Comparative safety and effectiveness of rivaroxaban versus VKAs in patients with venous thromboembolismA Danish nationwide registry-based study 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.
03 October 2016
Accepted after major revision: 23 February 2017
28 November 2017 (online)
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.
KeywordsVenous thromboembolism - anticoagulation - vitamin K antagonists - rivaroxaban - non-vitamin K antagonist oral anticoagulants
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