Hamostaseologie. 2017;37(4):257-266. doi: 10.5482/HAMO-16-11-0043. Epub 2017 Dec 28.
The worldwide increase in the aging population and the associated increase in the prevalence of atrial fibrillation and venous thromboembolism as well as the widespread use of direct oral anticoagulants (DOAC) have resulted in an increase of the need for the management of bleeding complications and emergency operations in frail, elderly patients, in clinical practice. When severe bleeding occurs, general assessment should include evaluation of the bleeding site, onset and severity of bleeding, renal function, and concurrent medications with focus on anti-platelet drugs and nonsteroidal anti-inflammatory drugs (NSAID). The last intake of the DOAC and its residual concentration are also relevant. The site of bleeding should be immediately localized, anticoagulation should be interrupted, and local measures to stop bleeding should be taken. In life-threatening bleeding or emergency operations immediate reversal of the antithrombotic effect may be indicated. If relevant residual DOAC-concentrations are expected and surgery cannot be postponed, prothrombin complex concentrate (PCC) and/or a specific antidote should be given. While idarucizumab, the specific antidote for dabigatran, has been recently approved for clinical use, the recombinant factor X protein andexanet alfa, an antidote for the reversal of inhibitors of coagulation factor Xa, and ciraparantag, a universal antidote, are not available. Future cohort studies are necessary to assess the efficacy and safety of specific and unspecific reversal agents in "real-life" conditions. This was the rationale for introducing the RADOA-registry (RADOA: Reversal Agent use in patients treated with Direct Oral Anticoagulants or vitamin K antagonists), a prospective non-interventional registry, which will evaluate the effects of specific and unspecific reversal agents in patients with life-threatening bleeding or emergency operations either treated with DOACs or vitamin K antagonists.
全球人口老龄化的增加以及由此导致的心房颤动和静脉血栓栓塞症的患病率增加,以及直接口服抗凝剂(DOAC)的广泛使用,导致在临床实践中需要更多地管理脆弱、老年患者的出血并发症和紧急手术。当发生严重出血时,一般评估应包括评估出血部位、出血的发生和严重程度、肾功能以及同时使用的药物,重点是抗血小板药物和非甾体抗炎药(NSAID)。最后一次服用 DOAC 及其残留浓度也很重要。应立即定位出血部位,中断抗凝,并采取局部止血措施。在危及生命的出血或紧急手术中,可能需要立即逆转抗血栓作用。如果预计有相关的残留 DOAC 浓度且手术不能推迟,则应给予凝血酶原复合物浓缩物(PCC)和/或特定的解毒剂。达比加群的特异性解毒剂依达鲁单抗最近已被批准用于临床,而重组凝血因子 X 蛋白和andexanet alfa,一种凝血因子 Xa 抑制剂的逆转解毒剂,以及 ciraparantag,一种通用解毒剂,尚未上市。未来的队列研究有必要评估特定和非特定逆转剂在“真实生活”条件下的疗效和安全性。这就是引入 RADOA 登记处(RADOA:直接口服抗凝剂或维生素 K 拮抗剂治疗患者的逆转剂使用)的理由,RADOA 登记处是一项前瞻性非干预性登记处,将评估在有生命危险的出血或紧急手术中使用 DOAC 或维生素 K 拮抗剂治疗的患者中,特定和非特定逆转剂的效果。