Orale Thromboembolieprophylaxe mit Rivaroxaban und Dabigatran: Sind die Neuzulassungen Innovationen für die operative Orthopädie und Unfallchirurgie?

Zusammenfassung

Operativ tätige Orthopäden und Unfallchirurgen befassen sich täglich mit der Indikationsstellung einer Thromboembolieprophylaxe. Aktuell ergeben sich diesbezüglich relevante Veränderungen. Einerseits wurde im Mai eine neue, streng evidenzbasierte AWMF-Leitlinie von insgesamt 27 Fachgesellschaften verabschiedet. Erstmals werden hier konkrete Empfehlungen zu den einzelnen Indikationsgebieten ausgesprochen, die die Art der medikamentösen Prophylaxe und auch deren Dauer beschreiben. Viele der Empfehlungen werden dazu führen, dass bisher gängige Prozesse in den Kliniken und auch im ambulanten Bereich geändert werden. Nahezu zeitgleich wurden in Deutschland 2 neue orale Antikoagulanzien für die Prophylaxe der Thromboembolie nach Hüft- und Kniegelenkendoprothesen zugelassen. Dabigatran ist ein oraler Thrombinhemmer. Bei vergleichbarem Nebenwirkungs- und Komplikationsprofil zeigt er auch hinsichtlich der Wirksamkeit gegenüber Enoxaparin in der oben genannten Indikation keine klinisch relevanten Unterschiede. Rivaroxaban ist ein oraler Faktor-Xa-Hemmer, der gegenüber Enoxaparin bei ebenfalls vergleichbaren Nebenwirkungs- und Komplikationsraten eine signifikant bessere Effektivität bei der Reduktion thrombotischer Komplikationen nach Hüft- und Kniegelenkendoprothesen zeigen konnte. Diese signifikante Überlegenheit gilt in gepoolten Analysen aus der Phase 3 auch für symptomatische Ereignisse. Die Übersichtsarbeit diskutiert relevante Aspekte der neuen AWMF-Leitlinie ebenso wie die möglichen Effekte der neuen Antikoagulanzien auf Prozesse in der Klinik.

Abstract

Today the indication for thrombosis prophylaxis is a relevant and daily concern in orthopaedic surgery. Recently there are some changes concerning the German guidelines, which are approved by 27 German medical societies. For the first time the guidelines give distinct recommendations for the different indications, the kind of thrombosis prophylaxis and its duration. Some of the recommendations will lead to changes of both processes in outpatient and inpatient management. In parallel 2 new oral anticoagulants have been approved for the prevention of thromboembolic events after elective knee and hip replacement. Dabigatran is an oral thrombin inhibitor. Compared to enoxaparin it has a comparable profile of side effects and efficacy. Rivaroxaban is an oral Xa inhibitor which shows a sigificantly better efficacy compared to enoxaparin and no difference in side effects. The significant reduction of symptomatic thromboembolisms after elective knee and hip replacement was shown for rivaroxaban compared to enoxaparin in a pooled analysis of phase III data. This review discusses the main topics of the new German guideline and impact of the new oral anticoagulants on in- and outpatient treatment procedures.

Schlüsselwörter

AWMF‐Leitlinien - Thromboembolie - Prophylaxe - Gelenkendoprothesen - Dabigatran - Rivaroxaban

Key words

guideline - thromboembolism - prophylaxis - joint replacement - dabigatran - rivaroxaban

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