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Improved risk-stratification of patients with atrial fibrillation : an integrated GARFIELD-AF tool for the prediction of mortality, stroke and bleed in patients with and without anticoagulation
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GARFIELD-AF Investigators (Including: Fox, Keith A. A., Lucas, Joseph E., Pieper, Karen S., Bassand, Jean-Pierre, Camm, A John, Fitzmaurice, David, Goldhaber, Samuel Z., Goto, Shinya, Haas, Sylvia, Hacke, Werner, Kayani, Gloria, Oto, Ali, Mantovani, Lorenzo G., Misselwitz, Frank, Piccini, Jonathan P., Turpie, Alexander G. G., Verheugt, Freek W. A. and Kakkar, Ajay K.). (2017) Improved risk-stratification of patients with atrial fibrillation : an integrated GARFIELD-AF tool for the prediction of mortality, stroke and bleed in patients with and without anticoagulation. BMJ Open, 7 . e017157. doi:10.1136/bmjopen-2017-017157 ISSN 2044-6055.
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Official URL: https://doi.org/10.1136/bmjopen-2017-017157
Abstract
Objectives:
To provide an accurate, web-based tool for stratifying patients with atrial fibrillation to facilitate decisions on the potential benefits/risks of anticoagulation, based on mortality, stroke, and bleeding risks.
Design:
The new tool was developed, using stepwise regression, for all and then applied to lower risk patients. C-statistics were compared with CHA2DS2-VASc using 30-fold cross-validation to control for overfitting. External validation was undertaken in an independent dataset, ORBIT-AF.
Participants:
Data from 39,898 patients enrolled in the prospective GARFIELD-AF registry provided the basis for deriving and validating an integrated risk tool to predict stroke risk, mortality and bleeding risk.
Results:
The discriminatory value of the GARFIELD-AF risk model was superior to CHA2DS2-VASc for patients with or without anticoagulation. C-statistics (95% CI) for all-cause mortality, ischaemic stroke/systemic embolism and haemorrhagic stroke/major bleeding (treated patients) were: 0.77 (0.76-0.78), 0.69 (0.67-0.71) and 0.66 (0.62-0.69), respectively, for the GARFIELD-AF risk models, and 0.66 (0.64-0.67), 0.64 (0.61-0.66) and 0.64 (0.61-0.68), respectively, for CHA2DS2-VASc (or HAS-BLED for bleeding). In very low to low risk patients (CHA2DS2-VASc 0 or 1 [men] and 1 or 2 [women]), the CHA2DS2-VASc and HAS-BLED (for bleeding) scores offered weak discriminatory value for mortality, stroke/systemic embolism and major bleeding. C-statistics for the GARFIELD-AF risk tool were 0.69 (0.64-0.75), 0.65 (0.56-0.73) and 0.60 (0.47-0.73) for each end point respectively, versus 0.50 (0.45-0.55), 0.59 (0.50-0.67) and 0.55 (0.53-0.56) for CHA2DS2-VASc (or HAS-BLED for bleeding). Upon validation in the ORBIT-AF population, C statistics showed that the GARFIELD-AF risk tool was effective for predicting 1-yr all-cause mortality using the full and simplified model for all-cause mortality: C statistics 0.75 (0.73-0.77) and 0.75 (0.73-0.77), respectively; and for predicting for any stroke or systemic embolism over 1 year, C-statistic 0.68 (0.62-0.74).
Conclusions:
Performance of the GARFIELD-AF risk tool was superior to CHA2DS2-VASc in predicting stroke and mortality and superior to HAS-BLED for bleeding, overall and in lower risk patients. The GARFIELD-AF tool has the potential for incorporation in routine electronic systems, and for the first time, permits simultaneous evaluation of ischaemic stroke, mortality and bleeding risks.
| Item Type: | Journal Article | ||||||
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| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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| Journal or Publication Title: | BMJ Open | ||||||
| Publisher: | BMJ | ||||||
| ISSN: | 2044-6055 | ||||||
| Official Date: | 21 December 2017 | ||||||
| Dates: |
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| Volume: | 7 | ||||||
| Article Number: | e017157 | ||||||
| DOI: | 10.1136/bmjopen-2017-017157 | ||||||
| Status: | Peer Reviewed | ||||||
| Publication Status: | Published | ||||||
| Access rights to Published version: | Open Access (Creative Commons) | ||||||
| Date of first compliant deposit: | 2 November 2017 | ||||||
| Date of first compliant Open Access: | 28 February 2018 |
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