Thromboembolic events, bleeding, and drug discontinuation in patients with atrial fibrillation on anticoagulation: a prospective hospital-based registry

BMC Cardiovascular Disorders, Dec 2016

Background The clinical practice of stroke prevention in atrial fibrillation (AF) with direct oral anticoagulants (DOACS) differs from anticoagulation in randomized trial patients. We investigated the risk of thromboembolism, bleeding, and drug discontinuation in a hospital-based real-world setting. Methods All-comer patients with non-valvular AF were recruited into a registry at an academic tertiary care center. After informed consent, patients underwent a personal structured interview including medical history, past and current anticoagulation, and returned for follow-up after 6–12 months. Results The registry comprised 282 patients (42% women, median age 71 years) with a median CHA2DS2-Vasc-Score of 4 (25. to 75. percentile 2.5–5), who were prospectively followed 285 days in median. At inclusion, 118 patients took vitamin-K-antagonists, 33 dabigatran, 87 rivaroxaban, 30 apixaban, 5 low-molecular-weight heparin, and 9 were on no anticoagulant. Occurrence of stroke (rate 2.8/100 patient-years), was associated with prior stroke (hazard ratio [HR] 18.5, 95% confidence interval 2.16–159), increased HbA1c (HR per 1% increase 1.71, 1.20–2.45) and borderline significantly associated with vascular disease (HR 8.33, 0.97–71.3). Further we observed a high rate of major bleeding (2.8/100 patient-years), clinically relevant non-major bleeding (4.1/100 patient-years), and venous thromboembolism (2.8/100 patient-years). Anticoagulation was discontinued by 80 patients (36.9/100 patient-years), and diabetes (HR 2.31, 1.32–4.02), history of bleeding (HR 2.51, 1.44–4.37) and elevated leucocyte count (HR per 1G/l increase 1.02, 1.00–1.05) were associated with increased risk of discontinuation. Conclusions In this hospital-based registry, patients with atrial fibrillation had an increased risk of thromboembolic events despite anticoagulation. The low drug persistence may be attributable to distinct comorbid conditions and bleeding complications.

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Thromboembolic events, bleeding, and drug discontinuation in patients with atrial fibrillation on anticoagulation: a prospective hospital-based registry

Königsbrügge et al. BMC Cardiovascular Disorders Thromboembolic events, bleeding, and drug discontinuation in patients with atrial fibrillation on anticoagulation: a prospective hospital-based registry Oliver Königsbrügge 0 3 Alexander Simon 2 Hans Domanovits 2 Ingrid Pabinger 0 3 Cihan Ay 0 1 3 0 Department of Medicine I, Clinical Division of Hematology & Hemostaseology, Medical University of Vienna , Währinger Gürtel 18-20, A-1090 Vienna , Austria 1 Department of Medicine, Thrombosis and Hemostasis Program, McAllister Heart Institute, University of North Carolina at Chapel Hill , Chapel Hill, NC , USA 2 Department of Emergency Medicine, Medical University of Vienna , Vienna , Austria 3 Department of Medicine I, Clinical Division of Hematology & Hemostaseology, Medical University of Vienna , Währinger Gürtel 18-20, A-1090 Vienna , Austria Background: The clinical practice of stroke prevention in atrial fibrillation (AF) with direct oral anticoagulants (DOACS) differs from anticoagulation in randomized trial patients. We investigated the risk of thromboembolism, bleeding, and drug discontinuation in a hospital-based real-world setting. Methods: All-comer patients with non-valvular AF were recruited into a registry at an academic tertiary care center. After informed consent, patients underwent a personal structured interview including medical history, past and current anticoagulation, and returned for follow-up after 6-12 months. Results: The registry comprised 282 patients (42% women, median age 71 years) with a median CHA2DS2-Vasc-Score of 4 (25. to 75. percentile 2.5-5), who were prospectively followed 285 days in median. At inclusion, 118 patients took vitamin-K-antagonists, 33 dabigatran, 87 rivaroxaban, 30 apixaban, 5 low-molecular-weight heparin, and 9 were on no anticoagulant. Occurrence of stroke (rate 2.8/100 patient-years), was associated with prior stroke (hazard ratio [HR] 18.5, 95% confidence interval 2.16-159), increased HbA1c (HR per 1% increase 1.71, 1.20-2.45) and borderline significantly associated with vascular disease (HR 8.33, 0.97-71.3). Further we observed a high rate of major bleeding (2.8/100 patient-years), clinically relevant non-major bleeding (4.1/100 patient-years), and venous thromboembolism (2.8/100 patient-years). Anticoagulation was discontinued by 80 patients (36.9/100 patient-years), and diabetes (HR 2.31, 1.32-4. 02), history of bleeding (HR 2.51, 1.44-4.37) and elevated leucocyte count (HR per 1G/l increase 1.02, 1.00-1.05) were associated with increased risk of discontinuation. Conclusions: In this hospital-based registry, patients with atrial fibrillation had an increased risk of thromboembolic events despite anticoagulation. The low drug persistence may be attributable to distinct comorbid conditions and bleeding complications. Atrial fibrillation; Anticoagulation; Tertiary healthcare; Stroke; Hemorrhage; Medication persistence - Background The increased risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF) can be attenuated with continuous oral anticoagulation treatment [1]. Direct oral anticoagulants (DOACs), including the direct thrombin inhibitor dabigatran and the direct factor Xa inhibitors rivaroxaban, apixaban, and edoxaban, have shifted the paradigm of anticoagulation treatment from routine drug monitoring and dose adjustment to a onesize-fits-all strategy, and changed clinical practice of oral anticoagulation. Real-world data have confirmed the efficacy and safety of DOACs for stroke prevention [2, 3]. However, in a hospital-based patient population with AF, comorbid conditions, comedications and surgical interventions may complicate treatment with anticoagulant drugs, which has not been specifically addressed in previous realworld investigation. © The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Furthermore, there is still concern that the ease of drug administration and clinical management with DOACs may not guarantee better persistence on treatment in a real-world setting. Drug persistence is defined as the total time a patient stays on a prescribed medication and reduced persistence increases the risk of stroke [4, 5]. In the randomized controlled trials that led to the licensing of DOACs for stroke prevention in AF, 20.7%–34.3% of patients receiving DOACs discontinued drug treatment during the study period and 16.6%–34.4% discontinued the control treatment (...truncated)


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Oliver Königsbrügge, Alexander Simon, Hans Domanovits, Ingrid Pabinger, Cihan Ay. Thromboembolic events, bleeding, and drug discontinuation in patients with atrial fibrillation on anticoagulation: a prospective hospital-based registry, BMC Cardiovascular Disorders, 2016, pp. 254, 16, DOI: 10.1186/s12872-016-0438-5