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Abelacimab for Prevention of Venous Thromboembolism

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Abstract

Background

The position of issue XI within the pathogenesis of postoperative venous thromboembolism is unsure. Abelacimab is a monoclonal antibody that binds to issue XI and locks it within the zymogen (inactive precursor) conformation.

Methods

In this open-label, parallel-group trial, we randomly assigned 412 sufferers who had been present process complete knee arthroplasty to obtain one of three regimens of abelacimab (30 mg, 75 mg, or 150 mg) administered postoperatively in a single intravenous dose or to obtain 40 mg of enoxaparin administered subcutaneously as soon as each day. The major efficacy consequence was venous thromboembolism, detected by obligatory venography of the leg concerned within the operation or goal affirmation of symptomatic occasions. The principal security consequence was a composite of main or clinically related nonmajor bleeding as much as 30 days after surgical procedure.

Results

Venous thromboembolism occurred in 13 of 102 sufferers (13%) within the 30-mg abelacimab group, 5 of 99 sufferers (5%) within the 75-mg abelacimab group, and 4 of 98 sufferers (4%) within the 150-mg abelacimab group, as in contrast with 22 of 101 sufferers (22%) within the enoxaparin group. The 30-mg abelacimab routine was noninferior to enoxaparin, and the 75-mg and 150-mg abelacimab regimens had been superior to enoxaparin (P<0.001). Bleeding occurred in 2%, 2%, and none of the sufferers within the 30-mg, 75-mg, and 150-mg abelacimab teams, respectively, and in none of the sufferers within the enoxaparin group.

Conclusions

This trial confirmed that issue XI is vital for the event of postoperative venous thromboembolism. Factor XI inhibition with a single intravenous dose of abelacimab after complete knee arthroplasty was efficient for the prevention of venous thromboembolism and was related to a low danger of bleeding. (Funded by Anthos Therapeutics; ANT-005 TKA EudraCT quantity, 2019-003756-37).

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