Effect of Osocimab in Preventing Venous Thromboembolism Among Patients Undergoing Knee Arthroplasty
Key result
Preoperative osocimab 1.8 mg/kg was superior to enoxaparin for preventing venous thromboembolism (risk difference 15.1%; 90% CI 4.9%-25.2%), while postoperative doses ≥0.6 mg/kg were noninferior.
Why the study?
The efficacy of factor XIa inhibition for thromboprophylaxis is unknown.
Does osocimab prevent venous thromboembolism compared to enoxaparin or apixaban in adult patients undergoing unilateral knee arthroplasty?
Population
813 adult patients undergoing unilateral knee arthroplasty across 54 hospitals in 13 countries
Comparison
Different doses of osocimab vs enoxaparin vs apixaban
Design
Randomized, open-label, adjudicator-blinded, dose-observer-blinded phase 2 noninferiority trial
Follow-up
10 to 13 days postoperatively
Authors
Discussion
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Member takes
Implication
May warrant heightened VTE vigilance in this population; leaves open whether the observed difference is robust or requires larger confirmatory trials.
Study Design
Type
RCT (n=813)
Blinding
Open-label, adjudicator-blinded, with observer blinding for osocimab doses
Randomization
Randomized
Multicenter
Yes
Structured PICO
Does osocimab prevent venous thromboembolism compared to enoxaparin or apixaban in adult patients undergoing unilateral knee arthroplasty?
P
Population
813 adult patients undergoing unilateral knee arthroplasty randomized to osocimab, enoxaparin, or apixaban, followed for 10 to 13 days postoperatively.
I
Intervention
Single intravenous osocimab (factor XIa inhibitor) given postoperatively (0.3, 0.6, 1.2, or 1.8 mg/kg) or preoperatively (0.3 or 1.8 mg/kg).
C
Comparator
Subcutaneous enoxaparin 40 mg once daily or oral apixaban 2.5 mg twice daily for at least 10 days or until venography.
O
Outcome
Venous thromboembolism incidence between 10 and 13 days postoperatively (assessed by mandatory bilateral venography performed 10 to 13 days after surgery or confirmed symptomatic deep vein thrombosis or pulmonary embolism).composite
Main Result
Absolute Risk Reduction: 15.1 (95% CI 4.9–25.2)
Absolute Event Rate: 11.3% vs 26.3%
Absolute Risk Reduction: 15.1%
Osocimab, a novel factor XIa inhibitor, demonstrated noninferiority (postoperative dosing) and superiority (preoperative 1.8 mg/kg dosing) compared to enoxaparin for VTE prophylaxis after knee arthroplasty.
Cite This Study
Weitz et al. (2020) conducted an RCT in Venous thromboembolism in knee arthroplasty (n=813). Osocimab vs. Enoxaparin 40 mg once daily or apixaban 2.5 mg twice daily was evaluated on Venous thromboembolism incidence between 10 and 13 days postoperatively (Risk difference 15.1%, 95% CI 4.9% to 25.2%). Preoperative osocimab 1.8 mg/kg was superior to enoxaparin for preventing venous thromboembolism (risk difference 15.1%; 90% CI 4.9%-25.2%), while postoperative doses ≥0.6 mg/kg were noninferior.