Cardiac Diagnostics and Monitoring

STROKE AF study

Reveal LINQ™ insertable cardiac monitor (ICM) is superior to site-specific usual care for atrial fibrillation (AF) detection in large- and small-vessel stroke patients.1

Download study overview
Alert Indications, Safety, and Warnings
#

Reveal LINQ™ ICM

Study design

General overview

  • Prospective, multisite, randomized clinical trial enrolling 496 patients at 33 centers in the United States
  • Randomization 1:1 to continuous monitoring arm with Reveal LINQ ICM or control arm following site-specific usual care for detection of cardiac arrhythmias
  • Follow-up: minimum 12 months, maximum 36 months

Inclusion criteria

  • Patients with an ischemic stroke attributed by the local investigator using standard diagnostic workup to small-vessel occlusion, or large-artery (cervical or intracranial) atherosclerosis within the past 10 days
  • Age ≥ 60 years, or 50–59 years with at least one additional risk factor for stroke: congestive heart failure, hypertension, diabetes, prior stroke (within 90 days of index stroke), or vascular disease (prior MI, peripheral artery disease, or aortic plaque)

Key exclusion criteria

  • Previous cryptogenic or cardioembolic stroke
  • Prior history of AF or atrial flutter
  • Permanent indication or contraindication for oral anticoagulation (OAC) therapy
  • Pacemaker, ICD, CRT, or an implantable hemodynamic monitor

End points

Primary objective

To determine whether long-term cardiac monitoring is superior to usual care for AF detection in patients with stroke attributed to large- or small-vessel disease through 12 months of follow-up.

Secondary objective

Compare incidence rates of AF between study arms through 36 months of follow-up.

Key findings

Reveal LINQ ICM detected 7.4x more AF in large- and small-vessel stroke patients when compared to site-specific usual care.

12.1% (n = 27) in the Reveal LINQ ICM arm versus 1.8% (n = 4) in the control group.

Detection of AF at 12 months

Results of the Stroke AF study of patients with AF detected with the Reveal LINQ ICM versus site-specific usual care

Hazard ratio, 8.8 (95% CI, 3.5–22.2)
p < 0.001 by log-rank test

Large- and small-vessel stroke patients are at high risk of having asymptomatic AF.

  • Approximately 1 in 8 patients in the ICM arm had AF detected.
  • At 12 months, 96.3% (n = 27) of first AF episodes were asymptomatic in the ICM arm.
  • The majority of patients (55.5%, n = 27) with AF detected in the ICM arm had an episode lasting greater than one hour.

Short-term monitoring is not enough.

  • Median time to detection of AF was 99 days in the ICM arm.
  • At 12 months, 78% (n = 27) of patients with AF would have been missed if only monitored for 30 days.

Inform your secondary stroke prevention strategies.

Use Reveal LINQ ICM to detect AF and inform your secondary stroke prevention strategy for large- and small-vessel stroke patients.

Learn more about Medtronic ICMs
Reveal LINQ ICM shown vertically

Related pages

Join our email list.

Receive updates and ongoing information.

Sign up now

Resources and downloads

Reference

1

Bernstein RA, Kamel H, Granger CB, et al. 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. JAMA. June 1, 2021;325(21):2169–2177.