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Medtronic Insertable Cardiac Monitor Detects Significantly Higher Rates of Atrial Fibrillation in 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.1 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 STROKE AF study evaluated 496 patients2, 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 (HR=7.41; p<0.001). 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.3
- 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; 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
"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
STROKE AF is a 1:1, randomized clinical trial, taking place at 33 clinical sites across the
"Medtronic has been an innovative leader in ICM technology for 20 years and has made significant contributions to understanding the clinical utility of using ICMs in the cryptogenic stroke population, including publication of the CRYSTAL-AF Study in 2014. Now with the STROKE AF study, we are able to deepen our understanding in this additional patient population," said
In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services of the highest quality that deliver clinical and economic value to healthcare consumers and providers around the world.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the
1 Virani SS, Alonso A, Benjamin EJ, Bittencourt MS, Callaway CW, Carson AP, et al. Heart disease and stroke statistics—2020 update: a report from the American Heart Associationexternal icon. Circulation. 2020;141(9):e139–e596.
2 A total of 496 patients were enrolled in the study and 492 were randomized
3 Based on data through 12 months
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