Europace Advance Access originally published online on September 25, 2007
Europace 2007 9(11):1006-1023; doi:10.1093/europace/eum191
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AFNET
Outcome parameters for trials in atrial fibrillation
Recommendations from a consensus conference organized by the German Atrial Fibrillation Competence NETwork and the European Heart Rhythm Association
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, 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 and 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, Pavia, Italy; 17 Department of Pharmacology, Technical University Dresden, Dresden, Germany; 18 Department of Cardiology, Ludwigs-Maximilian University of Munich, Munich, Germany; 19 Astra Zeneca R&D, Mölndal, Sweden; 20 Academic Medical Center, Amsterdam, The Netherlands; 21 Medtronic, Arnhem, The Netherlands
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. New treatment modalities are therefore currently under evaluation in clinical trials. Given the multifold clinical consequences of AF, controlled 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 outcome parameters are described in each outcome domain. 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: antiarrhythmic drugs, anticoagulation, atrial fibrillation, cardioversion, catheter ablation, controlled trial, death, end point, left ventricular function, outcome parameter, quality of life, randomized trial, rate control, rhythm control, stroke, therapy, treatment
* Corresponding author. Tel: + 49 251 83 45185; fax: +49 251 83 47864. E-mail address: kirchhp{at}uni-muenster.de
Manuscript submitted 19 April 2007. Accepted after revision 7 August 2007.
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