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Reveal LINQ Stroke AF Study

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

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 insertable cardiac monitor (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 significantly higher rates of 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.

Chart showing the detection of AF at 12 months with the Reveal LINQ insertable cardiac monitor versus standard of care

Large and Small Vessel Stroke Patients Are at High Risk of Having Asymptomatic AF 


1 in 8

Approximately 1 in 8 patients in the ICM arm had AF detected.

96.3% 

At 12 months, 96.3% (n = 27) of first AF episodes were asymptomatic in the ICM arm.

55.5%

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.

Additional Resources

Reference

1

Bernstein RA, Kamel H, Granger CB, et al. for the STROKE AF Investigators. 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. JAMA. Published online June 1, 2021. doi:10.1001/jama.2021.6470.