Thromb Haemost 2017; 117(06): 1182-1191
DOI: 10.1160/TH16-10-0745
Stroke, Systemic or Venous Thromboembolism
Schattauer GmbH

Comparative safety and effectiveness of rivaroxaban versus VKAs in patients with venous thromboembolism

A Danish nationwide registry-based study
Caroline Sindet-Pedersen
1  Department of Cardiology, Copenhagen University Hospital Herlev and Gentofte, Hellerup, Denmark
3  Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
,
Jannik Langtved Pallisgaard
1  Department of Cardiology, Copenhagen University Hospital Herlev and Gentofte, Hellerup, Denmark
3  Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
,
Laila Staerk
1  Department of Cardiology, Copenhagen University Hospital Herlev and Gentofte, Hellerup, Denmark
3  Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
,
Thomas Alexander Gerds
2  The Danish Heart Foundation, Copenhagen, Denmark
7  Department of Public Health, Section of Biostatistics, University of Copenhagen, Copenhagen, Denmark
,
Emil Loldrup Fosbøl
1  Department of Cardiology, Copenhagen University Hospital Herlev and Gentofte, Hellerup, Denmark
2  The Danish Heart Foundation, Copenhagen, Denmark
6  Department of Cardiology, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark;
,
Christian Torp-Pedersen
1  Department of Cardiology, Copenhagen University Hospital Herlev and Gentofte, Hellerup, Denmark
5  Institute of Health, Science and Technology, Aalborg University, Aalborg, Denmark
,
Gunnar Gislason
1  Department of Cardiology, Copenhagen University Hospital Herlev and Gentofte, Hellerup, Denmark
2  The Danish Heart Foundation, Copenhagen, Denmark
3  Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark
4  The National Institute of Public Health, University of Southern Denmark, Copenhagen, Denmark
,
Jonas Bjerring Olesen
1  Department of Cardiology, Copenhagen University Hospital Herlev and Gentofte, Hellerup, Denmark
› Author Affiliations
Financial support: The Danish council of independent research supported this study (No.: 4183–00008). Gislason is supported by an unrestricted clinical research scholarship from the Novo Nordisk Foundation. The sponsor had no influence on the study design, interpretation of results, or the decision to submit the manuscript for publication.
Further Information

Publication History

Received: 03 October 2016

Accepted after major revision: 23 February 2017

Publication Date:
28 November 2017 (online)

Summary

The approval of rivaroxaban has changed the landscape of treatment of venous thromboembolism (VTE). Little is known about the effect of rivaroxaban compared with vitamin K antagonists (VKA), when used in the everyday clinical practice. The aim of this study was to investigate the safety and effectiveness of rivaroxaban compared with VKAs among patients with VTE, using the Danish nationwide registries. All patients diagnosed with VTE and treated with either rivaroxaban or VKAs between 2013 and 2015 were included. A total of 12,318 patients were diagnosed with VTE and treated with VKAs [n=6,907] or rivaroxaban [n=5,411.]. Combined Cox regression analyses showed that the standardised absolute six-month risk of recurrent VTE was 3.03 % [95 % CI: 2.57 % to 3.48 %] in the rivaroxaban group and 3.13 % [95 % CI: 2.70 % to 3.56 %] in the VKA group (absolute risk difference of –0.11 % [95 % CI: –0.76 % to 0.54 %]). The standardised absolute six-months risk of bleeding was 2.28 % [95 % CI: 1.87 % to 2.67 %] for patients in the rivaroxaban group and 2.10 % [95 % CI: 1.78 % to 2.43 %] in the VKA group (absolute risk difference of 0.18 % [95 % CI: –0.34 % to 0.67]). In conclusion, rivaroxaban was associated with similar risk of recurrent VTE and bleeding compared with VKA.

Supplementary Material to this article is available online at www.thrombosis-online.com.