Comparison between rivaroxaban versus enoxaparin for venous thromboembolism prophylaxis following spine surgeries, a randomized clinical trial

Abstract

Background: Enoxaparin is currently used for VTE prophylaxis. Rivaroxaban is more cost-effective and is as potent as enoxaparin in VTE prophylaxis. Methods: The study was held at Al-Zahra and Kashani university hospitals in Isfahan, Iran, from January 2019 to October 2020. Two hundred ninety-six patients requiring instrumented spine surgery were enrolled; 23 were excluded (lack of consent/interfering medical situations). They were randomized into the groups of rivaroxaban (case, n = 137) and enoxaparin receiving (control, n = 136). Medical data were recorded and 244 patients (case = 123, control = 121) were analyzed value < 0.05 was meaningful. Results: 150 patients were males, and 94 were females. The mean age was 52.09 +/- 12.6 years. Postoperative drain volume was higher in rivaroxaban received patients than in enoxaparin (p = 0.02). Post-operation epidural hematoma was detected in 3 patients in the case and 1 in the control group, which was not meaningful(p = 0.622). All of them were evacuated surgically. POH was associated with cervical canal stenosis surgery, existing comorbidities, and new medical events. New medical events were associated with postoperative wound dehiscence (p = 0.001). Short and long-term postoperative outcomes were similar in both groups. The mean follow-up duration was 25.8 +/- 7.5 months. Conclusion: Rivaroxaban is as effective as enoxaparin in venous thromboembolic event prophylaxis. Regarding postoperative epidural hematoma, statistical analysis showed equal safety of both drugs. Still, the authors would like to recommend more discretion in rivaroxaban administration in cervical spine laminectomy until future studies are conducted.