Abstract
Introduction
Rivaroxiban is a direct inhibitor of factor Xa, a licensed oral thromboprophylactic agent that is increasingly being adopted for lower limb arthroplasty. Rivaroxiban has been NICE-approved for use in primary hip and knee arthroplasty following the RECORD 4 trials; proving it more effective in preventing venous thrombo-embolic (VTE) events compared to enoxaparin. Enhanced Recovery Programmes (ERP) are designed to enable patients to recover quickly and return home safely within a few days.
Methods
We prospectively studied 1223 patients (age- and sex-matched) who underwent lower-limb arthroplasty enrolled in our ERP between March 2010 and December 2011; 454 patients (Group 1) received enoxaparin, 769 patients (Group 2) received rivaroxiban. Patients wore thrombo-embolic stockings for six weeks post surgery. Patients were monitored for thrombo-embolic events and wound-related complications for 42 days post-operatively.
Results
1223 patients underwent lower-limb arthroplasty during our study period. There were similar numbers of THRs and TKRs in each group 230:224 and 370:399. Average length of stay was 4.9 days (range 1–19) in group 1 and 4.5 days (range 2–23) in group 2. The rate of VTE events was the same in both groups (< 1%). In group 1 (enoxaparin), 21(4.6%) of the 454 patients experienced oozing/infected wounds that required further surgical attention. In group 2 (rivaroxiban), 46 (6%) of the 769 patients had wound-related complications, of which 70% were in primary THR patients.
Conclusion
Rivaroxabans use in clinical practice has been questioned concerning its wound-related complications. The RECORD 4 trial focused on major bleeding as the primary safety outcome, however we postulate slow post-operative oozing can lead to haematoma formation, increasing the risk of superficial wound and deep infections potentially requiring revision surgery. This study shows an increased wound complication rate in the Rivaroxiban group, highlighting the need for further clinical trials to assess its safety and efficacy.
