Paris, November 16 (ots/PRNewswire)
- The RealiseAF Registry Will Help to Better Define and
Understand the Cardiovascular Risk Profile of AF Patients and
Characterize Their Cardiovascular Outcomes
Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today the
launch of the RealiseAF registry (Real Life global Survey Evaluating
patients with Atrial Fibrillation), an international,
cross-sectional, observational registry that will be conducted in
patients with atrial fibrillation (AF). This disease can worsen
patients' prognosis, increase the risk of hospitalization, stroke and
mortality. RealiseAF will provide a real-life picture of the global
burden of AF in more than 10,000 patients in 27 countries.
"Sanofi-aventis is a major contributor to the efforts to reduce
the public health burden of atrial fibrillation," said Jean-Pierre
Lehner, Chief Medical Officer, sanofi-aventis. "The company strives
to respond to the medical needs of patients and physicians, not only
with innovative therapeutic solutions, but also via investment in
registries such as RealiseAF, dedicated to furthering the
understanding of the risk profiles of patients with atrial
RealiseAF is designed to assess the control of atrial
fibrillation (AF) and investigate the CV risk profile of a broad
spectrum of AF populations in Europe, Latin America, Asia, Middle
East and North Africa. This new registry is intended to generate new
data on a broad AF population including patients with paroxysmal,
persistent as well as permanent atrial fibrillation, AF due to
transient causes. It will provide a better understanding of this
disease and associated CV consequences, which may help to further
improve the burden of AF.
"RealiseAF will provide more data to help physicians to
understand the true impact of AF, its burden and how to improve
outcomes," said Professor G. Steg, Department of Cardiology, Hopital
Bichat, Paris, France, on behalf of the RealiseAF steering committee.
"This study will give us a unique picture both globally and locally
about the AF patient population and how patients are managed."
RealiseAF was designed to complement the results of the RecordAF
registry (Registry on Cardiac Rhythm Disorders, an international,
observational, prospective survey assessing the control of Atrial
Fibrillation), presented during the late breaking session of the
American Heart Association 2009 meeting in Orlando, USA. The results
of the RecordAF registry show that 18% of all patients had
cardiovascular (CV) clinical events at 1 year mainly driven by CV
hospitalization. A rhythm control strategy was preferred by 55% of
cardiologists and achieved better therapeutic success than a rate
control strategy (60% vs 47%). Nevertheless, rhythm control
strategies with existing therapies at the time of this study did not
translate into better outcomes than rate control.
None of these 2 strategies appeared to be really satisfactory for
physicians; 22% of physicians changed their strategy and 52% modified
AF treatment within a strategy during the 12 months period.
These results highlight the need for newer anti-arrhythmic
drugs able to successfully achieve rhythm and rate control as well as
decrease clinical events.
The recruitment of the RealiseAF patients recently started at the
end of October 2009 and final results are expected by the end of
2010. RealiseAF is supported by an unrestricted educational grant
The RealiseAF registry will follow more than 10,000 patients in
926 centers from 27 countries with a history of atrial fibrillation
and at least one AF episode in the last 12 months, or documented
Adults with paroxysmal, persistent as well as permanent AF, and
AF due to transient causes (thyrotoxicosis, alcohol intoxication,
acute phase of myocardial infarction, pericarditis, myocarditis,
electrocution, pulmonary embolism or other pulmonary disease,
hydroelectrolytic disorder, metabolic disorder, etc.) are included.
Data collected will include the following measures: family and
personal cardiovascular risk factors, history of comorbidities,
cardiovascular events leading to hospitalisation in the last 12
months, cardiovascular interventions, history and characteristics of
AF, AF management, and quality of life assessment. Cardiologists
(office-based and hospital-based) and internists will be randomly
selected to participate in the study.
The RecordAF registry recruited 5,604 patients with recent onset
atrial fibrillation from 21 countries spanning North and South
America, Europe and Asia. They were studied for a period of one year.
The primary outcomes of the study were therapeutic success and
clinical outcomes associated with rhythm- and rate-control
strategies. Therapeutic success at 1 year required that treatment
strategy was unchanged, that no clinical events occurred during
follow-up, and that sinus rhythm was achieved in the rhythm-control
group or the heart rate less than or equal to 80 bpm in the
Physicians involved in the registry were randomly selected from
an initial representative and exhaustive global list of office- and
About atrial fibrillation
Atrial fibrillation is the most common cardiac arrhythmia and
affects nearly 7 million people in the European Union and the United
States(1). AF currently represents a major economic burden for
society and leads to potential life-threatening complications. AF
increases the risk of stroke up to five-fold(2), worsens the
prognosis of patients with cardiovascular risk factors(3), and
doubles the risk of mortality(4) with significant burden on
patients, health care providers and payers. Hospitalizations for AF
have increased dramatically (two-to-three-fold) in recent years(1).
AF hospitalizations now represent a third of all hospitalizations
for arrhythmia and mortality in the US and Europe(3). Seventy
percent of the annual cost of AF management in Europe is driven by
hospital care and interventional procedures(5).
Sanofi-aventis, a leading global pharmaceutical company,
discovers, develops and distributes therapeutic solutions to improve
the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT:
SAN) and in New York (NYSE: SNY). For more information, visit:
For more information please visit: http://www.realiseaf.org
(1) Go AS, Hylek EM, Phillips KA, et al. Prevalence of diagnosed
atrial fibrillation in adults: national implications for rhythm
management and stroke prevention: the AnTicoagulation and Risk
Factors in Atrial Fibrillation (ATRIA) Study. JAMA 2001; 285:2370-5.
(2) Lloyd-Jones et al. Lifetime Risk for Development of Atrial
Fibrillation: The Framingham Heart Study. Circulation. 2004;
(3) Fuster V et al. ACC/AHA/ESC 2006 guidelines for the management of
patients with atrial fibrillation. European Heart Journal (2006)
(4) Benjamin EJ, Wolf PA, D'Agostino RB, Silbershatz H, Kannel WB, Levy
D. Impact of atrial fibrillation on the risk of death: the Framingham
Heart Study. Circulation 1998 Sep 8; 98(10):946-52.
(5) Ringborg A, Nieuwlaat R, Lindgren P, Jonsson B, Fidan D, Maggioni AP,
Lopez-Sendon J, Stepinska J, Cokkinos DV, Crijns HJ. Costs of atrial
fibrillation in five European countries: results from the Euro Heart
Survey on atrial fibrillation. Europace. 2008 Apr;10(4):403-11.
Epub 2008 Mar 7.
ots Originaltext: sanofi-aventis Group
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