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Rivaroxaban or Enoxaparin in Nonmajor Orthopedic Surgery

Authors:
- Marc Samama, Silvy Laporte, Nadia Rosencher, Philippe Girard, Juan Llau, Patrick Mouret, William Fisher, Javier Martínez-Martín, Daniel Duverger, Béatrice Deygas, Emilie Presles, Michel Cucherat, Patrick Mismetti — for the PRONOMOS Investigators

Abstract

This double-blind, randomized trial investigated venous thromboembolism (VTE) prophylaxis in 3,604 adults undergoing nonmajor orthopedic surgery of the lower limbs. Participants received either oral rivaroxaban (10 mg daily) or subcutaneous enoxaparin (40 mg daily). The primary outcome was major VTE defined as symptomatic deep-vein thrombosis (DVT), pulmonary embolism, or VTE-related death, plus asymptomatic proximal DVT. Rivaroxaban significantly reduced major VTE (0.2% vs. 1.1%; RR 0.25; P<0.001 for noninferiority; P=0.01 for superiority) with no significant difference in major bleeding or clinically relevant nonmajor bleeding (1.1% vs. 1.0%). The findings support rivaroxaban’s use as effective and safe prophylaxis during lower-limb immobilization after nonmajor orthopedic procedures.

Keywords: rivaroxaban enoxaparin venous thromboembolism orthopedic surgery lower limbs PRONOMOS trial thromboprophylaxis deep-vein thrombosis pulmonary embolism bleeding risk
DOI: https://doi.ms/10.00420/ms/5691/EXQEW/EDV | Volume: 382 | Issue: 20 | Views: 0
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