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RecordAF registry

First Global Atrial Fibrillation Registry, RecordAF, Shows Rhythm-Control Strategy With Current Therapies Achieves Improved Disease Control but not Clinical Outcomes

Orlando, Florida, November 15 (ots/PRNewswire)

Results from the
RecordAF registry (REgistry on Cardiac rhythm disORDers assessing the
control of Atrial Fibrillation), presented today at the Scientific
Sessions of the American Heart Association, show that in recently
diagnosed and actively treated patients with atrial fibrillation
(AF), a rhythm-control strategy provides better short term control of
the arrhythmia versus a rate-control strategy but does not translate
into a reduction in the occurrence of clinical events at 1 year.
RecordAF also confirmed that these patients suffer from a high rate
of clinical events, mainly cardiovascular (CV) hospitalisations.
(Logo: http://www.newscom.com/cgi-bin/prnh/20091115/366795-a )
(Logo: http://www.newscom.com/cgi-bin/prnh/20091115/366795-b )
(Logo: http://www.newscom.com/cgi-bin/prnh/20091115/366795-c )
(Logo: http://www.newscom.com/cgi-bin/prnh/20091115/366795-d )
RecordAF is the first international prospective, observational
survey established to help assess the global burden of atrial
fibrillation by investigating the way in which it is managed in "real
world" clinical cardiology settings, identifying best clinical
practice, and shaping the future management of the disease. 5,604
patients with recently diagnosed atrial fibrillation (first
diagnosed, paroxysmal or persistent) participated in the RecordAF
registry over 12 months, from Apr 2007 to Apr 2008.
"RecordAF shows that while a rhythm-control strategy achieves
superior therapeutic success in atrial fibrillation than a
rate-control strategy, there is no difference in the occurrence of
clinical outcomes between strategies," said Prof John Camm, St
George's University, London, UK, joint-lead investigator. "To truly
optimise the management of atrial fibrillation we need
anti-arrhythmic drugs that improve both rhythm- and rate-control and
significantly reduce clinical events."
Atrial fibrillation is a potentially life-threatening disease
caused by an erratic electrical activity in the heart which worsens
the prognosis of patients with CV risk factors and increases the risk
of hospitalization, stroke, and mortality. [1],[2],[3],[4],[5]
RecordAF shows that a rhythm control strategy was the preferred
therapeutic option (55 percent) at the start of the study.
Therapeutic success (unchanged strategy; no adverse events;
maintenance of sinus rhythm or reduction of heart rate less than or
equal to 80 beats per minute) was 60 percent with a rhythm-control
strategy compared to 47 percent with a rate-control strategy. After
one year, 54 percent of patients on  rate-control strategy had
developed permanent atrial fibrillation compared with 13 percent of
patients in the rhythm-control strategy group.
In RecordAF, a high number of patients (18%) suffered a clinical
event of which 90% were CV hospitalizations. This highlights the
increased CV morbidity and mortality in the AF patient population.
There was no difference in the reduction of clinical events between
patients on the rhythm or rate control groups with 17% vs 18% of CV
events respectively.
"A large scale registry such as RecordAF improves our
understanding of the impact of different therapeutic strategies on
clinical outcomes," said Prof Peter Kowey, Lankenau Hospital,
Wynnewood, PA, USA, joint-lead investigator. "We now know that
rate-control is not an easier or better treatment strategy than
rhythm-control and there is a strong argument to persist with a
rhythm-control strategy."
"The incidence of atrial fibrillation is increasing rapidly and
becoming a greater burden on our practices. Research such as the
RecordAF registry provides a unique insight into factors that
influence therapeutic success. This is very important data for
physicians who manage patients with atrial fibrillation," said Prof.
Eric Prystowsky, St Vincent Hospital and Health Center Program,
Indianapolis, IN, USA, joint-lead investigator.
RecordAF is supported by an unrestricted educational grant
from sanofi-aventis.
About RecordAF registry
The RecordAF survey recruited 5,604 patients with recent onset
atrial fibrillation from 21 countries spanning North and South
America, Europe and Asia (5,171 patients - 92.3 percent were
evaluable after 12-month follow-up). They were followed-up 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 required that
therapeutic strategy was unchanged, without clinical events;
maintenance of sinus rhythm was required in the rhythm control group
and heart rate less than or equal to 80 beats per minute in the rate
control  group.
532 physicians involved in the registry were randomly selected
from an initial representative and exhaustive global list of office-
and hospital-based cardiologists. Patients aged greater than or equal
to 18 years  were considered for enrolment if they presented with AF
or a history of AF,  diagnosed by standard electrocardiogram (ECG) or
ECG Holter monitoring and  if they were eligible for pharmacological
treatment by rhythm- or  rate-control agents. Three visits took place
at baseline, 6 months (plus or  minus 2 months) -not mandatory- , and
12 months (plus or minus 3 months).
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],[6] 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-fold4, worsens the prognosis
of patients with CV risk factors[1],[3], and doubles the risk of
mortality[5] with significant burden on patients, health care
providers and payers. Hospitalizations for AF have increased
dramatically (two-to-three-fold) in recent years.[2],[7] AF
hospitalizations now represent a third of all hospitalizations for
arrhythmia and mortality in the US and Europe.[1] Seventy percent of
the annual cost of  AF management in Europe is driven by hospital
care and interventional procedures.[8]
References
[1] Fuster V et al. ACC/AHA/ESC 2006 guidelines for the
management of patients with atrial fibrillation. European Heart
Journal (2006) 27, 1979-2030.
[2] Wattigney WA, Mensah GA & Croft JB. Increasing trends in
hospitalization for atrial fibrillation in the US 1985 through 1999
Implications for primary prevention. Circulation. 2003;108:711-716.
[3] Dorian P et al. J Am Coll Cardiol. 2000;36:1303-1309
[4] Lloyd-Jones et al. Lifetime Risk for Development of Atrial
Fibrillation: The Framingham Heart Study. Circulation. 2004;
110:1042-1046.
[5] 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.
[6] 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
[7] Wattigney WA, Circulation. 2003;108:711-716
[8] Ringborg A, Nieuwlaat R, Lindgren P, Jönsson 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.
For more information visit: http://www.recordaf.org

Contact:

Press contact: Joanna Tubbs, Tel: +44-207-878-3107,
joanna.tubbs@mslworldwide.com