Abelacimab for Prevention of Venous Thromboembolism
| Autor: | Peter, Verhamme, B Alexander, Yi, Annelise, Segers, Janeen, Salter, Daniel, Bloomfield, Harry R, Büller, Gary E, Raskob, Jeffrey I, Weitz, Chernivtsi Y, Vasylchyshyn |
|---|---|
| Přispěvatelé: | Vascular Medicine, ACS - Pulmonary hypertension & thrombosis |
| Rok vydání: | 2021 |
| Předmět: |
Adult
Male medicine.medical_specialty 2019-20 coronavirus outbreak Coronavirus disease 2019 (COVID-19) Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Injections Subcutaneous Hemorrhage Antibodies Monoclonal Humanized Gastroenterology Pathogenesis Postoperative Complications Internal medicine medicine Humans Enoxaparin Arthroplasty Replacement Knee Infusions Intravenous Injections subcutaneous Factor XI Aged Aged 80 and over medicine.diagnostic_test Dose-Response Relationship Drug business.industry Anticoagulants General Medicine Venous Thromboembolism Middle Aged Female Partial Thromboplastin Time business Venous thromboembolism Partial thromboplastin time |
| Zdroj: | New England journal of medicine, 385(7), 609-617. Massachussetts Medical Society |
| ISSN: | 1533-4406 0028-4793 |
| Popis: | The role of factor XI in the pathogenesis of postoperative venous thromboembolism is uncertain. Abelacimab is a monoclonal antibody that binds to factor XI and locks it in the zymogen (inactive precursor) conformation.In this open-label, parallel-group trial, we randomly assigned 412 patients who were undergoing total knee arthroplasty to receive one of three regimens of abelacimab (30 mg, 75 mg, or 150 mg) administered postoperatively in a single intravenous dose or to receive 40 mg of enoxaparin administered subcutaneously once daily. The primary efficacy outcome was venous thromboembolism, detected by mandatory venography of the leg involved in the operation or objective confirmation of symptomatic events. The principal safety outcome was a composite of major or clinically relevant nonmajor bleeding up to 30 days after surgery.Venous thromboembolism occurred in 13 of 102 patients (13%) in the 30-mg abelacimab group, 5 of 99 patients (5%) in the 75-mg abelacimab group, and 4 of 98 patients (4%) in the 150-mg abelacimab group, as compared with 22 of 101 patients (22%) in the enoxaparin group. The 30-mg abelacimab regimen was noninferior to enoxaparin, and the 75-mg and 150-mg abelacimab regimens were superior to enoxaparin (P0.001). Bleeding occurred in 2%, 2%, and none of the patients in the 30-mg, 75-mg, and 150-mg abelacimab groups, respectively, and in none of the patients in the enoxaparin group.This trial showed that factor XI is important for the development of postoperative venous thromboembolism. Factor XI inhibition with 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. (Funded by Anthos Therapeutics; ANT-005 TKA EudraCT number, 2019-003756-37.). |
| Databáze: | OpenAIRE |
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