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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 /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.

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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 ---------------------------------

[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.

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