Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty.

Raffaele Landolfi, Mr Lassen, W Ageno, Borris Lc, Lieberman Jr, N Rosencher, Bandel Tj, F Misselwitz, Turpie Ag

Risultato della ricerca: Contributo in rivistaArticolo in rivista

1193 Citazioni (Scopus)

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, 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.)
Lingua originaleEnglish
pagine (da-a)2776-2786
Numero di pagine11
RivistaNew England Journal of Medicine
Stato di pubblicazionePubblicato - 2008

Keywords

  • Rivaroxaban
  • hip arthroplasty
  • thromboprophylaxis

Fingerprint Entra nei temi di ricerca di 'Rivaroxaban versus enoxaparin for thromboprophylaxis after hip arthroplasty.'. Insieme formano una fingerprint unica.

Cita questo