Avoiding triggers for Atrial Fibrillation has no effect on Quality of Life: results from I-STOP-A-FIB show

Key Points:

• Interest in this study was generated by patients with atrial fibrillation, who wanted to know if avoiding triggers really did create an impact.
• The design of the trial was a randomized n-of-1 study, in which patients were asked to avoid, then re-introduce, self-reported triggers for atrial fibrillation in their lives three times for a total of six weeks.
• Participants were given an instant remote ECG device (KardiaMobile) and asked to periodically test their rhythm. ECGs concerning for AF were automatically reviewed by a Cardiologist.
• At the end of ten weeks, there was no difference in overall quality of life in participants who chose to avoid AF triggers, despite fewer incidences of AF when resisting the trigger.

Atrial fibrillation trials are not in short supply these days. But despite the various studies assessing anticoagulation, left atrial appendage occlusion, and new catheter-based ablation strategies, one question is often overlooked: what do patients with atrial fibrillation want to know?  Dr. Gregory Marcus of University of California San Francisco, along with his team, sought to ask and answer this very question. With help from the PCORI (Patient Outcomes Research Institute), investigators learned that patients wanted to know whether avoidance of AF triggers would actually decrease the incidence of AF .

During a Late Breaking Session of the 2021 American Heart Association Scientific Sessions, Dr. Marcus presented the results of the Individualized Studies of Triggers of Paroxysmal Atrial Fibrillation Trial (I STOP AFib). The first step was to determine common triggers for AF, which in descending order, were found to be alcohol, caffeine, exercise, lack of sleep, dehydration, stress/anxiety, and others. Participants were then digitally recruited and consented to the study via a smartphone-app. All participants must have had a history of Atrial Fibrillation but were excluded if they had planned to change their AF management strategy in the coming 6 months, did not speak English, or had a history of AV junction ablation. Participants were sent a KardiaMobile (AliveCor, San Francisco) device to check for AF periodically at home.

At the start of the study, participants were asked to self-identify triggers for AF. They underwent a quality of life questionnaire from which a score, called the AFEQT score, was generated. They were then randomized to either the experimental arm, in which introduction and avoidance of said trigger ensued weekly for six weeks, or the control arm, in which data was monitored. Approximately 250 participants were enrolled into each arm of the study. Participants were middle-aged with a mean age of 58 years, and more than 90% were white. Comorbidities were few, with the most common being hypertension.

Participants randomized to the n-of-1 arm reported significantly fewer AF episodes at ten weeks, after changing their lifestyle. This was driven mostly by avoidance of alcohol, dehydration and exercise. Despite this, there were no differences in the overall quality of life (AFEQT) scores among these same participants. In a meta-analysis of the triggers most associated with AF, alcohol was the only trigger that was significantly associated with more AF. Caffeine, while the most self-reported trigger, was not associated with increased AF episodes throughout the study period.

“We learned a lot from conducting this study,” said Dr. Marcus, “the first being that a completely remote study is possible. Many lessons were learned, and we hope to inspire others to use this n-of-1 design, for which the smartphone is well-suited.”