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

Jan Beyer-Westendorf; Franziska Ebertz; Kati Förster; Vera Gelbricht; Franziska Michalski; Christina Köhler; Sebastian Werth; Heike Endig; Sven Pannach; Luise Tittl; Kurtulus Sahin; Katharina Daschkow; Norbert Weiss

doi:10.1160/TH14-11-0954

Thrombosis and Haemostasis, Inhaltsverzeichnis

Thromb Haemost 2015; 113(06): 1247-1257
DOI: 10.1160/TH14-11-0954

Coagulation and Fibrinolysis

Schattauer GmbH

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

Results from the Dresden NOAC Registry

Jan Beyer-Westendorf

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

,

Franziska Ebertz

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

,

Kati Förster

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

,

Vera Gelbricht

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

,

Franziska Michalski

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

,

Christina Köhler

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

,

Sebastian Werth

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

,

Heike Endig

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

,

Sven Pannach

²Department of Medicine I, Division of Gastroenterology, University Hospital “Carl Gustav Carus” der Technischen Universität Dresden, Dresden, Germany

,

Luise Tittl

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

,

Kurtulus Sahin

³ClinStat GmbH, Institute for Clinical Research and Statistics, Cologne, Germany

,

Katharina Daschkow

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

,

Norbert Weiss

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

› Institutsangaben

Abstract

summary

The effectiveness and safety of dabigatran for stroke prevention in atrial fibrillation (SPAF) demonstrated in RE-LY needs to be confirmed in daily care. To evaluate treatment persistence, effectiveness and safety of dabigatran therapy in SPAF patients in daily care, we used data from an ongoing, prospective, non-interventional registry of more than 2,500 patients on novel oral anticoagulants in daily care. Between October 1, 2011 and February 28, 2013, a total of 341 SPAF patients receiving dabigatran were enrolled. The combined endpoint of stroke/transient ischaemic attack/systemic embolism occurred at a rate of 2.93/100 patient-years in the intention-to-treat analysis (95%-CI 1.6–4.9) and at 1.9/100 patient-years in the on treatment analysis (events within three days after last intake). On-treatment rates were higher in patients selected for 110 mg dabigatran (n=183) BID compared to the 158 patients selected for 150 mg BID (2.88 [95% CI 1.16–5.93] vs 0.86/100 patient-years [95% CI 0.10, 3.12]). On treatment, major bleeding occurred at a rate of 2.3/100 patient-years and numerically more often in patients receiving the 110 mg BID dose compared to the 150 mg BID dose (2.9 vs 1.7/100 patient-years). Dabigatran treatment discontinuation occurred in a total of 124 patients during follow-up (25.8 per 100 patient-years in Kaplan Meier analysis). Main reasons for treatment discontinuation were nonbleeding side effects. Our data contribute to the confirmation of effectiveness and relative safety of dabigatran in unselected patients in daily care. However, discontinuation rates are not lower than those reported for patients treated with vitamin K antagonists.

Keywords

Anticoagulation - atrial fibrillation - bleeding - dabigatran

Volltext

Referenzen

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