JAMA
Effect of Long-term Continuous Cardiac Monitoring vs Usual Care on Detection of Atrial Fibrillation in Patients With Stroke Attributed to Large- or Small-Vessel Disease: The STROKE-AF Randomized Clinical Trial.
Abstract
Importance
Patients with ischemic stroke attributed to large- or small-vessel disease are not considered at high risk for atrial fibrillation (AF), and the AF incidence rate in this population is unknown.
Objectives
To determine whether long-term cardiac monitoring is more effective than usual care for AF detection in patients with stroke attributed to large- or small-vessel disease through 12 months of follow-up.
Design, setting, and participants
The STROKE-AF trial was a randomized (1:1), multicenter (33 sites in the US) clinical trial that enrolled 496 patients between April 2016 and July 2019, with primary end point follow-up through August 2020. Eligible patients were aged 60 years or older or aged 50 to 59 years with at least 1 additional stroke risk factor and had an index stroke attributed to large- or small-vessel disease within 10 days prior to insertable cardiac monitor (ICM) insertion.
Interventions
Patients randomized to the intervention group (n = 242) received ICM insertion within 10 days of the index stroke; patients in the control group (n = 250) received site-specific usual care consisting of external cardiac monitoring, such as 12-lead electrocardiograms, Holter monitoring, telemetry, or event recorders.
Main outcomes and measures
Incident AF lasting more than 30 seconds through 12 months.
Results
Among 492 patients who were randomized (mean [SD] age, 67.1 [9.4] years; 185 [37.6%] women), 417 (84.8%) completed 12 months of follow-up. The median (interquartile range) CHA2DS2-VASc (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, stroke or transient ischemic attack, vascular disease, age 65 to 74 years, sex category) score was 5 (4-6). AF detection at 12 months was significantly higher in the ICM group vs the control group (27 patients [12.1%] vs 4 patients [1.8%]; hazard ratio, 7.4 [95% CI, 2.6-21.3]; P < .001). Among the 221 patients in the ICM group who received an ICM, 4 (1.8%) had ICM procedure-related adverse events (1 site infection, 2 incision site hemorrhages, and 1 implant site pain).
Conclusions and relevance
Among patients with stroke attributed to large- or small-vessel disease, monitoring with an ICM compared with usual care detected significantly more AF over 12 months. However, further research is needed to understand whether identifying AF in these patients is of clinical importance.
Trial registration
ClinicalTrials.gov Identifier: NCT02700945.
Related Questions
Do you generally switch aspirin to another antiplatelet agent if a patient has a non-embolic ischemic stroke and isn't a candidate for DAPT?
I do tend to switch, mainly to impress the patient that I am trying hard to prevent another stroke, and not because there is clear evidence of one antiplatelet over another. Clopidogrel or ticagrelor would be candidates, or I might add cilostazol to aspirin, as this combination has little bleeding r...
Would it be prudent to complete long term cardiac monitoring (ie. 30 day) in a patient with a new typical appearing lacunar type thalamic infarct and history of hypertension?
This is a really good question. Until this year, I probably would have said that looking for AF in patients with a clear lacunar stroke is not needed. But the recent results from the STROKE AF trial (Bernstein et al., PMID 34061145.) suggest that long term monitors (implanted monitors, so a little d...