Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
Department of Obstetrics and Gynecology, University of Colorado, Aurora, CO, USA.
Ann Surg Oncol. 2024 Aug;31(8):5102-5110. doi: 10.1245/s10434-024-15369-8. Epub 2024 May 23.
Venous thromboembolism is a preventable complication of gynecologic cancer surgery that leads to postoperative morbidity and mortality. This study compared apixaban with enoxaparin to identify whether apixaban had the same safety and efficacy for patients undergoing gynecologic cancer surgery.
The study identified patients with a gynecologic malignancy who underwent surgery and were prescribed apixaban at discharge between June 2020 and April 2023. International Classification of Diseases 10 codes were used to identify patients who had a thromboembolism within 90 days or a bleeding event within 60 days after surgery. The rates of events for patients prescribed apixaban were compared with those for a historical cohort of patients who received enoxaparin. Fisher's exact tests were used to compare categorical variables, and t tests were used to compare continuous variables. A logistic regression was performed to compare the odds of thromboembolism between the two groups.
Baseline patient characteristics differed in terms of body mass index (BMI), race, route of surgery, and type of cancer. Of the 490 patients in the apixaban cohort, 12 (2.4%) had a thromboembolism compared with 3 (2.1%) of the 138 patients in the enoxaparin group (adjusted odds ratio [aOR], 1.02; 95% confidence interval [CI] 0.30-4.70; p > 0.999). The odds ratio was adjusted for BMI, age, and route of surgery. A bleeding event occurred for 1 (0.2%) of the 490 patients in the apixaban group and for 1 (0.7%) of the 138 patients in the enoxaparin group.
This validation study showed that apixaban is a safe and effective method of postoperative venous thromboembolism prophylaxis. The data provide support to previous data and guideline updates recommending the use of apixaban for postoperative prophylaxis.
静脉血栓栓塞症是妇科癌症手术后可预防的并发症，会导致术后发病率和死亡率升高。本研究比较了阿哌沙班与依诺肝素，以确定阿哌沙班是否对行妇科癌症手术的患者具有相同的安全性和疗效。
本研究纳入了 2020 年 6 月至 2023 年 4 月期间因妇科恶性肿瘤接受手术并在出院时开处阿哌沙班的患者。使用国际疾病分类第 10 版（ICD-10）编码来识别术后 90 天内发生血栓栓塞或 60 天内发生出血事件的患者。比较服用阿哌沙班的患者的事件发生率与接受依诺肝素的历史队列患者的发生率。使用 Fisher 确切检验比较分类变量，使用 t 检验比较连续变量。使用 logistic 回归比较两组患者发生血栓栓塞的几率。
阿哌沙班组的 490 例患者和依诺肝素组的 138 例患者的基线患者特征在体重指数（BMI）、种族、手术途径和癌症类型方面存在差异。阿哌沙班组有 12 例（2.4%）患者发生血栓栓塞，依诺肝素组有 3 例（2.1%）患者发生血栓栓塞（校正比值比[aOR]，1.02；95%置信区间[CI]，0.30-4.70；p＞0.999）。对 BMI、年龄和手术途径进行了调整。阿哌沙班组有 1 例（0.2%）患者发生出血事件，依诺肝素组有 1 例（0.7%）患者发生出血事件。
这项验证性研究表明，阿哌沙班是一种安全有效的术后静脉血栓栓塞预防方法。该数据为之前的数据和指南更新提供了支持，这些数据和指南建议将阿哌沙班用于术后预防。
