Abelacimab for Prevention of Venous Thromboembolism | NEJM

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Abstract

Background

The function 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 general knee arthroplasty to obtain one in every of 3 regimens of abelacimab (30 mg, 75 mg, or 150 mg) administered postoperatively in one intravenous dose or to obtain 40 mg of enoxaparin administered subcutaneously as soon as day-to-day. The number one efficacy consequence was once venous thromboembolism, detected by means of obligatory venography of the leg concerned within the operation or purpose affirmation of symptomatic occasions. The primary protection consequence was once a composite of main or clinically related nonmajor bleeding as much as 30 days after surgical procedure.

Results

Venous thromboembolism came about in 13 of 102 sufferers (13%) within the 30-mg abelacimab organization, 5 of 99 sufferers (5%) within the 75-mg abelacimab organization, and four of 98 sufferers (4%) within the 150-mg abelacimab organization, as when put next with 22 of 101 sufferers (22%) within the enoxaparin organization. The 30-mg abelacimab routine was once noninferior to enoxaparin, and the 75-mg and 150-mg abelacimab regimens had been awesome to enoxaparin (P<0.001). Bleeding came about in 2%, 2%, and not one of the sufferers within the 30-mg, 75-mg, and 150-mg abelacimab teams, respectively, and in not one of the sufferers within the enoxaparin organization.

Conclusions

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


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