Effect of Osocimab in Preventing Venous Thromboembolism Among Patients Undergoing Knee Arthroplasty
Jeffrey I. Weitz, MD,corresponding author1,2 Rupert Bauersachs, MD,3,4 Bastian Becker, MSc,5 Scott D. Berkowitz, MD,5 Maria C. S. Freitas, MD, PhD,5 Michael R. Lassen, MD,6 Carola Metzig, MD,5 and Gary E. Raskob, PhD7Knee
Importance
The efficacy of factor XIa inhibition for thromboprophylaxis is unknown. Osocimab is a long-acting, fully human monoclonal antibody that inhibits factor XIa.
Objective
To compare different doses of osocimab with enoxaparin and apixaban for thromboprophylaxis in patients who have undergone knee arthroplasty.
Design, Setting, and Participants
Randomized, open-label, adjudicator-blinded, phase 2 noninferiority trial with observer blinding for osocimab doses, conducted at 54 hospitals in 13 countries. Adult patients undergoing unilateral knee arthroplasty were randomized from October 2017 through August 2018 and followed up until January 2019.
Interventions
Single intravenous osocimab postoperative doses of 0.3 mg/kg (n = 107), 0.6 mg/kg (n = 65), 1.2 mg/kg (n = 108), or 1.8 mg/kg (n = 106); preoperative doses of 0.3 mg/kg (n = 109) or 1.8 mg/kg (n = 108); or 40 mg of subcutaneous enoxaparin once daily (n = 105) or 2.5 mg of oral apixaban twice daily (n = 105) for at least 10 days or until venography.
Main Outcomes and Measures
The primary outcome was venou
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