The effectiveness and safety of apixaban for stroke prevention in atrial fibrillation (SPAF) demonstrated in ARISTOTLE needs to be confirmed in daily care. To evaluate effectiveness and safety of apixaban therapy in SPAF patients in daily care, we used data from an ongoing, prospective, non-interventional registry of more than 3000 patients on novel oral anticoagulants in daily care. Between 1 December 2012 and 31 August 2015, 514 patients receiving apixaban were enrolled. During a mean follow-up of 803.5 ± 228.9 days, the combined endpoint of stroke/transient ischaemic attack/systemic embolism occurred at a rate of 2.4/100 patient-years in the intention-to-treat analysis (95% confidence interval [CI] 1.5–3.5) and at 1.8/100 patient-years (95% CI 1.0–2.8) in the on-treatment analysis (events within 3 days after last intake). On-treatment rates were numerically lower for patients selected for 5 mg apixaban (n = 404) twice daily [BID] compared with the 110 patients selected for 2.5 mg BID [1.6 (95% CI 0.8 to 2.7) vs. 2.6/100 patient-years (95% CI 0.8–6.1)]. On treatment, major bleeding occurred at a rate of 2.8/100 patient-years and significantly more often in patients receiving the 2.5 mg BID dose compared with the 5 mg BID dose (5.3 vs. 2.2/100 patient-years). Apixaban treatment discontinuation occurred in a total of 122 patients during follow-up (12.5/100 patient-years in Kaplan–Meier analysis). Our data contribute to the confirmation of effectiveness and relative safety of apixaban in daily-care patients. Furthermore, apixaban discontinuation rates were considerably lower than those reported for vitamin K antagonists.
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We are grateful to all participating patients and physicians, who continue to provide detailed information and documentation on the patients’ clinical course.
The sponsor of the Dresden NOAC Registry is the Gesellschaft für Technologie- und Wissenstransfer der Technischen Universität Dresden (GWT-TUD GmbH), Germany. The registry is supported by grants from Bayer, Boehringer Ingelheim, Daiichi Sankyo and Pfizer. All authors declare that these companies and institutions had no influence on the study design, conduct of the study, data collection, statistical analysis, or preparation of the manuscript. All statistical analyses were performed by ClinStat GmbH, Institute for Clinical Research and Statistics, Max-Planck-Str. 22a; D-50858 Cologne, Germany.
Conflict of interest
J.B.-W.: honoraria and research support from Bayer, Boehringer Ingelheim, Daiichi Sanyko. Pfizer and Portola S.M.: honoraria from Bayer. All other authors has no conflict of interest to declare.
The study protocol of the Dresden NOAC Registry was approved by the local ethics committee at the Technical University Dresden (AZ EK 349092011) and registered at ClinicalTrials.gov (NCT01588119). All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Informed consent was obtained from all individual participants included in the study.
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Helmert, S., Marten, S., Mizera, H. et al. Effectiveness and safety of apixaban therapy in daily-care patients with atrial fibrillation: results from the Dresden NOAC Registry. J Thromb Thrombolysis 44, 169–178 (2017). https://doi.org/10.1007/s11239-017-1519-8
- Atrial fibrillation