Use, Persistence, Efficacy, and Safety of Apixaban in Patients with Non-Valvular Atrial Fibrillation in Unselected Patients in Germany. Results of the Prospective Apixaban in Atrial Fibrillation (APAF) Registry

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. Electronic supplementary material The online version of this article (10.1007/s40119-020-00188-1) contains supplementary material, which is available to authorized users.

Vitamin-K-antagonist phenprocoumon versus low-dose direct oral anticoagulants (DOACs) in patients with atrial fibrillation: a real-world analysis of German claims data

“…Although quality of coding renal impairment in claims data is known to be low, this still might indicate that a noticeable part could be underdosed with ld-DOAC. Previous studies showed that many patients (22 to 57%) with ld-DOAC do not meet the criteria for reduced dose [13,16,18,31]. Assumingly, prescribing a lower dose than recommended might be induced by the intention to protect the patient, as inadequate ld-DOAC is often prescribed in elderly patients at a higher risk for bleeding and stroke [16,18,31,32].…”

“…Previous studies showed that many patients (22 to 57%) with ld-DOAC do not meet the criteria for reduced dose [13,16,18,31]. Assumingly, prescribing a lower dose than recommended might be induced by the intention to protect the patient, as inadequate ld-DOAC is often prescribed in elderly patients at a higher risk for bleeding and stroke [16,18,31,32]. In the case of VKA therapy, patients at risk would possibly receive a close INR-monitoring to prevent overdosing or a dose targeted at the lower border of INR, as low-intensity VKA-therapy was shown to be as efficient and safer as standard VKA-therapy in a recent metaanalysis [33].…”

“…In the ORBIT-AF II registry (USA), 16% of patients with DOACs received a reduced dose [13]. Higher rates of ld-DOACs were reported in Denmark and Germany, ranging from 32 to 52% [14][15][16][17]. In a Japanese single-centre cohort study, the ld-DOAC cohort included as many as 56% of patients [18].…”

Trends in the Prescription of Non-Vitamin K Antagonist Oral Anticoagulants for Atrial Fibrillation: Results of the Polish Atrial Fibrillation (POL-AF) Registry

“…In the present study, the mean CHA 2 DS 2 -VASc scores were 4.6, 4.2, and 4.2 for patients treated with apixaban, dabigatran, and rivaroxaban, respectively. In the XANTUS (Xarelto for Prevention of Stroke in Patients With Atrial Fibrillation) (registry the mean CHA 2 DS 2 -VASc score was 3.4 for rivaroxaban-treated patients [23], while in the APAF registry the mean CHA 2 DS 2 -VASc score was 3.8 for apixaban-treated patients [24].…”