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Cardiovascular medicine
Original research
GARFIELD-AF model for prediction of stroke and major bleeding in atrial fibrillation: a Danish nationwide validation study
  1. Frederik Dalgaard1,2,
  2. Karen Pieper2,3,
  3. Freek Verheugt4,
  4. A John Camm5,
  5. Keith AA Fox6,
  6. Ajay K Kakkar3,7,
  7. Jannik L Pallisgaard8,
  8. Peter V Rasmussen1,
  9. Henk van Weert9,
  10. Tommi Bo Lindhardt1,
  11. Christian Torp-Pedersen1,10,
  12. Gunnar H Gislason1,11,12,
  13. Martin H Ruwald1,
  14. Ralf E Harskamp9
  1. 1 Cardiology, Gentofte Hospital, Hellerup, Copenhagen, Denmark
  2. 2 Duke Clinical Research Institute, Duke University, Durham, United States
  3. 3 Department of Clinical Research, Thrombosis Research Institute, London, UK
  4. 4 Onze Lieve Vrouwe Gasthuis, Amsterdam, Noord-Holland, the Netherlands
  5. 5 Department of Cardiology, University of London St George's Molecular and Clinical Sciences Research Institute, London, UK
  6. 6 Cardiology, University of Edinburgh and Royal Infirmary of Edinburgh, Edinburgh, UK
  7. 7 Department of Surgery, University College London, London, United Kingdom
  8. 8 Department of Cardiology, Bispebjerg Hospital, Kobenhavn, Denmark
  9. 9 Department of General Practice, Amsterdam UMC, Amsterdam Public Health and Amsterdam Cardiovascular Sciences Research Institutes, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands
  10. 10 Department of Clinical Investigation and Cardiology, Nordsjællands Hospital, Hillerod, Denmark
  11. 11 The Danish Heart Foundation, Copenhagen, Denmark
  12. 12 The National Institute of Public Health, University of Southern Denmark, Odense, Denmark
  1. Correspondence to Dr Frederik Dalgaard; fdalgaard87{at}gmail.com

Abstract

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 CHA2DS2VASc 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 CHA2DS2VASc 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 CHA2DS2VASc in predicting stroke/SE and comparable with HAS-BLED for predicting major bleeding.

  • stroke
  • cardiology
  • pacing & electrophysiology

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjopen-2019-033283

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    Footnotes

    • Twitter @F_dalgaard

    • Contributors FD, RH, MR, FV, KF, AKK, HVW and KP contributed to the study concept and design; FD and KP conducted the data analysis; REH and FD drafted the manuscript; FD, REH, MR, FV, KF, AKK, HVW, JC, JP, PVR, TBL, CTP and GHG critically reviewed all drafts of the manuscript.

    • Funding REH reports salary support from The Netherlands Organization for Scientific Research (NWO) through a RUBICON-grant to study bleeding risks associated with NOAC use. FD is funded by Danish Heart Foundation (Grant no: 17-R115-A7443-22062) and Gangstedfonden (Grant no. A35136) and reports travel grants from Knud Højgaard Fonden, Torben og Alice Frimodts Fond. KP is funded by the Duke Clinical Research Institute.

    • Competing interests KF has received research grants Bayer/Janssen and AstraZeneca and Consulting/Fees Bayer, Sanofi/Regeneron and Verseon. FV has received honoraria for consulting and presentations from Bayer HealthCare, Boehringer Ibgelheimy, BMSPfizer and Daiichi-Sankyo. GHG has ownership of stocks in Novo Nordisk Pharmaceuticals and reports research grants from Pfizer, Bristol Myers Squibb, Boehringer Ingelheim and Bayer. CTP declares grants for studies from Bayer. Other authors have no conflicts of interest to declare.

    • Patient consent for publication Obtained.

    • Ethics approval For the GARFIELD-AF registry, an independent ethics committee and hospital-based institutional review board approvals were obtained for the registry protocol. In Denmark, retrospective register studies do not require approval from the ethics committees. The Danish Data Protection Agency approved this study (Ref no: 2007-58-0015, I-Suite no: 02732, GEH-2014-014). Data were made available in an anonymised format such that specific individuals could not be identified.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data availability statement Due to restrictions related to Danish law and protecting patient privacy, the combined set of data as used in this study can only be made available through a trusted third party, Statistics Denmark. This state organisation holds the data used for this study. Any request on data access should be addressed to Statistics Denmark https://www.dst.dk/en.aspx%23