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    • 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 more, 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 10 times 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

    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.

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