European Heart Journal Advance Access originally published online on September 25, 2007
European Heart Journal 2007 28(22):2803-2817; doi:10.1093/eurheartj/ehm358
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Outcome parameters for trials in atrial fibrillation: executive summary
Recommendations from a consensus conference organized by the German Atrial Fibrillation Competence NETwork (AFNET) and the European Heart Rhythm Association (EHRA)
1 Department of Cardiology and Angiology, University Hospital Münster, Albert-Schweitzer-Straße 33, D-48149 Münster, Germany
2 German Atrial Fibrillation competence NETwork (AFNET), Germany
3 Fondazione Cardiocentro Ticino, Lugano, Switzerland
4 University Hospital Leiden, The Netherlands
5 Department of Cardiology, University of Maastricht, The Netherlands
6 British Heart Foundation Professor, St George's University of London, London, UK
7 Department of Neurology, University of Duisburg-Essen, Germany
8 Department of Cardiology, University of Magdeburg, Germany
9 Department of Cardiology, University of Leipzig, Germany
10 Department of Cardiology, University of Frankfurt/Main, Germany
11 Cardio-Met, Geneva, Switzerland
12 Department of Cardiology, General Hospital St Georg, Hamburg, Germany
13 Haemostasis Thrombosis & Vascular Biology Unit, University Department of Medicine, City Hospital, Birmingham, UK
14 Department of Cardiology/Clinical Sciences, University Hospital, Lund, Sweden
15 Department of Cardiology, University of Hamburg, Germany
16 University of Pavia, Italy
17 Department of Pharmacology, Technical University Dresden, Germany
18 Department of Cardiology, Ludwigs-Maximilian University of Munich, Germany
19 Astra Zeneca R&D, Mölndal, Sweden
20 Academic Medical Center, Amsterdam, The Netherlands
21 Medtronic, Arnhem, The Netherlands
Received 25 April 2007; revised 16 July 2007; accepted 26 July 2007; online publish-ahead-of-print 25 September 2007.
* Corresponding author. Tel: +49 0251 83 45341; fax: +49 0251 83 45343. E-mail address: kirchhp{at}uni-muenster.de
Atrial fibrillation (AF), the most common atrial arrhythmia, has a complex aetiology and causes relevant morbidity and mortality due to different mechanisms, including but not limited to stroke, heart failure, and tachy- or bradyarrhythmia. Current therapeutic options (rate control, rhythm control, antithrombotic therapy, ‘upstream therapy’) only prevent a part of this burden of disease. Several new treatment modalities are therefore under evaluation in controlled trials. Given the multifold clinical consequences of AF, trials in AF patients should assess the effect of therapy in each of the main outcome domains. This paper describes an expert consensus of required outcome parameters in seven relevant outcome domains, namely death, stroke, symptoms and quality of life, rhythm, left ventricular function, cost, and emerging outcome parameters. In addition to these ‘requirements’ for outcome assessment in AF trials, further, more detailed outcome parameters are described. In addition to a careful selection of a relevant primary outcome parameter, coverage of outcomes in all major domains of AF-related morbidity and mortality is desirable for any clinical trial in AF.
Key Words: Atrial fibrillation • Controlled trial • Outcome parameter • Therapy, treatment • Randomized trial • End-point • Stroke death • Quality of life • Left ventricular function • Catheter ablation • Antiarrhythmic drugs • Cardioversion • Rate control • Rhythm control • Anticoagulation
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  O. Jolobe It is important to identify the presence of atrial fibrillation more accurately QJM, June 1, 2008; 101(6): 506 - 507. [Full Text] [PDF]
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