Medical Clinic III, Institute of Transfusion Medicine, University Hospital, Frankfurt/Main, Germany.
Thromb Haemost. 2012 Oct;108(4):625-32. doi: 10.1160/TH12-05-0319. Epub 2012 Jul 10.
To date, clinical studies show that the incidence of spontaneous bleeding with new direct oral anticoagulants (DOAs) is comparable to that of established anticoagulants. However, unlike vitamin K antagonists, there are currently no clinically available antidotes or approved reversal agents for new DOAs. Restoring normal coagulation is important in many cases, such as emergency surgeries, serious bleedings, or anticoagulant overdosing. Attempts have been made to restore normal coagulation after treatment with new DOAs using compounds such as recombinant activated factor VII (rFVIIa), prothrombin complex concentrate (PCC), or FEIBA (factor eight inhibitor bypassing activity). Limited pre-clinical data and even less clinical evidence are available on the usefulness of these methods in restoring normal coagulation for the emergency management of critical bleeding episodes. Evaluating the utility of DOAs is further complicated by the fact that it is unknown how predictive established test systems are of the bleeding risks. Clinical practice requires further evaluation of the emergency management options for the new DOAs to define the agents and the doses that are most useful. Furthermore, patients receiving long-term treatment with a DOA are likely to undergo elective surgery at some point, and there is lack of evidence regarding perioperative treatment regimens under such conditions. This review summarises potential bleeding management options and available data on the new DOAs.
迄今为止,临床研究表明,新型直接口服抗凝剂(DOA)自发性出血的发生率与已确立的抗凝剂相当。然而,与维生素 K 拮抗剂不同,目前尚无临床上可用的新型 DOA 解毒剂或批准的逆转剂。在许多情况下,如急诊手术、严重出血或抗凝剂过量,恢复正常凝血至关重要。已经尝试使用重组活化因子 VII(rFVIIa)、凝血酶原复合物浓缩物(PCC)或 FEIBA(因子八抑制剂旁路活性)等化合物在使用新型 DOA 治疗后恢复正常凝血。这些方法在恢复正常凝血以紧急处理严重出血发作方面的有效性的有限临床前数据和更少的临床证据。评估 DOA 的实用性更加复杂,因为尚不清楚既定的测试系统对出血风险的预测能力如何。临床实践需要进一步评估新型 DOA 的紧急管理选择,以确定最有用的药物和剂量。此外,接受 DOA 长期治疗的患者可能会在某个时候接受择期手术,而对于这种情况下的围手术期治疗方案,缺乏证据。这篇综述总结了潜在的出血管理选择和关于新型 DOA 的可用数据。