Effectiveness and safety of rivaroxaban therapy in daily-care patients with atrial fibrillation

Judith Hecker; Sandra Marten; Loretta Keller; Sindy Helmert; Franziska Michalski; Sebastian Werth; Kurtulus Sahin; Luise Tittl; Jan Beyer-Westendorf

doi:10.1160/TH15-10-0840

Thrombosis and Haemostasis, Table of Contents

Thromb Haemost 2016; 115(05): 939-949
DOI: 10.1160/TH15-10-0840

Coagulation and Fibrinolysis

Schattauer GmbH

Effectiveness and safety of rivaroxaban therapy in daily-care patients with atrial fibrillation

Results from the Dresden NOAC Registry

Judith Hecker

¹Center for Vascular Medicine and Department of Medicine III, Division of Angiology, University Hospital “Carl Gustav Carus” Dresden, Dresden, Germany

,

Sandra Marten

¹Center for Vascular Medicine and Department of Medicine III, Division of Angiology, University Hospital “Carl Gustav Carus” Dresden, Dresden, Germany

,

Loretta Keller

¹Center for Vascular Medicine and Department of Medicine III, Division of Angiology, University Hospital “Carl Gustav Carus” Dresden, Dresden, Germany

,

Sindy Helmert

¹Center for Vascular Medicine and Department of Medicine III, Division of Angiology, University Hospital “Carl Gustav Carus” Dresden, Dresden, Germany

,

Franziska Michalski

¹Center for Vascular Medicine and Department of Medicine III, Division of Angiology, University Hospital “Carl Gustav Carus” Dresden, Dresden, Germany

,

Sebastian Werth

¹Center for Vascular Medicine and Department of Medicine III, Division of Angiology, University Hospital “Carl Gustav Carus” Dresden, Dresden, Germany

,

Kurtulus Sahin

²ClinStat GmbH, Institute for Clinical Research and Statistics, Cologne, Germany

,

Luise Tittl

¹Center for Vascular Medicine and Department of Medicine III, Division of Angiology, University Hospital “Carl Gustav Carus” Dresden, Dresden, Germany

,

Jan Beyer-Westendorf

¹Center for Vascular Medicine and Department of Medicine III, Division of Angiology, University Hospital “Carl Gustav Carus” Dresden, Dresden, Germany

› Author Affiliations

Abstract

Summary

The effectiveness and safety of rivaroxaban for stroke prevention in atrial fibrillation (SPAF) demonstrated in ROCKET AF needs to be confirmed in daily care. To evaluate effectiveness and safety of rivaroxaban therapy in SPAF patients in daily care, we used data from an ongoing, prospective, non-interventional registry of more than 2700 patients on novel oral anticoagulants in daily care. Between October 1, 2011 and February 28, 2013, a total of 1204 SPAF patients receiving rivaroxaban were enrolled. During a mean follow-up of 796.2 ± 207.3 days, the combined endpoint of stroke/transient ischaemic attack/systemic embolism occurred at a rate of 2.03/100 patient-years in the intention-totreat analysis (95 % confidence interval [CI] 1.5–2.7) and at 1.7/100 patient-years in the on-treatment analysis (events within 3 days after last intake). On-treatment rates were higher in patients selected for 15 mg rivaroxaban (n=384) once daily [OD] compared with the 820 patients selected for 20 mg OD (2.7 [95 % CI 1.6–4.2] vs 1.25/100 patient-years [95 % CI 0.8–1.9]). On treatment, major bleeding occurred at a rate of 3.0/100 patient-years and significantly more often in patients receiving the 15 mg OD dose compared with the 20 mg OD dose (4.5 vs 2.4/100 patient-years). Rivaroxaban treatment discontinuation occurred in a total of 277 patients during follow-up (12.0/100 patientyears in Kaplan-Meier analysis). Our data contribute to the confirmation of effectiveness and relative safety of rivaroxaban in daily-care patients. Furthermore, rivaroxaban discontinuation rates were considerably lower than those reported for vitamin K antagonists.

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

Keywords

Anticoagulation - atrial fibrillation - bleeding - persistence - rivaroxaban

Full Text

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