A RCT study of Rivaroxaban, low-molecular-weight heparin, and sequential medication regimens for the prevention of venous thrombosis after internal fixation of hip fracture

Biomed Pharmacother. 2017 Aug:92:982-988. doi: 10.1016/j.biopha.2017.05.107. Epub 2017 Jun 8.

Abstract

The guidelines for the prevention of venous thromboembolism in orthopedic surgeries have reached a consensus on the postoperative conventional anticoagulation. However, the choice of anticoagulant drugs is yet controversial. The use of the drug rivaroxaban is expensive. Since the compliance of patients with low-molecular-weight heparin is considerably low, a cost-effective, efficacious and convenient anticoagulant program is essential. The present study investigated the efficacy, safety, patient compliance, and cost-effectiveness of low-molecular-weight heparin with sequential Rivaroxaban anticoagulant therapy in patients with a hip fracture, following internal fixation. A total of 287 patients with hip fractures were randomized into three groups: Rivaroxaban alone, Enoxaparin alone, and Enoxaparin followed by Rivaroxaban. The primary endpoint was the incidence of postoperative VTE, whereas the secondary endpoints were the compliance and treatment costs. Adverse reactions included bleeding and wound complications. The incidences of VTE were 5.21%, 14.74%, and 10.42% in the Rivaroxaban, low-molecular-weight heparin, and sequential therapy groups, respectively. The VTE-related mortality rates were 0%, 1.05%, and 1.04%. The average hospital stay was 12±8,15±7, and 11±5d, whereas the compliance rates of the three groups were 82.3%, 71.6%, and 88.5%, respectively. The incidences of adverse incisions were 14.6%, 4.2%, and 6.3% for the three groups examined. The effects and the incidence of postoperative bleeding in the treatment of low-molecular-weight heparin followed by Rivaroxaban did not differ significantly from that of Rivaroxaban alone. However, the postoperative drainage, the cost of treatment and the incidence of VTE reduced significantly, whereas the incidences of adverse incisions and the patient compliance were increased.

Trial registration: ChiCTR-INR-17010495.

Keywords: Enoxaparin; Hip fracture; Prophylaxis; Rivaroxaban; Venous thromboembolism.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Aged, 80 and over
  • China
  • Cost-Benefit Analysis
  • Double-Blind Method
  • Drug Administration Schedule
  • Drug Costs
  • Drug Therapy, Combination
  • Enoxaparin / administration & dosage*
  • Enoxaparin / adverse effects
  • Enoxaparin / economics
  • Factor Xa Inhibitors / administration & dosage*
  • Factor Xa Inhibitors / adverse effects
  • Factor Xa Inhibitors / economics
  • Female
  • Fracture Fixation, Internal / adverse effects*
  • Fracture Fixation, Internal / economics
  • Hemorrhage / chemically induced
  • Hip Fractures / complications
  • Hip Fractures / diagnostic imaging
  • Hip Fractures / economics
  • Hip Fractures / surgery*
  • Humans
  • Male
  • Medication Adherence
  • Middle Aged
  • Prospective Studies
  • Risk Factors
  • Rivaroxaban / administration & dosage*
  • Rivaroxaban / adverse effects
  • Rivaroxaban / economics
  • Time Factors
  • Treatment Outcome
  • Venous Thromboembolism / diagnosis
  • Venous Thromboembolism / economics
  • Venous Thromboembolism / etiology
  • Venous Thromboembolism / prevention & control*

Substances

  • Enoxaparin
  • Factor Xa Inhibitors
  • Rivaroxaban