title: 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.
authors.affiliation: Department of Orthopedics, Chinese PLA General Hospital, Beijing, 100853, People's Republic of China.
authors.forename: Anhua
authors.initials: A
authors.lastname: Long
authors.forename: Lihai
authors.initials: L
authors.lastname: Zhang
authors.forename: Yingze
authors.initials: Y
authors.lastname: Zhang
authors.forename: Baoguo
authors.initials: B
authors.lastname: Jiang
authors.forename: Zhi
authors.initials: Z
authors.lastname: Mao
authors.forename: Hongda
authors.initials: H
authors.lastname: Li
authors.forename: Shanbao
authors.initials: S
authors.lastname: Zhang
authors.forename: Zongyan
authors.initials: Z
authors.lastname: Xie
authors.forename: Peifu
authors.initials: P
authors.lastname: Tang
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000008:administration & dosage* / Q000009:adverse effects; D065427:Factor Xa Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D050723:Fractures, Bone / Q000453:epidemiology / Q000628:therapy*; D006470:Hemorrhage / Q000139:chemically induced / Q000453:epidemiology; D006495:Heparin, Low-Molecular-Weight / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D015994:Incidence; D007902:Length of Stay; D035002:Lower Extremity / Q000293:injuries; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000008:administration & dosage* / Q000009:adverse effects; D011183:Postoperative Complications / Q000139:chemically induced / Q000453:epidemiology; D012189:Retrospective Studies; D000069552:Rivaroxaban; D013876:Thiophenes / Q000008:administration & dosage* / Q000009:adverse effects; D054556:Venous Thromboembolism / Q000139:chemically induced / Q000453:epidemiology
chemical_list: D000925:Anticoagulants; D065427:Factor Xa Inhibitors; D006495:Heparin, Low-Molecular-Weight; D009025:Morpholines; D013876:Thiophenes; D000069552:Rivaroxaban