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Effectiveness and Safety of Apixaban for Treatment of Venous Thromboembolism in Daily Practice.
TH Open. 2020 Apr; 4(2):e119-e126.TO

Abstract

Introduction  Phase 3 trials have shown comparable efficacy of direct oral anticoagulants (DOACs) and vitamin K antagonists in patients with acute venous thromboembolism (VTE), with less major bleeding events in patients randomized to DOAC treatment. With DOACs being increasingly used in clinical practice, evaluation of the DOACs in daily practice-based conditions is needed to confirm their safety and effectiveness. The aim of this study is to evaluate the effectiveness and safety of apixaban in VTE patients in daily practice. Methods  In this retrospective cohort study, consecutive patients diagnosed with VTE in two Dutch hospitals (Leiden University Medical Center, Leiden and Haga Teaching Hospital, The Hague) were identified based on administrative codes. We assessed recurrent VTE, major bleeding and mortality during a 3-month follow-up period in those treated with apixaban. Results  Of 671 consecutive VTE patients treated with apixaban, 371 presented with acute pulmonary embolism (PE) and 300 patients with deep-vein thrombosis. During 3 months treatment, 2 patients had a recurrent VTE (0.3%; 95% confidence interval [CI]: 0.08-1.1), 12 patients had major bleeding (1.8%; 95% CI: 1.0-3.2), and 11 patients died (1.6%; 95% CI: 0.9-2.9), of which one patient with recurrent PE and one because of a intracerebral bleeding. Conclusion  In this daily practice-based cohort, apixaban yielded a low incidence of recurrent VTE, comparable to the phase 3 AMPLIFY study patients. The incidence of major bleeding was higher than in the AMPLIFY-study patients, reflecting the importance of daily practice evaluation and the fact that results from phase III clinical studies cannot be directly extrapolated toward daily practice.

Authors+Show Affiliations

Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, The Netherlands. Department of Medicine, Haga Teaching Hospital, The Hague, The Netherlands.Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, The Netherlands.Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, The Netherlands.Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, The Netherlands. Department of Medicine, Haga Teaching Hospital, The Hague, The Netherlands.Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, The Netherlands.Department of Internal Medicine, Leiden University Medical Center, Leiden, The Netherlands.Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, The Netherlands.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32607465

Citation

Hendriks, Stephan V., et al. "Effectiveness and Safety of Apixaban for Treatment of Venous Thromboembolism in Daily Practice." TH Open : Companion Journal to Thrombosis and Haemostasis, vol. 4, no. 2, 2020, pp. e119-e126.
Hendriks SV, Klok FA, Stenger WJE, et al. Effectiveness and Safety of Apixaban for Treatment of Venous Thromboembolism in Daily Practice. TH Open. 2020;4(2):e119-e126.
Hendriks, S. V., Klok, F. A., Stenger, W. J. E., Mairuhu, A. T. A., Eikenboom, J., Fogteloo, J., & Huisman, M. V. (2020). Effectiveness and Safety of Apixaban for Treatment of Venous Thromboembolism in Daily Practice. TH Open : Companion Journal to Thrombosis and Haemostasis, 4(2), e119-e126. https://doi.org/10.1055/s-0040-1713683
Hendriks SV, et al. Effectiveness and Safety of Apixaban for Treatment of Venous Thromboembolism in Daily Practice. TH Open. 2020;4(2):e119-e126. PubMed PMID: 32607465.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effectiveness and Safety of Apixaban for Treatment of Venous Thromboembolism in Daily Practice. AU - Hendriks,Stephan V, AU - Klok,Frederikus A, AU - Stenger,Wilhelmina J E, AU - Mairuhu,Albert T A, AU - Eikenboom,Jeroen, AU - Fogteloo,Jaap, AU - Huisman,Menno V, Y1 - 2020/06/24/ PY - 2020/03/24/received PY - 2020/05/25/accepted PY - 2020/7/2/entrez PY - 2020/7/2/pubmed PY - 2020/7/2/medline KW - apixaban KW - direct oral anticoagulants KW - efficacy KW - safety KW - venous thromboembolism SP - e119 EP - e126 JF - TH open : companion journal to thrombosis and haemostasis JO - TH Open VL - 4 IS - 2 N2 - Introduction  Phase 3 trials have shown comparable efficacy of direct oral anticoagulants (DOACs) and vitamin K antagonists in patients with acute venous thromboembolism (VTE), with less major bleeding events in patients randomized to DOAC treatment. With DOACs being increasingly used in clinical practice, evaluation of the DOACs in daily practice-based conditions is needed to confirm their safety and effectiveness. The aim of this study is to evaluate the effectiveness and safety of apixaban in VTE patients in daily practice. Methods  In this retrospective cohort study, consecutive patients diagnosed with VTE in two Dutch hospitals (Leiden University Medical Center, Leiden and Haga Teaching Hospital, The Hague) were identified based on administrative codes. We assessed recurrent VTE, major bleeding and mortality during a 3-month follow-up period in those treated with apixaban. Results  Of 671 consecutive VTE patients treated with apixaban, 371 presented with acute pulmonary embolism (PE) and 300 patients with deep-vein thrombosis. During 3 months treatment, 2 patients had a recurrent VTE (0.3%; 95% confidence interval [CI]: 0.08-1.1), 12 patients had major bleeding (1.8%; 95% CI: 1.0-3.2), and 11 patients died (1.6%; 95% CI: 0.9-2.9), of which one patient with recurrent PE and one because of a intracerebral bleeding. Conclusion  In this daily practice-based cohort, apixaban yielded a low incidence of recurrent VTE, comparable to the phase 3 AMPLIFY study patients. The incidence of major bleeding was higher than in the AMPLIFY-study patients, reflecting the importance of daily practice evaluation and the fact that results from phase III clinical studies cannot be directly extrapolated toward daily practice. SN - 2512-9465 UR - https://www.unboundmedicine.com/medline/citation/32607465/Effectiveness_and_Safety_of_Apixaban_for_Treatment_of_Venous_Thromboembolism_in_Daily_Practice L2 - http://www.thieme-connect.com/DOI/DOI?10.1055/s-0040-1713683 DB - PRIME DP - Unbound Medicine ER -
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