Medtronic 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.
Stroke impacts more than 795,000 people every year. More than 87% of strokes are ischemic strokes, which occur when vessels that allow blood to flow to the brain are blocked. AF is a major risk factor for ischemic stroke. In fact, there is a five-fold increase in ischemic stroke risk for AF patients. The findings were published in 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 Reveal LINQ ICM was superior to the standard of care for AF detection:
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. This equates to a greater than seven-fold increase in detecting AF in the ICM arm.
· 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.
· 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).
· 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.
"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 H. Schwamm, M.D., vice president of Virtual Care and Digital Health, Mass General Brigham and C. Miller Fisher chair in Vascular Neurology, Massachusetts General Hospital. "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."
