Prolonged versus standard thromboprophylaxis in oesophageal cancer patients undergoing surgery: A randomised, controlled study.

Abstract

Background: Recent guidelines recommend prolonged thromboprophylaxis after oesophagectomy due to cancer. However, no previous studies have examined if prolonged prophylaxis is superior to standard, in-hospital prophylaxis. We aimed to perform the first clinical, randomised study testing the efficacy of a prolonged, one-month thromboprophylaxis with low molecular weight heparin versus the standard treatment.

Methods: The study was an open-label, randomised, controlled trial including patients undergoing oesophagectomy. The primary endpoint was the difference in prothrombin fragment 1+2 (F1+2) levels one month after surgery between the standard and the intervention group. The secondary endpoints were incidence of venous thromboembolic events and mortality.

Results: The study was terminated before reaching the expected sample size of 100 patients due to low accrual. We included 79 patients. At follow-up one month after surgery, F1+2 levels did not differ between the standard and the intervention group (p=0.41). Incidence of venous thrombosis was similar in the two groups with 13% in the standard and 15% in the intervention group. Preoperative F1+2 levels were significantly higher in patients who developed a venous thrombosis within one month after surgery than in those who did not (p=0.01). The odds ratio of VTE per 50 pmol/L increase in F1+2 was 1.64 (95% CI 1.17-2.54). No patients died within one month after surgery.

Conclusions: No benefit of prolonged thromboprophylaxis after oesophagectomy was found. Preoperative F1+2 levels were found to be a predictor for incidence of postoperative thromboembolism.