EMBRACE (ambulatory ECG monitoring)
Trial question
What is the role of ambulatory ECG monitoring in patients with ischemic stroke or TIA, without known AF?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
45.0% female
55.0% male
N = 571
571 patients (257 female, 314 male).
Inclusion criteria: patients ≥ 55 years of age, without known AF, who had had a cryptogenic ischemic stroke or TIA within the previous 6 months (cause undetermined after standard tests, including 24-hour electrocardiography).
Key exclusion criteria: most likely etiologic diagnosis had already been determined (large-vessel or small-vessel disease or other known cause), exclusively retinal stroke or TIA event, past history of AF or atrial flutter, endocarditis, or pacemaker or ICD device.
Interventions
N=286 ambulatory ECG monitoring (with a 30-day event-triggered loop recorder).
N=285 time-limited ECG monitoring (with a 24-hour Holter recording).
Primary outcome
Rate of newly detected atrial fibrillation lasting ≥ 30 seconds within 90 days
16.1%
3.2%
16.1 %
12.1 %
8.1 %
4.0 %
0.0 %
Ambulatory ECG
monitoring
Time-limited ECG
monitoring
Significant
increase ▲
NNH = 7
Significant increase in the rate of newly detected AF lasting ≥ 30 seconds within 90 days (16.1% vs. 3.2%).
Secondary outcomes
Significant increase in detection of AF with duration ≥ 30 seconds (15.5% vs. 2.5%).
Significant increase in detection of AF with duration ≥ 2.5 min (9.9% vs. 2.5%).
Significant increase in the rate of prescription of oral anticoagulation therapy by 90 days (18.6% vs. 11.1%).
Conclusion
In patients ≥ 55 years of age, without known AF, who had had a cryptogenic ischemic stroke or TIA within the previous 6 months (cause undetermined after standard tests, including 24-hour electrocardiography), ambulatory ECG monitoring was superior to time-limited ECG monitoring with respect to the rate of newly detected AF lasting ≥ 30 seconds within 90 days.
Reference
Gladstone DJ, Spring M, Dorian P et al. Atrial fibrillation in patients with cryptogenic stroke. N Engl J Med. 2014 Jun 26;370(26):2467-77.
Open reference URL