FRIDAY, Nov. 19, 2021 (HealthDay News) -- For patients undergoing knee arthroplasty, factor XIa inhibition with oral milvexian reduced the risk for postoperative venous thromboembolism without an increased risk for bleeding compared with enoxaparin, according to a study published online Nov. 15 in the New England Journal of Medicine to coincide with the American Heart Association Scientific Sessions 2021, held virtually from Nov. 13 to 15.
Jeffrey I. Weitz, M.D., from McMaster University in Hamilton, Ontario, Canada, and colleagues randomly assigned 1,242 patients undergoing knee arthroplasty to receive one of seven postoperative regimens of milvexian (25, 50, 100, or 200 mg twice daily, or 25, 50, or 200 mg once daily) or enoxaparin (40 mg once daily) in a phase 2 trial.
The researchers found that among patients receiving milvexian, venous thromboembolism developed in 21, 11, 9, and 8 percent of those receiving 25, 50, 100, and 200 mg twice daily, respectively, and in 25, 24, and 7 percent of those taking 25, 50, and 200 mg once daily, respectively, compared with 21 percent among those receiving enoxaparin. There was a significant dose-response relationship with twice-daily milvexian, and the 12 percent incidence of venous thromboembolism was significantly lower than the prespecified benchmark of 30 percent. Bleeding of any severity occurred in 4 percent each of patients taking milvexian and enoxaparin; major or clinically relevant nonmajor bleeding occurred in 1 and 2 percent, respectively.
"The major side effect of current oral anticlotting drugs is bleeding, and the fear of bleeding leads to their underuse. This sets the need for safer oral anticoagulants and that is where milvexian comes in," Weitz said in a statement.
The study was funded by Bristol Myers Squibb and Janssen Research and Development, the developers of milvexian.