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Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty

Lassen, Michael R ; Ageno, Walter ; Borris, Lars C ; Lieberman, Jay R ; Rosencher, Nadia ; Bandel, Tiemo J ; Misselwitz, Frank and Turpie, Alexander G G (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.)

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author
; ; ; ; ; ; and
contributor
Levine, M ; LU orcid and Wykman, A
author collaboration
organization
publishing date
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
Massachussetts Medical Society
external identifiers
  • scopus:45949103416
  • pmid:18579812
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
2025-10-29 23:10:37
@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&lt;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    = {{Massachussetts 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}},
}