Gyldenholm Tua, Madsen Nina, Katballe Niels, Kjær Daniel Willy, Christensen Thomas Decker, Hvas Anne-Mette
Department of Clinical Biochemistry, Aarhus University Hospital, Aarhus, Denmark; Department of Clinical Medicine, Health, Aarhus University, Denmark.
Department of Radiology, Aarhus University Hospital, Aarhus, Denmark.
J Thromb Haemost. 2025 Apr;23(4):1367-1378. doi: 10.1016/j.jtha.2025.01.002. Epub 2025 Jan 20.
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.
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.
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.
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.
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.
近期指南建议对因癌症行食管切除术的患者进行延长时间的血栓预防。然而，据我们所知，此前尚无研究探讨延长预防是否优于标准的院内预防。
我们旨在开展首项临床随机研究，比较低分子量肝素延长1个月的血栓预防与标准治疗的疗效。
本研究为开放标签、随机、对照试验，纳入行食管切除术的患者。主要终点为标准组和干预组术后1个月凝血酶原片段1+2（F1+ 2）水平的差异。次要终点为静脉血栓栓塞事件的发生率和死亡率。
由于入组率低，该研究在达到预期的100例患者样本量之前终止。我们纳入了79例患者。术后1个月随访时，标准组和干预组的F1+2水平无差异（P = 0.41）。两组静脉血栓形成的发生率相似，标准组为13%，干预组为15%。术后1个月内发生静脉血栓的患者术前F1+2水平显著高于未发生者（P = 0.01）。F1+2每升高50 pmol/L，静脉血栓栓塞的比值比为1.64（95%CI，1.17 - 2.54）。术后1个月内无患者死亡。
未发现食管切除术后延长血栓预防有获益。术前F1+2水平被发现是术后血栓栓塞发生率的一个预测指标。
