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Phlebologie 2016; 45(04): 187-193
DOI: 10.12687/phleb2320-4-2016
Original article
Schattauer GmbH

Safety and effectiveness of rivaroxaban versus standard anticoagulation for the treatment of symptomatic deep vein thrombosis in routine clinical practice

Subgroup analysis of XALIA-DE for Germany Article in several languages: English | deutsch
R.M. Bauersachs
1   Klinikum Darmstadt GmbH, Klinik für Gefäßmedizin Angiologie, Gefäßzentrum Darmstadt, Germany
2   Centrum für Thrombose und Hämostase (CTH), Universitätsmedizin Mainz, Germany
,
S. Haas
3   Ehemals Klinikum Rechts der Isar, Technische Universität München, Germany
,
R. Kreutz
4   Charité – Universitätsmedizin Berlin, Institut für Klinische Pharmakologie und Toxikologie, Germany
,
M. Gebel
5   Bayer Pharma AG, Wuppertal, Germany
,
J. Herold
6   Universitätsklinikum Magdeburg, Klinik für Kardiologie und Angiologie, Abteilung für Angiologie, Germany
,
J. Schneider
7   Bayer Pharma AG, Berlin, Germany
,
P. Weyrauch
8   Bayer Vital GmbH, Leverkusen, Germany
,
J. Beyer-Westendorf
9   Universitätsklinikum Dresden, Universitäts GefäßCentrum (UGC), Bereich “Thromboseforschung”, Germany
,
für die XALIA-DE Studiengruppe › Author Affiliations
Further Information

Publication History

Received: 27 June 2016

Accepted: 28 June 2016

Publication Date:
21 December 2017 (online)

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Summary

In addition to parenteral anticoagulants and vitamin K antagonists (standard AC), non-vitamin K antagonist oral anticoagulants (NOAC) are increasingly being used for the acute and long-term treatment of deep vein thrombosis (DVT).

The international, prospective, non-interventional XALIA study compared the acute and long-term treatment of DVT with rivaroxaban or standard AC under routine clinical practice and confirmed the safety and efficacy of rivaroxaban demonstrated in Phase III studies: annual event rates for major bleeding, VTE and all-cause mortality were 1.2 %, 2.4 % and 0.8 % respectively, compared to 3.4 %, 3.9 %, and 6.2 % with standard AC.

The XALIA-DE subgroup analysis examined whether the XALIA results were applicable to Germany. The 586 rivaroxaban patients were younger and fewer had active cancer than the 355 treated with standard AC. As in XALIA, the incidence of major bleeding (1.6 vs. 4.1/100 patient-years [PY]), recurrent VTE (1.9 vs. 4.7/100 PY) and all-cause mortality (1.6 vs. 6.8/100 PY) were lower under rivaroxaban than under standard AC. These rates indicate a favourable benefit-risk profile of rivaroxaban under the conditions of everyday practice.

Keywords

Oral anticoagulation - NOAC - bleeding - recurrent VTE - rivaroxaban
 

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