Outcome parameters for trials in atrial fibrillation: executive summary.
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.
Kirchhof
Paulus
P
Department of Cardiology and Angiology, University Hospital Münster, Albert-Schweitzer-Strasse 33, D-48149 Münster, Germany. kirchhp@uni-muenster.de
Auricchio
Angelo
A
Bax
Jeroen
J
Crijns
Harry
H
Camm
John
J
Diener
Hans-Christoph
HC
Goette
Andreas
A
Hindricks
Gerd
G
Hohnloser
Stefan
S
Kappenberger
Lukas
L
Kuck
Karl-Heinz
KH
Lip
Gregory Y H
GY
Olsson
Bertil
B
Meinertz
Thomas
T
Priori
Silvia
S
Ravens
Ursula
U
Steinbeck
Gerhard
G
Svernhage
Elisabeth
E
Tijssen
Jan
J
Vincent
Alphons
A
Breithardt
Günter
G
D000889:Anti-Arrhythmia Agents / Q000627:therapeutic use; D000925:Anticoagulants / Q000627:therapeutic use; D001281:Atrial Fibrillation / Q000191:economics / Q000401:mortality / Q000628:therapy*; D017115:Catheter Ablation / Q000379:methods; D003365:Costs and Cost Analysis; D004554:Electric Countershock / Q000379:methods; D004562:Electrocardiography; D006333:Heart Failure / Q000209:etiology; D006760:Hospitalization; D006801:Humans; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D020521:Stroke / Q000209:etiology; D016896:Treatment Outcome; D018487:Ventricular Dysfunction, Left / Q000209:etiology
D000889:Anti-Arrhythmia Agents; D000925:Anticoagulants