期刊
EUROPACE
卷 9, 期 11, 页码 1006-1023出版社
OXFORD UNIV PRESS
DOI: 10.1093/europace/eum191
关键词
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
Atrial fibrillation (AF), the most common atria[ 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.
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