Abstract

AIMS: To determine whether the GARFIELD-AF integrated risk tool predicts mortality, non-haemorrhagic stroke/systemic embolism (SE), and major bleeding for up to two 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 (LASSO) 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 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 OAC therapy, thus allowing clinicians to compare the expected outcome of different anticoagulant treatment decisions (i.e., No OAC, NOACs 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.