法国巴黎大学附属医院C. Marc Samama小组在研究中取得进展。他们比较了利伐沙班和依诺肝素在非大型骨科手术后的疗效。该项研究成果发表在2020年3月29日出版的《新英格兰医学杂志》上。

下肢非大型骨科手术会导致短暂的活动性降低，从而使患者处于静脉血栓栓塞的风险中。利伐沙班预防这些患者的严重静脉血栓栓塞发生可能不逊于依诺肝素。

在这项国际、平行、随机、双盲、非劣效性试验中，研究组招募了3604例接受了下肢非大型骨科手术且静脉血栓栓塞风险较高的成年患者，将其随机分组，其中1809例接受利伐沙班治疗，1795例接受依诺肝素治疗。

严重静脉血栓栓塞的主要疗效结局是有症状的远端或近端深静脉血栓形成、肺栓塞、治疗期间与静脉血栓栓塞相关的死亡、治疗结束时无症状的近端深静脉血栓形成的综合结果。

利伐沙班组有0.2%的患者发生严重静脉血栓栓塞，依诺肝素组有1.1%，风险比为0.25。利伐沙班组与依诺肝素组的出血发生率分别为1.1%和1.0%，无显著差异。

总之，在下肢非大型骨科手术后的非活动期间，利伐沙班与依诺肝素相比，可更有效地预防静脉血栓栓塞事件。

附：英文原文

Title: Rivaroxaban or Enoxaparin in Nonmajor Orthopedic Surgery | NEJM

Author: C. Marc Samama, M.D.,, Silvy Laporte, Ph.D.,, Nadia Rosencher, M.D.,, Philippe Girard, M.D.,, Juan Llau, M.D.,, Patrick Mouret, M.D.,, William Fisher, M.D.,, Javier Martínez-Martín, M.D,, Daniel Duverger, M.D.,, Béatrice Deygas, M.Sc.,, Emilie Presles, M.Sc.,, Michel Cucherat, M.D.,, and Patrick Mismetti, M.D.

Issue&Volume: 2020-03-29

Abstract: Abstract

Background

Nonmajor orthopedic surgery of the lower limbs that results in transient reduced mobility places patients at risk for venous thromboembolism. Rivaroxaban may be noninferior to enoxaparin with regard to the prevention of major venous thromboembolism in these patients.

Methods

In this international, parallel-group, randomized, double-blind, noninferiority trial, we randomly assigned adult patients undergoing lower-limb nonmajor orthopedic surgery who were considered to be at risk for venous thromboembolism on the basis of the investigator’s judgment to receive either rivaroxaban or enoxaparin. The primary efficacy outcome of major venous thromboembolism was a composite of symptomatic distal or proximal deep-vein thrombosis, pulmonary embolism, or venous thromboembolism–related death during the treatment period or asymptomatic proximal deep-vein thrombosis at the end of treatment. A test for superiority was planned if rivaroxaban proved to be noninferior to enoxaparin. For all outcomes, multiple imputation was used to account for missing data. Prespecified safety outcomes included major bleeding (fatal, critical, or clinically overt bleeding or bleeding at the surgical site leading to intervention) and nonmajor clinically relevant bleeding.

Results

A total of 3604 patients underwent randomization; 1809 patients were assigned to receive rivaroxaban, and 1795 to receive enoxaparin. Major venous thromboembolism occurred in 4 of 1661 patients (0.2%) in the rivaroxaban group and in 18 of 1640 patients (1.1%) in the enoxaparin group (risk ratio with multiple imputation, 0.25; 95% confidence interval, 0.09 to 0.75; P<0.001 for noninferiority; P=0.01 for superiority). The incidence of bleeding did not differ significantly between the rivaroxaban group and the enoxaparin group (1.1% and 1.0%, respectively, for major bleeding or nonmajor clinically relevant bleeding; 0.6% and 0.7%, respectively, for major bleeding).

Conclusions

Rivaroxaban was more effective than enoxaparin in the prevention of venous thromboembolic events during a period of immobilization after nonmajor orthopedic surgery of the lower limbs.

DOI: 10.1056/NEJMoa1913808

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa1913808