First Global Atrial Fibrillation Registry, Recordaf, Shows Rhythm-control Strategy With Current Ther

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MEDIA RELEASE PR37099


First Global Atrial Fibrillation Registry, RecordAF, Shows Rhythm-Control Strategy With Current

Therapies Achieves Improved Disease Control but not Clinical Outcomes


ORLANDO, Florida, November 16 /PRNewswire-AsiaNet/ --


    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.










    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.


Community Health RecordAF Registry 3 image

    [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


    SOURCE: RecordAF registry


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