Rivaroxaban versus enoxaparin as thromboprophylaxis in degenerative spine surgery: a randomized blinded non-inferiority study

被引:0
作者
Kashani, Hamid Reza Khayat [1 ]
Salimi, Sohrab [2 ]
Alizadeh, Pooyan [3 ]
Paryan, Poorya [1 ]
Mohammadi, Zahra [1 ]
Kachoueian, Naser [4 ]
Heli, Maryam [1 ]
Ghalandari, Nasibeh [5 ]
Esmaily, Hadi [6 ,7 ,8 ]
机构
[1] Shahid Beheshti Univ Med Sci, Imam Hossein Med Ctr, Dept Neurosurg, Madani St, Tehran, Iran
[2] Shahid Beheshti Univ Med Sci, Imam Hossein Med Ctr, Dept Anaesthesiol, Madani St, Tehran, Iran
[3] Ahvaz Jundishapur Univ Med Sci, Dept Neurosurg, Ahwaz, Iran
[4] Shahid Beheshti Univ Med Sci, Imam Hossein Med Ctr, Dept Surg, Madani St, Tehran, Iran
[5] Hamadan Univ Med Sci, Sch Pharm, Dept Clin Pharm, Hamadan, Iran
[6] Shahid Beheshti Univ Med Sci, Sch Pharm, Dept Clin Pharm, Tehran, Iran
[7] Shahid Beheshti Univ Med Sci, Imam Hossein Educ Hosp, Clin Res Dev Ctr, Tehran, Iran
[8] Shahid Beheshti Univ Med Sci, Sch Pharm, Valiasr ST, Tehran 1996835113, Iran
关键词
Enoxaparin; Rivaroxaban; Spinal surgery; Venous thromboembolic event; Degenerative disc disease; VENOUS THROMBOEMBOLISM; TOTAL HIP; ORTHOPEDIC-SURGERY; PREVENTION; DABIGATRAN; WARFARIN; COST;
D O I
10.1007/s00586-025-08747-7
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
Purpose 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. Method 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. Result 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). Conclusion 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.
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页码:1926 / 1933
页数:8
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