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直接口服抗凝剂与华法林在肾移植受者中的安全性和有效性:一项回顾性单中心队列研究。

Safety and efficacy of direct-acting oral anticoagulants versus warfarin in kidney transplant recipients: a retrospective single-center cohort study.

机构信息

Department of Pharmacy Services, University Hospitals Cleveland Medical Center, Cleveland, OH, USA.

Department of Transplant Surgery, Keck Medical Center of USC, University of Southern California, Los Angeles, CA, USA.

出版信息

Transpl Int. 2020 Jul;33(7):740-751. doi: 10.1111/tri.13599. Epub 2020 Mar 30.

DOI:10.1111/tri.13599
PMID:32107804
Abstract

Despite the increased use, comparative safety and efficacy of direct-acting oral anticoagulants (DOACs) against warfarin have not been well studied in kidney transplant recipients. In this single-center retrospective study, we evaluated 197 adult kidney transplant recipients on DOAC or warfarin between January 1, 2011, and June 30, 2018. The primary outcome was incidence of major bleeding defined as a hemoglobin decrease ≥2 g/dl, blood transfusion ≥2 units, or symptomatic bleeding in a critical area or organ. Patients were initiated on anticoagulation therapy at a median of 6.5 years post-transplant and followed for a median of 12.3 months. The rates of major bleeding were 7.2% per year with DOACs vs. 11.4% per year with warfarin (Mantel-Cox P = 0.15). No difference was found in composite bleeding, clinically relevant nonmajor bleeding, or thromboembolic events between the groups. There was a lower incidence of major bleeding with apixaban compared to all other anticoagulants (6.7% vs. 19.0%, P = 0.027). After controlling for potential confounders, DOAC use was not associated with an increased risk of major bleeding (HR 0.73, 95% CI 0.27-1.95). Further research is warranted to definitively determine whether DOACs are effective and safe alternatives to warfarin for anticoagulation in kidney transplant recipients.

摘要

尽管直接作用的口服抗凝剂(DOACs)在肾移植受者中的应用增加,但与华法林相比,其安全性和疗效尚未得到很好的研究。在这项单中心回顾性研究中,我们评估了 2011 年 1 月 1 日至 2018 年 6 月 30 日期间接受 DOAC 或华法林治疗的 197 名成年肾移植受者。主要结局是主要出血的发生率,定义为血红蛋白下降≥2g/dl、输血≥2 单位或重要部位或器官出现症状性出血。患者在移植后中位 6.5 年开始接受抗凝治疗,中位随访 12.3 个月。DOAC 组的主要出血发生率为每年 7.2%,华法林组为每年 11.4%(Mantel-Cox P=0.15)。两组间复合出血、临床相关非重大出血或血栓栓塞事件发生率无差异。与其他所有抗凝剂相比,阿哌沙班的主要出血发生率较低(6.7%比 19.0%,P=0.027)。在控制潜在混杂因素后,DOAC 治疗与主要出血风险增加无关(HR 0.73,95%CI 0.27-1.95)。需要进一步研究以确定 DOAC 是否是肾移植受者抗凝治疗中替代华法林的有效和安全的选择。