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Cees B De Vos,
Günter Breithardt,
A John Camm,
Paul Dorian,
Peter R Kowey,
Jean-Yves Le Heuzey,
Lisa Naditch-Brûlé,
Eric N Prystowsky,
Peter J Schwartz, Christian Torp-Pedersen,
William S Weintraub,
Harry J Crijns
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ABSTRACT: Paroxysmal atrial fibrillation (AF) may progress to persistent AF. We studied the clinical correlates and the effect of rhythm-control strategy on AF progression.
RecordAF was a worldwide prospective survey of AF management. Consecutive eligible patients with recent-onset AF were included and allocated to rate or rhythm control according to patient/physician choice. A total of 2,137 patients were followed up for 12 months. Atrial fibrillation progression was defined as a change from paroxysmal to persistent/permanent AF.
Progression of AF occurred in 318 patients (15%) after 1 year. Patients with AF progression were older; had a higher diastolic blood pressure; and more often had a history of coronary artery disease, stroke or transient ischemic attack, hypertension, or heart failure. Patients treated with rhythm control were less likely to show progression than those treated only with rate control (164/1542 [11%] vs 154/595 [26%], P < .001). Multivariable analysis showed that history of heart failure (odds ratio [OR] 2.2, 95% CI 1.7-2.9, P < .0001), history of hypertension (OR 1.5, 95% CI 1.1-2.0, P = .01), and rate control rather than rhythm control (OR 3.2, 95% CI 2.5-4.1, P < .0001) were independent predictors of AF progression. The propensity score-adjusted OR of AF progression in patients with rate rather than rhythm control was 3.3 (95% CI 2.4-4.6, P < .0001).
Although heart failure and hypertension are associated with AF progression, rhythm control is associated with lower risk of AF progression.
American heart journal 05/2012; 163(5):887-93. · 4.65 Impact Factor
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ABSTRACT: BACKGROUND: Vernakalant is a novel, relatively atrial-selective antiarrhythmic drug. This analysis assessed the efficacy and safety of intravenous vernakalant for the rapid conversion of atrial fibrillation (AF) to sinus rhythm in patients with a history of ischemic heart disease (IHD). METHODS: The presence of IHD was extracted from the medical history of patients from four randomized placebo-controlled studies and one open label study. The efficacy analysis included patients with recent onset AF (consistent with the European labeled indication), while the safety analysis included all patients with AF or atrial flutter (AFL) (3h to 45days duration) who were exposed to study drug. RESULTS: A total of 1052 adult patients were enrolled and treated; 274 patients (91 placebo, 183 vernakalant) with a history of IHD and 778 patients (224 placebo, 554 vernakalant) without IHD. Conversion of AF to sinus rhythm was not influenced by IHD. In patients with recent onset AF, the placebo-subtracted conversion rate with vernakalant was 45.7% in the IHD group and 47.3% in the non-IHD group. In the 24h following treatment, the rate of treatment-emergent serious adverse events and discontinuations due to adverse events was similar in both the IHD and non-IHD groups, and there was no case of torsades de pointes, ventricular fibrillation, or death in patients with IHD. CONCLUSIONS: Vernakalant was safe and well tolerated in AF/AFL patients with a history of IHD, and was significantly more effective than placebo for the acute conversion of AF regardless of IHD status.
International journal of cardiology 11/2011; · 7.08 Impact Factor
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ABSTRACT: Vernakalant, a relatively atrial-selective antiarrhythmic drug, has previously demonstrated efficacy for the acute conversion of atrial fibrillation (AF) to sinus rhythm. This study was designed to determine the most appropriate oral dose of vernakalant for the prevention of AF recurrence postcardioversion.
Patients with nonpermanent AF were randomized to 150, 300, or 500 mg vernakalant or placebo twice daily for up to 90 days. The efficacy analysis was conducted on 605 of 735 patients who entered the maintenance phase on day 3 after cardioversion. The time to the first recurrence of symptomatic sustained AF was significantly longer in the 500 mg vernakalant group, with a median of >90 days versus 29 days in the placebo group (hazard ratio, 0.735; P=0.0275). No significant effect was seen at the lower doses. The percent of patients in sinus rhythm at day 90 was 41%, 39%, and 49% in the 150-mg (n=147), 300-mg (n=148), and 500-mg (n=150) vernakalant groups, respectively, compared with 36% in the placebo group (n=160). There were no vernakalant-related proarrhythmic events. Related serious adverse events occurred in 2 patients in the 150-mg vernakalant group and in 1 patient in each of the other groups.
Vernakalant, 500 mg twice daily, appears to be effective and safe for the prevention of AF recurrence after cardioversion. The absence of proarrhythmia and favorable safety profile is an important finding for the drug.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT00526136.
Circulation Arrhythmia and Electrophysiology 08/2011; 4(5):637-43. · 6.46 Impact Factor
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A John Camm,
Günter Breithardt,
Harry Crijns,
Paul Dorian,
Peter Kowey,
Jean-Yves Le Heuzey,
Ihsen Merioua,
Laurence Pedrazzini,
Eric N Prystowsky,
Peter J Schwartz, Christian Torp-Pedersen,
William Weintraub
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ABSTRACT: RECORDAF is the first worldwide, prospective, observational survey of management of atrial fibrillation (AF) in unselected, community-based patients.
Primary outcomes were therapeutic success and clinical outcomes associated with rhythm-control and rate-control strategies.
Patients with recent-onset AF were included (n = 5,604). Treatment strategy (rhythm control or rate control) was noted at baseline. Follow-up was 12 months. Therapeutic success required that strategy was unchanged without clinical events. Further maintenance of sinus rhythm was required in the rhythm-control group, and heart rate ≤80 beats/min in the rate-control group.
Data from 5,171 patients were assessable. Therapeutic success was 54% overall (rhythm control 60% vs. rate control 47%), a result driven by control of AF: rhythm control, 81% vs. rate control, 74%. After adjustment for propensity score quintiles, the rhythm-control strategy was significantly related to superior therapeutic success (odds ratio: 1.34, 95% confidence interval: 1.15 to 1.55; p = 0.0002). Clinical events occurred in 18% of patients. The arrhythmia management strategy was not predictive of clinical events. The type (persistent), presence at baseline visit, and duration (>3 months) of AF, together with age older than 75 years and the presence of heart failure, predicted progression to permanent AF. The choice of rhythm control reduced the likelihood of AF progression (odds ratio: 0.20, 95% confidence interval: 0.17 to 0.25; p < 0.0001).
Clinical outcomes in AF patients were driven mainly by hospitalizations for arrhythmia/proarrhythmia and other cardiovascular causes, but not by the choice of rate or rhythm strategy. Rhythm-control patients progressed less rapidly to permanent AF.
Journal of the American College of Cardiology 07/2011; 58(5):493-501. · 14.16 Impact Factor
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ABSTRACT: This randomized double-blind study compared the efficacy and safety of intravenous vernakalant and amiodarone for the acute conversion of recent-onset atrial fibrillation (AF).
Intravenous vernakalant has effectively converted recent-onset AF and was well tolerated in placebo-controlled studies.
A total of 254 adult patients with AF (3 to 48 h duration) eligible for cardioversion were enrolled in the study. Patients received either a 10-min infusion of vernakalant (3 mg/kg) followed by a 15-min observation period and a second 10-min infusion (2 mg/kg) if still in AF, plus a sham amiodarone infusion, or a 60-min infusion of amiodarone (5 mg/kg) followed by a maintenance infusion (50 mg) over an additional 60 min, plus a sham vernakalant infusion.
Conversion from AF to sinus rhythm within the first 90 min (primary end point) was achieved in 60 of 116 (51.7%) vernakalant patients compared with 6 of 116 (5.2%) amiodarone patients (p < 0.0001). Vernakalant resulted in rapid conversion (median time of 11 min in responders) and was associated with a higher rate of symptom relief compared with amiodarone (53.4% of vernakalant patients reported no AF symptoms at 90 min compared with 32.8% of amiodarone patients; p = 0.0012). Serious adverse events or events leading to discontinuation of study drug were uncommon. There were no cases of torsades de pointes, ventricular fibrillation, or polymorphic or sustained ventricular tachycardia.
Vernakalant demonstrated efficacy superior to amiodarone for acute conversion of recent-onset AF. Both vernakalant and amiodarone were safe and well tolerated in this study. (A Phase III Superiority Study of Vernakalant vs Amiodarone in Subjects With Recent Onset Atrial Fibrillation [AVRO]; NCT00668759).
Journal of the American College of Cardiology 01/2011; 57(3):313-21. · 14.16 Impact Factor
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Jean-Yves Le Heuzey,
Günter Breithardt,
John Camm,
Harry Crijns,
Paul Dorian,
Peter R Kowey,
Ihsen Merioua,
Eric N Prystowsky,
Peter J Schwartz, Christian Torp-Pedersen,
William Weintraub
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ABSTRACT: The REgistry on Cardiac rhythm disORDers assessing the control of Atrial Fibrillation (RecordAF) is the first worldwide, 1-year observational, longitudinal study of the management of paroxysmal/persistent atrial fibrillation (AF) in recently diagnosed patients. The study was conducted at 532 sites in 21 countries across Europe, America, and Asia; recruitment was completed in April 2008. The primary objectives were to prospectively assess the therapeutic success and clinical outcomes in rhythm- and rate-control strategies. The study design and patient baseline data are reported. A total of 5,814 patients with AF were registered, and 5,604 were eligible for evaluation. Rhythm- and rate-control strategies were applied to 55% and 45% of patients, respectively, at study inclusion. Rhythm-control patients mainly received class III agents (45%) or beta blockers (51%), except for sotalol, and rate-control patients mainly received beta blockers (72%), except for sotalol, or cardiac glycosides (34%). Patients receiving a rhythm-control strategy were younger, had a lower resting heart rate, were more frequently symptomatic, and were more likely to have recently diagnosed AF or paroxysmal AF compared to patients receiving a rate-control strategy. A rate-control strategy was more common in patients with a history of heart failure or valvular heart disease and persistent AF. Rate-control patients more often had previous electrocardiographic evidence of AF and were not in sinus rhythm at inclusion (p <0.01 for both end points). Patients were followed at 6 and 12 months, and changes in therapeutic strategy and clinical outcomes were recorded. In conclusion, the RecordAF study results will provide a global perspective on current AF treatment strategies.
The American journal of cardiology 03/2010; 105(5):687-93. · 3.58 Impact Factor
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Peter R Kowey,
Günter Breithardt,
John Camm,
Harry Crijns,
Paul Dorian,
Jean-Yves Le Heuzey,
Laurence Pedrazzini,
Eric N Prystowsky,
Geneviève Salette,
Peter J Schwartz, Christian Torp-Pedersen,
William Weintraub
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ABSTRACT: The Registry on Cardiac Rhythm Disorders Assessing the Control of Atrial Fibrillation (RecordAF) study is the first worldwide, prospective, survey of real-life management of atrial fibrillation (AF) in recently diagnosed patients (n = 5604) with a 1-year follow-up.
Surveys of AF management have identified a divergence between guidelines and clinical practice, and an overinterpretation of guidelines in low-risk patients.
: Physicians' theoretical approaches to rhythm and rate control were investigated using a pre-study questionnaire.
One cardiologist, from each of the 583 sites in 6 regions, completed a questionnaire on their practice and management of AF patients. In AF patients with structural heart disease (SHD), amiodarone was the most frequent choice of first-line rhythm control agents in all regions. Amiodarone or sotalol tended to be the preferred second-line rhythm control agents, 1 exception being Central/South America. beta-Blockers were the first-line rate control agents for patients with AF and SHD in all regions, and calcium channel blockers and cardiac glycosides were the most common second-line rate control treatments in all regions, except Asia. In lone AF patients, propafenone (30.6%), flecainide (24.1%), and amiodarone (21.7%) were the most common global choices of first-line rhythm control, and amiodarone or sotalol were the preferred second-line rhythm control agents, 1 exception being Central/South America.
These results highlight points of divergence from the American College of Cardiology (ACC)/ American Heart Association (AHA)/European Society of Cardiology (ESC) guidelines for the management of AF in terms of first-line drug selection in patients with associated SHD or coronary artery disease.
Clinical Cardiology 03/2010; 33(3):172-8. · 2.15 Impact Factor
