Results of the 1st Phase of the International GLORIA-AF Registry Program: Regional Treatment Differences Before the Era of Novel Anticoagulants

MV Huisman, CS Ma, HC Diener, SJ Dubner, JL Halperin, KJ Rothman, C Teutsch, A Clemens, K Zint, E Kleine, DB Bartels, GYH Lip

for the GLORIA-AF Investigators

Background

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• Atrial fibrillation (AF) is the most common cardiac arrhythmia, and confers an increased mortality and morbidity from stroke and thromboembolism.

• Until recently, Vitamin K antagonists (VKA) were the gold standard treatment for stroke prevention

• Non-VKA oral anticoagulants (NOACs), like dabigatran, are changing treatment patterns of AF patients

• Information from registries would increase our understanding of ‘real world’ management of AF and related outcomes

• GLORIA-AF is a large, international, observational registry program of patients with newly diagnosed AF at risk of stroke

Am Heart J 2014;167:329-34.

up to 56,000 patients

2,200 sites

up to 50 countries

GLORIA-AF Registry Program – All Phases

GLORIA-AF

General practices

Specialist offices

Community hospitals

University hospitalsOutpatient care

centres

Anticoagulation clinics

Region 2 Europe

Denmark, France, Germany, Ireland, Italy, Greece, Switzerland, Norway,

Netherlands, Portugal, Spain, Sweden, UK, Austria, Czech Republic, Croatia, Romania, Bulgaria, Estonia, Latvia,

Lithuania, Slovakia, Slovenia)

Region 1 Asia

China, Korea, Russia, Hong Kong, Singapore, Taiwan,

India

Region 3 North

America USA, Canada

Region 4 Latin

America Argentina, Brazil, Ecuador, Mexico, Peru, Venezuela, Colombia, Chile

Region 5 Africa /

Middle EastLebanon, UAE, KSA, Egypt, Turkey, South

Africa

To date 11,661 patients enrolled word wide in Phase II of the registry ~ 1000 sites activated

GLORIA-AF Worldwide

GLORIA-AF Phase I Objectives

To characterize the newly diagnosed non-valvular AF patient population at risk for stroke and the selection of antithrombotic treatment for stroke prevention in a real-life setting

• Before NOACs are approved for the prevention of strokes and systemic emboli in different regions of the world (May 2011 – Jan 2013)

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Last country to approve NOACs (=dabigatran etexilate as the first) in our dataset was China in January 2013

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67%

27%6%Asia (China)

Europe (Nether-lands, Spain, Germany, Croa-tia)

Middle East (Egypt, Lebanon, Turkey, UAE)

(N=291)

(N=59)

(N=713)

Patient Disposition by Region

Total patient numbers = 1063

Categorization of AF (All Patients)

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Sympt

omat

ic

Min

imal

ly S

ympt

omat

ic

Asym

ptom

atic

Parox

ysm

al A

F

Persist

ent or

Per

man

ent AF

0%

2000%

4000%

6000%n =661

n=231n=171

n=665

n=398

33,8 % persistent3,7 % permanent

Patient Demographics & Medical history

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Demographics AsiaN=713

EuropeN=291

Middle EastN=59

Age (years) Median (IQR) 69.0 (59.0-77.0) 71.0 (64.0-79.0) 65.0 (57.0-74.0)

Female N(%) 305 (42.8) 147 (50.5) 34 (57.6)

BMI Median (IQR) 23.9 (21.5-26.1) 28.1 (25.4-31.2) 27.3 (24.2-33.3)

Patient Demographics & Medical history

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Medical History AsiaN=713 (100%)

EuropeN=291 (100%)

Middle EastN=59 (100%)

Previous stroke 73 (10.2) 31 (10.7) 6 (10.2)

Myocardial infarction (MI) 59 (8.3) 32 (11.0) 8 (13.6)

Coronary artery disease (CAD)

181 (25.4) 59 (20.3) 16 (27.1)

Congestive heart failure 176 (24.7) 65 (22.3) 15 (25.4)

History of hypertension 500 (70.1) 248 (85.2) 47 (79.7)

Diabetes mellitus 139 (19.5) 79 (27.1) 22 (37.3)

Chronic gastrointestinal diseases

61 (8.6) 9 (3.1) 3 (5.1)

Stroke and bleeding risk scores

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AsiaN=713 (100%)

EuropeN=291 (100%)

Middle EastN=59 (100%)

CHADS2 score class Low (score=0) Moderate (score=1) High (score ≥2)

84 (11.8)270 (37.9)359 (50.4)

16 (5.5)95 (32.6)180 (61.9)

2 (3.4)21 (35.6)36 (61.0)

CHA2DS2VASC score class Low (score=0) Moderate (score=1) High (score ≥2)

0 184 (25.8)529 (74.2)

0 (0.0)36 (12.4)255 (87.6)

0 (0.0)6 (10.2)53 (89.8)

HAS-BLED score class Low (score <3) High (score ≥3) Missing

596 (83.6)88 (12.3)29 (4.1)

224 (77.0)23 (7.9)

44 (15.1)

40 (67.8)10 (16.9)9 (15.3)

Antithrombotic treatment choice at baseline by regionall eligible

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* 19 patients from Middle East and 1 patient from Europe are/is excluded from this table as they received NOACs

Asia (n=713) Europe (n=291) Middle East (n=59)0

100

200

300

400

500

600

700

800

None

Antiplt. other than ASA

ASA

VKA

Region

An

tih

rom

bo

tic

at

Ba

se

line 25.9 %

None 8.5 %

VKA30.5 %

49.6 %

4.1 %

20.3 %

63.9 %

25.4 %

Antiplt. 25.4 %

None 8.6 %

Antiplt. 3.4 %

ASA 25.4 %

Conclusions

• Data collection from the time prior to NOACs entering the market (Phase I) included1063 patients with 67% of the patients from China

• 1st Phase of GLORIA-AF shows lower VKA use in those with paroxysmal AF, and in those with low stroke risk.

• Geographical differences exists in the use of VKA therapy in the era before the availability of NOACs - notably lower use of VKA in Asia.

• In Asia, most patients are treated with antiplatelet agents or do not get any antithrombotic treatment. The shift to more VKA use in patients with AF can be seen when “going West”.

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Acknowledgements

Scientific Steering Committee• MV Huisman, Leiden University Medical Center, Netherlands (Chair)• GYH Lip, University of Birmingham, UK (Co-Chair)• HC Diener, Universitätsklinikum Essen, Germany• SJ Dubner, Clinica y Maternidad Suizo, Argentina• JL Halperin, Mount Sinai School of Medicine, USA• CS Ma, Beijing An Zhen Hospital, China• KJ Rothman, Harvard School of Public Health, USA

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Boehringer Ingelheim Study Team• DB Bartels• A Clemens• E Kleine• Liz Nacar• M Paquette• C Teutsch• K Zint