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)

Abstract

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.

2012 HRS/EHRA/ECAS Expert Consensus Statement on Catheter and Surgical Ablation of Atrial Fibrillation: Recommendations for Patient Selection, Procedural Techniques, Patient Management and Follow-up, Definitions, Endpoints, and Research Trial Design

“…974 Nevertheless, early recurrences have been shown to predict arrhythmia recurrences late after catheter ablation of AF in some patients. 260,329,935,976,977,978 …”

“…63,974 AF-specific QOL measures, including the AF Effect on QOL (AFEQT) questionnaire, 1095 the Mayo AF Symptom Inventories, 63 and the Arrhythmia-Specific questionnaire in Tachycardia and Arrhythmia (ASTA), 1096 have been developed and are in the process of validation. A recent study reported that disease-specific assessments of QOL are superior to generic questionnaires.…”

Prevalence and characteristics of OSAFED syndrome in atrial fibrillation primary care patients

“…As the mean life-span increases, partially as a function of more effective interventional procedures and preventive measures, AF prevalence consequently increases (it is expected to double in the next 50 years) [3,4]. This phenomenon is especially evident in subjects at high CV risk [5] where screening for AF in patients with ischaemic stroke reveals arrhythmia in over 20% of cases [5,6].…”

Electronic Alert System for Improving Stroke Prevention Among Hospitalized Oral‐Anticoagulation‐Naïve Patients With Atrial Fibrillation: A Randomized Trial

“…One quarter of all 40‐year‐olds will develop this arrhythmia during the course of their lives 3. AF increases the risk of stroke by 5 times4 and doubles the risk of cardiovascular deaths and strokes after just 1 year 5…”