GARFIELD-AF risk score for mortality, stroke, and bleeding within 2 years in patients with atrial fibrillation

doi:10.1093/ehjqcco/qcab028

Observational Study

. 2022 Mar 2;8(2):214-227.

doi: 10.1093/ehjqcco/qcab028.

GARFIELD-AF risk score for mortality, stroke, and bleeding within 2 years in patients with atrial fibrillation

Keith A A Fox¹, Saverio Virdone², Karen S Pieper², Jean-Pierre Bassand^{2

3}, A John Camm⁴, David A Fitzmaurice⁵, Samuel Z Goldhaber⁶, Shinya Goto⁷, Sylvia Haas⁸, Gloria Kayani², Ali Oto⁹, Frank Misselwitz¹⁰, Jonathan P Piccini¹¹, Frederik Dalgaard¹², Alexander G G Turpie¹³, Freek W A Verheugt¹⁴, Ajay K Kakkar^{2

15}; GARFIELD-AF Investigators

Affiliations

¹ Centre for Cardiovascular Science, University of Edinburgh, Queen's Medical Research Institute, 47 Little France Crescent, Edinburgh EH16 4TJ, UK.
² Thrombosis Research Institute, Manresa Road, London, SW3 6LR, UK.
³ Department of Cardiology, University of Besançon, Boulevard Fleming, 25000 Besançon, France.
⁴ Cardiology Clinical Academic Group Molecular & Clinical Sciences Research Institute, St George's University of London, Cranmer Terrace, Tooting, London SW17 0RE,UK.
⁵ Warwick Medical School, University of Warwick, Coventry, CV4 7AL, UK.
⁶ Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 75 Francis Street, Boston, MA 02115, USA.
⁷ Department of Medicine (Cardiology), Tokai School of medicine, 143 Shimokasuya, Isehara, Kanagawa 259-1143, Japan.
⁸ Department of Medicine, Formerly Technical University of Munich, Normannenstr. 34a, Munich 80333, Germany.
⁹ Department of Cardiology, Memorial Ankara Hospital, Sihhiye, 06100, Ankara, Turkey.
¹⁰ Formerly, Bayer AG, Müllerstraße 178, 13353 Berlin, Germany.
¹¹ Duke Clinical Research Institute, 40 Duke Medicine Circle, Clinic 2F/2G, Durham, NC 27710, USA.
¹² Department of Cardiology, Herlev & Gentofte Hospital, 2900 Hellerup, Copenhagen, Denmark.
¹³ Department of Medicine, McMaster University, 237 Barton St E Hamilton, Ontario L8L 2X2, Canada.
¹⁴ Department of Cardiology, Onze Lieve Vrouwe Gasthuis (OLVG), Oosterpark 9, NL-1091-AC Amsterdam, Netherlands.
¹⁵ University College London, Gower St, London WC1E 6BT, UK.

PMID: 33892489
PMCID: PMC8888127
DOI: 10.1093/ehjqcco/qcab028

Observational Study

GARFIELD-AF risk score for mortality, stroke, and bleeding within 2 years in patients with atrial fibrillation

Keith A A Fox et al. Eur Heart J Qual Care Clin Outcomes. 2022.

. 2022 Mar 2;8(2):214-227.

doi: 10.1093/ehjqcco/qcab028.

Authors

Affiliations

¹ Centre for Cardiovascular Science, University of Edinburgh, Queen's Medical Research Institute, 47 Little France Crescent, Edinburgh EH16 4TJ, UK.
² Thrombosis Research Institute, Manresa Road, London, SW3 6LR, UK.
³ Department of Cardiology, University of Besançon, Boulevard Fleming, 25000 Besançon, France.
⁴ Cardiology Clinical Academic Group Molecular & Clinical Sciences Research Institute, St George's University of London, Cranmer Terrace, Tooting, London SW17 0RE,UK.
⁵ Warwick Medical School, University of Warwick, Coventry, CV4 7AL, UK.
⁶ Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, 75 Francis Street, Boston, MA 02115, USA.
⁷ Department of Medicine (Cardiology), Tokai School of medicine, 143 Shimokasuya, Isehara, Kanagawa 259-1143, Japan.
⁸ Department of Medicine, Formerly Technical University of Munich, Normannenstr. 34a, Munich 80333, Germany.
⁹ Department of Cardiology, Memorial Ankara Hospital, Sihhiye, 06100, Ankara, Turkey.
¹⁰ Formerly, Bayer AG, Müllerstraße 178, 13353 Berlin, Germany.
¹¹ Duke Clinical Research Institute, 40 Duke Medicine Circle, Clinic 2F/2G, Durham, NC 27710, USA.
¹² Department of Cardiology, Herlev & Gentofte Hospital, 2900 Hellerup, Copenhagen, Denmark.
¹³ Department of Medicine, McMaster University, 237 Barton St E Hamilton, Ontario L8L 2X2, Canada.
¹⁴ Department of Cardiology, Onze Lieve Vrouwe Gasthuis (OLVG), Oosterpark 9, NL-1091-AC Amsterdam, Netherlands.
¹⁵ University College London, Gower St, London WC1E 6BT, UK.

PMID: 33892489
PMCID: PMC8888127
DOI: 10.1093/ehjqcco/qcab028

Abstract

Aims: To determine whether the Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) integrated risk tool predicts mortality, non-haemorrhagic stroke/systemic embolism, and major bleeding for up to 2 years after new-onset AF and to assess how this risk tool performs compared with CHA2DS2-VASc and HAS-BLED.

Methods and results: Potential predictors of events included demographic and clinical characteristics, choice of treatment, and lifestyle factors. A Cox proportional hazards model was identified for each outcome by least absolute shrinkage and selection operator methods. Indices were evaluated in comparison with CHA2DS2-VASc and HAS-BLED risk predictors. Models were validated internally and externally in ORBIT-AF and Danish nationwide registries. Among the 52 080 patients enrolled in GARFIELD-AF, 52 032 had follow-up data. The GARFIELD-AF risk tool outperformed CHA2DS2-VASc for all-cause mortality in all cohorts. The GARFIELD-AF risk score was superior to CHA2DS2-VASc for non-haemorrhagic stroke, and it outperformed HAS-BLED for major bleeding in internal validation and in the Danish AF cohort. In very low- to low-risk patients [CHA2DS2-VASc 0 or 1 (men) and 1 or 2 (women)], the GARFIELD-AF risk score offered strong discriminatory value for all the endpoints when compared to CHA2DS2-VASc and HAS-BLED. The GARFIELD-AF tool also included the effect of oral anticoagulation (OAC) therapy, thus allowing clinicians to compare the expected outcome of different anticoagulant treatment decisions [i.e. no OAC, non-vitamin K antagonist (VKA) oral anticoagulants, or VKAs].

Conclusions: The GARFIELD-AF risk tool outperformed CHA2DS2-VASc at predicting death and non-haemorrhagic stroke, and it outperformed HAS-BLED for major bleeding in overall as well as in very low- to low-risk group patients with AF.

Clinical trial registration: URL: http://www.clinicaltrials.gov. Unique identifier for GARFIELD-AF: NCT01090362, ORBIT-AF I: NCT01165710; ORBIT-AF II: NCT01701817.

Keywords: Atrial fibrillation; CHA2DS2-VASc; Risk stratification; GARFIELD-AF.

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Figures

**Figure 1**
Comparison of the performance [C-statistic (95% confidence interval)] of the GARFIELD-AF risk models vs. CHA₂DS₂-VASc (A) all-cause mortality and (B) non-haemorrhagic stroke/systemic embolism] or (C) HAS-BLED (for major bleeding/haemorrhagic stroke) at 2 years of follow-up in the whole GARFIELD-AF population and by baseline anticoagulation and risk category. Very low to low risk: CHA₂DS₂-VASc score of 0 or 1 (men) and 1 or 2 (women); HAS-BLED 0 or 1 for major bleeding/haemorrhagic stroke. GARFIELD-AF, Global Anticoagulant Registry in the FIELD–Atrial Fibrillation; OAC, oral anticoagulation.

**Figure 2**
Calibration of GARFIELD-AF risk models for all-cause mortality (A), non-haemorrhagic stroke/systemic embolism (B), and major bleeding/haemorrhagic stroke (C) at 2 years of follow-up in the GARFIELD-AF population. SE, systemic embolism.

**Figure 3**
Distribution of CHA₂DS₂-VASc score categories by GARFIELD-AF stroke score deciles. GARFIELD-AF, Global Anticoagulant Registry in the FIELD–Atrial Fibrillation.

**Figure 4**
(A and B) GARFIELD-AF online risk calculator. NOAC, non-VKA oral anticoagulant; OAC, oral anticoagulation; VKA, vitamin K antagonist.

See this image and copyright information in PMC

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References

1. Wolf PA, Abbott RD, Kannel WB.. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991;22:983–988. - PubMed
1. Odutayo A, Wong CX, Hsiao AJ, Hopewell S, Altman DG, Emdin CA.. Atrial fibrillation and risks of cardiovascular disease, renal disease, and death: systematic review and meta-analysis. BMJ 2016;354:i4482. - PubMed
1. Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomström-Lundqvist C. et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS): the Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC). Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J 2021;42:373–498. - PubMed
1. Fox KAA, Lucas JE, Pieper KS, Bassand J-P, Camm AJ, Fitzmaurice DA. et al.; GARFIELD-AF Investigators. Improved risk stratification of patients with atrial fibrillation: an integrated GARFIELD-AF tool for the prediction of mortality, stroke and bleed in patients with and without anticoagulation. BMJ Open 2017;7:e017157. - PMC - PubMed
1. Dalgaard F, Pieper K, Verheugt F, Camm AJ, Fox KA, Kakkar AK. et al. GARFIELD-AF model for prediction of stroke and major bleeding in atrial fibrillation: a Danish nationwide validation study. BMJ Open 2019;9:e033283. - PMC - PubMed

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[1] Wolf PA, Abbott RD, Kannel WB.. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991;22:983–988. - PubMed

[2] Wolf PA, Abbott RD, Kannel WB.. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991;22:983–988. - PubMed

[3] Odutayo A, Wong CX, Hsiao AJ, Hopewell S, Altman DG, Emdin CA.. Atrial fibrillation and risks of cardiovascular disease, renal disease, and death: systematic review and meta-analysis. BMJ 2016;354:i4482. - PubMed

[4] Odutayo A, Wong CX, Hsiao AJ, Hopewell S, Altman DG, Emdin CA.. Atrial fibrillation and risks of cardiovascular disease, renal disease, and death: systematic review and meta-analysis. BMJ 2016;354:i4482. - PubMed

[5] Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomström-Lundqvist C. et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS): the Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC). Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J 2021;42:373–498. - PubMed

[6] Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomström-Lundqvist C. et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS): the Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC). Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J 2021;42:373–498. - PubMed

[7] Fox KAA, Lucas JE, Pieper KS, Bassand J-P, Camm AJ, Fitzmaurice DA. et al.; GARFIELD-AF Investigators. Improved risk stratification of patients with atrial fibrillation: an integrated GARFIELD-AF tool for the prediction of mortality, stroke and bleed in patients with and without anticoagulation. BMJ Open 2017;7:e017157. - PMC - PubMed

[8] Fox KAA, Lucas JE, Pieper KS, Bassand J-P, Camm AJ, Fitzmaurice DA. et al.; GARFIELD-AF Investigators. Improved risk stratification of patients with atrial fibrillation: an integrated GARFIELD-AF tool for the prediction of mortality, stroke and bleed in patients with and without anticoagulation. BMJ Open 2017;7:e017157. - PMC - PubMed

[9] Dalgaard F, Pieper K, Verheugt F, Camm AJ, Fox KA, Kakkar AK. et al. GARFIELD-AF model for prediction of stroke and major bleeding in atrial fibrillation: a Danish nationwide validation study. BMJ Open 2019;9:e033283. - PMC - PubMed

[10] Dalgaard F, Pieper K, Verheugt F, Camm AJ, Fox KA, Kakkar AK. et al. GARFIELD-AF model for prediction of stroke and major bleeding in atrial fibrillation: a Danish nationwide validation study. BMJ Open 2019;9:e033283. - PMC - PubMed

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GARFIELD-AF risk score for mortality, stroke, and bleeding within 2 years in patients with atrial fibrillation

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GARFIELD-AF risk score for mortality, stroke, and bleeding within 2 years in patients with atrial fibrillation

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