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Two-year follow-up of patients treated with dabigatran for stroke prevention in atrial fibrillation: Global Registry on Long-Term Antithrombotic Treatment in Patients with Atrial Fibrillation (GLORIA-AF) registry

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收录情况： ◇ SCIE

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机构： [a]Department of Thrombosis and Hemostasis, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, The Netherlands, [b]RTI Health Solutions, Research Triangle Institute, Research Triangle Park, NC, USA, [c]Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada, [d]Department of Medicine, Boehringer Ingelheim Ltd., Burlington, Ontario, Canada, [e]Medical Department, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany, [f]Department of Neurology, University of Duisburg-, Essen, Germany, [g]Clínica y Maternidad Suizo Argentina, Buenos Aires, Argentina, [h]Icahn School of Medicine at Mount Sinai, New York, NY, USA, [i]Cardiology Department, Atrial Fibrillation Center, Beijing AnZhen Hospital, Capital Medical University, Beijing, China, [j]Global Epidemiology Department, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany, [k]Biostatistics and Data Sciences Department, Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany, [l]Biostatistics and Data Sciences Department, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA, [m]Institute for Epidemiology, Social Medicine and Health Systems Research, Hannover Medical School, Hannover, Germany, [n]Institute of Cardiovascular Sciences, University of Birmingham, UK and Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.

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Background and purpose GLORIA-AF is a large, global, prospective registry program of newly diagnosed atrial fibrillation (AF) patients with >= 1 stroke risk factors. We describe the effectiveness and safety of dabigatran etexilate over 2 years from routine clinical practice in nearly 3000 patients from GLORIA-AF who are newly diagnosed with non-valvular AF and at risk of stroke. Methods Consecutive enrollment into phase II of GLORIA-AF was initiated following approval of dabigatran for stroke prevention in non-valvular AF. Within this Phase II, 2937 dabigatran patients completed 2-year follow-up by May 2016 and were eligible for analysis. Patients who took at least 1 dose of dabigatran (n = 2932) were used to estimate incidence rates. Results Overall incidence rates per 100 person-years of 0.63 (95% confidence interval [CI], 0.42-0.92) for stroke, 1.12 (0.83-1.49) for major bleeding, 0.47 (0.29-0.72) for myocardial infarction, and 2.69 (2.22-3.23) for all-cause death were observed. For patients taking 150 mg dabigatran twice daily (BID), corresponding rates (95% CI) were 0.56 (0.30-0.94), 1.00 (0.64-1.47), 0.48 (0.25-0.83), and 2.07 (1.55-2.72), respectively. For patients taking 110 mg dabigatran BID, event rates (95% CI) were 0.67 (0.33-1.20), 1.16 (0.70-1.80), 0.43 (0.17-0.88), and 3.16 (2.36-4.15). Conclusions These global data confirm the sustained safety and effectiveness of dabigatran over 2 years of follow-up, consistent with the results from clinical trials as well as contemporary real-world studies. What is known Non-vitamin K antagonist (VKA) anticoagulants (NOACs) are the preferred therapy for prevention of ischemic stroke based on phase 3 trials, but there is insufficient information on their efficacy and safety in daily practice, based on prospectively collected data. What is new This study shows that in non-valvular AF patient population, with up to 2 years of follow-up, the use of dabigatran led to a low incidence of ischemic stroke, major bleeding, and myocardial infarction in routine clinical care, confirming the sustained safety and effectiveness of dabigatran in clinical practice over 2 years of follow-up.

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出版当年[2017]版：

大类 | 2 区医学

小类 | 3 区心脏和心血管系统

最新[2023]版：

大类 | 2 区医学

小类 | 3 区心脏和心血管系统

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出版当年[2016]版：

Q2 CARDIAC & CARDIOVASCULAR SYSTEMS

最新[2023]版：

Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

影响因子： 3.7 最新[2023版] 3.6 最新五年平均 4.436 出版当年[2016版] 4.532 出版当年五年平均 4.332 出版前一年[2015版] 4.171 出版后一年[2017版]

第一作者：

第一作者机构： [a]Department of Thrombosis and Hemostasis, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, The Netherlands, [*1]Department of Thrombosis and Hemostasis, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, The Netherlands.

通讯作者：

通讯机构： [a]Department of Thrombosis and Hemostasis, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, The Netherlands, [n]Institute of Cardiovascular Sciences, University of Birmingham, UK and Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark. [*1]Department of Thrombosis and Hemostasis, Leiden University Medical Center, Albinusdreef 2, 2333 ZA Leiden, The Netherlands. [*2]University of Birmingham Institute of Cardiovascular Sciences, City Hospital, Birmingham, B18 7QH, United Kingdom.

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