title: [NOAC: Real-life data and the role of antidotes for the treatment of bleeding].
abstract: The non-vitamin K antagonists (NOAC) are an integral component of our antithrombotic prevention and therapy. For four of the NOAC, their non-inferiority or even superiority versus vitamin K antagonists (VKA) has been proven. Thus, the management of special patient cohorts or the management of active bleeding complications is a focus of current discussion.In addition to prospective trials, numerous retrospective analyses of health insurers or public health provider data have been analyzed and published as "real life" or "real-world evidence" data. In almost all data sets the results of the NOAC approval trials were confirmed, demonstrating their non-inferiority or even superiority versus VKA. Attempts to compare the various NOAC with each other must be viewed critically since the real-world evidence (RWE) analysis provides very divergent results depending on the cohorts analyzed. Thus, a substantial prescriber-bias must be taken into account and never be excluded.In order to improve the management of bleeding complications, NOAC antidotes were developed. While the factors Xa antidote, andexanet alpha, a modified coagulation factor deleted of an intrinsic activity, will not be available before 2018, the dabigatran antidote idarucizumab is already in clinical use. Idarucizumab, a monoclonal antibody fragment directed against dabigatran, is able to completely antagonize the effect of dabigatran within minutes. Therefore, the drug has the potential to terminate life-threatening bleeding complications earlier and make emergency surgical or interventional procedures possible without an elevated bleeding risk.
authors.affiliation: Klinik für Kardiologie, Angiologie, Nephrologie und konservative Intensivmedizin, Vivantes Klinikum Neukölln, Rudower Str. 48, 12351, Berlin, Deutschland. harald.darius@vivantes.de.
authors.forename: H
authors.initials: H
authors.lastname: Darius
mesh_terms: D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects* / Q000627:therapeutic use; D000925:Anticoagulants / Q000009:adverse effects* / Q000627:therapeutic use*; D000931:Antidotes / Q000009:adverse effects / Q000627:therapeutic use*; D000069604:Dabigatran / Q000009:adverse effects / Q000037:antagonists & inhibitors / Q000627:therapeutic use; D015951:Factor Xa / Q000009:adverse effects / Q000627:therapeutic use; D065427:Factor Xa Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D006470:Hemorrhage / Q000139:chemically induced* / Q000188:drug therapy*; D006801:Humans; D008297:Male; D011720:Pyrazoles / Q000009:adverse effects / Q000037:antagonists & inhibitors; D011728:Pyridones / Q000009:adverse effects / Q000037:antagonists & inhibitors; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D000069552:Rivaroxaban / Q000009:adverse effects / Q000037:antagonists & inhibitors; D020521:Stroke / Q000097:blood* / Q000188:drug therapy*; D013923:Thromboembolism / Q000097:blood / Q000517:prevention & control*; D014812:Vitamin K / Q000037:antagonists & inhibitors; D014859:Warfarin / Q000009:adverse effects / Q000037:antagonists & inhibitors
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000925:Anticoagulants; D000931:Antidotes; D065427:Factor Xa Inhibitors; C580915:PRT064445; D011720:Pyrazoles; D011728:Pyridones; D011994:Recombinant Proteins; D014812:Vitamin K; C522181:apixaban; D014859:Warfarin; C000594745:idarucizumab; D000069552:Rivaroxaban; D015951:Factor Xa; D000069604:Dabigatran
keywords: Antidotes; Blood coagulation factors; Dabigatran; Factor Xa; Stroke