Key result
Prolonged 1-month thromboprophylaxis fails to reduce venous thrombosis after esophagectomy compared to standard care.
Why the study?
Guidelines recommend prolonged thromboprophylaxis after esophagectomy for cancer, but no prior studies have evaluated whether prolonged prophylaxis is superior to standard in-hospital prophylaxis.
Does prolonged 1-month thromboprophylaxis with low-molecular-weight heparin reduce prothrombin fragment 1 + 2 levels in patients with esophageal cancer undergoing esophagectomy?
RCT (n=79)
Open-label
randomized
Does prolonged 1-month thromboprophylaxis with low-molecular-weight heparin reduce prothrombin fragment 1 + 2 levels in patients with esophageal cancer undergoing esophagectomy?
Prolonged 1-month thromboprophylaxis with low-molecular-weight heparin did not show benefit over standard in-hospital prophylaxis in reducing F1+2 levels or VTE incidence after esophagectomy, challenging recent guideline recommendations.
Answers are grounded in this paper and cite their sources.
No benefit from 1-month extended prophylaxis after esophagectomy; challenges recent guidelines recommending prolonged LMWH.
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.
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Gyldenholm et al. (2025) conducted an RCT in esophageal cancer (n=79). Prolonged thromboprophylaxis with low-molecular-weight heparin vs. Standard in-hospital prophylaxis was evaluated on difference in prothrombin fragment 1 + 2 (F1 + 2) levels 1 month after surgery (p=.41). Prolonged 1-month thromboprophylaxis after esophagectomy did not reduce F1+2 levels or venous thrombosis incidence compared to standard prophylaxis.
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