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Rivaroxaban or Enoxaparin in Nonmajor Orthopedic Surgery.

C Marc Samama1, Silvy Laporte1, Nadia Rosencher1

  • 1From the Department of Anesthesia and Critical Care, Groupe Hospitalo-Universitaire Assistance Publique-Hôpitaux de Paris Centre-Université de Paris, Hôpital Cochin (C.M.S., N.R.), Unité de Recherche Clinique, Innovation, Pharmacologie, Centre Hospitalier Universitaire de Saint-Etienne, Sainboise INSERM Unité 1059, Université Jean Monnet, and INSERM CIE1408 (S.L., B.D., E.P., P. Mismetti), French Clinical Research Infrastructure Network (F-CRIN), Investigation Network on Venous Thromboembolism (INNOVTE) (S.L., P.G., P. Mismetti), and Institut du Thorax Curie-Montsouris, Institut Mutualiste Montsouris (P.G.), Paris, INSERM Centre National de la Recherche Scientifique 5558, Université Claude Bernard, Université de Lyon, Lyon (M.C.), and the Department of Anesthesia and Critical Care, Polyclinique du Parc, Saint Saulve (D.D.) - all in France; the Department of Anesthesia and Critical Care, University Hospital Doctor Peset, Valencia (J.L.), and the Department of Anesthesia and Critical Care, Hospital Universitario Fundación de Alcorcón, Madrid (J.M.-M.) - both in Spain; Sektionsleiter Endoprothetik, Sana Klinikum Offenbach, Offenbach am Main, Germany (P. Mouret); and McGill University, Montreal (W.F.).

The New England Journal of Medicine
|March 31, 2020
PubMed
Summary
This summary is machine-generated.

Rivaroxaban demonstrated superior efficacy compared to enoxaparin in preventing major venous thromboembolism following lower limb orthopedic surgery. This study highlights rivaroxaban as a more effective option for VTE prophylaxis in at-risk patients.

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Area of Science:

  • Orthopedic Surgery
  • Pharmacology
  • Vascular Medicine

Background:

  • Nonmajor orthopedic surgery of the lower limbs can lead to transient immobility, increasing the risk of venous thromboembolism (VTE).
  • Current prophylactic strategies aim to mitigate this risk, with enoxaparin being a common choice.

Purpose of the Study:

  • To compare the efficacy and safety of rivaroxaban versus enoxaparin in preventing major VTE in patients undergoing lower-limb nonmajor orthopedic surgery.
  • To assess if rivaroxaban is noninferior, and potentially superior, to enoxaparin for VTE prevention.

Main Methods:

  • An international, randomized, double-blind, noninferiority trial involving 3604 adult patients at risk for VTE.
  • Patients received either rivaroxaban or enoxaparin post-surgery.
  • Primary efficacy outcome was major VTE; safety outcomes included major and nonmajor bleeding.

Main Results:

  • Major VTE occurred in 0.2% of patients receiving rivaroxaban versus 1.1% receiving enoxaparin (P<0.001 for noninferiority; P=0.01 for superiority).
  • Rivaroxaban showed a statistically significant reduction in VTE events.
  • The incidence of major bleeding and nonmajor clinically relevant bleeding was similar between the two groups.

Conclusions:

  • Rivaroxaban is more effective than enoxaparin in preventing venous thromboembolic events after lower limb nonmajor orthopedic surgery.
  • Rivaroxaban offers a superior prophylactic option for VTE in this patient population.