CC BY 4.0 · TH Open 2021; 05(01): e35-e42
DOI: 10.1055/s-0040-1722706
Original Article

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

Sake J. van der Wall
1   Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, The Netherlands
,
Christine Teutsch
2   Department of CardioMetabolism and Respiratory Medicine, Boehringer Ingelheim International GmbH, Ingelheim, Germany
,
Sergio J. Dubner
3   Electrophysiology Service, Clínica y Maternidad Suizo Argentina, Buenos Aires, Argentina
,
Hans-Christoph Diener
4   Faculty of Medicine, University of Duisburg-Essen, Germany
,
Jonathan L. Halperin
5   The Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York City, New York, United States
,
Chang Sheng Ma
6   Cardiology Department, Atrial Fibrillation Center, Beijing Anzhen Hospital, Capital Medical University, Beijing, China
,
Kenneth J. Rothman
7   RTI Health Solutions, Research Triangle Institute, Research Triangle Park, North Carolina, United States
,
Miney Paquette
8   Department of Medicine, Boehringer Ingelheim, Burlington, Ontario, Canada; Global Epidemiology at Boehringer Ingelheim GmbH, Ingelheim, Germany
,
Kristina Zint
9   Global Epidemiology Department, Boehringer Ingelheim International GmbH, Ingelheim, Germany
,
Lionel Riou França
9   Global Epidemiology Department, Boehringer Ingelheim International GmbH, Ingelheim, Germany
,
Shihai Lu
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
,
Menno V. Huisman*
1   Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, The Netherlands
,
on behalf of the GLORIA-AF Investigators
› Author Affiliations
Funding This study was funded by Boehringer Ingelheim GmbH.

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.

Note

This study is registered with ClinicalTrials.gov with identifier no. NCT01468701 (http://www.clinicaltrials.gov).


* Joint senior authors and co-Chairs of the GLORIA-AF Registry Program.


# For complete list of Phase II GLORIA AF Principal Investigators, please refer to the [Supplementary Material].


Supplementary Material



Publication History

Received: 02 September 2020

Accepted: 03 December 2020

Article published online:
06 February 2021

© 2021. The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution License, permitting unrestricted use, distribution, and reproduction so long as the original work is properly cited. (https://creativecommons.org/licenses/by/4.0/)

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