PMID- 29370229 OWN - NLM STAT- MEDLINE DCOM- 20180326 LR - 20181113 IS - 1932-6203 (Electronic) IS - 1932-6203 (Linking) VI - 13 IP - 1 DP - 2018 TI - Risk factors for death, stroke, and bleeding in 28,628 patients from the GARFIELD-AF registry: Rationale for comprehensive management of atrial fibrillation. PG - e0191592 LID - 10.1371/journal.pone.0191592 [doi] LID - e0191592 AB - 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. FAU - Bassand, Jean-Pierre AU - Bassand JP AUID- ORCID: 0000-0003-4492-1269 AD - Department of Cardiology-EA 3920, University of Besancon, Besancon, France. AD - Thrombosis Research Institute, London, United Kingdom. FAU - Accetta, Gabriele AU - Accetta G AD - Thrombosis Research Institute, London, United Kingdom. FAU - Al Mahmeed, Wael AU - Al Mahmeed W AD - Cardiology, Heart and Vascular Institute, Cleveland Clinic Abu Dhabi, Abu Dhabi, United Arab Emirates. FAU - Corbalan, Ramon AU - Corbalan R AD - Department of Cardiology, Catholic University School of Medicine, Santiago, Chile. FAU - Eikelboom, John AU - Eikelboom J AD - Department of Medicine, McMaster University, Hamilton, Canada. FAU - Fitzmaurice, David A AU - Fitzmaurice DA AD - Warwick Medical School, University of Warwick, Coventry, United Kingdom. FAU - Fox, Keith A A AU - Fox KAA AD - Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, United Kingdom. FAU - Gao, Haiyan AU - Gao H AD - Thrombosis Research Institute, London, United Kingdom. FAU - Goldhaber, Samuel Z AU - Goldhaber SZ AD - Division of Cardiovascular Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts, United States of America. FAU - Goto, Shinya AU - Goto S AD - Department of Medicine (Cardiology), Tokai University School of Medicine, Kanagawa, Japan. FAU - Haas, Sylvia AU - Haas S AD - Formerly Klinikum rechts der Isar, Technical University of Munich, Munich, Germany. FAU - Kayani, Gloria AU - Kayani G AD - Thrombosis Research Institute, London, United Kingdom. FAU - Pieper, Karen AU - Pieper K AD - Thrombosis Research Institute, London, United Kingdom. AD - Duke Clinical Research Institute, Durham, North Carolina, United States of America. FAU - Turpie, Alexander G G AU - Turpie AGG AD - Department of Medicine, McMaster University, Hamilton, Canada. FAU - van Eickels, Martin AU - van Eickels M AD - Bayer AG, Berlin, Germany. FAU - Verheugt, Freek W A AU - Verheugt FWA AD - Department of Cardiology, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands. FAU - Kakkar, Ajay K AU - Kakkar AK AD - Thrombosis Research Institute, London, United Kingdom. AD - University College London, London, United Kingdom. CN - GARFIELD-AF Investigators LA - eng SI - ClinicalTrials.gov/NCT01090362 PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20180125 PL - United States TA - PLoS One JT - PloS one JID - 101285081 RN - 0 (Anticoagulants) RN - 0 (Fibrinolytic Agents) SB - IM MH - Aged MH - Aged, 80 and over MH - Anticoagulants/therapeutic use MH - Atrial Fibrillation/complications/drug therapy/*epidemiology/*mortality MH - Cohort Studies MH - Comorbidity MH - Death MH - Female MH - Fibrinolytic Agents/therapeutic use MH - Heart Failure/complications MH - Hemorrhage/chemically induced/epidemiology MH - Humans MH - Male MH - Prospective Studies MH - Registries MH - Renal Insufficiency, Chronic/complications MH - Risk Assessment MH - Risk Factors MH - Stroke/epidemiology MH - Treatment Outcome MH - Vascular Diseases/complications PMC - PMC5784935 COIS- 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. EDAT- 2018/01/26 06:00 MHDA- 2018/03/27 06:00 PMCR- 2018/01/25 CRDT- 2018/01/26 06:00 PHST- 2017/09/06 00:00 [received] PHST- 2018/01/08 00:00 [accepted] PHST- 2018/01/26 06:00 [entrez] PHST- 2018/01/26 06:00 [pubmed] PHST- 2018/03/27 06:00 [medline] PHST- 2018/01/25 00:00 [pmc-release] AID - PONE-D-17-32611 [pii] AID - 10.1371/journal.pone.0191592 [doi] PST - epublish SO - PLoS One. 2018 Jan 25;13(1):e0191592. doi: 10.1371/journal.pone.0191592. eCollection 2018.