Individualized Studies of Triggers of Paroxysmal Atrial Fibrillation - I-STOP-AFIB

Dec 22, 2023
Font Size
A
A
A
Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC; Kim A. Eagle, MD, MACC
Trial Sponsor:
Patient-Centered Outcomes Research Institute (PCORI)
Date Presented:
11/14/2021
Date Published:
12/13/2023
Date Updated:
12/22/2023
Original Posted Date:
11/14/2021
References

Contribution To Literature:

Highlighted text has been updated as of December 22, 2023.

The I-STOP-AFIB trial showed that individual trigger testing did not result in improved AF-related quality of life, although these patients did report less AF episodes in the next 4 weeks.

Description:

The goal of the trial was to assess the efficacy of trigger-based testing for atrial fibrillation (AF) versus routine tracking alone among patients with AF.

Study Design

Patients were enrolled via a mobile application. They were randomized in a 1:1 fashion to either trigger testing (n = 251) or tracking alone (n = 248). The top three triggers selected for testing were caffeine, alcohol, and reduced sleep.

  • Total number of enrollees: 499
  • Duration of follow-up: 10 weeks
  • Mean patient age: 58 years
  • Percentage female: 42%

Inclusion criteria:

  • Adult symptomatic AF patients
  • Owned a smartphone (either Android or iOS)
  • Interested in testing a presumed AF trigger they could readily introduce or withhold

Exclusion criteria:

  • Those who planned to change their AF management (e.g., with catheter ablation or medication changes) in the subsequent 6 months
  • Did not speak English
  • A history of an atrioventricular (AV) junction ablation

Other salient features/characteristics:

  • White race: 93%
  • Taking Vaughn-Williams class I or III drug at baseline: 25%
  • Baseline Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) for trigger-testing vs. monitoring only: 76.1 vs. 72.4

Principal Findings:

The primary outcome, change in AFEQT at week 10 compared with baseline, for trigger testing vs. monitoring only, was 1.7% vs. 0.5% (p = 0.17).

Secondary outcomes:

Those randomized to N-of-1 testing self-reported 40% fewer AF events in the 4 weeks following receiving the results of their N-of-1 study compared to monitoring-only participants during the same time frame (adjusted relative risk 0.60, 95% confidence interval [CI] 0.43-0.83, p < 0.0001). This was driven by those testing alcohol, dehydration, and exercise.

Preceding night sleep quality and AF: Data were available for 419 patients (15,755 days). Sleep quality was characterized as “Amazing,” “Good,” “Average,” “Bad,” or “Horrible.” Each one-category worst sleep quality on any given night was associated with higher odds of a self-reported AF episode the next day (odds ratio [OR] 1.15, 95% CI 1.10-1.20, p < 0.0001, after adjustment for the day of the week). On the other hand, no statistically significant associations between worsening sleep quality and mobile electrocardiogram (ECG)-confirmed AF events were observed (OR 1.04, 95% CI 0.95-1.13, p = 0.43). Poor sleep was also associated with longer self-reported AF episodes, with each progressive category of worsening sleep associated with 16 (95% CI 12-21, p < 0.001) more minutes of AF the next day.

Interpretation:

The results of this trial indicate that individual trigger testing did not result in improved AF-related quality of life, although these patients did report less AF episodes in the next 4 weeks. Alcohol exhibited consistent evidence of a near-term effect on self-reported AF episodes. Poor sleep quality the night before appeared to have an association with self-reported but not mobile ECG-confirmed AF events the next day. There was also an increase in prolonged AF episodes the subsequent day.

References:

Wong CX, Modrow MF, Sigona K, et al. Preceding Night Sleep Quality and Atrial Fibrillation Episodes in the I-STOP-AFIB Randomized Trial. JACC Clin Electrophysiol 2023;Nov 1:[Epublished].

Editorial Comment: Heinzinger CM, Chung MK, Mehra R. Salient Temporalities of Patient-Reported Sleep Disturbance and Burden of Atrial Fibrillation. JACC Clin Electrophysiol 2023;Dec 13:[Epublished].

Presented by Dr. Gregory M. Marcus at the American Heart Association Virtual Annual Scientific Sessions (AHA 2021), November 14, 2021.

Clinical Topics: Arrhythmias and Clinical EP, Prevention, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Sleep Apnea

Keywords: AHA Annual Scientific Sessions, AHA21, Arrhythmias, Cardiac, Atrial Fibrillation, Mobile Applications, Secondary Prevention, Sleep Deprivation, Smartphone


< Back to Listings