Prolonged vs standard thromboprophylaxis in patients with esophageal cancer undergoing surgery: a randomized controlled study

Abstract

Background

Recent guidelines recommend prolonged thromboprophylaxis after esophagectomy due to cancer. However, to our knowledge, no previous studies have examined if prolonged prophylaxis is superior to standard in-hospital prophylaxis.

Objectives

We aimed to perform the first clinical randomized study testing the efficacy of a prolonged 1-month thromboprophylaxis with low-molecular-weight heparin vs the standard treatment.

Methods

The study was an open-label, randomized, controlled trial including patients undergoing esophagectomy. The primary endpoint was the difference in prothrombin fragment 1 + 2 (F1 + 2) levels 1 month after surgery between the standard group and the intervention group. The secondary endpoints were the 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 1 month after surgery, F1 + 2 levels did not differ between the standard group and the intervention group (P = .41). Incidence of venous thrombosis was similar in the 2 groups, with 13% in the standard group and 15% in the intervention group. Preoperative F1 + 2 levels were significantly higher in patients who developed a venous thrombosis within 1 month after surgery than in those who did not (P = .01). The odds ratio of venous thromboembolism per 50 pmol/L increase in F1 + 2 was 1.64 (95% CI, 1.17-2.54). No patients died within 1 month after surgery.

Conclusion

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