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, 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

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.

© The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.

Figures

Graphical Abstract
Graphical Abstract
Figure 1
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
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
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
Figure 4
(A and B) GARFIELD-AF online risk calculator. NOAC, non-VKA oral anticoagulant; OAC, oral anticoagulation; VKA, vitamin K antagonist.

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