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Observational Study
. 2013 May 21;8(5):e63479.
doi: 10.1371/journal.pone.0063479. Print 2013.

Risk profiles and antithrombotic treatment of patients newly diagnosed with atrial fibrillation at risk of stroke: perspectives from the international, observational, prospective GARFIELD registry

Ajay K Kakkar  1 , Iris Mueller, Jean-Pierre Bassand, David A Fitzmaurice, Samuel Z Goldhaber, Shinya Goto, Sylvia Haas, Werner Hacke, Gregory Y H Lip, Lorenzo G Mantovani, Alexander G G Turpie, Martin van Eickels, Frank Misselwitz, Sophie Rushton-Smith, Gloria Kayani, Peter Wilkinson, Freek W A Verheugt; GARFIELD Registry Investigators
Affiliations
Observational Study

Risk profiles and antithrombotic treatment of patients newly diagnosed with atrial fibrillation at risk of stroke: perspectives from the international, observational, prospective GARFIELD registry

Ajay K Kakkar et al. PLoS One. .

Abstract

Background: Limited data are available on the characteristics, clinical management, and outcomes of patients with atrial fibrillation at risk of stroke, from a worldwide perspective. The aim of this study was to describe the baseline characteristics and initial therapeutic management of patients with non-valvular atrial fibrillation across the spectrum of sites at which these patients are treated.

Methods and findings: The Global Anticoagulant Registry in the FIELD (GARFIELD) is an observational study of patients newly diagnosed with non-valvular atrial fibrillation. Enrollment into Cohort 1 (of 5) took place between December 2009 and October 2011 at 540 sites in 19 countries in Europe, Asia-Pacific, Central/South America, and Canada. Investigator sites are representative of the distribution of atrial fibrillation care settings in each country. Cohort 1 comprised 10,614 adults (≥18 years) diagnosed with non-valvular atrial fibrillation within the previous 6 weeks, with ≥1 investigator-defined stroke risk factor (not limited to those in existing risk-stratification schemes), and regardless of therapy. Data collected at baseline included demographics, medical history, care setting, nature of atrial fibrillation, and treatments initiated at diagnosis. The mean (SD) age of the population was 70.2 (11.2) years; 43.2% were women. Mean±SD CHADS2 score was 1.9±1.2, and 57.2% had a score ≥2. Mean CHA2DS2-VASc score was 3.2±1.6, and 8,957 (84.4%) had a score ≥2. Overall, 38.0% of patients with a CHADS2 score ≥2 did not receive anticoagulant therapy, whereas 42.5% of those at low risk (score 0) received anticoagulant therapy.

Conclusions: These contemporary observational worldwide data on non-valvular atrial fibrillation, collected at the end of the vitamin K antagonist-only era, indicate that these drugs are frequently not being used according to stroke risk scores and guidelines, with overuse in patients at low risk and underuse in those at high risk of stroke.

Trial registration: ClinicalTrials.gov TRI08888.

Trial registration: ClinicalTrials.gov NCT01090362.

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Conflict of interest statement

Competing Interests: Dr. Kakkar’s research was supported by Bayer HealthCare, sanofi-aventis, Boehringer Ingelheim (BI), Pfizer, Bristol Myers Squibb (BMS), and Eisai. Dr. Kakkar provided consultancy for Bayer HealthCare, sanofi-aventis, BI, Pfizer, BMS, Eisai, Aryx Therapeutics, and Canyon. Dr. Kakkar received honoraria from Bayer HealthCare, sanofi-aventis, BI, Pfizer, BMS, Eisai, and GSK (GSK). Dr. Kakkar has been a Scientific Advisory Board (SAB) member for Bayer HealthCare, sanofi-aventis, BI, Pfizer, BMS, and Eisai. Dr. Bassand received consultancy fees or honoraria from Bayer, Eli Lilly, Iroko, Astra Zeneca, and GSK. Dr. Fitzmaurice received honoraria from Bayer, BI, and sanofi-aventis. Dr. Goldhaber received research grants from BI, BMS, Eisai, EKOS, Johnson & Johnson, and sanofi-aventis, and provided consultancy (all <$10 K) for BI, BMS, Daiichi Sankyo, Eisai, EKOS, Medscape, Merck, Portola, and sanofi-aventis. Dr. Goto received research grants from sanofi-aventis, Eisai, BI, Otsuka, and Daiichi-Sankyo; and consultancy fees and honoraria from Eisai, sanofi-aventis, Otsuka, Bayer, Novartis, AstraZeneca, Asteras, Pfizer, Medtronic-Japan, Tanabe-Mitsubishi, Takeda, Daiichi-Sankyo, Mochida, and MSD. Dr. Haas has been a SAB member for Bayer, sanofi-aventis, BMS, and CSL-Behring; and received honoraria from Bayer, sanofi-aventis, BI, BMS, and Daiichi-Sankyo. Dr. Hacke received significant reimbursement from Bayer for work on the ROCKET-AF Executive Committee and for being a speaker at several industry-sponsored symposia; and reimbursement from BI for participation in Advisory Boards and industry-sponsored symposia. Dr. Lip has been a consultant for Bayer, Astellas, Merck, AstraZeneca, sanofi, BMS/Pfizer, Biotronik, Portola, and BI; and on the Speakers’ bureau for Bayer, BMS/Pfizer, Boehringer, and sanofi-aventis. Dr. Mantovani received research funding from Bayer Research, Pfizer, and BMS (in the field of AF) and Bayer, Boehringer-Ingelheim (outside AF); speaker’s fees from BMS, Boehringer-Ingelheim (In AF), Pfizer (outside AF); and Advisory Board fees from Bayer, Daiichi Sankyo (in AF) and Pfizer (outside AF). Dr. Turpie provided consultancy for Bayer, J & J, Astellas, Merck, sanofi-aventis, Takeda, and Portola; and on Speakers’ Bureaus for Bayer, BMS/Pfizer, Boehringer-Ingelheim, J & J, GSK, and sanofi-aventis. Dr. van Eickels is employed by Bayer Healthcare Pharmaceuticals, Berlin, Germany. Dr. Misselwitz is employed by Bayer Healthcare Pharmaceuticals, Berlin, Germany and owns a significant number of Bayer AG stocks. Dr. Rushton-Smith has provided consultancy for the European Society of Cardiology, Genzyme, Medtronic, sanofi-aventis, Servier and The Medicines Company. Dr. Verheugt has received educational and research grants from Bayer AG, Roche, Eli Lilly, and BI; and consultancy honoraria from Daiichi- Sankyo, Eli Lilly, Merck, The Medicines Company, and Bayer AG. The affiliations to the funding organization (Bayer AG) and the declarations provided in the competing interests form do not alter the authors' adherence to all the PLOS ONE policies on sharing data and materials.

Figures

Figure 1
Figure 1. Number of patients enrolled per country in Cohort 1 (n = 10,614).
Figure 2
Figure 2. Distribution of CHADS2 and CHA2DS2-VASc scores (n = 10,607) (scores not available for 7 patients).
Figure 3
Figure 3. Use of antithrombotic therapies, overall and according to (A) CHADS2 score and (B) CHA2DS2VASc score (n = 10,607).
AP indicates antiplatelet; FXa/DTI, activated coagulation factor X inhibitor/direct thrombin inhibitor (irrespective of AP use); VKA, vitamin K antagonist.
See this image and copyright information in PMC

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