Rivaroxaban or Enoxaparin in Nonmajor Orthopedic Surgery
| Autor: | C Marc Samama, Pronomos Investigators, Patrick Mouret, Javier Martínez-Martín, Nadia Rosencher, Michel Cucherat, Daniel Duverger, Patrick Mismetti, Beatrice Deygas, Emilie Presles, Juan Llau, William Fisher, Philippe Girard, Silvy Laporte |
|---|---|
| Přispěvatelé: | Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP) |
| Rok vydání: | 2020 |
| Předmět: |
Adult
Male medicine.medical_specialty [SDV]Life Sciences [q-bio] Injections Subcutaneous Administration Oral Hemorrhage 030204 cardiovascular system & hematology law.invention 03 medical and health sciences 0302 clinical medicine Postoperative Complications Randomized controlled trial Double-Blind Method Rivaroxaban law Medicine Humans Orthopedic Procedures 030212 general & internal medicine Enoxaparin Venous Thrombosis Lower extremity surgery business.industry Anticoagulants Reduced mobility General Medicine Venous Thromboembolism Middle Aged 3. Good health Surgery Multicenter study Lower Extremity Orthopedic surgery Female business Pulmonary Embolism Venous thromboembolism medicine.drug |
| Zdroj: | New England Journal of Medicine New England Journal of Medicine, Massachusetts Medical Society, 2020, 382 (20), pp.1916-1925. ⟨10.1056/NEJMoa1913808⟩ |
| ISSN: | 1533-4406 0028-4793 |
| DOI: | 10.1056/NEJMoa1913808⟩ |
| Popis: | International audience; Background: Nonmajor orthopedic surgery of the lower limbs that results in transient reduced mobility places patients at risk for venous thromboembolism. Rivaroxaban may be noninferior to enoxaparin with regard to the prevention of major venous thromboembolism in these patients.Methods: In this international, parallel-group, randomized, double-blind, noninferiority trial, we randomly assigned adult patients undergoing lower-limb nonmajor orthopedic surgery who were considered to be at risk for venous thromboembolism on the basis of the investigator's judgment to receive either rivaroxaban or enoxaparin. The primary efficacy outcome of major venous thromboembolism was a composite of symptomatic distal or proximal deep-vein thrombosis, pulmonary embolism, or venous thromboembolism-related death during the treatment period or asymptomatic proximal deep-vein thrombosis at the end of treatment. A test for superiority was planned if rivaroxaban proved to be noninferior to enoxaparin. For all outcomes, multiple imputation was used to account for missing data. Prespecified safety outcomes included major bleeding (fatal, critical, or clinically overt bleeding or bleeding at the surgical site leading to intervention) and nonmajor clinically relevant bleeding.Results: A total of 3604 patients underwent randomization; 1809 patients were assigned to receive rivaroxaban, and 1795 to receive enoxaparin. Major venous thromboembolism occurred in 4 of 1661 patients (0.2%) in the rivaroxaban group and in 18 of 1640 patients (1.1%) in the enoxaparin group (risk ratio with multiple imputation, 0.25; 95% confidence interval, 0.09 to 0.75; P |
| Databáze: | OpenAIRE |
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