Patterns of antithrombotic therapy and type of atrial fibrillation:insights from the Global Anticoagulant Registry in the FIELD (GARFIELD)Gregory YH Lip,1 Sophie K Rushton-Smith,2 Shinya Goto,3 Freek WA Verheugt,4 Samuel Z Goldhaber,5 Sylvia Haas,6 Jean-Pierre Bassand,7 Iris Mueller,2

Ajay K Kakkar,2 for the GARFIELD Investigators

PURPOSE

METHODS

RESULTS

1University of Birmingham, Centre for Cardiovascular Sciences, City Hospital, Birmingham, UK; 2Thrombosis Research Institute, London, UK; 3Department of Medicine, Tokai University, Kanagawa, Japan; 4Onze Lieve Vrouwe Gasthuis (OLVG), Amsterdam, Netherlands; 5Harvard Medical School, and Brigham and Women's Hospital, Department of Medicine, Boston, MA, USA; 6Technical University of Munich, Munich, Germany; 7University Hospital Jean-Minjoz, Besançon, France

n=10,53770.2 (11.2)

4550 (43.2%)27.5 (5.3)

3475 (33.0%)86.7 (25.1)

2211 (21.0%)4122 (39.1%)8184 (77.7%)7313 (69.4%)4052 (38.5%)3515 (33.4%)2018 (19.2%)1925 (18.3%)2317 (22.0%)1010 (9.6%)1506 (14.3%)586 (9.6%)

864 (11.3%)155 (2.0%)54 (0.5%)738 (7.0%)363 (3.4%)149 (1.4%)80 (0.8%)362 (3.4%)214 (2.3%)297 (2.8%)

1.8 (1.2)2.9 (1.5)2.0 (0.9)

VariableAge (years)Women BMI (kg/m2)Smoking status (current/previous)Pulse (beats per minute)Medical history Congestive heart failure Hypercholesterolaemia Hypertension Age >65 years Age ≥75 years Age 65–74 years Coronary artery disease Family history of cardiac disease* Diabetes mellitus Stroke history (with or without prior TIA) Stroke or TIA history LVEF ≤40% Chronic renal disease (n=7630)† Moderate renal dysfunction (GFR 30–59 mL/min) Severe renal dysfunction (GFR <30 mL/min) Cirrhosis Peripheral artery disease Carotid occlusive disease Other thromboembolism‡ Systemic embolism History of bleeding Heavy alcohol consumption§ PE or DVT historyRisk scores CHADS2

CHA2DS2-VASc HAS-BLED¶

TABLE. Patient baseline characteristics: Cohort 1 of the GARFIELD Registry

DECLARATION OF INTEREST

The GARFIELD Registry is supported by an unrestricted research grant from Bayer Pharma AG.

ACKNOWLEDGEMENTS

We thank the physicians, nurses, and patients involved in the GARFIELD Registry. Peter Wilkinson (Wilkinson Associates) performed the statistical analyses.

REFERENCES

FIGURE 1 Type of atrial fibrillation (n=10,537).

FIGURE 2 Use of vitamin K antagonist and antiplatelet therapies according to type of AF and CHADS2 score (n=10,530). *New or as yet unclassified

FIGURE 4 Use of vitamin K antagonist and antiplatelet therapies according to type of AF and HAS-BLED score (n=6327). *New or as yet unclassified

FIGURE 3 Use of vitamin K antagonist and antiplatelet therapies according to type of AF and CHA2DS2-VASc score (n=10,530). *New or as yet unclassified

CONCLUSIONS

◆ Oral anticoagulation is recommended for all patients with atrial fibrillation (AF) who are at moderate to high risk of stroke and without contraindications, irrespective of the type of AF (paroxysmal, persistent or permanent).1

◆ Patient enrolment into cohort 1 (of 5) took place between December 2009 and October 2011 at 543 sites in 19 countries in Asia-Pacific (n=2931, 27.8%; Australia, China, Korea, Japan), Canada (n=228, 2.2%), Europe (n=6535, 62.0%; Austria, Denmark, Finland, France, Germany, Italy, Netherlands, Norway, Poland, Spain, Sweden, UK), and Central/South America (n=843, 8.0%; Brazil, Mexico). Investigator sites are representative of the distri-bution of AF care settings in each country.

◆ Prospectively enrolled patients were ≥18 years old, newly diagnosed (≤6 weeks previously) with non-valvular AF, with ≥1 additional investigator-determined stroke risk factor, not limited to those included in existing risk scores. For patients with established AF (diagnosed 6–24 months before enrolment) and ≥1 additional stroke risk factor, baseline data were collected retrospectively from the time of their diagnosis. Data for prospective and retrospective patients were combined in this analysis, with similar numbers of patients in each group.

◆ We sought to compare rates of antithrombotic use according to CHADS2 score,2 CHA2DS2-VASc score,3 HAS-BLED score,4 and type of AF in an international cohort of patients from the Global Anticoagulant Registry in the FIELD (GARFIELD).

◆ The GARFIELD Registry is an ongoing, observational, multicentre, international study of adult patients newly diagnosed with AF and at risk of stroke.5

◆ Data collected at baseline included patient demographics, medical history, nature of AF, and antithrombotic treatments at diagnosis.

◆ CHADS2 = cardiac failure, hypertension, age, diabetes, stroke (doubled).

◆ Baseline characteristics for 10,537 patients enrolled in cohort 1 are given in the Table.

◆ Over half (55.2%) of the patients had a CHADS2 ≥2 (moderate or high risk), 36.3% had a score of 1 (moderate risk), and 8.5% a score of 0 (low risk).

◆ Most patients (81.4%) had a CHA2DS2-VASc score of ≥2 (high risk), 15.2% had a score of 1 (moderate risk), and 33.9% had a score of 0 (‘truly’ low risk).

◆ Of 6327 patients with available HAS-BLED scores, most (74.1%) had a HAS-BLED score of 0–2 (low or intermediate risk), the other 25.9% had a score >2 (high risk).

◆ Patients with paroxysmal AF showed lower rates of vitamin K antagonist use across all categories of CHADS2 score (Figure 2), CHA2DS2-VASc score (Figure 3), and HAS-BLED score (Figure 4).

◆ The classification of AF types is shown in Figure 1.

◆ CHA2DS2-VASc = congestive heart failure, hypertension, age ≥75 years (doubled), diabetes, stroke (doubled), vascular disease, age 65–74 years, sex (female).

◆ HAS-BLED = hypertension, abnormal renal/liver function, stroke, bleeding history or predisposition, labile international normalized ratio, elderly, drugs/alcohol concomitantly.

Risk score definitions

Data are n (%) or mean (SD). BMI=body mass index. BP=blood pressure. DVT=deep vein thrombosis. GFR=glomerular filtra-tion rate. LVEF=left ventricular ejection fraction. NSAID=non-steroidal anti-inflammatory drug. PE=pulmonary embolism. TIA=transient ischaemic attack. *First-degree relative with premature cardiac history (age <55 years [male], <65 years [female]).†Data not available for 2907 patients. ‡For example, central venous thrombosis, retinal occlusion. §Investigator defined.¶Excluding INR fluctuations.

◆ All components of the CHADS2, CHA2DS2-VASc, and HAS-BLED risk scores are captured in the GARFIELD database, allowing for objective retrospective risk stratification.

New/unclassified29.7%

Paroxysmal27.3%

Persistent18.1%

Permanent24.9%

◆ These contemporary, observational data suggest lower rates of vitamin K antagonist use in patients with paroxysmal AF versus other types of AF across all risk groups in everyday clinical practice.

◆ A substantial proportion of patients at low risk of stroke received vitamin K antagonist therapy across both stroke risk scores, but notably among ‘truly’ low-risk patients (CHA2DS2-VASc score of 0).

◆ These data highlight a substantial gap between evidence-based risk stratification, management recommendations, and their application in clinical practice.

◆ The GARFIELD Registry will provide validated, rigorous, worldwide data on ‘real-world’ risk stratification, management – including the uptake into clinical practice of new oral anticoagulant therapies – and associated outcomes of patients newly diagnosed with AF and at risk of stroke.

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Camm AJ, Kirchhof P, Lip GY, Schotten U, Savelieva I, Ernst S, Van Gelder IC, Al-Attar N, Hindricks G, Prendergast B, Heidbuchel H, Alfieri O, Angelini A, Atar D, Colonna P, De Caterina R, De Sutter J, Goette A, Gorenek B, Heldal M, Hohloser SH, Kolh P, Le Heuzey JY, Ponikowski P, Rutten FH. Guidelines for the management of atrial fibrillation: the Task Force for the Management of Atrial Fibrillation of the European Society of Cardiology (ESC). Eur Heart J 2010;31(19):2369-429.Gage BF, Waterman AD, Shannon W, Boechler M, Rich MW, Radford MJ. Validation of clinical classification schemes for predicting stroke: results from the National Registry of Atrial Fibrillation. JAMA 2001;285(22):2864-70.Lip GY, Nieuwlaat R, Pisters R, Lane DA, Crijns HJ. Refining clinical risk stratification for predicting stroke and thromboembolism in atrial fibrillation using a novel risk factor-based approach: the euro heart survey on atrial fibrillation. Chest 2010;137(2):263-72.Pisters R, Lane DA, Nieuwlaat R, de Vos CB, Crijns HJ, Lip GY. A novel user-friendly score (HAS-BLED) to assess 1-year risk of major bleeding in patients with atrial fibrillation: the Euro Heart Survey. Chest 2010;138(5):1093-100.Kakkar AK, Mueller I, Bassand JP, Fitzmaurice DA, Goldhaber SZ, Goto S, Haas S, Hacke W, Lip GY, Mantovani LG, Verheugt FW, Jamal W, Misselwitz F, Rushton-Smith S, Turpie AG. International longitudinal registry of patients with atrial fibrillation at risk of stroke: Global Anticoagulant Registry in the FIELD (GARFIELD). Am Heart J 2012;163(1):13-19 e1.

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