Medtronic LINQ Insertable Cardiac Monitor detects 10 times more atrial fibrillation in ischemic stroke patients at three years compared to standard of care

Rhea-AI Summary

Medtronic (NYSE: MDT) released late-breaking results from the STROKE AF clinical study, highlighting the effectiveness of the Reveal LINQ™ insertable cardiac monitor (ICM) in detecting atrial fibrillation (AF) among ischemic stroke patients. At three years, AF detection was 21.7% in the ICM cohort compared to just 2.4% in standard care, showing a 10-fold increase. The study also revealed that 67% of patients with AF had episodes longer than one hour, with most being asymptomatic. The data underscore the necessity of long-term continuous cardiac monitoring in preventing subsequent strokes, particularly for high-risk groups.

Positive

• Significant increase in AF detection rate (21.7% vs. 2.4%) for ICM patients at three years.
• Demonstrated effectiveness of long-term monitoring to reduce the risk of subsequent strokes.
• 67% of patients with detected AF had clinically relevant episodes lasting over one hour.

Negative

• Only 70% of patients diagnosed with AF initiated anticoagulation therapy.

ISC23: Late-breaking results from STROKE AF study reinforce importance of long-term continuous cardiac monitoring in ischemic stroke patients

DUBLIN and DALLAS, Feb. 8, 2023 /PRNewswire/ -- Medtronic (NYSE: MDT) today announced late-breaking clinical data from the STROKE AF clinical study, which showed large and small vessel disease stroke patients had a 10-fold increase in AF detection with the Reveal LINQ™ insertable cardiac monitor (ICM) at three years compared to patients randomized to standard of care who did not receive continuous, long-term monitoring. The latest results, presented today as a late-breaking clinical trial at the American Stroke Association's International Stroke Conference (ISC) 2023, build on the STROKE AF study 12-month primary endpoint results published in JAMA in June 2021.

Over the first year, 12.5%* of patients in the ICM arm had AF detected compared to 1.8% of patients randomized to standard of care (consisting of external cardiac monitoring such as 12-lead ECGs, Holter monitoring, telemetry, or event recorders). At three years, the rate of AF detection increased to 21.7% of patients in the ICM arm compared to 2.4% in the control arm, resulting in a statistically significant hazard ratio of 10 (95% CI 4.0-25.2, p<0.001). The study also showed that 67% of patients (31 out of 46) in the ICM arm had clinically relevant AF episodes lasting more than one hour in duration, while 88% of AF episodes were asymptomatic.

"What these data show us is that we can't always rely on patients to tell us they are having palpitations or irregular heartbeats because the majority of AF detected in the study was asymptomatic," said Lee H. Schwamm, M.D., chief digital advisor, Mass General Brigham, C. Miller Fisher endowed chair in vascular neurology and professor of Neurology at Massachusetts General Hospital and Harvard Medical School. "Importantly, these outcomes underscore the criticality of long-term monitoring with ICMs in these patients as much of the AF detected would have been missed at 30 days. AF is a risk that we can't afford to miss for patients who have already suffered a stroke — the consequences could be devastating."

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 Patients with AF are at a five-fold increased risk for ischemic stroke.

While the STROKE AF study was not designed to detect or explain treatment differences, only 70% of patients with AF detected in the ICM arm were subsequently started on anticoagulation therapy—medication that helps prevent blood clots.

New Insights on Predictors of AF

The one-year outcomes from the STROKE AF study Predictors of AF analysis recently published in JAMA Neurology, add insights for predicting AF in patients with small or large vessel ischemic strokes. Patients with either congestive heart failure (CHF) and/or left atrial enlargement (LAE), for example, had an AF detection rate of 23.4% compared to 5% for patients with neither attribute, suggesting these patients are at greater risk of having AF.

"The STROKE AF Predictors analysis helps us better identify the patients who are most at-risk of unsuspected AF, which can inform stroke prevention strategies," said Schwamm. "Not every ischemic stroke patient may need an ICM, but these data suggest some patients are more likely to experience AF and should be monitored more closely."

The STROKE AF study is a prospective, randomized study of 496 large and small vessel stroke patients across 33 centers in the U.S. The Reveal LINQ ICM was cleared in the U.S. in 2014 and is available worldwide.

About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people across 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for all. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE:MDT), visit www.Medtronic.com and follow @Medtronic on Twitter and LinkedIn.

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. Circulation. 2020;141(9):e139–e596.
*vs. 12.1% previously reported at 12 months because one patient was missing data

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FAQ

What were the key findings of the STROKE AF study presented by Medtronic on February 8, 2023?

The STROKE AF study found that the Reveal LINQ ICM detected atrial fibrillation in 21.7% of ischemic stroke patients at three years, compared to 2.4% in standard care, indicating a significant improvement in detection rates.

How does the Reveal LINQ ICM improve atrial fibrillation detection in stroke patients?

The Reveal LINQ ICM enables long-term continuous cardiac monitoring, which has been shown to detect significantly more cases of atrial fibrillation, especially in asymptomatic patients.

What percentage of patients in the ICM arm had AF detected within one year?

In the first year, 12.5% of patients in the ICM arm had atrial fibrillation detected, compared to 1.8% in the control group.

What is the significance of the study results for patients who suffered a stroke?

The study emphasizes that many atrial fibrillation cases are asymptomatic and that long-term monitoring can prevent serious complications, potentially reducing the risk of further strokes.