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

Monday, November 16, 2009 General News
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ORLANDO, Florida, November 15 Results from the RecordAFregistry (REgistry on Cardiac rhythm disORDers assessing the control ofAtrial Fibrillation), presented today at the Scientific Sessions of theAmerican Heart Association, show that in recently diagnosed and activelytreated patients with atrial fibrillation (AF), a rhythm-control strategyprovides better short term control of the arrhythmia versus a rate-controlstrategy but does not translate into a reduction in the occurrence ofclinical events at 1 year. RecordAF also confirmed that these patients sufferfrom a high rate of clinical events, mainly cardiovascular (CV)hospitalisations.

RecordAF is the first international prospective, observational surveyestablished to help assess the global burden of atrial fibrillation byinvestigating the way in which it is managed in "real world" clinicalcardiology settings, identifying best clinical practice, and shaping thefuture management of the disease. 5,604 patients with recently diagnosedatrial fibrillation (first diagnosed, paroxysmal or persistent) participatedin the RecordAF registry over 12 months, from Apr 2007 to Apr 2008.

"RecordAF shows that while a rhythm-control strategy achieves superiortherapeutic success in atrial fibrillation than a rate-control strategy,there is no difference in the occurrence of clinical outcomes betweenstrategies," said Prof John Camm, St George's University, London, UK,joint-lead investigator. "To truly optimise the management of atrialfibrillation we need anti-arrhythmic drugs that improve both rhythm- andrate-control and significantly reduce clinical events."

Atrial fibrillation is a potentially life-threatening disease caused byan erratic electrical activity in the heart which worsens the prognosis ofpatients 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 preferredtherapeutic option (55 percent) at the start of the study. Therapeuticsuccess (unchanged strategy; no adverse events; maintenance of sinus rhythmor reduction of heart rate less than or equal to 80 beats per minute) was 60percent with a rhythm-control strategy compared to 47 percent with arate-control strategy. After one year, 54 percent of patients on rate-controlstrategy had developed permanent atrial fibrillation compared with 13 percentof patients in the rhythm-control strategy group.

In RecordAF, a high number of patients (18%) suffered a clinical event ofwhich 90% were CV hospitalizations. This highlights the increased CVmorbidity and mortality in the AF patient population. There was no differencein the reduction of clinical events between patients on the rhythm or ratecontrol groups with 17% vs 18% of CV events respectively.

"A large scale registry such as RecordAF improves our understanding ofthe impact of different therapeutic strategies on clinical outcomes," saidProf Peter Kowey, Lankenau Hospital, Wynnewood, PA, USA, joint-leadinvestigator. "We now know that rate-control is not an easier or bettertreatment strategy than rhythm-control and there is a strong argument topersist with a rhythm-control strategy."

"The incidence of atrial fibrillation is increasing rapidly and becominga greater burden on our practices. Research such as the RecordAF registryprovides a unique insight into factors that influence therapeutic success.This is very important data for physicians who manage patients with atrialfibrillation," said Prof. Eric Prystowsky, St Vincent Hospital and HealthCenter Program, Indianapolis, IN, USA, joint-lead investigator.

RecordAF is supported by an unrestricted educational grant fromsanofi-aventis.

About RecordAF registry

The RecordAF survey recruited 5,604 patients with recent onset atrialfibrillation from 21 countries spanning North and South America, Europe andAsia (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 thestudy were therapeutic success and clinical outcomes associated with rhythm-and rate-control strategies. Therapeutic success required that therapeuticstrategy was unchanged, without clinical events; maintenance of sinus rhythmwas required in the rhythm control group and heart rate less than or equal to80 beats per minute in the rate control group.

532 physicians involved in the registry were randomly selected from aninitial representative and exhaustive global list of office- andhospital-based cardiologists. Patients aged greater than or equal to 18 yearswere considered for enrolment if they presented with AF or a history of AF,diagnosed by standard electrocardiogram (ECG) or ECG Holter monitoring and ifthey were eligible for pharmacological treatment by rhythm- or rate-controlagents. Three visits took place at baseline, 6 months (plus or minus 2months) -not mandatory- , and 12 months (plus or minus 3 months).

About atrial fibrillation

Atrial fibrillation is the most common cardiac arrhythmia and affectsnearly 7 million people in the European Union and the United States.[1],[6]AF currently represents a major economic burden for society and leads topotential life-threatening complications. AF increases the risk of stroke upto 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 increaseddramatically (two-to-three-fold) in recent years.[2],[7] AF hospitalizationsnow represent a third of all hospitalizations for arrhythmia and mortality inthe US and Europe.[1] Seventy percent of the annual cost of AF management inEurope is driven by hospital care and interventional procedures.[8]

References ---------------------------------

[1] Fuster V et al. ACC/AHA/ESC 2006 guidelines for the management ofpatients with atrial fibrillation. European Heart Journal (2006) 27,1979-2030.

[2] Wattigney WA, Mensah GA & Croft JB. Increasing trends inhospitalization for atrial fibrillation in the US 1985 through 1999Implications 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 AtrialFibrillation: The Framingham Heart Study. Circulation. 2004; 110:1042-1046.

[5] Benjamin EJ, Wolf PA, D'Agostino RB, Silbershatz H, Kannel WB, LevyD. Impact of atrial fibrillation on the risk of death: the Framingham HeartStudy. Circulation 1998 Sep 8; 98(10):946-52.

[6] Go AS, Hylek EM, Phillips KA, et al. Prevalence of diagnosed atrialfibrillation in adults: national implications for rhythm management andstroke prevention: the AnTicoagulation and Risk Factors in AtrialFibrillation (ATRIA) Study. JAMA 2001; 285:2370-5

[7] Wattigney WA, Circulation. 2003;108:711-716

[8] Ringborg A, Nieuwlaat R, Lindgren P, J├Ânsson B, Fidan D, Maggioni AP,Lopez-Sendon J, Stepinska J, Cokkinos DV, Crijns HJ. Costs of atrialfibrillation in five European countries: results from the Euro Heart Surveyon atrial fibrillation. Europace. 2008 Apr;10(4):403-11. Epub 2008 Mar 7.

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SOURCE RecordAF registry

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