The effects of rivaroxaban on the complications of surgery after total hip or knee replacement

Results from the RECORD programme

M. R. Lassen, M. Gent, A. K. Kakkar, B. I. Eriksson, M. Homering, S. D. Berkowitz, A. G. G. Turpie

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.

Footnotes

  • The Medical Dictionary for Regulatory Activities (MedDRA®) trademark is owned by IFPMA on behalf of ICH.

    This study was supported by Bayer HealthCare Pharmaceuticals and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. The authors would like to acknowledge S. Atkinson, who provided editorial support with funding from Bayer HealthCare Pharmaceuticals and Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    The author or one or more of the authors have received or will receive benefits for personal or professional use from a commercial party related directly or indirectly to the subject of this article.

  • Received February 24, 2012.
  • Accepted August 7, 2012.
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