Kashani Hamid Reza Khayat, Salimi Sohrab, Alizadeh Pooyan, Paryan Poorya, Mohammadi Zahra, Kachoueian Naser, Heli Maryam, Ghalandari Nasibeh, Esmaily Hadi
Department of Neurosurgery, Imam Hossein medical centre, Shahid Beheshti University of Medical Sciences, Madani street, Tehran, Iran.
Department of Anaesthesiology, Imam Hossein medical centre, Shahid Beheshti University of Medical Sciences, Madani street, Tehran, Iran.
Eur Spine J. 2025 May;34(5):1926-1933. doi: 10.1007/s00586-025-08747-7. Epub 2025 Apr 1.
Venous thromboembolism (VTE) is a significant postoperative complication. The most recommended prophylactic measures involve using the unfractionated heparin, and low molecular weight heparins. Since oral anticoagulants can be administered orally and are cost-effective, they have recently gained attention as a newer intervention. This study aimed to compare the effects of rivaroxaban, and enoxaparin thromboprophylaxis in degenerative spine surgeries.
Patients diagnosed with degenerative disc disease, and undergoing spinal surgery were randomly assigned to receive either a subcutaneous injection of 40 mg enoxaparin or 10 mg oral rivaroxaban daily in a non-inferiority trial. The evaluation at two weeks, and three months after surgery included the assessments of VTE and other postoperative complications.
According to the study protocol, 220 patients were enrolled in the study and included in the intention-to-treat analysis. However, the results were only available for 204 subjects as per-protocol. Ninety-seven in enoxaparin and 107 in rivaroxaban group. VTE was detected in 4 patients (3.6%) in the enoxaparin group, and 2 patients (1.9%) in the rivaroxaban group (P = 0.154). Reoperation rates were significantly higher in the enoxaparin group (P = 0.008). Moreover, the enoxaparin group experienced a significantly longer hospital stay (P = 0.033). However, other outcomes did not show significant differences between two groups (P > 0.05).
This study shows that rivaroxaban effectively prevents VTE incidence in degenerative disc spinal surgeries which is non-inferior to enoxaparin in terms of VTE prophylaxis. Furthermore, the patients in the rivaroxaban group experienced shorter hospital stays and a lower necessity for reoperation.
静脉血栓栓塞症（VTE）是一种严重的术后并发症。最推荐的预防措施包括使用普通肝素和低分子肝素。由于口服抗凝剂可口服给药且具有成本效益，它们最近作为一种新的干预措施受到关注。本研究旨在比较利伐沙班和依诺肝素在退行性脊柱手术中预防血栓形成的效果。
在一项非劣效性试验中，将诊断为退行性椎间盘疾病并接受脊柱手术的患者随机分配，分别每日皮下注射40mg依诺肝素或口服10mg利伐沙班。术后两周和三个月的评估包括对VTE和其他术后并发症的评估。
根据研究方案，220例患者纳入研究并进行意向性分析。然而，根据方案，仅204例受试者有结果。依诺肝素组97例，利伐沙班组107例。依诺肝素组4例患者（3.6%）检测到VTE，利伐沙班组2例患者（1.9%）检测到VTE（P = 0.154）。依诺肝素组再次手术率显著更高（P = 0.008）。此外，依诺肝素组住院时间显著更长（P = 0.033）。然而，两组之间的其他结果没有显著差异（P > 0.05）。
本研究表明，利伐沙班可有效预防退行性椎间盘脊柱手术中的VTE发生率，在预防VTE方面不劣于依诺肝素。此外，利伐沙班组患者住院时间更短，再次手术的必要性更低。
