Anticoagulation Prescription and Outcomes in Relation to Renal Function in Patients with Atrial Fibrillation: Results from GLORIA-AF

Author:

van der Wall Sake J.1,Teutsch Christine2,Dubner Sergio J.3,Diener Hans-Christoph4,Halperin Jonathan L.5,Ma Chang Sheng6,Rothman Kenneth J.7,Paquette Miney8,Zint Kristina9,França Lionel Riou9,Lu Shihai10,Lip Gregory Y. H.1112ORCID,Huisman Menno V.1,

Affiliation:

1. Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, The Netherlands

2. Department of CardioMetabolism and Respiratory Medicine, Boehringer Ingelheim International GmbH, Ingelheim, Germany

3. Electrophysiology Service, Clínica y Maternidad Suizo Argentina, Buenos Aires, Argentina

4. Faculty of Medicine, University of Duisburg-Essen, Germany

5. The Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York City, New York, United States

6. Cardiology Department, Atrial Fibrillation Center, Beijing Anzhen Hospital, Capital Medical University, Beijing, China

7. RTI Health Solutions, Research Triangle Institute, Research Triangle Park, North Carolina, United States

8. Department of Medicine, Boehringer Ingelheim, Burlington, Ontario, Canada; Global Epidemiology at Boehringer Ingelheim GmbH, Ingelheim, Germany

9. Global Epidemiology Department, Boehringer Ingelheim International GmbH, Ingelheim, Germany

10. Biostatistics and Data Sciences Department, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut, United States

11. Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, United Kingdom

12. Department of Clinical Medicine, Aalborg Thrombosis Research Unit, Aalborg University, Aalborg, Denmark

Abstract

Abstract Objective Anticoagulation management in patients with atrial fibrillation (AF) and impaired renal function is challenging. This study aimed to evaluate anticoagulation prescription patterns in relation to renal function and to describe 2-year clinical outcomes among dabigatran users. Methods Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation (GLORIA-AF) is an international, prospective, and observational study program involving patients with newly diagnosed AF at risk for stroke. Prescription patterns were assessed by creatinine clearance (CrCl) at enrollment. Dabigatran users were followed for 2 years. Clinical outcomes were standardized for stroke and bleeding risk, based on CHA2DS2-VASc and HAS-BLED scores, with missing values imputed. Results Baseline CrCl values were available for 12,056 of 15,308 eligible patients (79%). With declining renal function, prescriptions increased for vitamin K antagonists (VKAs) and decreased for dabigatran (30–47% and 34–12%, respectively). The prescription of other non-vitamin K antagonists remained similar across CrCl groups (14–19%). In 4,873 dabigatran users, standardized stroke rates were low across all CrCl groups; 0.58/100 patient-years (95% confidence interval [CI]: 0.30–0.90) in CrCl ≥80 mL/min, 0.85 (95% CI: 0.48–1.21) in CrCl 50 to 79 mL/min, and 0.33 (95% CI: 0.06–1.11) in CrCl 30 to 49 mL/min. Similarly, major bleeding rates were low and numerically increased with declining renal function (0.68/100 patient-years, 95% CI: 0.39–1.03; 0.92, 95% CI: 0.58–1.32; and 1.26, 95% CI: 0.66–1.97, respectively). Conclusion In patients with AF, VKA prescriptions increased and dabigatran prescriptions decreased with declining renal function. Rates of stroke and major bleeding in dabigatran patients remained low across the categories of renal impairment.

Funder

Boehringer Ingelheim GmbH

Publisher

Georg Thieme Verlag KG

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