GRADUATED COMPRESSION STOCKINGS DO NOT ADD TO THE EFFICACY OF FONDAPARINUX FOR THROMBOPROPHYLAXIS IN HIP REPLACEMENT SURGERY. A MULTI-CENTRE, MULTI-NATIONAL, RANDOMISED, OPEN-LABEL STUDY.

Abstract

Introduction: Pharmacological and mechanical methods are recommended to prevent venous thromboembolism (VTE) following hip replacement (THR). However, data on mechanical methods such as graduated compressive stockings (GCS) are limited. This study examined the efficacy and safety of GCS when added to fondaparinux.

Methods: The randomised treatments were 2.5 mg fondaparinux for 5–9 days starting postoperatively alone or with GCS for 42±7 days. The primary efficacy outcome was VTE or sudden death prior to Day 42±7. All patients were to have duplex USS at day 42 + 7. VTE was defined by verified symptomatic VTE or asymptomatic proximal DVT. The main safety outcomes were major and minor bleeding and VTE death.

Results: 856 patients were randomised, of which 799 were THR patients. Of these 756 (95%) were evaluable, 377 in the fondaparinux and 379 in the fondaparinux plus GCS groups. Risk factors for thrombosis were recorded (age > 75 in 20%, history of obesity in 21%, cancer in 6% and VTE in 3%). Compliance with GCS was high, with 85% wearing them continuously. The primary efficacy outcome of VTE or sudden death in THR patients was similar in each treatment group, the results were 5.5% in the fondaparinux only group and 5.3% in the fondaparinux with GCS group; odds ratio was 0.96, 95% confidence interval 0.50–1.83, p=0.91. Outcomes were not different for long-length and short-length stockings. Major bleeding occurred in one patient (< 1%), minor bleeding in 6.7%. No VTE deaths were reported.

Discussion: The addition of GCS to fondaparinux showed no benefit in thromboprophylaxis over fondaparinux alone in this large study of THR patients. Therefore GCS may not be indicated in patients receiving fondaparinux. Graduated compression stockings are time consuming to measure and fit, inconvenient and expensive; therefore we recommend a reconsideration of this current and commonly used practice in THR.