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. 2021 May 4;5(2):e143-e151.
doi: 10.1055/s-0041-1728675. eCollection 2021 Apr.

Venous Thromboembolism Therapy with Apixaban in Daily Care Patients: Results from the Dresden NOAC Registry

Jan Beyer-Westendorf  1   2 , Sandra Marten  1 , Luise Tittl  1 , Christiane Naue  1 , Martin Bornhäuser  1
Affiliations

Venous Thromboembolism Therapy with Apixaban in Daily Care Patients: Results from the Dresden NOAC Registry

Jan Beyer-Westendorf et al. TH Open. .

Abstract

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.

Keywords: anticoagulation; apixaban; bleeding; persistence; venous thromboembolism.

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Conflict of interest statement

Conflict of Interest J.B.-W. has received honoraria and research support from Bayer HealthCare, Boehringer Ingelheim, Daiichi Sankyo, Doasense, BMS/Pfizer, and Portola. S.M. has received honoraria from Bayer HealthCare and Daiichi Sankyo. L.T. received honoraria from Daiichi Sankyo. None of the other authors declared a conflict of interest with regard to the NOAC registry or this manuscript.

Figures

Fig. 1
Fig. 1
Flowchart of study cohort.
See this image and copyright information in PMC

References

    1. van Es N, Coppens M, Schulman S, Middeldorp S, Büller H R. Direct oral anticoagulants compared with vitamin K antagonists for acute venous thromboembolism: evidence from phase 3 trials. Blood. 2014;124(12):1968–1975. - PubMed
    1. Kearon C, Akl E A, Ornelas J. Antithrombotic therapy for VTE disease: Chest guideline and expert panel report. Chest. 2016;149(02):315–352. - PubMed
    1. ESC Scientific Document Group . Konstantinides S V, Meyer G, Becattini C. 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS) Eur Heart J. 2020;41(04):543–603. - PubMed
    1. AMPLIFY Investigators . Agnelli G, Buller H R, Cohen A. Oral apixaban for the treatment of acute venous thromboembolism. N Engl J Med. 2013;369(09):799–808. - PubMed
    1. AMPLIFY-EXT Investigators . Agnelli G, Buller H R, Cohen A. Apixaban for extended treatment of venous thromboembolism. N Engl J Med. 2013;368(08):699–708. - PubMed