Medtronic has announced clinical trial results from the STROKE AF trial demonstrating the superiority of the Reveal LINQ insertable cardiac monitor (ICM) to detect abnormal heartbeats, otherwise known as atrial fibrillation (AF), in both large and small vessel stroke patients compared to standard of care. The findings were published in the June 2021 issue of the Journal of the American Medical Association (JAMA).
The STROKE AF study evaluated 496 patients, including 284 large vessel and 208 small vessel stroke patients. The findings demonstrated at 12 months, AF was detected in 12.1% (or one in eight) patients in the ICM arm compared to 1.8% in the standard of care arm (HR=7.41; p<0.001). Additionally, 78% of patients who had AF would have been missed if only monitored for 30 days.
Median time to detection of AF was 99 days, while rates of AF detection in the ICM arm were similar between patients with index strokes due to small vessel versus large vessel disease (12.6% compared to 11.7% respectively; p=0.74). At 12 months, 96.3% of first AF episodes were asymptomatic in ICM arm. The majority (55.5%) of patients with AF detected had an episode lasting more than one hour.
“STROKE AF showed that many patients with large vessel or small vessel stroke actually have AF, which is challenging to find using standard cardiac monitoring,” said Richard Bernstein, Northwestern Medicine Distinguished Physician in Vascular Neurology, Medical Director of Telehealth, and professor of Neurology, Northwestern University Feinberg School of Medicine, Chicago, USA. “Our job as neurologists includes identifying potential causes of future strokes to adequately protect our patients. AF is a risk that we can’t afford to miss, and without long-term monitoring, we are missing it.”
“The Stroke AF trial shows that long-term monitoring with an ICM resulted in significantly higher rates of AF detection compared to routine follow-up at both six months and one year after the patient’s index stroke,” said Lee Schwamm, vice president of Virtual Care and Digital Health, Mass General Brigham and C Miller Fisher chair in Vascular Neurology, Massachusetts General Hospital, Boston, USA. “Preventing recurrent stroke is challenging. I believe the findings from the STROKE AF study strongly suggest the need to re-examine the role of ICMs in secondary prevention, go beyond just the cryptogenic stroke patient, and embrace a broader conceptual framework that shifts the emphasis away from the cause of the index stroke and onto future stroke prevention.”
STROKE AF is a 1:1, randomised clinical trial, taking place at 33 clinical sites across the USA. Individuals 60 years and older with ischaemic stroke believed to be due to small vessel disease, large vessel cervical or intracranial atherosclerosis within the past 10 days, as well as individuals 50‒59 years older with stroke risk factors, were enrolled in the trial.
Patients randomised to the ICM arm were given a Medtronic Reveal LINQ insertable cardiac monitor. 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. Incidence rates of AF and recurrent stroke will be compared over a three-year study duration. The study is led by co-principal investigators, Bernstein and Schwamm.