OBJECTIVES To investigate whether the use of graduated compression stockings (GCS) offers any adjuvant benefit when pharmaco-thromboprophylaxis is used for venous thromboembolism prophylaxis in patients undergoing elective surgery. DESIGN Open, multicentre, randomised, controlled, non-inferiority trial. SETTING Seven National Health Service tertiary hospitals in the United Kingdom. PARTICIPANTS 1905 elective surgical inpatients (≥18 years) assessed as being at moderate or high risk of venous thromboembolism were eligible and consented to participate. INTERVENTION Participants were randomly assigned (1:1) to receive low molecular weight heparin (LMWH) pharmaco-thromboprophylaxis alone or LMWH pharmaco-thromboprophylaxis and GCS. OUTCOME MEASURES The primary outcome was imaging confirmed lower limb deep vein thrombosis with or without symptoms, or pulmonary embolism with symptoms within 90 days of surgery. Secondary outcome measures were quality of life, compliance with stockings and LMWH, lower limb complications related to GCS, bleeding complications, adverse reactions to LMWH, and all cause mortality. RESULTS Between May 2016 and January 2019, 1905 participants were randomised. 1858 were included in the intention to treat analysis (17 were identified as ineligible after randomisation and 30 did not undergo surgery). A primary outcome event occurred in 16 of 937 (1.7%) patients in the LMWH alone group compared with 13 of 921 (1.4%) in the LMWH and GCS group. The risk difference between the two groups was 0.30% (95% confidence interval -0.65% to 1.26%). Because the 95% confidence interval did not cross the non-inferiority margin of 3.5% (P<0.001 for non-inferiority), LMWH alone was confirmed to be non-inferior. CONCLUSIONS For patients who have elective surgery and are at moderate or high risk of venous thromboembolism, administration of pharmaco-thromboprophylaxis alone is non-inferior to a combination of pharmaco-thromboprophylaxis and GCS. These findings indicate that GCS might be unnecessary in most patients undergoing elective surgery. TRIAL REGISTRATION ISRCTN13911492.

中文翻译：

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分级压力袜作为择期手术患者药物血栓预防的辅助手段（GAPS 研究）：随机对照试验。

目的 研究当药物血栓预防用于择期手术患者的静脉血栓栓塞预防时，使用分级弹力袜 (GCS) 是否提供任何辅助益处。设计 开放、多中心、随机、对照、非劣效性试验。设置 英国的七家国家卫生服务三级医院。参与者 1905 名经评估为中度或高度静脉血栓栓塞风险的择期手术住院患者（≥18 岁）符合条件并同意参与。干预 参与者被随机分配 (1:1) 接受单独的低分子量肝素 (LMWH) 药物血栓预防或 LMWH 药物血栓预防和 GCS。结果测量 主要结果是影像学证实有或无症状的下肢深静脉血栓形成，或在手术后 90 天内出现症状的肺栓塞。次要结局指标是生活质量、对长袜和 LMWH 的依从性、与 GCS 相关的下肢并发症、出血并发症、对 LMWH 的不良反应和全因死亡率。结果 2016 年 5 月至 2019 年 1 月期间，1905 名参与者被随机分组​​。1858 人被纳入意向治疗分析（17 人在随机化后被确定为不合格，30 人未接受手术）。LMWH 单独组 937 名患者中有 16 名（1.7%）发生了主要结局事件，而 LMWH 和 GCS 组 921 名患者中有 13 名（1.4%）发生了主要结局事件。两组之间的风险差异为 0.30%（95% 置信区间 -0.65% 至 1.26%）。因为 95% 的置信区间没有超过 3.5% 的非劣效性边界（非劣效性 P<0.001），单独的 LMWH 被证实是非劣效的。结论 对于接受择期手术且处于中度或高度静脉血栓栓塞风险的患者，单独使用药物血栓预防并不劣于药物血栓预防和 GCS 的组合。这些发现表明，在大多数接受择期手术的患者中，GCS 可能是不必要的。试用注册 ISRCTN13911492。