Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty
(2008) In The New England journal of medicine 358(26). p.86-2776- Abstract
BACKGROUND: We investigated the efficacy of rivaroxaban, an orally active direct factor Xa inhibitor, in preventing venous thrombosis after total knee arthroplasty.
METHODS: In this randomized, double-blind trial, 2531 patients who were to undergo total knee arthroplasty received either oral rivaroxaban, 10 mg once daily, beginning 6 to 8 hours after surgery, or subcutaneous enoxaparin, 40 mg once daily, beginning 12 hours before surgery. The primary efficacy outcome was the composite of any deep-vein thrombosis, nonfatal pulmonary embolism, or death from any cause within 13 to 17 days after surgery. Secondary efficacy outcomes included major venous thromboembolism (i.e., proximal deep-vein thrombosis, nonfatal pulmonary embolism,... (More)
BACKGROUND: We investigated the efficacy of rivaroxaban, an orally active direct factor Xa inhibitor, in preventing venous thrombosis after total knee arthroplasty.
METHODS: In this randomized, double-blind trial, 2531 patients who were to undergo total knee arthroplasty received either oral rivaroxaban, 10 mg once daily, beginning 6 to 8 hours after surgery, or subcutaneous enoxaparin, 40 mg once daily, beginning 12 hours before surgery. The primary efficacy outcome was the composite of any deep-vein thrombosis, nonfatal pulmonary embolism, or death from any cause within 13 to 17 days after surgery. Secondary efficacy outcomes included major venous thromboembolism (i.e., proximal deep-vein thrombosis, nonfatal pulmonary embolism, or death related to venous thromboembolism) and symptomatic venous thromboembolism. The primary safety outcome was major bleeding.
RESULTS: The primary efficacy outcome occurred in 79 of 824 patients (9.6%) who received rivaroxaban and in 166 of 878 (18.9%) who received enoxaparin (absolute risk reduction, 9.2%; 95% confidence interval [CI], 5.9 to 12.4; P<0.001). Major venous thromboembolism occurred in 9 of 908 patients (1.0%) given rivaroxaban and 24 of 925 (2.6%) given enoxaparin (absolute risk reduction, 1.6%; 95% CI, 0.4 to 2.8; P=0.01). Symptomatic events occurred less frequently with rivaroxaban than with enoxaparin (P=0.005). Major bleeding occurred in 0.6% of patients in the rivaroxaban group and 0.5% of patients in the enoxaparin group. The incidence of drug-related adverse events, mainly gastrointestinal, was 12.0% in the rivaroxaban group and 13.0% in the enoxaparin group.
CONCLUSIONS: Rivaroxaban was superior to enoxaparin for thromboprophylaxis after total knee arthroplasty, with similar rates of bleeding. (ClinicalTrials.gov number, NCT00361894.)
(Less)
- author
- Lassen, Michael R ; Ageno, Walter ; Borris, Lars C ; Lieberman, Jay R ; Rosencher, Nadia ; Bandel, Tiemo J ; Misselwitz, Frank and Turpie, Alexander G G
- contributor
- Levine, M
; Flondell, M.
LU
and Wykman, A
- author collaboration
- organization
- publishing date
- 2008-06-26
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- Adult, Aged, Aged, 80 and over, Anticoagulants/adverse effects, Arthroplasty, Replacement, Knee, Double-Blind Method, Enoxaparin/adverse effects, Factor Xa Inhibitors, Female, Humans, Male, Middle Aged, Morpholines/adverse effects, Pulmonary Embolism/epidemiology, Rivaroxaban, Thiophenes/adverse effects, Venous Thromboembolism/epidemiology, Venous Thrombosis/epidemiology
- in
- The New England journal of medicine
- volume
- 358
- issue
- 26
- pages
- 86 - 2776
- publisher
- Massachusetts Medical Society
- external identifiers
-
- pmid:18579812
- scopus:45949103416
- ISSN
- 0028-4793
- DOI
- 10.1056/NEJMoa076016
- language
- English
- LU publication?
- yes
- additional info
- 2008 Massachusetts Medical Society
- id
- d8184a98-8c7f-41d6-a80e-4a39b20d9587
- date added to LUP
- 2023-01-30 18:53:02
- date last changed
- 2024-06-24 15:09:27
@article{d8184a98-8c7f-41d6-a80e-4a39b20d9587, abstract = {{<p>BACKGROUND: We investigated the efficacy of rivaroxaban, an orally active direct factor Xa inhibitor, in preventing venous thrombosis after total knee arthroplasty.</p><p>METHODS: In this randomized, double-blind trial, 2531 patients who were to undergo total knee arthroplasty received either oral rivaroxaban, 10 mg once daily, beginning 6 to 8 hours after surgery, or subcutaneous enoxaparin, 40 mg once daily, beginning 12 hours before surgery. The primary efficacy outcome was the composite of any deep-vein thrombosis, nonfatal pulmonary embolism, or death from any cause within 13 to 17 days after surgery. Secondary efficacy outcomes included major venous thromboembolism (i.e., proximal deep-vein thrombosis, nonfatal pulmonary embolism, or death related to venous thromboembolism) and symptomatic venous thromboembolism. The primary safety outcome was major bleeding.</p><p>RESULTS: The primary efficacy outcome occurred in 79 of 824 patients (9.6%) who received rivaroxaban and in 166 of 878 (18.9%) who received enoxaparin (absolute risk reduction, 9.2%; 95% confidence interval [CI], 5.9 to 12.4; P<0.001). Major venous thromboembolism occurred in 9 of 908 patients (1.0%) given rivaroxaban and 24 of 925 (2.6%) given enoxaparin (absolute risk reduction, 1.6%; 95% CI, 0.4 to 2.8; P=0.01). Symptomatic events occurred less frequently with rivaroxaban than with enoxaparin (P=0.005). Major bleeding occurred in 0.6% of patients in the rivaroxaban group and 0.5% of patients in the enoxaparin group. The incidence of drug-related adverse events, mainly gastrointestinal, was 12.0% in the rivaroxaban group and 13.0% in the enoxaparin group.</p><p>CONCLUSIONS: Rivaroxaban was superior to enoxaparin for thromboprophylaxis after total knee arthroplasty, with similar rates of bleeding. (ClinicalTrials.gov number, NCT00361894.)</p>}}, author = {{Lassen, Michael R and Ageno, Walter and Borris, Lars C and Lieberman, Jay R and Rosencher, Nadia and Bandel, Tiemo J and Misselwitz, Frank and Turpie, Alexander G G}}, issn = {{0028-4793}}, keywords = {{Adult; Aged; Aged, 80 and over; Anticoagulants/adverse effects; Arthroplasty, Replacement, Knee; Double-Blind Method; Enoxaparin/adverse effects; Factor Xa Inhibitors; Female; Humans; Male; Middle Aged; Morpholines/adverse effects; Pulmonary Embolism/epidemiology; Rivaroxaban; Thiophenes/adverse effects; Venous Thromboembolism/epidemiology; Venous Thrombosis/epidemiology}}, language = {{eng}}, month = {{06}}, number = {{26}}, pages = {{86--2776}}, publisher = {{Massachusetts Medical Society}}, series = {{The New England journal of medicine}}, title = {{Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty}}, url = {{http://dx.doi.org/10.1056/NEJMoa076016}}, doi = {{10.1056/NEJMoa076016}}, volume = {{358}}, year = {{2008}}, }