2021
ANT-005 TKA TRIAL
M
Abelacimab for Prevention of Venous Thromboembolism (VTE)
Phase 2,open-label, prospective randomized trial
400
Objective: To compare the efficacy & safety of abelacimab administered postoperatively with the efficacy & safety of enoxaparin in patients undergoing total knee arthroplasty.
patients
Inclusion criteria: Patients 18 to 80 years of age undergoing elective primary unilateral total knee arthroplasty & those with active bleeding or a high risk of bleeding or h/o VTE were ruled out.
(A)Abelacimab 30 mg [n = 102]
13
2
(A)Abelacimab
(A)Abelacimab
(E)Enoxaparin
75 mg [n = 99] 150 mg [n = 98]
40mg [n = 101]
PRIMARY OUTCOME
Incidence of venous thromboembolism %
(A)30mg vs (E) :Diff -9.2; P=0.08 (A)75mg vs (E) :Diff -16.8; P< 0.001 (A)150mg vs (E) :Diff -17.8; P< 0.001
All 3 regimens of Abelacimab met noninferiority criteria
5
4
SECONDARY OUTCOME
Major or clinically relevant non major bleeding within 30 days%
2
22
Conclusion: A single intravenous dose of abelacimab after total knee arthroplasty was effective for the prevention of venous thromboembolism and was associated with a low risk of bleeding
P Verhamme et al. NEJM 2021; 385:609-617
