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Thromb Haemost 2022; 122(12): 2030-2041
DOI: 10.1055/s-0042-1756355
Stroke, Systemic or Venous Thromboembolism

Clinical Complexity Domains, Anticoagulation, and Outcomes in Patients with Atrial Fibrillation: A Report from the GLORIA-AF Registry Phase II and III

Giulio Francesco Romiti    *
1   Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, United Kingdom
2   Department of Translational and Precision Medicine, Sapienza University of Rome, Rome, Italy
,
Marco Proietti   *
2   Department of Translational and Precision Medicine, Sapienza University of Rome, Rome, Italy
3   Department of Clinical Sciences and Community Health, University of Milan, Milan, Italy
4   Geriatric Unit, IRCCS Istituti Clinici Scientifici Maugeri, Milan, Italy
,
Niccolò Bonini
2   Department of Translational and Precision Medicine, Sapienza University of Rome, Rome, Italy
5   Cardiology Division, Department of Biomedical, Metabolic and Neural Sciences, University of Modena and Reggio Emilia, Policlinico di Modena, Modena, Italy
,
Wern Yew Ding
1   Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, United Kingdom
,
Giuseppe Boriani
5   Cardiology Division, Department of Biomedical, Metabolic and Neural Sciences, University of Modena and Reggio Emilia, Policlinico di Modena, Modena, Italy
,
Menno V. Huisman   **
6   Department of Thrombosis and Hemostasis, Leiden University Medical Center, Leiden, The Netherlands
,
Gregory Y. H. Lip    **
1   Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart & Chest Hospital, Liverpool, United Kingdom
7   Department of Clinical Medicine, Aalborg University, Aalborg, Denmark
,
on behalf of the GLORIA-AF Investigators › Author Affiliations Funding This study was funded by Boehringer Ingelheim GmbH. The authors are solely responsible for the design and conduct of this study, all study analyses, the drafting and editing of the manuscript, and its final contents.
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Abstract

Background Clinical complexity is common in atrial fibrillation (AF) patients. We assessed the impact of clinical complexity on oral anticoagulant (OAC) treatment patterns and major adverse outcomes in a contemporary cohort of AF patients.

Methods The GLORIA-AF Phase II and III Registry enrolled newly diagnosed AF patients with at least one stroke risk factor. Among patients with CHA2DS2-VASc score ≥2, we defined four domains of perceived clinical complexity: frail elderly (age ≥75 years and body mass index <23 kg/m2), chronic kidney disease (CKD, creatinine clearance <60 mL/min), history of bleeding, and those with ≥2 of the above conditions. We evaluated the associations between clinical complexity domains and antithrombotic treatment prescription, risk of OAC discontinuation, and major adverse outcomes.

Results Among the 29,625 patients included (mean age 69.6 ± 10.7 years, 44.2% females), 9,504 (32.1%) presented with at least one complexity criterion. Clinical complexity was associated with lower OAC prescription, with stronger associations in frail elderly (odds ratio [OR]: 0.47, 95% confidence interval [CI]: 0.36–0.62) and those with ≥2 complexity domains (OR: 0.50, 95% CI: 0.44–0.57). Risk of OAC discontinuation was higher among frail elderly (hazard ratio [HR]: 1.30, 95% CI: 1.00–1.69), CKD (HR: 1.10, 95% CI: 1.02–1.20), and those with ≥2 complexity domains (HR: 1.39, 95% CI: 1.23–1.57). Clinical complexity was associated with higher risk of the primary outcome of all-cause death, thromboembolism, and major bleeding, with the highest magnitude in those with ≥2 criteria (HR: 1.63, 95% CI: 1.43–1.86).

Conclusion In AF patients, clinical complexity influences OAC treatment management, and increases the risk of poor clinical outcomes. These patients require additional efforts, such as integrated care approach, to improve their management and prognosis.

Keywords

atrial fibrillation - clinical complexity - oral anticoagulants - persistence - outcomes

Note

This publication is based on research using data from data contributors of Boehringer Ingelheim that have been made available through Vivli, Inc. Vivli has not contributed to or approved, and is not in any way responsible for, the contents of this publication.


Author Contributions

G.F.R., M.P., and G.Y.H.L. conceived the study and interpreted study results; G.F.R. run the analyses; G.F.R. and M.P. drafted the first version of the manuscript; N.B., W.Y.D., G.B., M.V.H. and G.Y.H.L. provided important intellectual contribution in the finalization of the manuscript. All authors approved the final version of the manuscript.


* Joint first authors.


** Profs. Lip and Huisman are co-chairs of the GLORIA-AF Registry programme.


*** The list of investigators is given in [ Supplementary Appendix ] [available in the online version].


Note: The review process for this paper was fully handled by Christian Weber, Editor-in-Chief.


Supplementary Material



Publication History

Received: 11 August 2022

Accepted: 18 August 2022

Article published online:
29 August 2022

© 2022. Thieme. All rights reserved.

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany

 

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