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

被引:39
作者
Huisman, Menno V. [1 ]
Rothman, Kenneth J. [2 ]
Paquette, Miney [3 ,4 ]
Teutsch, Christine [5 ]
Diener, Hans-Christoph [6 ]
Dubner, Sergio J. [7 ]
Halperin, Jonathan L. [8 ]
Ma, Chang Sheng [9 ]
Zint, Kristina [10 ]
Elsaesser, Amelie [11 ]
Lu, Shihai [12 ]
Bartels, Dorothee B. [10 ,13 ]
Lip, Gregory Y. H. [14 ,15 ]
机构
[1] Leiden Univ, Med Ctr, Dept Thrombosis & Hemostasis, Albinusdreef 2, NL-2333 ZA Leiden, Netherlands
[2] RTI Hlth Solut, Res Triangle Inst, Res Triangle Pk, NC USA
[3] McMaster Univ, Dept Hlth Res Methods Evidence & Impact, Hamilton, ON, Canada
[4] Boehringer Ingelheim Ltd, Dept Med, Burlington, ON, Canada
[5] Boehringer Ingelheim Pharma GmbH & Co KG, Dept Med, Ingelheim, Germany
[6] Univ Duisburg, Dept Neurol, Essen, Germany
[7] Clin & Maternidad Suizo Argentina, Buenos Aires, DF, Argentina
[8] Icahn Sch Med Mt Sinai, New York, NY 10029 USA
[9] Capital Med Univ, Beijing AnZhen Hosp, Atrial Fibrillat Ctr, Cardiol Dept, Beijing, Peoples R China
[10] Boehringer Ingelheim Pharma GmbH & Co KG, Global Epidemiol Dept, Ingelheim, Germany
[11] Boehringer Ingelheim Pharma GmbH & Co KG, Biostat & Data Sci Dept, Ingelheim, Germany
[12] Ingelheim Pharmaceut Inc, Biostat & Data Sci Dept, Ridgefield, CT USA
[13] Hannover Med Sch, Inst Epidemiol Social Med & Hlth Syst Res, Hannover, Germany
[14] Univ Birmingham, Inst Cardiovasc Sci, Birmingham, W Midlands, England
[15] Aalborg Univ, Dept Clin Med, Aalborg Thrombosis Res Unit, Aalborg, Denmark
关键词
WARFARIN; SAFETY; METAANALYSIS; THERAPY; CARE;
D O I
10.1016/j.ahj.2017.08.018
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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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收藏
页码:55 / 63
页数:9
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