergoing knee arthroplasty in a dose-dependent manner without increasing bleeding risks compared with the use of a more conventional anticoagulant. Disclaimer: Lupin makes no representation or warranty of any kind, expressed or implied, regarding the accuracy, adequacy, validity, reliability, availability, or completeness of any scientific information shared by the HCP on the ­­­STAR UPDATE podcast. You should not allow the contents of this to substitute for your own medical judgment, which you should exercise in evaluating the information on this website.