Department of Pharmacy, Fujian Maternity and Child Health Hospital College of Clinical Medicine for Obstetrics & Gynecology and Pediatrics, Fujian Medical University, Fuzhou, 350001, Fujian, China.
School of Medicine, Huaqiao University, Quanzhou, 362021, Fujian, China.
World J Surg Oncol. 2024 Feb 26;22(1):69. doi: 10.1186/s12957-024-03341-5.
Direct oral anticoagulants (DOACs) used as an alternative to low-molecular-weight heparin (LMWH) for thromboprophylaxis after cancer surgery for venous thromboembolic events (VTE) remains unclear. This study aimed to investigate the efficacy and safety of DOACs versus LMWH in these patients.
A search of EMBASE, MEDLINE, Cochrane Central Register of Controlled Trials (CENTRAL), and Web of Science was carried out and included all randomized controlled trials (RCTs) and observational studies that directly compared DOACs with LMWH for thromboprophylaxis in patients after cancer surgery through July 25, 2023. The primary efficacy and safety outcomes were VTE, major bleeding, and clinically relevant non-major bleeding (CRNMB) within 30 days of surgery. The risk of bias was assessed using the Cochrane Risk of Bias 2 (RoB2) tool for RCTs and ROBINS-I tool for non-randomized studies. This study was registered in PROSPERO (CRD42023445386).
We retrieved 5149articles, selected 27 for eligibility, and included 10 studies (three RCTs and seven observational studies) encompassing 3054 patients who underwent postoperative thromboprophylaxis with DOACs (41%) or LMWH (59%). Compared to LMWH thromboprophylaxis, DOACs had a comparable risk of VTE (RR:0.69[95% CI:0.46-1.02], I = 0%), major bleeding (RR:1.55 [95% CI:0.82-2.93], I = 2%), and CRNMB (RR, 0.89 [95% CI, 0.4-1.98], I = 31%) during the 30-day postoperative period. Subgroup analysis of VTE and major bleeding suggested no differences according to study type, extended thromboprophylaxis, tumor types, or different types of DOAC.
DOACs are potentially effective alternatives to LMWH for thromboprophylaxis in patients undergoing cancer surgery, without increasing the risk of major bleeding events.
在癌症手术后预防静脉血栓栓塞事件(VTE)中,直接口服抗凝剂(DOAC)替代低分子肝素(LMWH)的效果仍不明确。本研究旨在探究 DOAC 与 LMWH 在这些患者中的疗效和安全性。
我们对 EMBASE、MEDLINE、Cochrane 对照试验中心注册库(CENTRAL)和 Web of Science 进行了检索,并纳入了截至 2023 年 7 月 25 日所有直接比较 DOAC 与 LMWH 用于癌症手术后患者血栓预防的随机对照试验(RCT)和观察性研究。主要疗效和安全性结局为手术后 30 天内 VTE、大出血和临床相关非大出血(CRNMB)。采用 Cochrane 偏倚风险工具 2(RoB2)评估 RCT 的偏倚风险,采用 ROBINS-I 工具评估非随机研究的偏倚风险。本研究已在 PROSPERO(CRD42023445386)注册。
我们检索到 5149 篇文章,筛选出 27 篇符合条件的文章,纳入了 10 项研究(3 项 RCT 和 7 项观察性研究),共纳入 3054 例接受 DOAC(41%)或 LMWH(59%)术后血栓预防的患者。与 LMWH 相比,DOAC 的 VTE 风险相当(RR:0.69[95% CI:0.46-1.02],I=0%),大出血风险(RR:1.55[95% CI:0.82-2.93],I=2%)和 CRNMB 风险(RR:0.89[95% CI:0.4-1.98],I=31%)在术后 30 天内也无显著差异。VTE 和大出血的亚组分析提示,无论研究类型、延长的血栓预防、肿瘤类型还是不同类型的 DOAC,结果均无差异。
DOAC 可能是癌症手术后患者血栓预防的有效 LMWH 替代药物,不会增加大出血事件的风险。