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

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. 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.

Anti-thromboembolic strategies in atrial fibrillation

“…In coronary artery disease (CAD), antiplatelets are effective for reducing thrombotic complications [7]. Almost a third of AF-patients have a CAD, many develop an acute coronary syndrome (ACS) and undergo a percutaneous coronary intervention with stent implantation (PCI-SI).…”

Paroxysmal atrial fibrillation in young cryptogenic ischemic stroke: A 3-week ECG Holter monitoring study

“…All records from 3-week Loop Holter were processed in an external medical data transfer (MDT) center and evaluated by specially trained and blinded cardiologists. The presence of AF was defined as at least 1 period of > 30 seconds' duration of an absolute arrhythmia without detectable P waves and without a pattern more consistent with an alternative diagnosis 17,18 .…”

“…Although PAF has been defined as an episode of AF in duration > 30 s (ref. 17,18 ), we assume that shorter periods of AF (< 30 s) may be also relevant for detection of PAF. We agree with the suggestion that very short AF episodes may be associated with longer undetected AF episodes of sufficient duration, which result in thrombus formation and subsequent embolization 19 .…”

Approaches to Antithrombotic Therapy in Elderly Patients With Atrial Fibrillation

“…Согласно данным эпидемиологических ис-следований у лиц старше 80 лет она достигает 15-20% по сравнению с <0,1% у лиц моложе 40 лет [1,2]. Воз-можно, что реальная распространенность ФП еще выше, так как методы, применяемые в эпидемиологи-ческих исследованиях, недостаточно выявляют паро-ксизмальную форму ФП [3].…”

“…Согласно данным эпидемиологических ис-следований у лиц старше 80 лет она достигает 15-20% по сравнению с <0,1% у лиц моложе 40 лет [1,2]. Воз-можно, что реальная распространенность ФП еще выше, так как методы, применяемые в эпидемиологи-ческих исследованиях, недостаточно выявляют паро-ксизмальную форму ФП [3].По данным Фремингемского исследования рас-пространенность и частота ФП удваиваются каждое де-сятилетие после 50 лет [4]. Например, среди мужчин 75-79 лет распространенность ФП в 2 раза превыша-ет таковую среди мужчин в возрасте 65-69 лет и в 5 раз -в возрасте 55-59 лет [5].…”