Importance The guidelines by the National Comprehensive Cancer Network and the American Society for Clinical Oncology recommend the routine use of thromboprophylaxis for patients with gastric adenocarcinoma. However, many physicians in Asian countries use venous thromboembolism (VTE) prophylaxis much less often because of the perceived lower VTE incidence in this population.

Objectives To evaluate the incidence of postgastrectomy VTE in Korean patients with gastric adenocarcinoma, and to identify the complications and evaluate the efficacy and safety of VTE prevention methods.

Design, Setting, and Participants The Optimal Prophylactic Method for Venous Thromboembolism After Gastrectomy in Korean Patients (PROTECTOR) randomized clinical trial was conducted between August 1, 2011, and March 31, 2015. Patients with histologically confirmed gastric adenocarcinoma presenting to a single center (Seoul St Mary’s Hospital in Seoul, South Korea) were enrolled.Patients were randomized to either an intermittent pneumatic compression (IPC)–only group or an IPC+low-molecular-weight (LMW) heparin sodium group. The data were analyzed on intention-to-treat and per protocol bases. Data analysis was performed from April 1, 2016, to October 30, 2017.

Main Outcomes and Measures Venous thromboembolism incidence was the primary outcome. Postoperative complications, particularly those associated with VTE prophylaxis methods, were the secondary end point.

Results Of the 682 patients enrolled and randomized, 447 (65.5%) were male and 245 (34.5%) were female, with a mean (SD) age of 57.67 (12.94) years. Among the 666 patients included in the analysis, the overall incidence of VTE was 2.1%. The incidence of VTE was statistically significantly higher in the IPC-only group compared with the IPC+LMW heparin group (3.6%; 95% CI, 2.05%-6.14% vs 0.6%; 95% CI, 0.17%-2.18%; P = .008). Among the 14 patients (2.1%) with VTE, 13 were asymptomatic and received a deep vein thrombosis diagnosis, whereas 1 patient received a symptomatic pulmonary thromboembolism diagnosis. The overall incidence of bleeding complications was 5.1%. The incidence of bleeding complications was significantly higher in the IPC+LMW heparin group compared with the IPC-only group (9.1% vs 1.2%; P < .001). No cases of VTE–associated mortality were noted.

Conclusions and Relevance Use of IPC alone is inferior to the use of IPC+LMW heparin in preventing postoperative VTE. Because LMW heparin is associated with a high bleeding risk, further study is needed to stratify the patients at high risk for perioperative development of VTE.

Trial Registration ClinicalTrials.gov Identifier: NCT01448746

重要性 国家综合癌症网络和美国临床肿瘤学会的指南建议对胃腺癌患者常规使用血栓预防措施。但是，亚洲国家的许多医生很少采用静脉血栓栓塞（VTE）预防措施，因为该人群的VTE发病率较低。

目的 评估韩国胃腺癌患者胃切除术后VTE的发生率，确定并发症并评估VTE预防方法的有效性和安全性。

设计，设置和参与者 韩国患者胃切除术后静脉血栓栓塞的最佳预防方法（PROTECTOR）于2011年8月1日至2015年3月31日进行了随机临床试验。韩国首尔的首尔圣玛丽医院被招募。将患者随机分为仅间歇性气压治疗（IPC）组或IPC +低分子量（LMW）肝素钠组。在意向治疗和每个协议的基础上分析数据。数据分析于2016年4月1日至2017年10月30日进行。

主要结果和措施 静脉血栓栓塞发生率是主要结局。术后并发症是次要终点，尤其是与VTE预防方法相关的并发症。

结果 在682例入选并随机分组的患者中，男性447例（65.5％），女性245例（34.5％），平均（SD）年龄为57.67（12.94）岁。在分析的666名患者中，VTE的总发生率为2.1％。与仅IPC + LMW肝素组相比，仅IPC组的VTE发生率在统计学上显着更高（3.6％; 95％CI，2.05％-6.14％vs 0.6％; 95％CI，0.17％-2.18％; P = .008）。在14例VTE患者（2.1％）中，有13例无症状并接受了深静脉血​​栓形成诊断，而1例患者接受了有症状的肺血栓栓塞诊断。出血并发症的总发生率为5.1％。与仅使用IPC的组相比，IPC + LMW肝素组的出血并发症发生率显着更高（9.1％比1.2％；P  <.001）。没有发现与VTE相关的死亡病例。

结论和相关性 单独使用IPC在预防术后VTE方面不如使用IPC + LMW肝素。由于LMW肝素与高出血风险相关，因此需要进一步研究以将高风险围手术期发生VTE的患者分层。

试验注册 ClinicalTrials.gov标识符：NCT01448746