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The Atrial FibriLlatiOn (FLOW-AF) Registry in the Middle East and North Africa: Patient Characteristics, Treatment Patterns and Outcomes

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Abstract

Introduction

Limited data on atrial fibrillation (AF) are available from the Middle East and North Africa region (MENA). The aim of the FLOW-AF registry was to evaluate the characteristics, treatment patterns, and clinical and economic outcomes of patients with newly diagnosed non-valvular atrial fibrillation (NVAF) in MENA.

Methods

This multi-center, prospective, observational study (the FLOW-AF registry) enrolled patients newly diagnosed with NVAF across Egypt, Lebanon, Kingdom of Saudi Arabia, and United Arab Emirates. The data collection occurred at enrollment (baseline) and after 6- and 12-months (follow-up). Baseline data included demographics, AF characteristics, medical history, and anti-thrombotic treatment patterns. Clinical events, healthcare resource utilization, and direct costs were collected at follow-up.

Results

The study enrolled a total of 1418 patients (52.7% males and 47.3% females). The mean age of the patients was 64.5 years and 90.6% were white. The mean (standard deviation) CHA2DS2-VASc and HAS-BLED risk scores were 2.7 (1.6) and 1.6 (1.2), respectively. Non-vitamin K antagonist oral anticoagulants, antiplatelet therapy, and vitamin K antagonists were prescribed to 65.8%, 16.4%, and 12.9% patients, respectively. During follow-up, the following rates of clinical outcomes were observed: bleeding events (1.7%), transient ischemic attack (1.7%), all-cause mortality (1.7%), stroke (0.6%), myocardial infarction (0.2%), and systemic embolism (0.08%).

Conclusions

This MENA patient population was younger and had lower mean baseline CHA2DS2-VASc and HAS-BLED scores. The rates of clinical outcomes over 1-year in this study were low. Longer follow-up is required to comprehensively assess clinical outcomes in this patient population.

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Data Availability

The data that support the findings of this study are available from the corresponding author upon reasonable request.

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Acknowledgements

We thank the participants of the study.

Medical Writing/Editorial Assistance

Editorial/medical writing support was provided by Saurabh Trikha and Anshika Singhal of IQVIA, India and was funded by Pfizer.

Funding

The study was sponsored by Pfizer. The rapid service fee for publication was provided by Pfizer.

Author information

Authors and Affiliations

  1. Cleveland Clinic Abu Dhabi, Abu Dhabi, United Arab Emirates

    Wael A. Almahmeed

  2. Faculty of Medicine, King Saud University, Riyadh, Kingdom of Saudi Arabia

    Ahmad Hersi

  3. IQVIA, Real-World Evidence, Dubai, United Arab Emirates

    Natasha Khalife

  4. Pfizer Gulf, Dubai, United Arab Emirates

    Mohamed Fathy Soliman Gamaleldin & Sid Ahmed Kherraf

  5. Alexandria University, Alexandria, Egypt

    Mohamed A. Sobhy

  6. International Cardiac Center (ICC) Hospital, Alexandria, Egypt

    Mohamed A. Sobhy

  7. Cardiovascular Research, Education & Prevention Foundation (CVREP) Foundation, Alexandria, Egypt

    Mohamed A. Sobhy

  8. Duke University School of Medicine, The Duke Clinical Research Institute, Durham, NC, USA

    Renato D. Lopes

  9. Cardiology Department, American University of Beirut, Beirut, Lebanon

    Maurice Khoury

Authors
  1. Wael A. Almahmeed
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Contributions

Wael A. Almahmeed, Natasha Khalife, Mohamed Fathy Soliman Gamaleldin and Sid Ahmed Kherraf made substantial contributions to the conception and design of the work, acquisition, analysis, and interpretation of data. Natasha Khalife drafted the work. Wael A. Almahmeed, Ahmad Hersi, Natasha Khalife, Mohamed Fathy Soliman Gamaleldin, Sid Ahmed Kherraf, Mohamed A. Sobhy, Renato D. Lopes, and Maurice Khoury revised the manuscript critically for important intellectual content, and read and approved the final manuscript.

Corresponding author

Correspondence to Wael A. Almahmeed.

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Conflict of Interest

Ahmad Hersi received honoraria from Pfizer Inc. for giving talks and workshops. Mohamed A. Sobhy and Maurice Khoury have no conflicts to disclose. Wael A. Almahmeed is on the Pfizer Advisory board for the study. Natasha Khalife is an employee of IQVIA, which conducted the study on behalf of the sponsor. Mohamed Fathy Soliman Gamaleldin and Sid Ahmed Kherraf are employees of Pfizer Inc., the study sponsor. Renato D. Lopes reports research grants or contracts from Amgen, Bristol-Myers Squibb, GlaxoSmithKline, Medtronic, Pfizer, Sanofi-Aventis; funding for educational activities or lectures from Pfizer, Bristol-Myers Squibb, Novo Nordisk, AstraZeneca, and funding for consulting from Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Novo Nordisk, AstraZeneca.

Ethical Approval

Institutional review board (IRB) approvals were obtained. Table S1 in the Supplementary Material provides the list of IRBs and corresponding protocol approval dates. The registry was conducted in accordance with the principles of the Declaration of Helsinki, local regulatory requirements, and the International Conference on Harmonisation-Good Pharmacoepidemiological and Clinical Practice guidelines. In addition, written informed consent was obtained from all study participants and confidentiality and anonymity of all patients recruited into this registry were maintained.

Additional information

Prior Presentation: The results of this study were presented in part at the American College of Cardiology (Journal of the American College of Cardiology, 2023 March, 81 (8_Supplement) 399).

Supplementary Information

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Almahmeed, W.A., Hersi, A., Khalife, N. et al. The Atrial FibriLlatiOn (FLOW-AF) Registry in the Middle East and North Africa: Patient Characteristics, Treatment Patterns and Outcomes. Adv Ther 41, 2868–2889 (2024). https://doi.org/10.1007/s12325-024-02895-w

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