Fallaha Mohammad Amre, Radha Sarkhell, Patel Sheena
1Imperial College School of Medicine, London, UK.
2Department of Orthopaedics, Chelsea and Westminster Hospital (CWH), London, UK.
Patient Saf Surg. 2018 Aug 14;12:22. doi: 10.1186/s13037-018-0169-x. eCollection 2018.
Venous thromboembolism (VTE) remains a significant complication following knee and hip arthroplasty. National and international guidelines recommend pharmacological and mechanical thromboprophylaxis following surgery, unless contraindicated, to reduce the risk of VTE. This study aimed to explore the safety and efficacy profile of an adapted thromboprophylaxis regimen consisting of sequential enoxaparin and rivaroxaban for thromboprophylaxis following knee or hip arthroplasty at a London teaching hospital.
A total of 265 patients who received sequential enoxaparin and rivaroxaban and mechanical thromboprophylaxis following knee and hip arthroplasty were included in the study. Efficacy outcomes assessed for 90 days post-operatively included: pulmonary embolism, deep-vein thrombosis, other VTE, myocardial infarction, stroke and death secondary to thrombosis. Safety outcomes were assessed during and for two days after thromboprophylaxis course duration and consisted of major bleeding episodes, clinically-relevant non-major bleeding episodes, and total bleeding.
There was 1 patient (0.4%) who experienced a stroke, and no other efficacy outcomes occurred. Major bleeding occurred in 2.3% ( = 6/265) of patients, whilst clinically-relevant non-major bleeding occurred in 3.4% ( = 9/265), with a total bleeding incidence of 16.2% ( = 43/265). No patients required a return to theatre.
The regimen consisting of sequential enoxaparin and rivaroxaban is associated with a significant bleeding risk, although the risk of patients requiring a return to theatre is low. Further prospective trials are required to compare the safety and efficacy profiles of this regimen with established thromboprophylaxis regimens.
静脉血栓栓塞症（VTE）仍是膝关节和髋关节置换术后的一个重大并发症。国家和国际指南建议，除非有禁忌证，术后应进行药物和机械性血栓预防，以降低VTE风险。本研究旨在探讨一种调整后的血栓预防方案的安全性和有效性，该方案由依诺肝素和利伐沙班序贯用药组成，用于伦敦一家教学医院膝关节或髋关节置换术后的血栓预防。
本研究纳入了265例在膝关节和髋关节置换术后接受依诺肝素和利伐沙班序贯用药及机械性血栓预防的患者。术后90天评估的疗效指标包括：肺栓塞、深静脉血栓形成、其他VTE、心肌梗死、中风以及血栓继发死亡。在血栓预防疗程期间及疗程结束后两天评估安全性指标，包括大出血事件、临床相关非大出血事件和总出血情况。
有1例患者（0.4%）发生中风，未出现其他疗效指标事件。2.3%（n = 6/265）的患者发生大出血，而临床相关非大出血事件发生率为3.4%（n = 9/265），总出血发生率为16.2%（n = 43/265）。没有患者需要返回手术室。
依诺肝素和利伐沙班序贯用药方案有显著的出血风险，尽管患者返回手术室的风险较低。需要进一步的前瞻性试验来比较该方案与既定血栓预防方案的安全性和有效性。
