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Randomized Controlled Trial
. 2019 Jul 26;24(1):25.
doi: 10.1186/s40001-019-0383-8.

Early prolonged ambulatory cardiac monitoring in stroke (EPACS): an open-label randomised controlled trial

Amit Kaura  1   2 , Laszlo Sztriha  3 , Fong Kum Chan  3 , John Aeron-Thomas  3 , Nicholas Gall  3 , Bartlomiej Piechowski-Jozwiak  3 , James T Teo  3
Affiliations
Randomized Controlled Trial

Early prolonged ambulatory cardiac monitoring in stroke (EPACS): an open-label randomised controlled trial

Amit Kaura et al. Eur J Med Res. .

Abstract

Background: Cardioembolism in paroxysmal atrial fibrillation (PAF) is a preventable cause of transient ischaemic attack (TIA) or ischaemic stroke; however, due to its transient nature, a short-duration Holter monitor may miss a significant proportion of events.

Methods: We conducted an open-label randomised controlled trial of cardiac monitoring after a TIA or ischaemic stroke comparing a 14-day ECG monitoring patch (Zio® Patch, iRhythm Technologies) with short-duration Holter monitoring for the detection of PAF. The primary outcome was the detection of one or more episodes of ECG-documented PAF lasting at least 30 s within 90 days in each of the study arms. A budget impact analysis from the healthcare perspective was performed.

Results: From February 2016 through February 2017, 43 (76.8%) of the 56 patients assigned to the patch-based monitoring group and 47 (78.3%) of the 60 patients assigned to short-duration Holter monitoring group had successful monitor placement with 90 days of follow-up. Of the 26 protocol failures between the two groups, 23 (88.5%) were due to patient refusal for outpatient short-duration ECG monitor placement, whilst only 1 (3.8%) was due unsuccessful ZioPatch placement. The rate of detection of PAF at 90 days was 16.3% in the patch-based monitoring group (seven patients) compared to 2.1% in the short-duration Holter monitoring group (1 patient), with an odds ratio of 8.9 (95% CI 1.1-76.0; P = 0.026). An economic model demonstrated that implementation of the Zio Patch service would result in 10.8 more strokes avoided per year compared to current practice with Holter monitoring with an associated yearly saving in direct medical costs of £113,630, increasing to £162,491 over 5 years.

Conclusions: Early, prolonged, patch-based monitoring after an index stroke or TIA is superior to short-duration Holter monitoring in the detection of PAF and likely cost-effective for preventing recurrent strokes. Trial registration http://www.isrctn.com. Unique identifier: ISRCTN 50253271. Registered 21 January 2016.

Keywords: Atrial fibrillation; Cardiac monitoring; Electrocardiography; Ischaemic stroke; Medical devices.

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Conflict of interest statement

JT has received grants from Bristol-Meyers-Squibb; Goldman Sachs, Michael J Fox Foundation for Parkinson’s disease.

Figures

Fig. 1
Fig. 1
Flowchart of trial protocol. PAF paroxysmal atrial fibrillation
Fig. 2
Fig. 2
Flowchart of enrolment, randomisation and follow-up of study participants. ECG electrocardiography, PAF paroxysmal atrial fibrillation. *Patient refusal for outpatient short-duration ECG monitor placement
See this image and copyright information in PMC

References

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