Effectiveness and safety of dabigatran therapy in daily care patients with atrial fibrillation - results from the Dresden NOAC Registry

NOACs on the rise for stroke prevention in atrial fibrillation

Bleeding risks are a common concern when it comes to blood thinners. Non-Vitamin K antagonist oral anticoagulants (NOACs) seem to be effective in both clinical trials and daily care, while good quality anticoagulation control with vitamin-K-antagonist therapy can be harder to achieve during daily routine. 

NOACs are highly convenient, as effective as vitamin K antagonists and - on top of it - associated with a lower rate of life-threatening bleeding complications. These potential benefits, stem from clinical trials with selected patient populations and thus need to be confirmed in large cohorts of unselected patients in daily routine, PD Dr. Jan Beyer-Westendorf, Head of Division Thrombosis Research and Deputy Head of Division Angiology, Vascular Center and Medical Clinic III, University Hospital Carl Gustav Carus, Technische Universität Dresden, Germany, explained.

Therefore, Beyer-Westendorf and his colleagues evaluated efficacy, management and safety of dabigatran in daily care. The authors of the paper "Effectiveness and safety of dabigatran therapy in daily care patients with atrial fibrillation. Results from the Dresden NOAC Registry" published in Thrombosis and Haemostasis, relied on a large daily-care registry of patients with NOAC treatment for stroke prevention in atrial fibrillation. 

The authors concluded that the trial results do actually translate to daily care. They found low rates of stroke and major bleeding associated with dabigatran therapy. "Our data indicate that dabigatran, if adequately dosed, adequately taken and tolerated by the patient, is a highly effective and safe anticoagulant option for atrial fibrillation patients," Beyer-Westendorf said. The authors also mention that discontinuation of dabigatran treatment seems to be comparable with the discontinuation rate seen in vitamin K antagonist patients but were higher in daily care patients than in the respective phase-III trial. In fact, dabigatran discontinuation was driven by non-bleeding side effects rather than bleeding, drug costs or thromboembolic complications. He added: "Interestingly, we found that physicians seem to favor the lower dosage (of dabigatran), indicating that bleeding risks are a concern in daily care."  

The authors concede that "as a stand alone study, our data will probably not influence overall clinical practice (limitations: low numbers, only German patients included)." However, they provide additional prospective long-term follow-up data. "We hope that our data help to implement NOACs as the standard anticoagulant therapy in patients with stroke prevention in atrial fibrillation worldwide.... Furthermore, we hope that we were able to indicate that careful selection of patient, type of anticoagulant and dosage is essential to achieve high-quality therapy with low complication rates." Moreover, the paper indicates the value of carefully conducted prospective registries.
Werner Zwick, M.A., Munich, Germany

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, and Norbert Weiss: Effectiveness and Safety of Dabigatran Therapy in Daily-Care Patients With Atrial Fibrillation - Results From the Dresden NOAC Registry. Opens external link in new windowThromb Haemost 2015: 113/6 (June) pp. 1159–1382

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