Patients with venous thromboembolism (VTE) comorbid renal insufficiency (RI) are at higher risk of bleeding and thrombosis. Recommendations in guidelines on anticoagulation therapy for those patients remain ambiguous. The goal of this study is to compare the efficacy and safety between different anticoagulant regimens in VTE patients comorbid RI at different stages of treatment and prophylaxis. We performed English-language searches of Pubmed, EMBASE, and Web of Science (inception to Nov 2022). RCTs evaluated anticoagulants for VTE treatment at the acute phase, extension phase, and prophylaxis in patients with RI and reported efficacy and safety outcomes were selected. The methodological quality of the studies was assessed at the outcome level using the risk-of-bias assessment tool developed by the Cochrane Bias Methods Group. A meta-analysis of twenty-five RCTs was conducted, comprising data from twenty-three articles, encompassing a total of 9,680 participants with RI. In the acute phase, the risk of bleeding was increased with novel oral anticoagulants (NOACs) compared to LMWH (RR 1.29, 95% CI 1.04–1.60). For the prophylaxis of VTE, NOACs were associated with an elevated risk of bleeding compared with placebo (RR 1.31, 95%CI 1.02–1.68). In comparison to non-RI patients, both NOACs and vitamin K antagonists (VKA) could increase the risk of bleeding among RI patients (RR 1.45, 95%CI 1.14–1.84 and RR 1.53, 95%CI 1.25–1.88, respectively) during acute phase, while NOACs may increase the incidence of VTE in RI population (RR 1.74, 95%CI 1.29–2.34). RI patients who are under routine anticoagulation have a significantly higher risk of adverse outcomes. LMWH is the most effective and safe option for VTE treatment or prophylaxis in patients with RI. • Renal insufficient (RI) patients were at significant higher risk of adverse outcomes, especially bleeding, than non-RI patients under the use of routine anticoagulation treatment. • Low molecular weight heparin (LWMH) would be an optimized option for patients with RI undergoing VTE treatment and prophylaxis, both in terms of efficacy and safety. • These findings provide comprehensive evidence for the optimal choice of anticoagulants for the treatment and prevention of VTE in patients with comorbid RI.

中文翻译：

---

抗凝剂治疗和预防肾功能不全 VTE 患者的有效性和安全性：系统评价和荟萃分析

静脉血栓栓塞 (VTE) 合并肾功能不全 (RI) 的患者出血和血栓形成的风险较高。针对这些患者的抗凝治疗指南中的建议仍然不明确。本研究的目的是比较不同抗凝方案对合并 RI 的 VTE 患者在不同治疗和预防阶段的疗效和安全性。我们对 Pubmed、EMBASE 和 Web of Science（启动至 2022 年 11 月）进行了英语检索。随机对照试验评估了抗凝药物在急性期、延长期的 V​​TE 治疗以及 RI 患者的预防作用，并选择了报告的疗效和安全性结果。使用 Cochrane 偏倚方法组开发的偏倚风险评估工具在结果层面评估研究的方法学质量。对 25 项 RCT 进行了荟萃分析，其中包括 23 篇文章的数据，总共涉及 9,680 名 RI 参与者。在急性期，与 LMWH 相比，新型口服抗凝剂 (NOAC) 的出血风险增加（RR 1.29，95% CI 1.04–1.60）。对于预防 VTE，与安慰剂相比，NOAC 会增加出血风险（RR 1.31，95% CI 1.02-1.68）。与非 RI 患者相比，NOAC 和维生素 K 拮抗剂 (VKA) 均可能增加 RI 患者出血风险（分别为 RR 1.45、95%CI 1.14–1.84 和 RR 1.53、95%CI 1.25–1.88）。急性期，而 NOAC 可能会增加 RI 人群中 VTE 的发生率（RR 1.74，95% CI 1.29-2.34）。接受常规抗凝治疗的 RI 患者出现不良后果的风险明显更高。 LMWH 是 RI 患者 VTE 治疗或预防的最有效和安全的选择。 • 肾功能不全（RI）患者在接受常规抗凝治疗时，与非肾功能不全（RI）患者相比，出现不良后果（尤其是出血）的风险显着更高。 • 低分子量肝素(LWMH) 对于接受VTE 治疗和预防的RI 患者来说，无论是从疗效还是安全性方面来说都是最佳选择。 • 这些发现为合并RI 患者治疗和预防VTE 的抗凝药物的最佳选择提供了全面的证据。