Fuji Takeshi, Fujita Satoru, Kimura Tetsuya, Ibusuki Kei, Abe Kenji, Tachibana Shintaro, Nakamura Mashio
Department of Orthopedic Surgery, Japan Community Healthcare Organization Osaka Hospital, 4-2-78 Fukushima, Fukushima-ku, Osaka 553-0003 Japan.
Department of Orthopedic Surgery, Takarazuka Daiichi Hospital, 19-5 Kogetsu-cho, Takarazuka, 665-0832 Japan.
Thromb J. 2016 Jun 8;14:13. doi: 10.1186/s12959-016-0087-z. eCollection 2016.
Guidelines from the Japanese Circulation Society recommend prophylaxis with anticoagulation plus intermittent pneumatic compression or graduated compression stockings (GCS) among patients at the highest risk for developing venous thromboembolism (VTE). However, the benefits of concomitant GCS use for patients undergoing total knee arthroplasty (TKA) and receiving anticoagulation remain unknown. In this study, the efficacy of GCS plus anticoagulation compared with anticoagulation alone was evaluated among patients undergoing TKA.
This study is a post hoc analysis of a previously reported phase 3 trial involving patients undergoing TKA. In the primary study, which permitted the use of GCS for mechanical prophylaxis, patients were randomized to receive edoxaban 30 mg once daily or enoxaparin 20 mg twice daily for 11 to 14 days following TKA. The primary endpoint was the incidence of VTE, a composite of symptomatic deep vein thrombosis (DVT), symptomatic pulmonary embolism (PE), and asymptomatic DVT. Treatment comparisons were performed using the chi-square test, and the 95 % confidence intervals were calculated.
Among patients receiving edoxaban, the incidence of VTE was 3.8 and 5.8 % for patients with and without GCS, respectively. For patients receiving enoxaparin, VTE incidence was 8.4 and 20.8 % among those with and without GCS, respectively. Overall, VTE incidence was 6.0 and 13.0 % for anticoagulated patients with and without GCS mechanical prophylaxis, respectively. No deaths or symptomatic PE were reported during this study.
Although the incidence of VTE was >2-fold lower among patients receiving anticoagulation plus GCS compared with those receiving anticoagulation alone, statistical significance was not achieved. Further studies are required to confirm the findings of this preliminary analysis.
ClinicalTrials.gov Identifier: NCT01181102.
日本循环学会的指南建议，对于发生静脉血栓栓塞（VTE）风险最高的患者，采用抗凝治疗加间歇性气动压迫或分级加压弹力袜（GCS）进行预防。然而，对于接受全膝关节置换术（TKA）并接受抗凝治疗的患者同时使用GCS的益处仍不明确。在本研究中，对接受TKA的患者评估了GCS加抗凝治疗与单纯抗凝治疗相比的疗效。
本研究是对先前报道的一项涉及接受TKA患者的3期试验的事后分析。在允许使用GCS进行机械预防的主要研究中，患者在TKA后11至14天被随机分配接受每日一次30mg依度沙班或每日两次20mg依诺肝素治疗。主要终点是VTE的发生率，其为有症状的深静脉血栓形成（DVT）、有症状的肺栓塞（PE）和无症状DVT的综合指标。使用卡方检验进行治疗比较，并计算95%置信区间。
在接受依度沙班治疗的患者中，使用和未使用GCS的患者VTE发生率分别为3.8%和5.8%。对于接受依诺肝素治疗的患者，使用和未使用GCS的患者VTE发生率分别为8.4%和20.8%。总体而言，接受抗凝治疗且有和没有GCS机械预防的患者VTE发生率分别为6.0%和13.0%。本研究期间未报告死亡或有症状的PE。
尽管接受抗凝加GCS治疗的患者VTE发生率比单纯接受抗凝治疗的患者低2倍以上，但未达到统计学显著性。需要进一步研究以证实这一初步分析的结果。
ClinicalTrials.gov标识符：NCT01181102。
