Department of Haematology, St Vincent's Hospital, Melbourne, Victoria, Australia.
Intern Med J. 2023 May;53(5):803-811. doi: 10.1111/imj.15621. Epub 2022 Aug 23.
Direct acting oral anticoagulants (DOAC) are now commonly prescribed medications. Urgent reversal of their anticoagulant effect is sometimes required in emergency situations. In Australia, a specific reversal agent for factor Xa (FXa)-inhibitor DOAC is not available. Instead, two non-specific haemostatic agents, activated prothrombin complex concentrate (aPCC) and 3 factor-prothrombin complex concentrate (3F-PCC), are used off-label despite a paucity of evidence for their effectiveness or safety.
To provide further insight into the efficacy and safety of 3F-PCC and aPCC for the reversal of the anticoagulant effect of FXa inhibitor DOACs.
We conducted a single-centre retrospective cohort study to investigate the use of aPCC and 3F-PCC for patients on FXa-inhibitor DOAC who present with a significant bleeding event or who require urgent surgery. The primary outcome was haemostatic efficacy according to prespecified criteria. Safety outcomes included the thromboembolic event rate and all-cause mortality during the hospital admission.
A total of 51 patients was included in the study (36 patients who had a spontaneous bleeding event and 15 non-bleeding patients who required urgent perioperative management). Thirty-one patients received aPCC and 20 patients received 3F-PCC. Haemostasis was adjudicated as effective in all assessable patients (n = 50; 100%). Thromboembolic events occurred in three patients who received aPCC and one patient who received 3F-PCC. All-cause mortality was 7.8% (four patients).
Both aPCC and 3F-PCC are useful adjuncts for the management of patients who require urgent reversal of the anticoagulant effect of FXa-inhibitor DOAC. However, the risk of thromboembolism in this patient group requires careful consideration. Prospective, comparator studies are needed along with the development of guidelines that reflect the availability of haemostatic agents in Australia.
直接作用的口服抗凝剂（DOAC）现在是常用的处方药物。在紧急情况下，有时需要迅速逆转其抗凝作用。在澳大利亚，没有专门用于因子 Xa（FXa）抑制剂 DOAC 的逆转剂。相反，尽管缺乏关于其有效性或安全性的证据，但两种非特异性止血剂，即激活的凝血酶原复合物浓缩物（aPCC）和 3 因子-凝血酶原复合物浓缩物（3F-PCC），仍被超适应证使用。
进一步了解 3F-PCC 和 aPCC 逆转 FXa 抑制剂 DOAC 抗凝作用的疗效和安全性。
我们进行了一项单中心回顾性队列研究，以调查 aPCC 和 3F-PCC 在接受 FXa 抑制剂 DOAC 治疗且出现大出血事件或需要紧急手术的患者中的使用情况。主要结局是根据预设标准评估的止血效果。安全性结局包括血栓栓塞事件发生率和住院期间的全因死亡率。
共有 51 名患者纳入研究（36 名自发性出血患者和 15 名需要紧急围手术期管理的非出血患者）。31 名患者接受了 aPCC，20 名患者接受了 3F-PCC。所有可评估患者（n=50；100%）的止血效果均被判定为有效。接受 aPCC 的 3 名患者和接受 3F-PCC 的 1 名患者发生血栓栓塞事件。全因死亡率为 7.8%（4 名患者）。
aPCC 和 3F-PCC 都是用于需要迅速逆转 FXa 抑制剂 DOAC 抗凝作用的患者的有用辅助治疗药物。然而，该患者群体的血栓栓塞风险需要仔细考虑。需要进行前瞻性、对照研究，并制定反映澳大利亚止血剂可用性的指南。
