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Original Investigation
June 1, 2021

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

Author Affiliations
  • 1Davee Department of Neurology, Feinberg School of Medicine of Northwestern University, Chicago, Illinois
  • 2Department of Neurology, Weill Cornell Medicine, New York, New York
  • 3Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina
  • 4Cone Health Stroke Center, Greensboro, North Carolina
  • 5Guilford Neurologic Research Associates, Greensboro, North Carolina
  • 6Department of Neurology, North Shore University Hospital, Manhasset, New York
  • 7Department of Radiology, North Shore University Hospital, Manhasset, New York
  • 8Cardiac Rhythm and Heart Failure, Medtronic Inc, Minneapolis, Minnesota
  • 9Department of Neurology, Massachusetts General Hospital, Boston
JAMA. 2021;325(21):2169-2177. doi:10.1001/jama.2021.6470
Key Points

Question  Do insertable cardiac monitors (ICMs) detect more atrial fibrillation than usual care in patients with a recent ischemic stroke attributed to large-vessel or small-vessel disease?

Findings  This randomized clinical trial included 492 patients with stroke attributed to large- or small-vessel disease evaluated with an ICM or usual care. Over 12 months, atrial fibrillation was detected in 12.1% of patients in the ICM group vs 1.8% in the usual care group, a difference that was statistically significant.

Meaning  Among patients with stroke attributed to large- or small-vessel disease, AF was more commonly detected via ICM than usual care, but whether this is of clinical importance is not addressed by the study findings.


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