Appropriate outcome measures in trials evaluating treatment of atrial fibrillation
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BACKGROUND: Atrial fibrillation (AF) is a widespread disease that has only recently received the focused attention of arrhythmia specialists despite being the most frequently occurring significant cardiac arrhythmia. METHODS AND RESULTS: The wide variety of trial designs used to evaluate AF treatment is a reflection of the diverse outcomes associated with this condition. The best trials assess the impact of treatment on a clearly measured outcome that is of clinical relevance to patients. This review discusses the different designs of AF treatment trials and analyzes the utility of the various outcomes that can be assessed. CONCLUSIONS: A sensible goal of AF treatment is to reduce the frequency of recurrences and to prolong the time between them. The most appropriate trials focus on AF recurrences that are symptomatic and therefore relevant to the patient. We still do not know if there is value in AF prevention, beyond preventing symptoms. However, ongoing and future studies will show whether AF suppression reduces the longer-term risks of stroke or death and improves patient quality of life. Cost of care will increasingly be studied in future trials of AF management.
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