EP392/#193 Single-arm confirmatory clinical trial of perioperative management to prevent postoperative symptomatic pulmonary embolism for gynecological cancer patients with asymptomatic venous thrombosis embolism preoperatively (GOTIC-VTE trial)

Objectives

There is no established optimal perioperative venous thrombosis embolism (VTE) prophylaxis for gynecological cancer patients with asymptomatic VTE preoperatively. The GOTIC-VTE trial was a prospective, multi-center, single-arm, confirmatory clinical trial to investigate the prevention of postoperative symptomatic pulmonary embolism (PE) onset by seamless anticoagulant therapy from the preoperative to 4 weeks after surgery instead of withholding intermittent pneumatic compression (IPC).

Methods

Anticoagulant therapy was started immediately after the diagnosis of asymptomatic VTE, administration of unfractionated heparin (UFH) was resumed within 12 hours after surgery, and anticoagulant therapy was continued for 28 days by combining UFH, low-molecular weight heparin and edoxaban. IPC was not used during the perioperative period. The primary outcome was the incidence of symptomatic PE during the 28 days after surgery, which was compared with historical controls who received short-term anticoagulant therapy.

Results

Between February 2018 and September 2020, 99 patients were enrolled and 82 were included in the full analysis set. There were 58 patients with ovarian cancer, 21 with endometrial cancer and 3 with cervical cancer. 47 patients had deep vein thrombosis (DVT) alone, 18 had PE alone and 17 had DVT and PE in combination at the time of registration. No symptomatic PE was observed during the 28 days after surgery. Two patients had bleeding events. The AEs of Grade3 were only 3 cases, increased ALT, AST and GGT, respectively.

Conclusions

The seamless anticoagulant therapy from the preoperative to postoperative 4 weeks for gynecological malignancies with asymptomatic VTE was effective in preventing the onset of postoperative symptomatic PE.