Uwe Zeymer1,2, Christiane Lober3, Andreas Wolf4, Frank Richard5, Heinrich Schäfer6, Jens Taggeselle7, Hans-Joachim Kabitz8, Roland Prondzinsky9, Tim Süselbeck10. 1. Klinikum Ludwigshafen, Ludwigshafen, Germany. uwe.zeymer@t-online.de. 2. Institut für Herzinfarktforschung Ludwigshafen, Ludwigshafen, Germany. uwe.zeymer@t-online.de. 3. Institut für Herzinfarktforschung Ludwigshafen, Ludwigshafen, Germany. 4. Kardiologische Praxis, Stahnsdorf, Germany. 5. Praxis Dr. Richard, Erfurt, Germany. 6. Praxis Dr. Schäfer, Herfurth, Germany. 7. Praxis Markkleeberg, Markkleeberg, Germany. 8. Klinikum Konstanz, Konstanz, Germany. 9. Carl-Von-Basedow-Klinikum Merseburg, Merseburg, Germany. 10. Kardiologische Praxisklinik Ludwigshafen, Ludwigshafen, Germany.
Abstract
INTRODUCTION: Apixaban has been shown to be superior to warfarin in patients with non-valvular atrial fibrillation in the randomized ARISTOTLE trial and its use is recommended in current guidelines. There are only scarce data about its use, efficacy, and safety in unselected patients in Germany. METHODS AND RESULTS: The APAF registry is a prospective non-interventional study enrolling 5015 patients with non-valvular atrial fibrillation. Of these, 1349 (26.9%) patients were initially treated with apixaban and followed up at 3 and 12 months. The dose of apixaban used was 1 × 2.5 mg in 1.6%, 2 × 2.5 mg in 30.4%, and 2 × 5 mg daily in 68.0% of patients, respectively. Inappropriate underdosing of apixaban was observed in 22.3%, mostly in elderly patients with higher HAS-BLED Score and a history of bleeding. Persistence to apixaban after 1 year was 88.6%, while the dose was changed in 3.7% of patients. Switching to other NOACs or VKAs occurred in 5.1%. After 12 months, all-cause mortality was 5.0%, non-fatal stroke occurred in 0.4%, non-fatal myocardial infarction in 0.6%, ISTH major bleeding in 0.8%, moderate or minor bleeding in 4.3% of patients, respectively. CONCLUSIONS: In this prospective experience in unselected patients with atrial fibrillation, persistence to apixaban was high, and efficacy and safety were comparable to the results in clinical trials, supporting its use in clinical practice.
INTRODUCTION:Apixaban has been shown to be superior to warfarin in patients with non-valvular atrial fibrillation in the randomized ARISTOTLE trial and its use is recommended in current guidelines. There are only scarce data about its use, efficacy, and safety in unselected patients in Germany. METHODS AND RESULTS: The APAF registry is a prospective non-interventional study enrolling 5015 patients with non-valvular atrial fibrillation. Of these, 1349 (26.9%) patients were initially treated with apixaban and followed up at 3 and 12 months. The dose of apixaban used was 1 × 2.5 mg in 1.6%, 2 × 2.5 mg in 30.4%, and 2 × 5 mg daily in 68.0% of patients, respectively. Inappropriate underdosing of apixaban was observed in 22.3%, mostly in elderly patients with higher HAS-BLED Score and a history of bleeding. Persistence to apixaban after 1 year was 88.6%, while the dose was changed in 3.7% of patients. Switching to other NOACs or VKAs occurred in 5.1%. After 12 months, all-cause mortality was 5.0%, non-fatal stroke occurred in 0.4%, non-fatal myocardial infarction in 0.6%, ISTH major bleeding in 0.8%, moderate or minor bleeding in 4.3% of patients, respectively. CONCLUSIONS: In this prospective experience in unselected patients with atrial fibrillation, persistence to apixaban was high, and efficacy and safety were comparable to the results in clinical trials, supporting its use in clinical practice.
Authors: Iwona Gorczyca; Olga Jelonek; Beata Uziębło-Życzkowska; Magdalena Chrapek; Małgorzata Maciorowska; Maciej Wójcik; Robert Błaszczyk; Agnieszka Kapłon-Cieślicka; Monika Gawałko; Monika Budnik; Tomasz Tokarek; Renata Rajtar-Salwa; Jacek Bil; Michał Wojewódzki; Anna Szpotowicz; Janusz Bednarski; Elwira Bakuła-Ostalska; Anna Tomaszuk-Kazberuk; Anna Szyszkowska; Marcin Wełnicki; Artur Mamcarz; Beata Wożakowska-Kapłon Journal: J Clin Med Date: 2020-11-05 Impact factor: 4.241