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

Keith A A Fox; Saverio Virdone; Karen S Pieper; Jean-Pierre Bassand; A John Camm; David A Fitzmaurice; Samuel Z Goldhaber; Shinya Goto; Sylvia Haas; Gloria Kayani; Ali Oto; Frank Misselwitz; Jonathan P Piccini; Frederik Dalgaard; Alexander G G Turpie; Freek W A Verheugt; Ajay K Kakkar; GARFIELD-AF Investigators

doi:10.1093/ehjqcco/qcab028

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

Eur Heart J Qual Care Clin Outcomes. 2022 Mar 2;8(2):214-227. doi: 10.1093/ehjqcco/qcab028.

Authors

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.

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.

Publication types

Clinical Study
Research Support, Non-U.S. Gov't

MeSH terms

Anticoagulants / therapeutic use
Atrial Fibrillation* / complications
Atrial Fibrillation* / drug therapy
Female
Hemorrhage / chemically induced
Hemorrhage / epidemiology
Humans
Male
Registries
Risk Assessment
Risk Factors
Stroke* / drug therapy
Stroke* / epidemiology
Stroke* / etiology

Substances

Anticoagulants

Associated data

ClinicalTrials.gov/NCT01701817
ClinicalTrials.gov/NCT01165710
ClinicalTrials.gov/NCT01090362