Calderon Martinez Ernesto, Sanchez Cruz Camila, Diarte Acosta Edna Y, Aguirre Cano Daniel Alejandro, Espinosa Ana Maria, Othón Martínez Diana, Furman Flor, Obando Vera Sebastian
Universidad Nacional Autónoma de México, Ciudad de Mexico, México.
Universidad Autónoma de Sinaloa, Sinaloa, México.
J Nephrol. 2025 Jan;38(1):111-126. doi: 10.1007/s40620-024-02130-3. Epub 2024 Nov 29.
Chronic Kidney Disease (CKD) significantly increases the risk of cardiovascular diseases, including atrial fibrillation, which usually requires anticoagulant therapy. The effectiveness and safety of direct oral anticoagulants compared to vitamin K antagonists in patients with CKD remain insufficiently studied, particularly in the more advanced stages.
This systematic review, registered in PROSPERO (CRD42023410192), adhered to PRISMA guidelines and included randomized clinical trials and cohort studies comparing direct oral anticoagulants and vitamin K antagonists in CKD patients. Major databases were searched, and studies were selected based on strict inclusion criteria. A meta-analysis was performed using random-effects models.
Twenty-three studies with a total of 465,673 CKD patients were included. Direct oral anticoagulants showed a significant reduction in major bleeding events compared to vitamin K antagonists (Relative Risk [RR] = 0.62, 95% Confidence Interval: 0.49-0.79, p < 0.01) and a non-significant trend toward reducing thromboembolic events (RR = 0.69, 95% Confidence Interval: 0.43-1.14, p = 0.11). Furthermore, direct oral anticoagulants were associated with a significant reduction in all-cause mortality (RR = 0.63, 95% Confidence Interval: 0.43-0.91, p = 0.02).
Direct oral anticoagulants may offer a safe alternative to vitamin K antagonists in CKD patients, particularly in terms of reducing bleeding risks and potentially improving survival. However, their role in preventing thromboembolic events remains uncertain, highlighting the need for further research, especially in patients with advanced CKD and kidney failure.
慢性肾脏病（CKD）显著增加心血管疾病风险，包括心房颤动，而心房颤动通常需要抗凝治疗。与维生素K拮抗剂相比，直接口服抗凝剂在CKD患者中的有效性和安全性仍研究不足，尤其是在疾病更晚期阶段。
本系统评价已在国际前瞻性系统评价注册库（PROSPERO，注册号：CRD42023410192）登记，遵循PRISMA指南，纳入比较直接口服抗凝剂与维生素K拮抗剂在CKD患者中应用情况的随机临床试验和队列研究。检索了主要数据库，并根据严格的纳入标准选择研究。采用随机效应模型进行荟萃分析。
纳入23项研究，共465,673例CKD患者。与维生素K拮抗剂相比，直接口服抗凝剂显著降低了大出血事件（相对风险[RR]=0.62，95%置信区间：0.49-0.79，p<0.01），且在降低血栓栓塞事件方面有不显著的趋势（RR=0.69，95%置信区间：0.43-1.14，p=0.11）。此外，直接口服抗凝剂与全因死亡率显著降低相关（RR=0.63，95%置信区间：0.43-0.91，p=0.02）。
对于CKD患者，直接口服抗凝剂可能是维生素K拮抗剂的安全替代药物，尤其是在降低出血风险和可能改善生存率方面。然而，其在预防血栓栓塞事件中的作用仍不确定，这凸显了进一步研究的必要性，特别是在晚期CKD和肾衰竭患者中。
