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. 2018 Jan 25;13(1):e0191592.
doi: 10.1371/journal.pone.0191592. eCollection 2018.

Risk factors for death, stroke, and bleeding in 28,628 patients from the GARFIELD-AF registry: Rationale for comprehensive management of atrial fibrillation

Jean-Pierre Bassand  1   2 , Gabriele Accetta  2 , Wael Al Mahmeed  3 , Ramon Corbalan  4 , John Eikelboom  5 , David A Fitzmaurice  6 , Keith A A Fox  7 , Haiyan Gao  2 , Samuel Z Goldhaber  8 , Shinya Goto  9 , Sylvia Haas  10 , Gloria Kayani  2 , Karen Pieper  2   11 , Alexander G G Turpie  5 , Martin van Eickels  12 , Freek W A Verheugt  13 , Ajay K Kakkar  2   14 ; GARFIELD-AF Investigators
Affiliations

Risk factors for death, stroke, and bleeding in 28,628 patients from the GARFIELD-AF registry: Rationale for comprehensive management of atrial fibrillation

Jean-Pierre Bassand et al. PLoS One. .

Abstract

Background: The factors influencing three major outcomes-death, stroke/systemic embolism (SE), and major bleeding-have not been investigated in a large international cohort of unselected patients with newly diagnosed atrial fibrillation (AF).

Methods and results: In 28,628 patients prospectively enrolled in the GARFIELD-AF registry with 2-year follow-up, we aimed at analysing: (1) the variables influencing outcomes; (2) the extent of implementation of guideline-recommended therapies in comorbidities that strongly affect outcomes. Median (IQR) age was 71.0 (63.0 to 78.0) years, 44.4% of patients were female, median (IQR) CHA2DS2-VASc score was 3.0 (2.0 to 4.0); 63.3% of patients were on anticoagulants (ACs) with or without antiplatelet (AP) therapy, 24.5% AP monotherapy, and 12.2% no antithrombotic therapy. At 2 years, rates (95% CI) of death, stroke/SE, and major bleeding were 3.84 (3.68; 4.02), 1.27 (1.18; 1.38), and 0.71 (0.64; 0.79) per 100 person-years. Age, history of stroke/SE, vascular disease (VascD), and chronic kidney disease (CKD) were associated with the risks of all three outcomes. Congestive heart failure (CHF) was associated with the risks of death and stroke/SE. Smoking, non-paroxysmal forms of AF, and history of bleeding were associated with the risk of death, female sex and heavy drinking with the risk of stroke/SE. Asian race was associated with lower risks of death and major bleeding versus other races. AC treatment was associated with 30% and 28% lower risks of death and stroke/SE, respectively, compared with no AC treatment. Rates of prescription of guideline-recommended drugs were suboptimal in patients with CHF, VascD, or CKD.

Conclusions: Our data show that several variables are associated with the risk of one or more outcomes, in terms of death, stroke/SE, and major bleeding. Comprehensive management of AF should encompass, besides anticoagulation, improved implementation of guideline-recommended therapies for comorbidities strongly associated with outcomes, namely CHF, VascD, and CKD.

Trial registration: ClinicalTrials.gov NCT01090362.

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Conflict of interest statement

Competing Interests: We have the following interests: This work was supported by an unrestricted research grant from Bayer AG, Berlin, Germany (http://pharma.bayer.com) to the Thrombosis Research Institute, London, UK (A.K.K.), which sponsors the GARFIELD-AF registry. J.E.: consulting fees and/or honoraria: Astra-Zeneca, Bayer, Boehringer-Ingelheim, Bristol-Myer-Squibb, Daiichi-Sankyo, Eli-Lilly, Glaxo-Smith-Kline, Pfizer, Janssen, and Sanofi-Aventis; grants and/or in-kind support: Astra-Zeneca, Bayer, Boehringer-Ingelheim, Bristol-Myer-Squibb, Glaxo-Smith-Kline, Pfizer, Janssen, and Sanofi-Aventis. K.A.A.F.: grants from Bayer, Johnson and Johnson, and Astra Zeneca; personal fees from Bayer, Johnson and Cover Letter Johnson, Lilly, Astra Zeneca, and Sanofi/Regeneron. S.G.: personal fees from the Thrombosis Research Institute, Harvard University, the American Heart Association, Medscape, Boehringer Ingelheim, Armethrom, Medtronic, Bayer, and AstraZeneca; grants from Sanofi, Ono, and Pfizer. S.H.: personal fees from Aspen, Bayer Healthcare, BMS/Pfizer, Daiichi-Sankyo, and Sanofi. A.G.G.T.: personal fees from Bayer Healthcare, Janssen Pharmaceutical Research & Development LLC, Astellas, Portola, and Takeda. M.v.E.: employee of Bayer AG. F.W.A.V.: educational and research grants from Bayer Healthcare; personal fees from Bayer Healthcare, BMS/Pfizer, Daiichi-Sankyo, and Boehringer-Ingelheim. A.K.K.: research support from Bayer AG; personal fees from Bayer AG, Boehringer-Ingelheim Pharma, Daiichi Sankyo Europe, Janssen Pharma, and Sanofi SA. J.-P.B., G.A., D.A.F., W.A.M., R.C., H.G., S.Z.G., G.K., and K.P.: none. There are no patents, products in development, or marketed products to declare. This does not alter our adherence to all the PLOS ONE policies on sharing data and materials.

Figures

Fig 1
Fig 1
Adjusted hazard ratios for 2-year outcomes according to baseline characteristics and anticoagulant treatment: (A) all-cause mortality; (B) stroke/systemic embolism; (C) major bleeding. ‘Anticoagulant treatment’ includes both vitamin K antagonists and non-vitamin K antagonist oral anticoagulants. For race, ‘Asian’ includes Asian (not Chinese) and Chinese, and ‘other’ includes Afro-Caribbean, mixed/other, and unwilling to declare/not recorded. Reference groups, from top: <65 years, men, Caucasian/Hispanic/Latino, never smoker, no history of disease (for diabetes, hypertension, stroke/TIA/SE, history of bleeding, cardiac failure, vascular disease, and renal disease), no AC treatment, paroxysmal AF, alcohol abstinence. Hazard ratios were adjusted for all variables in the model. AC, anticoagulant; AF, atrial fibrillation; CI, confidence interval; HR, hazard ratio; SE, systemic embolism; TIA, transient ischaemic attack.
Fig 2
Fig 2. Relationships between variables and clinical outcomes during 2-year follow-up.
Key to symbols used: upwards arrow indicates increased risk, downwards arrow indicates reduced risk, double-headed arrow indicates no change in risk. AF, atrial fibrillation; SE, systemic embolism; TIA, transient ischaemic attack.
See this image and copyright information in PMC

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