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 - 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.

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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

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[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: www.recordaf.org

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