Abstract
Introduction
The Global Anticoagulant Registry in the FIELD–Atrial Fibrillation (GARFIELD-AF) aims to determine real-life treatment patterns and clinical outcomes of patients with newly diagnosed non-valvular atrial fibrillation (AF) and at least one investigator-determined risk factor for stroke. The registry includes a wide array of baseline characteristics and has a particular focus on: (1) bleeding and thromboembolic events; (2) international normalized ratio fluctuations; and (3) therapy compliance and persistence patterns.
Methods
Evolution in baseline treatment for patients enrolled in sequential cohorts showed an increase in prescribing of novel oral anticoagulants over time. Variability in novel oral anticoagulant prescription is primarily due to differences in availability of treatment and prescribing habits between countries and care settings. The GARFIELD-AF registry also provides insights into clinical management and related outcomes of AF in Middle East populations.
Results
A total of 1660 patients with non-valvular AF (median age 64.0 years, interquartile range 56.0–72.0), mostly diagnosed in cardiology settings from Egypt, the United Arab Emirates and Turkey, were recruited in cohorts 3–5. Data from patient populations in the Middle East related to the rates of stroke/systemic embolism, major bleeding and all-cause mortality 1 year after diagnosis of AF and treatment strategies, based on the stroke and bleeding risk, have been analysed and compared with the rest of the world. The use of antithrombotic treatment in the Middle East was generally higher than the non-Middle East, with increased prescription of antiplatelet therapy (AP) therapy. Appropriate use of Factor Xa inhibitors/direct thrombin inhibitors (DTIs) were 74.4% and Factor Xa/DTI + APs were 70.4% in the overall population, whereas they were 57.1% and 63.6%, respectively, in the Middle East.
Conclusion
We have found that rates of stroke and bleeding were lower, although mortality was higher, in the Middle East population. This paper describes the baseline characteristics, patterns of antithrombotic treatment and 1-year outcomes in Middle East AF patients.
Trial Registration
http://www.clinicaltrials.gov. Identifier, NCT01090362.
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Acknowledgements
This study also carried out on behalf of GARFIELD-AF investigators*. We thank the physicians, nurses, and patients involved in GARFIELD-AF. Editorial support was provided by Saverio Virdone (TRI, London, UK).
Funding
This work was supported by an unrestricted research grant from Bayer AG (Berlin, Germany) to the Thrombosis Research Institute (London, UK). The funding source had no involvement in the data collection, data analysis, or data interpretation.
No funding or sponsorship was received for this study or publication of this article. The Rapid Service Fee was funded by the authors.
Authorship
All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.
Authorship Contributions
Begum Yetis Sayin , Wael Al Mahmeed , Hany Ibrahim Ragy, Atef Elbahry, Saverio Virdone, Ajay K. Kakkar, Murat Ersanlı and Ali Oto contributed to the study design. Begum Yetis Sayin , Wael Al Mahmeed , Hany Ibrahim Ragy, Atef Elbahry, Saverio Virdone, Ajay K. Kakkar, Murat Ersanlı and Ali Oto contributed to data acquisition. Saverio Virdone analysed the data. All authors contributed to data interpretation. All authors critically reviewed the report and approved the final manuscript.
Disclosures
Begum Yetis Sayin , Wael Al Mahmeed , Hany Ibrahim Ragy, Atef Elbahry, Murat Ersanlı and Ali Oto have nothing to disclose. Saverio Virdone has no direct competing interests but has received sponsorship or consulted for companies with an interest in anticoagulation including Bayer, BI and Pfizer.
Compliance with Ethics Guidelines
All patients provided written informed consent to participate. Independent ethics committee and hospital-based institutional review board approvals were obtained, as necessary, for the registry protocol (protocol number: TRI08888, project code: IPAA4663). The registry is conducted in accordance with the Declaration of Helsinki and guidelines from the International Conference on Harmonisation on Good Clinical Practice and Good Pharmaco-epidemiological Practice, and adheres to all applicable national laws and regulations.
Data Availability
All relevant data are within the paper/as supplementary information files. The datasets generated during the current study are not expected to be made publicly available as participant consent forms and ethics approval did not include permission for secondary use, with access to data only approved for researchers involved in the analysis.
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Sayin, B.Y., Al Mahmeed, W., Ragy, H.I. et al. Middle East Treatment Strategies and Clinical Outcomes in Patients with Atrial Fibrillation: One-Year Follow-up Data from Garfield-AF Study. Adv Ther 38, 2391–2405 (2021). https://doi.org/10.1007/s12325-021-01670-5
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DOI: https://doi.org/10.1007/s12325-021-01670-5