Abstract | BACKGROUND: METHODS: 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. RESULTS:
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 (P<0.001). 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. CONCLUSIONS:
|
Authors | Peter Verhamme, B Alexander Yi, Annelise Segers, Janeen Salter, Daniel Bloomfield, Harry R Büller, Gary E Raskob, Jeffrey I Weitz, ANT-005 TKA Investigators |
Journal | The New England journal of medicine
(N Engl J Med)
Vol. 385
Issue 7
Pg. 609-617
(08 12 2021)
ISSN: 1533-4406 [Electronic] United States |
PMID | 34297496
(Publication Type: Comparative Study, Journal Article, Randomized Controlled Trial)
|
Copyright | Copyright © 2021 Massachusetts Medical Society. |
Chemical References |
- Antibodies, Monoclonal, Humanized
- Anticoagulants
- Enoxaparin
- Factor XI
- abelacimab
|
Topics |
- Adult
- Aged
- Aged, 80 and over
- Antibodies, Monoclonal, Humanized
(administration & dosage, adverse effects, therapeutic use)
- Anticoagulants
(administration & dosage, adverse effects, therapeutic use)
- Arthroplasty, Replacement, Knee
- Dose-Response Relationship, Drug
- Enoxaparin
(adverse effects, therapeutic use)
- Factor XI
(antagonists & inhibitors, metabolism)
- Female
- Hemorrhage
(chemically induced)
- Humans
- Infusions, Intravenous
- Injections, Subcutaneous
- Male
- Middle Aged
- Partial Thromboplastin Time
- Postoperative Complications
(prevention & control)
- Venous Thromboembolism
(prevention & control)
|