Among patients with ischemic stroke attributed to
large artery atherosclerosis or small vessel occlusion, atrial
fibrillation (Afib) detection was increased more than seven-fold with an
implantable cardiac monitor (ICM) compared with standard care,
according to the STROKE AF trial.
After 1 year, the Reveal LINQ device picked up previously
unidentified Afib in 12.1% of patients, while usual care identified just
1.8% (HR 7.41, 95% CI 2.60-21.28, P<0.001), reported Lee H.
Schwamm, MD, of Massachusetts General Hospital in Boston, at the
American Stroke Association's virtual International Stroke Conference.
The findings of non-cardioembolic stroke of presumed known origin tracked almost exactly with those seen previously in the CRYSTAL AF trial, which established loop recorder use in cryptogenic strokes, said Schwamm.
"Forget about the first stroke," he told MedPage Today. "If
you find fibrillation, you should treat it. ... The reality is it sort
of doesn't matter what provoked it, other than direct manipulation of
the heart during heart surgery."
The real question, he said, is "should we start monitoring anybody
with a stroke or a sufficiently elevated CHADS VASC score to try to
detect undetected atrial fibrillation? Because it will change how we try
to prevent their stroke."
That makes this an important study, commented Louise McCullough, MD,
PhD, of the University of Texas Health Science Center at Houston.
"Every time we send somebody with a stroke, either with large vessel
atherosclerosis or small vessel disease, out on antiplatelets, we feel
like we're protecting them," she said. "But if they have occult Afib,
we're not."
Such
patients who initially appear to be in sinus rhythm typically haven't
been considered for extended rhythm monitoring, she noted.
"Even if you prevent a few cardioembolic strokes, that's a huge cost
savings for public health," she said. "We need to catch these people; we
need to have a very low bar and a high index of suspicion. This study
shows it needs to be even higher than we had previously thought."
Notably, median time to the first Afib episode in STROKE AF with the device was 99 days, and 78% would have been missed with 30-day monitoring, suggesting that a patch or Holter monitor wouldn't catch many of these cases.
The number needed to monitor to detect one case of Afib was just
eight in the ICM group, compared with 56 in the standard-of-care group.
The open-label trial included 496 patients with ischemic stroke
attributed to small vessel occlusion or cervical or intracranial artery
atherosclerosis treated at 33 U.S. centers. The population was an
elevated-risk group: patients who weren't at least 60 years old could be
enrolled as young as 50 only if they had a documented medical history
of at least one additional stroke risk factor (congestive heart failure,
hypertension, diabetes, second stroke more than 90 days prior, or
vascular disease).
Participants
were randomized within 10 days of the index stroke to the continuous
monitoring arm with the Reveal LINQ ICM or to whatever the site-specific
standard of care was for arrhythmia detection.
Afib had to last for at least 30 seconds (although the ICM only
picked up episodes of at least 2 minutes' duration) without detectable P
waves and be adjudicated by a clinical events committee.
For 55% of the patients with Afib, the duration of the longest
detected episode was an hour or more, which "would be considered by many
physicians appropriate to treat with anticoagulation for secondary
prevention," Schwamm told the virtual session attendees.
Indeed, 18 of the 27 Afib patients (66.7%) in the ICM group were
started on an oral anticoagulant compared with three of the four
patients identified with usual care (75%).
While the trial was underpowered for such clinical endpoints, there
were numerically fewer recurrent strokes in the ICM group at 12 months
(15 vs 23 patients in the usual care group).
"Our long-term results (36 months) and other ongoing studies may shed
light on the clinical significance of ICM-detected [Afib] for stroke
recurrence," Schwamm noted in the presentation.
Disclosures
The study was funded by Medtronic.
Schwamm
disclosed relationships with Medtronic, the Massachusetts Department of
Public Health, Penumbra, Diffusion Pharma, and the NINDS StrokeNet
Network.