TY - JOUR

T1 - GARFIELD-AF model for prediction of stroke and major bleeding in atrial fibrillation

T2 - A Danish nationwide validation study

AU - Dalgaard, Frederik

AU - Pieper, Karen

AU - Verheugt, Freek

AU - Camm, A. John

AU - Fox, Keith A.A.

AU - Kakkar, Ajay K.

AU - Pallisgaard, Jannik L.

AU - Rasmussen, Peter V.

AU - Weert, Henk Van

AU - Lindhardt, Tommi Bo

AU - Torp-Pedersen, Christian

AU - Gislason, Gunnar H.

AU - Ruwald, Martin H.

AU - Harskamp, Ralf E.

PY - 2019

Y1 - 2019

N2 - Objectives To externally validate the accuracy of the Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) model against existing risk scores for stroke and major bleeding risk in patients with non-valvular AF in a population-based cohort. Design Retrospective cohort study. Setting Danish nationwide registries. Participants 90 693 patients with newly diagnosed non-valvular AF were included between 2010 and 2016, with follow-up censored at 1 year. Primary and secondary outcome measures External validation was performed using discrimination and calibration plots. C-statistics were compared with CHA 2 DS 2 VASc score for ischaemic stroke/systemic embolism (SE) and HAS-BLED score for major bleeding/haemorrhagic stroke outcomes. Results Of the 90 693 included, 51 180 patients received oral anticoagulants (OAC). Overall median age (Q1, Q3) were 75 (66-83) years and 48 486 (53.5%) were male. At 1-year follow-up, a total of 2094 (2.3%) strokes/SE, 2642 (2.9%) major bleedings and 10 915 (12.0%) deaths occurred. The GARFIELD-AF model was well calibrated with the predicted risk for stroke/SE and major bleeding. The discriminatory value of GARFIELD-AF risk model was superior to CHA 2 DS 2 VASc for predicting stroke in the overall cohort (C-index: 0.71, 95% CI: 0.70 to 0.72 vs C-index: 0.67, 95% CI: 0.66 to 0.68, p<0.001) as well as in low-risk patients (C-index: 0.64, 95% CI: 0.59 to 0.69 vs C-index: 0.57, 95% CI: 0.53 to 0.61, p=0.007). The GARFIELD-AF model was comparable to HAS-BLED in predicting the risk of major bleeding in patients on OAC therapy (C-index: 0.64, 95% CI: 0.63 to 0.66 vs C-index: 0.64, 95% CI: 0.63 to 0.65, p=0.60). Conclusion In a nationwide Danish cohort with non-valvular AF, the GARFIELD-AF model adequately predicted the risk of ischaemic stroke/SE and major bleeding. Our external validation confirms that the GARFIELD-AF model was superior to CHA 2 DS 2 VASc in predicting stroke/SE and comparable with HAS-BLED for predicting major bleeding.

AB - Objectives To externally validate the accuracy of the Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) model against existing risk scores for stroke and major bleeding risk in patients with non-valvular AF in a population-based cohort. Design Retrospective cohort study. Setting Danish nationwide registries. Participants 90 693 patients with newly diagnosed non-valvular AF were included between 2010 and 2016, with follow-up censored at 1 year. Primary and secondary outcome measures External validation was performed using discrimination and calibration plots. C-statistics were compared with CHA 2 DS 2 VASc score for ischaemic stroke/systemic embolism (SE) and HAS-BLED score for major bleeding/haemorrhagic stroke outcomes. Results Of the 90 693 included, 51 180 patients received oral anticoagulants (OAC). Overall median age (Q1, Q3) were 75 (66-83) years and 48 486 (53.5%) were male. At 1-year follow-up, a total of 2094 (2.3%) strokes/SE, 2642 (2.9%) major bleedings and 10 915 (12.0%) deaths occurred. The GARFIELD-AF model was well calibrated with the predicted risk for stroke/SE and major bleeding. The discriminatory value of GARFIELD-AF risk model was superior to CHA 2 DS 2 VASc for predicting stroke in the overall cohort (C-index: 0.71, 95% CI: 0.70 to 0.72 vs C-index: 0.67, 95% CI: 0.66 to 0.68, p<0.001) as well as in low-risk patients (C-index: 0.64, 95% CI: 0.59 to 0.69 vs C-index: 0.57, 95% CI: 0.53 to 0.61, p=0.007). The GARFIELD-AF model was comparable to HAS-BLED in predicting the risk of major bleeding in patients on OAC therapy (C-index: 0.64, 95% CI: 0.63 to 0.66 vs C-index: 0.64, 95% CI: 0.63 to 0.65, p=0.60). Conclusion In a nationwide Danish cohort with non-valvular AF, the GARFIELD-AF model adequately predicted the risk of ischaemic stroke/SE and major bleeding. Our external validation confirms that the GARFIELD-AF model was superior to CHA 2 DS 2 VASc in predicting stroke/SE and comparable with HAS-BLED for predicting major bleeding.

KW - cardiology

KW - pacing & electrophysiology

KW - stroke

U2 - 10.1136/bmjopen-2019-033283

DO - 10.1136/bmjopen-2019-033283

M3 - Journal article

C2 - 31719095

AN - SCOPUS:85074986312

VL - 9

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

IS - 11

M1 - e033283

ER -