title: The effects of rivaroxaban on the complications of surgery after total hip or knee replacement: results from the RECORD programme.
abstract: Post-operative complications after total hip or knee replacement can delay recovery, prolong hospitalisation, increase rates of re-admission and, in the most severe cases, lead to long-term disability or even death. In this analysis of pooled data from four large, randomised, phase III clinical trials that compared the oral, direct Factor Xa inhibitor rivaroxaban with subcutaneous enoxaparin for the prevention of venous thromboembolism after total hip or knee replacement (n = 12,729), the incidence of complications, including bleeding and adverse events related to surgery (such as wound infection, wound dehiscence and haemarthrosis) are reported. Interventions and procedures relating to surgery are also compared between the groups. Bleeding events, including excessive wound haematoma and surgical-site bleeding, occurred at similar rates in the rivaroxaban and enoxaparin groups. Over the total study duration, adverse surgical events occurred at a similar rate in the rivaroxaban group compared with the enoxaparin group after total knee replacement (2.26% vs. 2.69%, respectively) and total hip replacement (1.48% vs. 1.65%, respectively). Blood loss, wound drainage and transfusion requirements were also similar between the two groups. This analysis shows that the incidence of adverse surgical events with rivaroxaban was similar to enoxaparin.
authors.affiliation: Spine Center Copenhagen, Clinical Trial Unit, Copenhagen University Hospital Glostrup, Ndr. Ringvej 57, DK-2600, Glostrup, Denmark. mrud0006@regionh.dk
authors.forename: M R
authors.initials: MR
authors.lastname: Lassen
authors.forename: M
authors.initials: M
authors.lastname: Gent
authors.forename: A K
authors.initials: AK
authors.lastname: Kakkar
authors.forename: B I
authors.initials: BI
authors.lastname: Eriksson
authors.forename: M
authors.initials: M
authors.lastname: Homering
authors.forename: S D
authors.initials: SD
authors.lastname: Berkowitz
authors.forename: A G G
authors.initials: AG
authors.lastname: Turpie
mesh_terms: D000925:Anticoagulants / Q000009:adverse effects / Q000627:therapeutic use*; D058737:Arthroplasty, Replacement, Ankle / Q000009:adverse effects*; D019645:Arthroplasty, Replacement, Knee / Q000009:adverse effects*; D017326:Clinical Trials, Phase III as Topic; D017984:Enoxaparin / Q000009:adverse effects / Q000627:therapeutic use*; D006395:Hemarthrosis; D006470:Hemorrhage; D006801:Humans; D009025:Morpholines / Q000009:adverse effects / Q000627:therapeutic use*; D011183:Postoperative Complications / Q000188:drug therapy* / Q000453:epidemiology; D016032:Randomized Controlled Trials as Topic; D000069552:Rivaroxaban; D013876:Thiophenes / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D054556:Venous Thromboembolism
chemical_list: D000925:Anticoagulants; D017984:Enoxaparin; D009025:Morpholines; D013876:Thiophenes; D000069552:Rivaroxaban