Global Variations in the 1-year Rates of Death and Stroke in Patients Presenting to the Emergency Department with Atrial Fibrillation Results from the RE-LY AF Registry

Background AF is a major global disease; however, our understanding of AF is based largely on European and N. American studies Baseline results from the RE-LY AF registry (ESC 2011) demonstrated important regional variations in risk factors and treatment of AF The RE-LY AF registry followed patients for 1 year to document: Cause-specific mortality Clinical outcomes including stroke, embolism, heart failure, major bleeding and hospitalization

47 countries; 164 sites; 15,408 patients RegionSitesPatients Middle East8896 North America Africa Latin America India Western Europe China Eastern Europe SE Asia = Participating country

Study Methods Prospective registry Atrial fibrillation or atrial flutter Primary or secondary diagnosis Presenting to an emergency department Enrolled between January 2008 and April 2011 Follow-up completed May 2012 Occurred 1 year ± 4 weeks after enrolment Complete FU in 99.4% Complete reporting of ALL data in 97.7%

Patient Characteristics Arrhythmia Atrial fibrillation: 98%; Atrial flutter: 2% Reason for ER visit AF primary diagnosis: 44%; Secondary: 56% History of AF First episode: 21%;Prior history: 79% Pattern of AF Paroxysmal AF: 34% Persistent AF: 26% Permanent AF: 40%

Age Median; IQR (years)

Mean CHADS 2 Score

Mortality at 1-year in regional cohorts  Crude Mortality  Adjusted Mortality: (for age, sex, heart failure, coronary artery disease, hypertension, diabetes, rheumatic heart disease and reason for emergency department presentation Global Ave.

Mortality: by Reason for ED Visit  Other Primary Diagnosis  Primary Diagnosis of AF Global Ave.

Cause of Death: Global  Proportion of all Deaths

Proportion of Causes of Death by Region

Stroke rates in the regional cohorts  Crude Stroke Rate  Adjusted Stroke Rate: (for age, stroke/TIA, heart failure, hypertension and diabetes). NOT ADJUSTED FOR VKA USE Global Ave. (Crude)

Stroke rates in the regional cohorts  Crude Stroke Rate  Adjusted Stroke Rate: (for age, stroke/TIA, heart failure, hypertension, diabetes and VITAMIN K ANTAGONIST USE) Global Ave. (Crude)

Stroke Risk: Overall Global by RHD  No History of Rheumatic Heart Disease  History of Rheumatic Heart Disease No Rheumatic Heart Disease N=13,507 Rheumatic Heart Disease N=1788 Age66.2 years49.5 years Female sex45.4%64.9% Coronary Disease 34.3%5.5% Hypertension60.3%19.6% Heart Failure33.0%34.7% Warfarin Use32.0%68.7% *Adjusted for age, history of stroke/TIA, heart failure, diabetes, hypertension, region and VKA use N=1788 patients with RHD

Global CHADS 2 -Specific Stroke Rate (1-yr.)  Proportion of Patients with Stroke at 1 year, without RHD CHADS2: Congestive Heart Failure, Hypertension, Age ≥ 75, Diabetes Mellitus, Prior Stroke or TIA (2)  Proportion of Patients with Stroke at 1 year, with RHD, but no valve surgery

Conclusions In a global setting more than 10% of patients presenting to an emergency department with AF are dead within 1 year The rate appears highly variable between different countries However; may be unmeasured bias in types of patients recruited Mortality is 2-3 times higher when AF is a secondary diagnosis Despite the availability of modern medical therapy, more than 4% of AF patients experience stroke within one year Globally, CHADS 2 score has a greater influence on stroke risk than the presence of rheumatic heart disease Most of the difference in stroke rate between regions can be explained on the basis of VKA use

Conclusions II In a global setting the RELY AF registry shows very large unmet medical needs and large opportunities for improvement by applying currently generally available modalities for diagnosis, risk stratification and treatment of patients presenting with atrial fibrillation

Acknowledgements Steering committee J. Healey*, S. Connolly, S. Yusuf (Canada); J. Oldgren*, L. Wallentin (Sweden); M. Ezekowitz, A. Parekh (USA); A. Avezum (Brazil); P. Jansky (Czech Republic); P. Commerford (South Africa); J. Zhu, Lisheng Liu (China); P. Pais, A. Sigamani (India); A. Damasceno (Mozambique). * co-chairs Study Coordination A. Grinvalds, E. Themeles (Canada) Population Health Research Institute (Canada); Dante Pazzanese Institute Research Division(Brazil); St. John’s Research Institute (India); Fuwai Hospital (China) Study Sponsor Boehringer-Ingelheim: P. Reilly, J. Varrone