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CC BY 4.0 · TH Open 2020; 04(01): e20-e32
DOI: 10.1055/s-0040-1701206
Original Article
Georg Thieme Verlag KG Stuttgart · New York

Effects of Rivaroxaban on Biomarkers of Coagulation and Inflammation: A Post Hoc Analysis of the X-VeRT Trial

Paulus Kirchhof
1   Institute of Cardiovascular Sciences, University of Birmingham, Sandwell and West Birmingham Hospitals NHS Trust and University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom
2   Department of Cardiology, University Heart Center Hamburg, Hamburg, Germany
,
Michael D. Ezekowitz
3   Department of Cardiovascular Medicine, The Sidney Kimmel Medical College, Thomas Jefferson University, and the Lankenau Medical Center, Philadelphia, Pennsylvania, United States
,
Yanish Purmah
1   Institute of Cardiovascular Sciences, University of Birmingham, Sandwell and West Birmingham Hospitals NHS Trust and University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom
,
Sonja Schiffer
4   Translational Medicine, Global R&D, Bayer AG, Wuppertal, Germany
,
Isabelle L. Meng
5   Therapeutic Area Cardiovascular, Global Medical Affairs, Bayer AG, Berlin, Germany
,
A. John Camm
6   Division of Clinical Sciences, St George's, University of London, London, United Kingdom
,
Stefan H. Hohnloser
7   Division of Clinical Electrophysiology, Department of Cardiology, J. W. Goethe University, Frankfurt, Germany
,
Anke Schulz
8   Clinical Statistics EU, Global Clinical Development, Research and Clinical Sciences Statistics, Bayer AG, Berlin, Germany
,
Melanie Wosnitza
5   Therapeutic Area Cardiovascular, Global Medical Affairs, Bayer AG, Berlin, Germany
,
Riccardo Cappato
9   Arrhythmia and Electrophysiology Research Center, Humanitas Clinical and Research Center, Rozzano, Italy
› Author Affiliations Funding This study was funded by Bayer AG.
Further Information

Publication History

30 October 2019

18 December 2019

Publication Date:
23 January 2020 (online)

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Abstract

Introduction This X-VeRT (eXplore the efficacy and safety of once-daily oral riVaroxaban for the prevention of caRdiovascular events in patients with nonvalvular aTrial fibrillation scheduled for cardioversion) substudy evaluated the effects of treatment with rivaroxaban or a vitamin-K antagonist (VKA) on levels of biomarkers of coagulation (D-dimer, thrombin–antithrombin III complex [TAT] and prothrombin fragment [F1.2]) and inflammation (high sensitivity C-reactive protein [hs-CRP] and high-sensitivity interleukin-6 [hs-IL-6]) in patients with atrial fibrillation (AF) who were scheduled for cardioversion and had not received adequate anticoagulation at baseline (defined as, in the 21 days before randomization: no oral anticoagulant; international normalized ratio <2.0 with VKA treatment; or <80% compliance with non-VKA oral anticoagulant treatment).

Methods Samples for biomarker analysis were taken at baseline (n = 958) and treatment completion (42 days after cardioversion; n = 918). The influence of clinical characteristics on baseline biomarker levels and the effect of treatment on changes in biomarker levels were evaluated using linear and logistic models.

Results Baseline levels of some biomarkers were significantly associated with type of AF (D-dimer and hs-IL-6) and with history of congestive heart failure (hs-CRP, D-dimer, and hs-IL-6). Rivaroxaban and VKA treatments were associated with reductions from baseline in levels of D-dimer (−32.3 and −37.6%, respectively), TAT (−28.0 and −23.1%, respectively), hs-CRP (−12.5 and −17.9%, respectively), and hs-IL-6 (−9.2 and −9.8%, respectively). F1.2 levels were reduced from baseline in patients receiving a VKA (−53.0%) but not in those receiving rivaroxaban (2.7%).

Conclusion Anticoagulation with rivaroxaban reduced levels of key inflammation and coagulation biomarkers to a similar extent as VKAs, with the exception of F1.2. Further investigation to confirm the value of these biomarkers in patients with AF is merited.

Keywords

anticoagulants - atrial fibrillation - biomarkers - inflammation - rivaroxaban

Supplementary Material

 

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