Mariscal Gonzalo, Tarazona-Santabalbina Francisco José, Marin-Peña Oliver, Rotavista Erika, Martín Sara Arroyo, de Sevilla María Estrella Fernández, Gómez-Vallejo Jesús
Institute for Research on Musculoskeletal Disorders, Valencia Catholic University, Carrer de Quevedo, 2, València, 46001, Spain.
Geriatrics Department, University Hospital of la Ribera, Alzira, Valencia, Spain.
J Orthop Surg Res. 2025 May 29;20(1):538. doi: 10.1186/s13018-025-05950-6.
As life expectancy increases, the incidence of hip fractures and the demand for total hip arthroplasties (THA) are expected to rise. This demographic shift poses significant challenges, particularly in managing post-operative complications such as venous thromboembolism (VTE), a major cause of mortality. Despite advancements, the effectiveness of various anticoagulants, in preventing VTE post-THA or hip fracture surgery remains unclear due to conflicting study results. This study aims to thoroughly evaluate the efficacy and safety of fondaparinux in patients undergoing elective THA or hip fracture surgery.
This review adhered to PRISMA guidelines. Inclusion criteria targeted studies on hip surgery patients treated with fondaparinux versus placebo or other anticoagulants. Data was collected from three major databases in November 2024 using the PICOS framework, focusing on following outcomes: venous thromboembolism, mortality, and bleeding rates. Meta-analysis utilized Review Manager 5.4, and applying a fixed-effects model unless significant heterogeneity (I² ≥ 50%) was detected. Sensitivity and subgroup analyses further refined the results based on surgery type and control groups.
Nineteen studies (n = 32534) were included in the meta-analysis. Fondaparinux significantly reduced the incidence of VTE compared to controls (OR 0.43, 95% CI 0.31 to 0.61) and low molecular weight heparins (LMWHs) (OR 0.55, 95% CI 0.41 to 0.74). The incidence of distal deep vein thrombosis (DVT) was also lower in fondaparinux group compared to LMWHs (OR 0.43, 95% CI 0.31 to 0.62). Proximal DVT showed a significant reduction overall (OR 0.33, 95% CI 0.15 to 0.75) in fondaparinux group, with no significant difference compared to enoxaparin specifically (OR 0.48, 95% CI 0.20 to 1.17). Additionally, there were no substantial differences in clinically significant bleeding. The average costs (euros, pounds and/or dollars) per patient per thromboembolic event at 90 days were lower in the fondaparinux group compared to enoxaparin, both in patients undergoing elective THA (132 vs. 216) and hip fracture surgery (339 vs. 518).
Based on the results of this meta-analysis, fondaparinux significantly reduced VTE and DVT incidence compared to LMWHs in patients undergoing elective THA and hip fracture surgery, with a similar incidence of clinically significant bleeding. Additionally, it demonstrated lower costs per thrombsoembolic event per patient than enoxaparin.
随着预期寿命的增加，髋部骨折的发生率以及全髋关节置换术（THA）的需求预计将会上升。这种人口结构的转变带来了重大挑战，尤其是在处理术后并发症方面，如静脉血栓栓塞（VTE），这是一个主要的死亡原因。尽管取得了进展，但由于研究结果相互矛盾，各种抗凝剂在预防THA或髋部骨折手术后的VTE方面的有效性仍不明确。本研究旨在全面评估磺达肝癸钠在接受择期THA或髋部骨折手术患者中的疗效和安全性。
本综述遵循PRISMA指南。纳入标准针对接受磺达肝癸钠治疗与安慰剂或其他抗凝剂治疗的髋部手术患者的研究。2024年11月使用PICOS框架从三个主要数据库收集数据，重点关注以下结果：静脉血栓栓塞、死亡率和出血率。荟萃分析使用Review Manager 5.4，除非检测到显著异质性（I²≥50%），否则应用固定效应模型。敏感性和亚组分析根据手术类型和对照组进一步细化结果。
19项研究（n = 32534）纳入荟萃分析。与对照组（OR 0.43，95%CI 0.31至0.61）和低分子量肝素（LMWHs）（OR 0.55，95%CI 0.41至0.74）相比，磺达肝癸钠显著降低了VTE的发生率。与LMWHs相比，磺达肝癸钠组远端深静脉血栓形成（DVT）的发生率也较低（OR 0.43，95%CI 0.31至0.62）。磺达肝癸钠组近端DVT总体上显著降低（OR 0.33，95%CI 0.15至0.75），与依诺肝素相比无显著差异（OR 0.48，95%CI 0.20至1.17）。此外，在具有临床意义的出血方面没有实质性差异。在接受择期THA的患者（132对216）和髋部骨折手术的患者（339对518）中，磺达肝癸钠组每例患者每90天血栓栓塞事件的平均成本（欧元、英镑和/或美元）低于依诺肝素。
基于该荟萃分析的结果，在接受择期THA和髋部骨折手术的患者中，与LMWHs相比，磺达肝癸钠显著降低了VTE和DVT的发生率，具有临床意义的出血发生率相似。此外，它显示出每例患者每血栓栓塞事件的成本低于依诺肝素。
