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. 2023 Dec 1;80(12):1277-1283.
doi: 10.1001/jamaneurol.2023.3931.

Atrial Fibrillation In Patients With Stroke Attributed to Large- or Small-Vessel Disease: 3-Year Results From the STROKE AF Randomized Clinical Trial

Richard A Bernstein  1 , Hooman Kamel  2   3 , Christopher B Granger  4 , Jonathan P Piccini  4 , Jeffrey M Katz  5 , Pramod P Sethi  6 , Erika Pouliot  7 , Noreli Franco  7 , Paul D Ziegler  8 , Lee H Schwamm  9 ; STROKE AF Investigators
Collaborators, Affiliations

Atrial Fibrillation In Patients With Stroke Attributed to Large- or Small-Vessel Disease: 3-Year Results From the STROKE AF Randomized Clinical Trial

Richard A Bernstein et al. JAMA Neurol. .

Abstract

Importance: The STROKE AF study found that in patients with prior ischemic stroke attributed to large-artery atherosclerotic disease (LAD) or small-vessel occlusive disease (SVD), 12% developed AF over 1 year when monitored with an insertable cardiac monitor (ICM). The occurrence over subsequent years is unknown.

Objectives: To compare the rates of AF detection through 3 years of follow-up between an ICM vs site-specific usual care in patients with prior ischemic stroke attributed to LAD or SVD.

Design, setting, and participants: This multicenter, randomized (1:1) clinical trial took place at 33 sites in the US with enrollment between April 2016 and July 2019 and 3-year follow-up through July 2022. Eligible patients were aged 60 years or older, or aged 50 to 59 years with at least 1 additional stroke risk factor and had an index ischemic stroke attributed to LAD or SVD within 10 days prior to ICM insertion. Of the 496 patients enrolled, 492 were randomized and 4 were excluded.

Interventions: ICM monitoring vs site-specific usual care.

Main outcomes and measures: The prespecified long-term outcome of the trial was AF detection through study follow-up (up to 3 years). AF was defined as an episode lasting more than 30 seconds, adjudicated by an expert committee.

Results: In total, 492 patients were randomized and included in the analyses (median [IQR] age, 66 [60-74] years; 307 men [62.4%] and 185 women [37.6%]), of whom 314 completed 3-year follow-up (63.8%). The incidence rate of AF at 3 years was 21.7% (46 patients) in the ICM group vs 2.4% (5 patients) in the control group (hazard ratio, 10.0; 95% CI, 4.0-25.2; P < .001).

Conclusions and relevance: Patients with ischemic stroke attributed to LAD or SVD face an increasing risk of AF over time and most of the AF occurrences are not reliably detected by standard medical monitoring methods. One year of negative monitoring should not reassure clinicians that patients who have experienced stroke will not develop AF over the next 2 years.

Trial registration: ClinicalTrials.gov Identifier: NCT02700945.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Bernstein reported nonfinancial support from Medtronic during the conduct of the study. Dr Kamel reported being a primary investigator for the ARCADIA trial (the National Institutes of Health/National Institute of Neurological Disorders and Stroke; U01NS095869), which received in-kind study drug from the Bristol Myers Squibb-Pfizer Alliance for Eliquis and ancillary study support from Roche Diagnostics; other funding from the National Institutes of Health (R01HL144541, R01NS123576, U01NS106513), participating in clinical trial steering/executive committees for Medtronic, Janssen, and Javelin Medical, participating in end point adjudication committees for AstraZeneca, Novo Nordisk, and Boehringer Ingelheim, and household ownership interests in TETMedical, Spectrum Plastics Group, and Burke Porter Group. Dr Granger reported personal fees from Medtronic during the conduct of the study, personal fees from Bristol Myers Squibb, Pfizer, Janssen, Boston Scientific, and Bayer and grants from Boehringer Ingelheim outside the submitted work. Dr Piccini reported grants from Boston Scientific, the American Heart Association, Abbott, Philips, iRhythm, and Bayer and consulting fees from Medtronic, Abbott, and Boston Scientific outside the submitted work. Dr Katz reported research support from Medtronic during the conduct of the study, personal fees from Medtronic and XCath, and grants from Siemens Healthineers outside the submitted work. Dr Sethi reported that Cone Health Medtronic supported the Stroke AF trial that the institution participated in during the conduct of the study; fees from Abbott, and consultant and speaker fees from Medtronic outside the submitted work. Dr Franco reported being an employee and shareholder of Medtronic. Dr Ziegler reported personal fees from Medtronic and being an employee and shareholder during the conduct of the study. Dr Schwamm reported grants and personal fees from Medtronic during the conduct of the study and personal fees from Life Image and Penumbra outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Patient Flow in STROKE AF Trial
ICM indicates insertable cardiac monitor.
Figure 2.
Figure 2.. Time to First Detection of Atrial Fibrillation (AF) Through 3 Years in the STROKE AF Trial
The median (IQR) observation time was 35.2 (18.6-36.4) months for the control group and 35.8 (29.5-36.9) months for the insertable cardiac monitor (ICM) group. HR indicates hazard ratio.
Figure 3.
Figure 3.. Time to Onset of 5 Thresholds of Daily Atrial Fibrillation (AF) Burden in Participants in STROKE AF Trial
Only patients from the insertable cardiac monitor (ICM) group were included in the analysis. At 36 months, the incidence of AF burden was 33.9%, 22.0%, 20.5%, 11.6%, and 1.9% for 6 or more minutes, 30 or more minutes, 1 or more hours, 6 or more hours, and 23 or more hours of AF in a day, respectively. The median (IQR) observation time was 35.8 (29.5-36.9) months for the ICM group.
Figure 4.
Figure 4.. Time to First Detection of Atrial Fibrillation (AF) Through 3 Years Among Participants With Congestive Heart Failure (CHF), Left Atrial Enlargement (LAE), Body Mass Index (BMI) More Than 30, and/or QRS Duration More Than 120 Milliseconds
Only patients from the insertable cardiac monitor group (ICM) group were included in the analysis. At 36 months, patients with CHF, LAE, BMI more than 30, and/or QRS more than 120 ms had an AF detection rate of 30.0% vs 8.6% in patients without any of those factors (hazard ratio [HR], 4.1; 95% CI, 1.7-9.7; P < .001). The median (IQR) observation time was 35.8 (29.5-36.9) months for the ICM group.
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References

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