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    Original Investigation
    October 2018

    Venous Thromboembolism Incidence and Prophylaxis Use After Gastrectomy Among Korean Patients With Gastric Adenocarcinoma: The PROTECTOR Randomized Clinical Trial

    Author Affiliations
    • 1Division of Gastrointestinal Surgery, Department of Surgery, Seoul St Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea
    • 2Division of Vascular and Transplantation Surgery, Department of Surgery, The Catholic University of Korea, Seoul, Republic of Korea
    • 3Clinical Research Coordinating Center of Catholic Medical Center, The Catholic University of Korea, Seoul, Republic of Korea
    JAMA Surg. 2018;153(10):939-946. doi:10.1001/jamasurg.2018.2081
    Key Points

    Question  Is it safe and effective to routinely use the conventional prophylaxis for venous thromboembolism in Asian patients after gastric cancer surgery?

    Findings  This randomized clinical trial of 666 Korean patients with gastric adenocarcinoma found that, overall, the incidence of venous thromboembolism was 2.1% and the incidence of bleeding complications was significantly higher among patients assigned to receive intermittent pneumatic compression combined with low-molecular-weight heparin sodium.

    Meaning  Use of intermittent pneumatic compression alone is inferior to the use of intermittent pneumatic compression combined with low-molecular-weight heparin in preventing postoperative venous thromboembolism; because pharmacological prophylaxis is associated with bleeding, further study is needed to stratify the patients at high risk for developing venous thromboembolism.

    Abstract

    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

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