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

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Alert Indications, Safety, and Warnings

  

Reveal LINQ ICM shown in a hand and surrounded by blue circles and dots

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 10x more AF in large- and small-vessel stroke patients when compared to site-specific usual care.*

21.7% (n = 46) in the Reveal LINQ ICM arm versus 2.4% (n = 5) in the control group.

  

Detection of AF at 36 months

Hazard ratio (95% CI) = 10.0 (4.0, 25.2), log-rank p-value < 0.001

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

  

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

  • At three years, 88% (n = 93) of AF episodes were asymptomatic in the ICM arm.
  • The majority of patients (67.4%, n = 31) with AF detected in the ICM arm had an episode lasting greater than one hour.
  • Most of the patients who had at least six minutes of AF burden (66%, n = 28) , had AF burden progression. The median (IQR) increase in AF burden from first to longest instance was 9.8 (4.0–15.3) hours.

Short-term monitoring is not enough.

  • Median time to detection of AF was 99 days at 12 months and 284 days at 36 months in the ICM arm.
  • At three years, 87% (n = 40) 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 surrounded by blue circles and dots

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Resources and downloads

*

Usual care: Patients in the control group received site-specific usual care, consisting of external cardiac monitoring such as 12-lead ECGs, Holter monitoring, telemetry, or event recorders.

Reference

1

Bernstein RA, et al. Atrial Fibrillation In Patients With Stroke Attributed to Large- or Small-Vessel Disease: 3-Year Results From the STROKE AF Randomized Clinical Trial. JAMA Neurol. 2023;80(12):1277–1283.