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Venous Thromboembolism Therapy with Apixaban in Daily Care Patients: Results from the Dresden NOAC RegistryFunding The DRESDEN NOAC REGISTRY is supported by the Gesellschaft für Technologie- und Wissenstransfer der Technischen Universität Dresden (GWT-TUD GmbH), Germany (sponsor), by research funds of the University Hospital “Carl Gustav Carus,” Dresden, and by the grants from Bayer HealthCare, 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.
The effectiveness and safety of venous thromboembolism (VTE) treatment with apixaban, demonstrated in phase III trials, need to be confirmed in daily care.
Using data from the prospective, noninterventional cross-indication Dresden NOAC Registry we evaluated rates of VTE recurrence and bleeding complications during apixaban treatment of VTE patients. For this analysis, we only included patients with acute VTE who started apixaban within 14 days after diagnosis and who were enrolled within these 14 days. Patient characteristics, treatment persistence, and clinical outcomes were assessed.
Between August 1st, 2014 and October 31, 2018, 352 patients with apixaban treatment for acute VTE were enrolled. During treatment (median exposure 13.7 ± 9.8 months; median follow-up 21.7 ± 6.1 months) rates of recurrent VTE and International Society on Thrombosis and Haemostasis major bleeding were 1.3/100 pt.years (95% confidence interval or CI 0.4–3.0) and 1.5/100 pt.years (0.6–3.3), respectively. At 6 months. 68.6% of patients were still taking apixaban, 23.9% had a scheduled end of treatment, 6.3% were switched to other anticoagulants, and the remaining 2.3% had unplanned complete discontinuation of anticoagulation.
Of the 188 patients stopping apixaban, 12 (6.4%) experienced a recurrent VTE (six pulmonary embolisms ± deep vein thrombosis, six deep vein thrombosis; mean time between stopping anticoagulation and VTE recurrence 5.2 ± 4.1 months [range 14–417 days]).
Our findings suggest that, in daily care, apixaban demonstrated high effectiveness, safety, and persistence in the treatment of acute VTE with low rates of unplanned discontinuation.
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). The study complies with the principles and requirements of the Declaration of Helsinki. All patients provided written informed consent, including a data protection waiver, before enrolment.
J.B.-W. has designed this analysis and has written the first draft of the manuscript. L.T., S.M., and C.N. have collected the data. L.T. has performed the statistical analyses and drafted the figures. All authors have provided significant contributions to the written presentation, have critically reviewed and approved the final version of the manuscript.
Received: 23 April 2020
Accepted: 23 February 2021
04 May 2021 (online)
© 2021. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/)
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