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DOI: 10.1055/s-0043-119893
Medizinische Thromboseprophylaxestrümpfe – große Wirkung in Zulassungsstudien von Edoxaban
Antiembolic Stockings – Great Effects in Edoxaban Approval StudiesPublikationsverlauf
Publikationsdatum:
27. Oktober 2017 (online)
![](https://www.thieme-connect.de/media/zblchir/201705/lookinside/thumbnails/10-1055-s-0043-119893_zbc1348-1.jpg)
Zusammenfassung
Der Nutzen von medizinischen Thromboseprophylaxestrümpfen (AES) als physikalisches Mittel zur Prävention von venösen Thrombosen der unteren Extremität wird im Zeitalter der evidenzbasierten Medizin infrage gestellt. Die aktuellen S3-Leitlinien schreiben sogar, dass ihre Nichtanwendung in den allermeisten Fällen explizit im Empfehlungskorridor dieser Leitlinie liegt. Die niedermolekularen Heparine (NMH) und die direkten oralen Antikoagulanzien (DOAK) haben über Studien zur Thromboseprophylaxe bei elektivem Knie- und Hüftgelenkersatz ihre Zulassung erhalten, allerdings ist zur Anwendung von AES in diesen Zulassungsstudien nichts bekannt. Nun wurden erstmals die Ergebnisse der zusätzlichen Wirkung der AES in den Zulassungsstudien von Edoxaban publiziert. Danach betrug die Inzidenz von venösen Thromboembolien 6,0%, wenn AES getragen wurden, und 13,0%, wenn keine AES getragen wurden. Da in den Zulassungsstudien von NMH und den DOAKs nicht die Anwendung von AES kontrolliert wurde, kann nicht gesagt werden, wie groß der Effekt der AES auf das Gesamtergebnis ist, und die Studienergebnisse gelten nur vor dem Hintergrund der allgemeinen Anwendung von AES.
Abstract
In this age of evidence-based medicine, the use of medical thrombosis prophylaxis stockings (AES) as a physical strategy for the prevention of lower limb venous thrombosis has been questioned. The current German S3 guidelines even state that their non-application is, in the vast majority of cases, explicitly covered by the recommendations of this guideline. Low molecular weight heparins (NMH) and direct oral anticoagulants (DOAK) have received approval for thrombosis prophylaxis in elective knee and hip joint replacement, but the use of AES is absent from these approval studies. The results of the additional effects of the AES in the approval studies of Edoxaban were published for the first time. According to these results, the incidence of venous thromboembolism was 6.0% when AES were worn and 13.0% when AES were not worn. Since the approval studies of NMH and the DOAKs did not control for the use of AES, the impact of AES on the overall results remains unclear. Therefore the study results are only valid in the context of the general application of AES. Guidelines commissions should take this into account in their recommendations.
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