Fondaparinux versus nadroparin for thromboprophylaxis following minimally invasive esophagectomy: A randomized controlled trial

Abstract

Background: The methodology of thromboprophylaxis post minimally invasive esophagectomy (MIE) is unclear. Thus, we compared the efficacy and safety of fondaparinux and nadroparin on the prophylaxis of venous thromboembolism (VTE) after MIE.

Materials and methods: We conducted a randomized, double-blind, treatment-controlled study. Consecutive patients undergoing MIE randomly received a single dose of either nadroparin 2850 AxaIU (Group H) or fondaparinux 2.5 mg (Group F) daily. We used ultrasonography to identify deep vein thrombosis (DVT) on postoperative day 7. The coagulation status was examined using thromboelastography (TEG) prior to and at 0, 24, 48, and 72 h after the operation. Bleeding events were recorded during anticoagulation therapy and analysis was performed on an intention-to-treat basis.

Results: We randomly assigned the patients to Group H (n = 57) or Group F (n = 59). Symptomatic or asymptomatic DVT was identified in seven patients in Group H and one patient in Group F (12.28% vs. 1.69%, p = 0.031). Pulmonary embolism developed in one patient in Group H, and the VTE incidence was significantly lower in Group F than Group H (1.69% vs. 14.04%, RR: 0.121, 95% CI: 0.016-0.935, p = 0.016). TEG analysis showed a more inhibited coagulation profile of Group F compared with Group H reflected by the significantly prolonged R time at 48 h and 72 h after operation (6.8 ± 2.2 min vs. 8.4 ± 2.7 min, p = 0.005; 7.1 ± 1.6 min vs. 9.2 ± 3.7 min, p = 0.002). Bleeding events were not recorded in either group.

Conclusions: Fondaparinux could provide similar efficacy and safety in postoperative thromboprophylaxis following MIE compared with nadroparin.

Keywords: Esophagectomy; Fondaparinux; Low molecular weight heparin; Thrombelastography; Venous thromboembolism.