Data_Sheet_1_The impact of direct oral anticoagulants on viscoelastic testing – A systematic review.docx

BackgroundIn case of bleeding patients and in acute care, the assessment of residual direct oral anticoagulant (DOAC) activity is essential for evaluating the potential impact on hemostasis, especially when a timely decision on urgent surgery or intervention is required. Viscoelastic tests are crucial in a modern goal-directed coagulation management to assess patients’ coagulation status. However, the role of viscoelastic test to detect and quantify residual DOAC plasma levels is controversially discussed. The aim of this review was to systematically summarize the evidence of viscoelastic tests for the assessment of residual DOAC activity.
MethodPubMed, Embase, Scopus, and the Cochrane Library were searched for original articles investigating the effect of rivaroxaban, apixaban, edoxaban, or dabigatran plasma levels on different viscoelastic tests of the adult population from database inception to December 31, 2021.
ResultsWe included 53 studies from which 31 assessed rivaroxaban, 22 apixaban, six edoxaban, and 29 dabigatran. The performance of viscoelastic tests varied across DOACs and assays. DOAC specific assays are more sensitive than unspecific assays. The plasma concentration of rivaroxaban and dabigatran correlates strongly with the ROTEM EXTEM, ClotPro RVV-test or ECA-test clotting time (CT) and TEG 6s anti-factor Xa (AFXa) or direct thrombin inhibitor (DTI) channel reaction time (R). Results of clotting time (CT) and reaction time (R) within the normal range do not reliable exclude relevant residual DOAC plasma levels limiting the clinical utility of viscoelastic assays in this context.
ConclusionViscoelastic test assays can provide fast and essential point-of-care information regarding DOAC activity, especially DOAC specific assays. The identification and quantification of residual DOAC plasma concentration with DOAC unspecific viscoelastic assays are not sensitive enough, compared to recommended anti-Xa activity laboratory measurements.
Systematic review registration[https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=320629], identifier [CRD42022320629].

背景：针对出血患者及急症护理场景，评估残余直接口服抗凝剂（direct oral anticoagulant, DOAC）活性，对判断其对止血功能的潜在影响至关重要，尤其当需要快速决策是否实施紧急手术或介入治疗时。粘弹性检测是现代目标导向凝血管理中评估患者凝血状态的关键手段。然而，粘弹性检测用于检测并量化血浆中残余DOAC水平的作用仍存在广泛争议。本综述旨在系统总结粘弹性检测用于评估残余DOAC活性的相关证据。
方法：检索PubMed、Embase、Scopus及Cochrane图书馆数据库自建库起至2021年12月31日止的原创性研究，探究成人群体中利伐沙班、阿哌沙班、依度沙班或达比加群的血浆水平对不同粘弹性检测结果的影响。
结果：本研究共纳入53项研究，其中31项针对利伐沙班、22项针对阿哌沙班、6项针对依度沙班、29项针对达比加群。粘弹性检测的性能因DOAC种类及检测方法而异。DOAC特异性检测的敏感性高于非特异性检测。利伐沙班与达比加群的血浆浓度与ROTEM EXTEM检测、ClotPro RVV试验或ECA试验的凝血时间（clotting time, CT），以及TEG 6s抗Xa因子（anti-factor Xa, AFXa）通道或直接凝血酶抑制剂（direct thrombin inhibitor, DTI）通道的反应时间（reaction time, R）呈强相关性。当凝血时间（CT）与反应时间（R）处于正常范围时，无法可靠排除存在临床相关的残余DOAC血浆水平，这限制了粘弹性检测在此场景中的临床应用价值。
结论：粘弹性检测可提供关于DOAC活性的快速且关键的床旁检测信息，其中DOAC特异性检测的表现尤为突出。与推荐的抗Xa活性实验室检测方法相比，采用DOAC非特异性粘弹性检测方法识别并量化血浆残余DOAC浓度的敏感性不足。
系统综述注册：[https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=320629]，标识符[CRD42022320629]。