Efficacy and safety of rivaroxaban versus low-molecular-weight heparin therapy in patients with lower limb fractures

Abstract

Thromboprophylaxis with rivaroxaban has proved effective and safe in patients undergoing hip and knee replacement surgery. As it is unclear whether it is also effective and safe in fracture patients, the aim of the present study was to evaluate the efficacy and safety of rivaroxaban in patients with lower limb fractures. We performed a retrospective cohort study of 2,050 consecutive patients treated for lower limb fractures at our trauma center, comparing rates of venous thromboembolism (VTE), bleeding and surgical complications, and the length of hospital stay for 608 patients who received rivaroxaban and 717 who received a low-molecular-weight heparin (LMWH). Rates of symptomatic VTE were 4.9 and 8.6% in the rivaroxaban and LMWH groups, respectively (p = 0.008), and distal VTE rates were 1.8 and 5.7%, respectively (p = 0.036). The incidence of major bleeding events in the rivaroxaban group was also lower than in the LMWH group (0.2 vs 0.6%), but the difference between the groups was not statistically significant. The mean length of hospital stay was significantly shorter in the rivaroxaban group (12.2 vs 13.1 days, respectively; p = 0.016). This retrospective cohort study is the first report documenting the efficacy and safety of rivaroxaban in patients with lower extremity fractures. In comparison with LMWH, rivaroxaban reduced the incidence of VTE by 45% without increasing the risk of bleeding. However, prospective, randomized controlled trials comparing rivaroxaban and LMWH are needed to confirm our findings.

Rivaroxaban does not impair fracture healing in a rat femur fracture model: an experimental study

“…Factor Xa is the active form of the coagulation factor thrombokinase and is synthesised in liver. Long et al have recently shown that in comparison with LMW heparins rivaroxaban reduced the incidence of VTE by 45% without increasing the risk of bleeding in patients with lower extremity fractures [ 10 ]. Patients receiving rivaroxaban do not need to undergo daily injection or regular drug monitoring and therefore profit from a higher comfort and greater compliance.…”

Management of Patients Taking Oral Anticoagulants Who Need Urgent Surgery for Hip Fracture

“…However, patients taking rivaroxaban were younger and with a lower number of fractures than patients taking LMWH. 19 All data on NOACs so far available in the field of emergency surgery are obtained in small cohorts or subgroups of patients and in retrospective studies; thus, we must be cautious of generalizing the results. Additional data from large and "ad hoc" studies in patients undergoing emergency hip fracture surgery are needed to provide evidence that NOACs are at least as effective and safe as LMWHs in emergency orthopaedic surgery.…”

Risk of gastrointestinal bleeding with direct oral anticoagulants: a systematic review and network meta-analysis

“…The evidence network for the primary analysis (figure 2) included 31 studies and six observational studies (52,(55)(56)(57)(58)62)) reporting on 287, 692 patients exposed to 230, 090 years of anticoagulant medication. We were unable to separate out upper and lower GI bleeds as most of the studies did not include this information.…”