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Hamostaseologie 2017; 37(04): 257-266
DOI: 10.5482/HAMO-16-11-0043
Review
Schattauer GmbH

Direct oral anticoagulants (DOAC) – Management of emergency situations

Rationale and design of the RADOA-RegistryManagement von NotfallsituationenRationale und Design des RADOA-Registers
Edelgard Lindhoff-Last
1   Cardioangiology Center Bethanien Hospital (CCB), Frankfurt, Germany
› Author Affiliations
Further Information

Publication History

received: 27 November 2016

accepted in revised form: 06 February 2017

Publication Date:
28 December 2017 (online)

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Summary

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.

Zusammenfassung

Durch eine weltweit alternde Bevölkerung nehmen Vorhofflimmern und venöse Thromboembolien und dadurch auch der Einsatz direkter oraler Antikoagulantien (DOAK) deutlich zu. Das Management von Blutungskomplikationen und Notfalloperationen bei diesen fragilen, alten Patienten stellt eine Herausforderung im klinischen Alltag dar. Bei Auftreten schwerer Blutungen sollten der Ort der Blutung, der Beginn und Schweregrad, sowie die Nierenfunktion und Begleitmedikationen wie Thrombozytenaggregationshemmer oder nichtsteroidale Antirheumatika (NSAR) Berücksichtigung finden. Der Zeitpunkt der letzten Tabletteneinnahme sowie die Restkonzentration des DOAK bei Aufnahme sind ebenfalls relevant. Die Antikoagulation sollte sofort unterbrochen und lokale Maßnahmen ergriffen werden, um die Blutung zu stillen. Bei lebensbedrohlicher Blutung oder rasch notwendiger Notfalloperation sollte der anti-koagulierende Effekt sofort aufgehoben werden. Die Gabe von PPSB kann erwogen werden, wenn spezifische Antidots nicht zur Verfügung stehen. Wenn relevante DOAK-Rest-konzentrationen vermutet werden und die Operation nicht aufgeschoben werden kann, dann sollten PPSB und/oder ein spezifisches Antidot präoperativ appliziert werden. Während Idarucizumab, das spezifische Antidot für Dabigatran, inzwischen zur Behandlung zugelassen ist, sind der rekombinante Faktor X Andexanet Alfa, der als Antidot gegen Faktor X-Inhibitoren wirkt und Ciraparantag, ein universelles Antidot, noch nicht für die klinische Anwendung verfügbar. Zukünftige Studien und Register sollten Effektivität und Sicherheit spezifischer und unspezifischer Gegenmittel im klinischen Alltag untersuchen. Diese Überlegungen haben zur Etablierung des RADOA-Registers (RADOA: Reversal Agent use in patients treated with Direct Oral Anticoagulants or vitamin K antagonists) geführt, ein prospektives, multizentrisches, nicht-interventionelles Register, das die Ef-fektivität spezifischer und unspezifischer Gegenmittel bei Patienten mit lebensbedrohlichen Blutungen oder Notfalloperation unter Behandlung mit DOAK oder Vitamin-K-Antagonisten erfassen und auswerten wird.

Keywords

direct oral anticoagulants - life-threatening bleeding - emergency operation - reversal agents - prothrombin complex concentrate (PCC) - antidotes

Schlüsselwörter

direkte orale Antikoagulanzien - lebensbedrohliche Blutung - Notfalloperation - Gegenmittel - PPSB - Antidots
 

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