Post on 31-Dec-2015
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